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Drug-drug Interaction Study of TPOXX When Co-administered With Phosphate Binders

Primary Purpose

Smallpox

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
TPOXX
Sponsored by
SIGA Technologies
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Smallpox

Eligibility Criteria

18 Years - 50 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Each subject must meet all of the following criteria to be enrolled in this study:

    1. Subject is male or female 18 to 50 years of age, inclusive.
    2. Phosphorus levels within normal laboratory reference range.
    3. Women of childbearing potential have a negative human chorionic gonadotropin pregnancy test (serum) at the screening visit and a confirmatory negative serum pregnancy test on Day -1 of each period before receipt of study drug, and meet one of the following criteria:

      1. The subject or their partner has undergone surgical sterilization
      2. The subject is postmenopausal, defined as 12 consecutive months with no menses without an alternative medical cause and has a documented plasma follicle-stimulating hormone level >40 IU/mL

Exclusion Criteria:

Subjects meeting any of the following criteria will be excluded from the study:

  1. Subject is a female who is pregnant or breastfeeding or planning to become pregnant within 3 months after the last dose of study drug.
  2. Subject has a history of any clinically significant conditions including:

    • Asthma treated with oral systemic steroids within the past 6 months
    • Diabetes mellitus (type 1 or 2), with the exception of gestational diabetes
    • Hypertension that is poorly controlled (repeat readings >140 mm Hg systolic and/or >90 mm Hg diastolic)
    • Thyroidectomy or thyroid disease that required medication within the past 12 months
    • Serious angioedema episodes within the previous 3 years or requiring medication in the previous 2 years
    • Head trauma resulting in a diagnosis of traumatic brain injury other than concussion
    • Frequent episodes of headache.
  3. Subject has received treatment in another clinical study of an investigational drug (or medical device) within 30 days or 5 half-lives (whichever is longer) before the first dose of study drug.
  4. Subject has a history of relevant drug and/or food allergies (ie, allergy to TPOXX or excipients, or any significant food allergy that could preclude a standard diet in the study site).
  5. Subject has any condition possibly affecting drug absorption (eg, previous surgery on the gastrointestinal tract, including removal of parts of the stomach, bowel, liver, gallbladder, or pancreas, with the exception of appendectomy).
  6. Subject has evidence or history of clinically significant allergic (except for untreated, asymptomatic, seasonal allergies at time of the first dose of study drug), hematological, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, or neurological disease. Exceptions to these criteria (eg, stable, mild joint disease unassociated with collagen vascular disease) may be made following discussions with the medical monitor.
  7. Subject has a history of cardiac disease, symptomatic or asymptomatic arrhythmias, syncopal episodes, or risk factors for torsades de pointes (eg, heart failure, hypokalemia).
  8. Subject has a family history of sudden cardiac death not clearly due to acute myocardial infarction.
  9. Subject has a seizure disorder or history of seizures (does not include childhood febrile seizures) or a past history that increases seizure risks such as significant head injury that caused loss of consciousness or other changes in the subject's daily function, concussion, stroke, central nervous system infection or disease, or alcohol or drug abuse or family history of idiopathic seizures.
  10. Subject has a history of a peptic ulcer or significant gastrointestinal bleeding.
  11. Subject has a bleeding disorder diagnosed by a doctor (eg, factor deficiency, coagulopathy, or platelet disorder requiring special precautions) or significant bruising or bleeding difficulties with blood draws.
  12. Subject has a malignancy that is active, or treated malignancy for which there is not reasonable assurance of sustained cure, or malignancy that is likely to recur during the period of the study (subject should be in complete remission for at least 5 years).
  13. Subject has neutropenia or other blood dyscrasia determined to be clinically significant by the investigator.
  14. Subject has used any of the following prohibited medications from within 7 days (or 5 half lives, whichever is longer) before the first dose of study drug: antidiabetic medication; anticoagulants; anticonvulsants; substrates of the breast cancer resistance protein transporter including methotrexate, mitoxantrone, imatinib, irinotecan, lapatinib, rosuvastatin, sulfasalazine, and topotecan; substrates of CYP2C8 including repaglinide, paclitaxel, Montelukast, pioglitazone, rosiglitazone; and substrates of CYP2C19 including S-mephenytoin, clobazam, diazepam, rabeprazole, voriconazole, lansoprazole, and omeprazole. Medications not listed here that are known (or thought) to be CYP3A4 substrates may be allowed at the investigator's discretion, after consultation with the medical monitor, if administration poses little to no risk to the subject.
  15. Subject has a history of drug or alcohol abuse or dependency within the last year before screening.
  16. Subject has a current or recent (<30 days before screening) history of clinically significant bacterial, fungal, or mycobacterial infection.
  17. Subject has a current clinically significant viral infection.
  18. Subject has a known clinically significant chronic viral infection (eg, human T cell lymphotropic virus I or II).
  19. Subject has consumed grapefruit or grapefruit juice, Seville orange or Seville orange containing products (eg, marmalade), or caffeine- or xanthine containing products within 48 hours before the first dose of study drug.
  20. Subject has used any prescription (excluding hormonal birth control) or over the counter medication (including herbal or nutritional supplements) within 14 days before the first dose of study drug.
  21. Subject demonstrates long-term use (≥14 consecutive days) of glucocorticoids including oral or parenteral prednisone or equivalent (>20 mg total dose per day) or high-dose inhaled steroids (>800 mcg/day of beclomethasone dipropionate or equivalent) within the preceding 1 month (low-dose [≤800 mcg/day of beclomethasone dipropionate or equivalent] inhaled and topical steroids are allowed).
  22. Subject has donated >450 mL blood or blood components within 30 days before the first dose of study drug. The investigator should instruct subjects who participate in this study to not donate blood or blood components for 4 weeks after the completion of the study.
  23. Subject is a smoker or has used nicotine or nicotine containing products (eg, cigarettes, electronic vapor cigarettes, cigars, chewing tobacco, snuff, nicotine patches, or nicotine gum) within 6 months before the first dose of study drug.
  24. Subject has consumed pomegranate or pomegranate juice, pomelo fruits or pomelo juice, or alcohol within 72 hours before the first dose of study drug.
  25. Subject reports participation in strenuous activity or contact sports within 24 hours before the first dose of study drug.
  26. Subject has known hepatitis B or C infection or positive test for hepatitis B surface antigen, hepatitis C virus antibody, or human immunodeficiency virus type 1 or 2 antibodies at screening.
  27. Subject has a positive test result for amphetamines (including methamphetamines and ecstasy/methylenedioxymethamphetamine), barbiturates, benzodiazepines, cannabinoids (including tetrahydrocannabinol), cocaine metabolites, opiates (including heroin, codeine, and oxycodone), or alcohol at screening or check-in.
  28. Subject has any of the following laboratory test results within 28 days before the first dose of study drug:

