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A Study to Compare the Blood Levels of Albaconazole in Healthy Subjects Who Have Received a Single Dose of 400 mg Albaconazole as a Tablet Versus Albaconazole as a Capsule

Primary Purpose

Onychomycosis

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Albaconazole tablet 400mg
Albaconazole 100mg capsules, then albaconazole 400mg tablet
Sponsored by
Stiefel, a GSK Company
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Onychomycosis focused on measuring Healthy Volunteers

Eligibility Criteria

18 Years - 45 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Capable of understanding and willing to provide signed and dated written voluntary informed consent (and any local or national authorization requirements) before any protocol specific procedures are performed.
  • Male or female aged from 18 to 45 years at time of consent and at time of first dose.
  • A body mass index (BMI) between 18.5 and 30 kg/m2.
  • Able to complete the study and to comply with study instructions.
  • Free of clinically significant disease as determined by history, physical examination, and laboratory testing.
  • The subject is a non-smoker or ex-smoker. If a subject is an ex smoker, he/she must not have used nicotine for at least 6 months before first dose.
  • The screening and baseline laboratory parameters must be within normal ranges unless agreed as not clinically relevant by the principal investigator and the sponsor. Alanine aminotransferase (ALT), aspartate aminotransferase (AST), alkaline phosphatase, and total bilirubin values should be lower than 1.5 times the upper normal limit at screening.
  • The subject will have negative results for the following tests at screening:

    • Hepatitis B surface antigen (HBsAg)
    • Hepatitis B core antibodies (HBcAc)
    • Anti-hepatitis C virus (Anti-HCV)
    • Human immunodeficiency virus (HIV) antibody test
    • Urine drug screen
  • Sexually active females of childbearing potential participating in the study must agree to use a medically acceptable method of contraception while receiving protocol-assigned product and until 30 days following the last dose of the study product. A woman of childbearing potential is defined as one who is biologically capable of becoming pregnant; including perimenopausal women who are less than 2 years from their last menses. Acceptable contraceptive methods include the following:

    • Hormonal contraception, including oral, injectable, or implantable methods started at least 2 months prior to screening. If hormonal contraception was started less than 2 months prior to screening, then a form of nonhormonal contraception should be added until the third continuous month of hormonal contraception has been completed.
    • Two forms of reliable nonhormonal contraception, to include the use of either an intrauterine device plus a reliable barrier method or 2 reliable barrier methods. Reliable barrier methods include condoms or diaphragms. A cervical cap is also a reliable barrier method, provided that the female subject has never given birth naturally. The combined use of a condom and spermicide constitute 2 forms of acceptable nonhormonal contraception, provided that they are both used properly. The use of spermicide alone and the improper use of condoms are inferior methods of contraception. Subjects with surgical sterilization, including tubal sterilization or partner's vasectomy, must use a form of nonhormonal contraception. A barrier method or sterilization plus spermatocide are acceptable.
  • Women who are not currently sexually active must agree to use a medically accepted method of contraception should they become sexually active while participating in the study. Male subjects and/or their partners must use a medically acceptable form of contraception

Exclusion Criteria:

  • Female who is pregnant (positive pregnancy test), trying to become pregnant, or breast feeding.
  • Received any investigational drug within 30 days of study day 1 or who are scheduled to receive an investigational drug other than the study product during the study.
  • Used prescription drug therapy, over the counter (nonprescription) medications, recreational drugs, or herbal products within 30 days of dosing, unless agreed as not clinically relevant by the principal investigator and sponsor.
  • Participated in a previous study of the same study product.
  • Currently using any medication that, in the opinion of the investigator, may affect the evaluation of the study product or place the subject at undue risk.
  • Currently suffering from any disease or condition that, in the opinion of the investigator, may affect the evaluation of the study product or place the subject at undue risk.
  • Has a history of anemia, iron deficiency, or iron depletion.
  • Has a history of any condition possibly affecting absorption of drug (eg, peptic ulcer disease, gastrectomy, intestinal malabsorption).
  • Considered immunocompromised.
  • History of drug, prescription medicine, or alcohol abuse within the past 2 years.
  • Has a history of known or suspected intolerance to any of the ingredients of the study products.
  • Has known drug allergies.
  • Has a clinically relevant history or presence of respiratory, gastrointestinal, renal, hepatic, hematological, lymphatic, neurological, cardiovascular, psychiatric, musculoskeletal, genitourinary, immunological, dermatological, or connective tissue diseases or disorders.
  • Intends to donate blood or blood components while receiving the study product or for the duration of the pharmacokinetic sampling period.
  • Has donated blood or has had significant blood loss (≥250 mL) within 30 days before dosing or has donated plasma within 7 days before dosing.
  • Has QT interval corrected for heart rate (Fridericia's correction formula) (QTcF) >450 ms or any ECG abnormality except for the following:

    • Mild sinus bradycardia in younger, athletic subjects (heart rate down to 46 beats per minute allowed).
    • Mild sinus arrhythmia.
    • Mild first degree atrioventricular (A-V) block (P-R interval <0.23 sec).
    • Mild right or left axis deviation.
    • Incomplete right bundle branch block.
    • Isolated left anterior fascicular block (left anterior hemiblock) in younger, athletic subjects.
    • Early repolarization.
    • Uncorrected QT interval or QT interval corrected for heart rate with Bazett's correction formula (QTcB) exceeding 450 ms, with a QTcF ≤450 ms.
  • Considered unable or unlikely to attend the necessary visits.
  • Employees of investigator/ clinical research organization or Stiefel involved in the study, or an immediate family member (partner, offspring, parents, siblings, or sibling's offspring) of an employee involved in the study.