    • Estimated serum creatinine clearance (Cockcroft-Gault) <70 mL/min
    • Creatinine in males >1.7 mg/dL and in females >1.4 mg/dL (1.3 times the upper laboratory reference range)
    • Hemoglobin ≤10% of the lower laboratory reference range
    • White blood cell count considered to be clinically significant by the investigator
    • Absolute neutrophil count <1000 cells/mm3
    • Platelets not within ±10% of laboratory reference range
    • Alanine aminotransferase >2.0 times above the upper laboratory reference range
    • Aspartate aminotransferase >2.0 times above the upper laboratory reference range
    • Alkaline phosphatase >20% above the upper laboratory reference range
    • Hemoglobin A1c ≥7.0%
    • Cholesterol ≥300 mg/dL and low density lipoprotein ≥190 mg/dL.
  29. Subject has a blood pressure considered to be clinically significant by the investigator. Blood pressure may be retested twice in the sitting position at 5 minute intervals.
  30. Subject has a resting heart rate of <40 beats per minute or >110 beats per minute at screening.
  31. Subject has an abnormal ECG at screening that is determined by the investigator to be clinically significant.
  32. Male subject has a QT interval corrected using Fridericia's formula (QTcF) >450 ms or female subject has a QTcF >470 ms at screening or Day -1.
  33. In the opinion of the investigator, the subject is not suitable for entry into the study.

Sites / Locations

  • PPD Phase I Clinic

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Other

Other

Other

Other

Arm Label

ABCDE

ACEBD

ADBEC

AEDCB

Arm Description

Single oral dose of TPOXX 600 mg Single oral dose of TPOXX 600 mg co-administered with single oral dose of 1600 mg sevelamer carbonate Single oral dose of TPOXX 600 mg co-administered with single oral dose of 500 mg sucroferric oxyhydroxide chewable tablet Single oral dose of TPOXX 600 mg co-administered with a single oral dose of 1334 mg calcium acetate Single oral dose of TPOXX 600 mg co-administered with a single oral dose of 500 mg lanthanum carbonate chewable tablet.

Single oral dose of TPOXX 600 mg Single oral dose of TPOXX 600 mg co-administered with single oral dose of 500 mg sucroferric oxyhydroxide chewable tablet Single oral dose of TPOXX 600 mg co-administered with a single oral dose of 500 mg lanthanum carbonate chewable tablet Single oral dose of TPOXX 600 mg co-administered with single oral dose of 1600 mg sevelamer carbonate Single oral dose of TPOXX 600 mg co-administered with a single oral dose of 1334 mg calcium acetate

Single oral dose of TPOXX 600 mg Single oral dose of TPOXX 600 mg co-administered with a single oral dose of 1334 mg calcium acetate Single oral dose of TPOXX 600 mg co-administered with single oral dose of 1600 mg sevelamer carbonate Single oral dose of TPOXX 600 mg co-administered with a single oral dose of 500 mg lanthanum carbonate chewable tablet Single oral dose of TPOXX 600 mg co-administered with single oral dose of 500 mg sucroferric oxyhydroxide chewable tablet

Single oral dose of TPOXX 600 mg Single oral dose of TPOXX 600 mg coadministered with a single oral dose of 500 mg lanthanum carbonate chewable tablet. Single oral dose of TPOXX 600 mg coadministered with a single oral dose of 1334 mg calcium acetate Single oral dose of TPOXX 600 mg coadministered with single oral dose of 500 mg sucroferric oxyhydroxide chewable tablet Single oral dose of TPOXX 600 mg coadministered with single oral dose of 1600 mg sevelamer carbonate

Outcomes

Primary Outcome Measures

Plasma PK Parameter for TPOXX
Area under the plasma concentration versus time curve (AUC)
Plasma PK Parameter for TPOXX
Area under the plasma concentration curve (AUC)
Plasma PK Parameter for TPOXX
Area under the plasma concentration curve (AUC)
Plasma PK Parameter for TPOXX
Area under the plasma concentration curve (AUC)
Plasma PK Parameter for TPOXX
Maximum drug concentration in plasma
Plasma PK Parameter for TPOXX
Time to maximum drug concentration in plasma

Secondary Outcome Measures

Safety of 600 mg oral TPOXX administered with 4 different phosphate binders
Monitoring and recording of adverse events
Safety of 600 mg oral TPOXX administered with 4 different phosphate binders
Laboratory testing: hematology, serum chemistry, pregnancy and urinalysis
Safety of 600 mg oral TPOXX administered with 4 different phosphate binders
Vital Signs measurements including: systolic and diastolic blood pressures, heart rate, respiratory rate, and body temperature
Safety of 600 mg oral TPOXX administered with 4 different phosphate binders
12 lead ECG results
Safety of 600 mg oral TPOXX administered with 4 different phosphate binders
Physical Examinations

Full Information

First Posted
May 11, 2020
Last Updated
July 17, 2023
Sponsor
SIGA Technologies
Collaborators
Biomedical Advanced Research and Development Authority, PPD
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1. Study Identification

Unique Protocol Identification Number
NCT04485039
Brief Title
Drug-drug Interaction Study of TPOXX When Co-administered With Phosphate Binders
Official Title
A Post-Marketing Open-Label, 5 Period Crossover, Drug-Drug Interaction Study of Orally Adminstered TPOXX When Co-administered With 4 Different Phosphate Binders in Healthy Subjects
Study Type
Interventional

2. Study Status

Record Verification Date
June 2022
Overall Recruitment Status
Completed
Study Start Date
June 8, 2022 (Actual)
Primary Completion Date
December 15, 2022 (Actual)
Study Completion Date
April 23, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
SIGA Technologies
Collaborators
Biomedical Advanced Research and Development Authority, PPD

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
An open-label, drug-drug interaction study with TPOXX and phosphate binders.
Detailed Description
A postmarketing open-label, 5 period crossover, drug-drug interaction study of orally administered TPOXX when coadministered with 4 different phosphate binders in healthy adult subjects.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Smallpox

7. Study Design

Primary Purpose
Other
Study Phase
Phase 4
Interventional Study Model
Crossover Assignment
Model Description
5 period crossover
Masking
None (Open Label)
Allocation
Randomized
Enrollment
44 (Actual)

8. Arms, Groups, and Interventions

Arm Title
ABCDE
Arm Type
Other
Arm Description
Single oral dose of TPOXX 600 mg Single oral dose of TPOXX 600 mg co-administered with single oral dose of 1600 mg sevelamer carbonate Single oral dose of TPOXX 600 mg co-administered with single oral dose of 500 mg sucroferric oxyhydroxide chewable tablet Single oral dose of TPOXX 600 mg co-administered with a single oral dose of 1334 mg calcium acetate Single oral dose of TPOXX 600 mg co-administered with a single oral dose of 500 mg lanthanum carbonate chewable tablet.
Arm Title
ACEBD
Arm Type
Other
Arm Description
Single oral dose of TPOXX 600 mg Single oral dose of TPOXX 600 mg co-administered with single oral dose of 500 mg sucroferric oxyhydroxide chewable tablet Single oral dose of TPOXX 600 mg co-administered with a single oral dose of 500 mg lanthanum carbonate chewable tablet Single oral dose of TPOXX 600 mg co-administered with single oral dose of 1600 mg sevelamer carbonate Single oral dose of TPOXX 600 mg co-administered with a single oral dose of 1334 mg calcium acetate
Arm Title
ADBEC
Arm Type
Other
Arm Description
Single oral dose of TPOXX 600 mg Single oral dose of TPOXX 600 mg co-administered with a single oral dose of 1334 mg calcium acetate Single oral dose of TPOXX 600 mg co-administered with single oral dose of 1600 mg sevelamer carbonate Single oral dose of TPOXX 600 mg co-administered with a single oral dose of 500 mg lanthanum carbonate chewable tablet Single oral dose of TPOXX 600 mg co-administered with single oral dose of 500 mg sucroferric oxyhydroxide chewable tablet
Arm Title
AEDCB
Arm Type
Other
Arm Description
Single oral dose of TPOXX 600 mg Single oral dose of TPOXX 600 mg coadministered with a single oral dose of 500 mg lanthanum carbonate chewable tablet. Single oral dose of TPOXX 600 mg coadministered with a single oral dose of 1334 mg calcium acetate Single oral dose of TPOXX 600 mg coadministered with single oral dose of 500 mg sucroferric oxyhydroxide chewable tablet Single oral dose of TPOXX 600 mg coadministered with single oral dose of 1600 mg sevelamer carbonate
Intervention Type
Drug
Intervention Name(s)
TPOXX
Other Intervention Name(s)
sevelamer carbonate oral tablet, sucroferric oxyhydroxide chewable tablet, calcium acetate oral tablet, lanthanum carbonate chewable tablet, TPOXX oral tablet
Intervention Description
oral antiviral and phosphate binders
Primary Outcome Measure Information:
Title
Plasma PK Parameter for TPOXX
Description
Area under the plasma concentration versus time curve (AUC)
Time Frame
Measured from time 0 to 24 hours
Title
Plasma PK Parameter for TPOXX
Description
Area under the plasma concentration curve (AUC)
Time Frame
Measured from time 0 to 48 hours
Title
Plasma PK Parameter for TPOXX
Description
Area under the plasma concentration curve (AUC)
Time Frame
Measured from time 0 to infinity
Title
Plasma PK Parameter for TPOXX
Description
Area under the plasma concentration curve (AUC)
Time Frame
Measured from time 0 to the last quantifiable concentration
Title
Plasma PK Parameter for TPOXX
Description
Maximum drug concentration in plasma
Time Frame
31 days
Title
Plasma PK Parameter for TPOXX
Description
Time to maximum drug concentration in plasma
Time Frame
31 days
Secondary Outcome Measure Information:
Title
Safety of 600 mg oral TPOXX administered with 4 different phosphate binders
Description
Monitoring and recording of adverse events
Time Frame
63 days
Title
Safety of 600 mg oral TPOXX administered with 4 different phosphate binders
Description
Laboratory testing: hematology, serum chemistry, pregnancy and urinalysis
Time Frame
38 days
Title
Safety of 600 mg oral TPOXX administered with 4 different phosphate binders
Description
Vital Signs measurements including: systolic and diastolic blood pressures, heart rate, respiratory rate, and body temperature
Time Frame
38 days
Title
Safety of 600 mg oral TPOXX administered with 4 different phosphate binders
Description
12 lead ECG results
Time Frame
38 days
Title
Safety of 600 mg oral TPOXX administered with 4 different phosphate binders
Description
Physical Examinations
Time Frame
38 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Each subject must meet all of the following criteria to be enrolled in this study: Subject is male or female 18 to 50 years of age, inclusive. Phosphorus levels within normal laboratory reference range. Women of childbearing potential have a negative human chorionic gonadotropin pregnancy test (serum) at the screening visit and a confirmatory negative serum pregnancy test on Day -1 of each period before receipt of study drug, and meet one of the following criteria: The subject or their partner has undergone surgical sterilization The subject is postmenopausal, defined as 12 consecutive months with no menses without an alternative medical cause and has a documented plasma follicle-stimulating hormone level >40 IU/mL Exclusion Criteria: Subjects meeting any of the following criteria will be excluded from the study: Subject is a female who is pregnant or breastfeeding or planning to become pregnant within 3 months after the last dose of study drug. Subject has a history of any clinically significant conditions including: Asthma treated with oral systemic steroids within the past 6 months Diabetes mellitus (type 1 or 2), with the exception of gestational diabetes Hypertension that is poorly controlled (repeat readings >140 mm Hg systolic and/or >90 mm Hg diastolic) Thyroidectomy or thyroid disease that required medication within the past 12 months Serious angioedema episodes within the previous 3 years or requiring medication in the previous 2 years Head trauma resulting in a diagnosis of traumatic brain injury other than concussion Frequent episodes of headache. Subject has received treatment in another clinical study of an investigational drug (or medical device) within 30 days or 5 half-lives (whichever is longer) before the first dose of study drug. Subject has a history of relevant drug and/or food allergies (ie, allergy to TPOXX or excipients, or any significant food allergy that could preclude a standard diet in the study site). Subject has any condition possibly affecting drug absorption (eg, previous surgery on the gastrointestinal tract, including removal of parts of the stomach, bowel, liver, gallbladder, or pancreas, with the exception of appendectomy). Subject has evidence or history of clinically significant allergic (except for untreated, asymptomatic, seasonal allergies at time of the first dose of study drug), hematological, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, or neurological disease. Exceptions to these criteria (eg, stable, mild joint disease unassociated with collagen vascular disease) may be made following discussions with the medical monitor. Subject has a history of cardiac disease, symptomatic or asymptomatic arrhythmias, syncopal episodes, or risk factors for torsades de pointes (eg, heart failure, hypokalemia). Subject has a family history of sudden cardiac death not clearly due to acute myocardial infarction. Subject has a seizure disorder or history of seizures (does not include childhood febrile seizures) or a past history that increases seizure risks such as significant head injury that caused loss of consciousness or other changes in the subject's daily function, concussion, stroke, central nervous system infection or disease, or alcohol or drug abuse or family history of idiopathic seizures. Subject has a history of a peptic ulcer or significant gastrointestinal bleeding. Subject has a bleeding disorder diagnosed by a doctor (eg, factor deficiency, coagulopathy, or platelet disorder requiring special precautions) or significant bruising or bleeding difficulties with blood draws. Subject has a malignancy that is active, or treated malignancy for which there is not reasonable assurance of sustained cure, or malignancy that is likely to recur during the period of the study (subject should be in complete remission for at least 5 years). Subject has neutropenia or other blood dyscrasia determined to be clinically significant by the investigator. Subject has used any of the following prohibited medications from within 7 days (or 5 half lives, whichever is longer) before the first dose of study drug: antidiabetic medication; anticoagulants; anticonvulsants; substrates of the breast cancer resistance protein transporter including methotrexate, mitoxantrone, imatinib, irinotecan, lapatinib, rosuvastatin, sulfasalazine, and topotecan; substrates of CYP2C8 including repaglinide, paclitaxel, Montelukast, pioglitazone, rosiglitazone; and substrates of CYP2C19 including S-mephenytoin, clobazam, diazepam, rabeprazole, voriconazole, lansoprazole, and omeprazole. Medications not listed here that are known (or thought) to be CYP3A4 substrates may be allowed at the investigator's discretion, after consultation with the medical monitor, if administration poses little to no risk to the subject. Subject has a history of drug or alcohol abuse or dependency within the last year before screening. Subject has a current or recent (<30 days before screening) history of clinically significant bacterial, fungal, or mycobacterial infection. Subject has a current clinically significant viral infection. Subject has a known clinically significant chronic viral infection (eg, human T cell lymphotropic virus I or II). Subject has consumed grapefruit or grapefruit juice, Seville orange or Seville orange containing products (eg, marmalade), or caffeine- or xanthine containing products within 48 hours before the first dose of study drug. Subject has used any prescription (excluding hormonal birth control) or over the counter medication (including herbal or nutritional supplements) within 14 days before the first dose of study drug. Subject demonstrates long-term use (≥14 consecutive days) of glucocorticoids including oral or parenteral prednisone or equivalent (>20 mg total dose per day) or high-dose inhaled steroids (>800 mcg/day of beclomethasone dipropionate or equivalent) within the preceding 1 month (low-dose [≤800 mcg/day of beclomethasone dipropionate or equivalent] inhaled and topical steroids are allowed). Subject has donated >450 mL blood or blood components within 30 days before the first dose of study drug. The investigator should instruct subjects who participate in this study to not donate blood or blood components for 4 weeks after the completion of the study. Subject is a smoker or has used nicotine or nicotine containing products (eg, cigarettes, electronic vapor cigarettes, cigars, chewing tobacco, snuff, nicotine patches, or nicotine gum) within 6 months before the first dose of study drug. Subject has consumed pomegranate or pomegranate juice, pomelo fruits or pomelo juice, or alcohol within 72 hours before the first dose of study drug. Subject reports participation in strenuous activity or contact sports within 24 hours before the first dose of study drug. Subject has known hepatitis B or C infection or positive test for hepatitis B surface antigen, hepatitis C virus antibody, or human immunodeficiency virus type 1 or 2 antibodies at screening. Subject has a positive test result for amphetamines (including methamphetamines and ecstasy/methylenedioxymethamphetamine), barbiturates, benzodiazepines, cannabinoids (including tetrahydrocannabinol), cocaine metabolites, opiates (including heroin, codeine, and oxycodone), or alcohol at screening or check-in. Subject has any of the following laboratory test results within 28 days before the first dose of study drug: Estimated serum creatinine clearance (Cockcroft-Gault) <70 mL/min Creatinine in males >1.7 mg/dL and in females >1.4 mg/dL (1.3 times the upper laboratory reference range) Hemoglobin ≤10% of the lower laboratory reference range White blood cell count considered to be clinically significant by the investigator Absolute neutrophil count <1000 cells/mm3 Platelets not within ±10% of laboratory reference range Alanine aminotransferase >2.0 times above the upper laboratory reference range Aspartate aminotransferase >2.0 times above the upper laboratory reference range Alkaline phosphatase >20% above the upper laboratory reference range Hemoglobin A1c ≥7.0% Cholesterol ≥300 mg/dL and low density lipoprotein ≥190 mg/dL. Subject has a blood pressure considered to be clinically significant by the investigator. Blood pressure may be retested twice in the sitting position at 5 minute intervals. Subject has a resting heart rate of <40 beats per minute or >110 beats per minute at screening. Subject has an abnormal ECG at screening that is determined by the investigator to be clinically significant. Male subject has a QT interval corrected using Fridericia's formula (QTcF) >450 ms or female subject has a QTcF >470 ms at screening or Day -1. In the opinion of the investigator, the subject is not suitable for entry into the study.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dennis Hruby, PhD
Organizational Affiliation
SIGA Technologies Chief Scientific Officer
Official's Role
Study Director
Facility Information:
Facility Name
PPD Phase I Clinic
City
Austin
State/Province
Texas
ZIP/Postal Code
78744
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Drug-drug Interaction Study of TPOXX When Co-administered With Phosphate Binders

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