Sites / Locations

  • Buffalo Clinical Research Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

1

2

Arm Description

Subjects randomized to study product sequence 1 will receive the single albaconazole 400-mg tablet during the first dosing period and the four 100-mg albaconazole capsules during the second dosing period.

Subjects randomized to study product sequence 2 will receive the four 100-mg albaconazole capsules during the first dosing period and the single albaconazole 400-mg tablet during the second dosing period.

Outcomes

Primary Outcome Measures

Bioavailability of albaconazole

Secondary Outcome Measures

Safety and tolerability of a single oral dose of 400mg albaconazole tablet

Full Information

First Posted
December 23, 2009
Last Updated
June 21, 2017
Sponsor
Stiefel, a GSK Company
Collaborators
GlaxoSmithKline
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1. Study Identification

Unique Protocol Identification Number
NCT01039883
Brief Title
A Study to Compare the Blood Levels of Albaconazole in Healthy Subjects Who Have Received a Single Dose of 400 mg Albaconazole as a Tablet Versus Albaconazole as a Capsule
Official Title
A Phase 1, Randomized, Open-Label, Crossover Safety and Pharmacokinetic Study of 400 mg Albaconazole as a Tablet Formulation Versus a Capsule Formulation in Healthy Subjects
Study Type
Interventional

2. Study Status

Record Verification Date
June 2017
Overall Recruitment Status
Completed
Study Start Date
November 23, 2009 (Actual)
Primary Completion Date
January 20, 2010 (Actual)
Study Completion Date
January 20, 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Stiefel, a GSK Company
Collaborators
GlaxoSmithKline

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this study is to determine whether albaconazole tablets and albaconazole capsules (single 400mg dose) act in the body in the same way over a period of time.
Detailed Description
The aim of this study is to compare the bioavailability of the formulation used in earlier clinical studies (albaconazole capsules) with the formulation intended for use in further development (albaconazole tablets). The study is also designed to assess the safety and tolerability of a single oral dose of albaconazole tablets (400 mg), and assess the bioequivalence of albaconazole tablets with albaconazole capsules.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Onychomycosis
Keywords
Healthy Volunteers

7. Study Design

Primary Purpose
Basic Science
Study Phase
Phase 1
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
Subjects randomized to study product sequence 1 will receive the single albaconazole 400-mg tablet during the first dosing period and the four 100-mg albaconazole capsules during the second dosing period.
Arm Title
2
Arm Type
Experimental
Arm Description
Subjects randomized to study product sequence 2 will receive the four 100-mg albaconazole capsules during the first dosing period and the single albaconazole 400-mg tablet during the second dosing period.
Intervention Type
Drug
Intervention Name(s)
Albaconazole tablet 400mg
Other Intervention Name(s)
Albaconazole
Intervention Description
Albaconazole tablet 400mg single dose, then four albaconazole capsule 100mg single dose
Intervention Type
Drug
Intervention Name(s)
Albaconazole 100mg capsules, then albaconazole 400mg tablet
Other Intervention Name(s)
Albaconazole
Intervention Description
Four albaconazole capsule 100mg single dose, then albaconazole tablet 400mg single dose
Primary Outcome Measure Information:
Title
Bioavailability of albaconazole
Time Frame
Blood samples taken predose and at 30 minutes, and 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12 (day 1 time points), 18 (day 2), 24 (day 2), hours post-dose and once a day on days 3-16
Secondary Outcome Measure Information:
Title
Safety and tolerability of a single oral dose of 400mg albaconazole tablet
Time Frame
ECGs and lab tests at screening, pre-dose, and 3 hours, and 16 days post-dose. Physical examination at screening, pre-dose and 16 days post-dose. Assessment of adverse events from consent to 16 days post-dose (second dosing period).

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Capable of understanding and willing to provide signed and dated written voluntary informed consent (and any local or national authorization requirements) before any protocol specific procedures are performed. Male or female aged from 18 to 45 years at time of consent and at time of first dose. A body mass index (BMI) between 18.5 and 30 kg/m2. Able to complete the study and to comply with study instructions. Free of clinically significant disease as determined by history, physical examination, and laboratory testing. The subject is a non-smoker or ex-smoker. If a subject is an ex smoker, he/she must not have used nicotine for at least 6 months before first dose. The screening and baseline laboratory parameters must be within normal ranges unless agreed as not clinically relevant by the principal investigator and the sponsor. Alanine aminotransferase (ALT), aspartate aminotransferase (AST), alkaline phosphatase, and total bilirubin values should be lower than 1.5 times the upper normal limit at screening. The subject will have negative results for the following tests at screening: Hepatitis B surface antigen (HBsAg) Hepatitis B core antibodies (HBcAc) Anti-hepatitis C virus (Anti-HCV) Human immunodeficiency virus (HIV) antibody test Urine drug screen Sexually active females of childbearing potential participating in the study must agree to use a medically acceptable method of contraception while receiving protocol-assigned product and until 30 days following the last dose of the study product. A woman of childbearing potential is defined as one who is biologically capable of becoming pregnant; including perimenopausal women who are less than 2 years from their last menses. Acceptable contraceptive methods include the following: Hormonal contraception, including oral, injectable, or implantable methods started at least 2 months prior to screening. If hormonal contraception was started less than 2 months prior to screening, then a form of nonhormonal contraception should be added until the third continuous month of hormonal contraception has been completed. Two forms of reliable nonhormonal contraception, to include the use of either an intrauterine device plus a reliable barrier method or 2 reliable barrier methods. Reliable barrier methods include condoms or diaphragms. A cervical cap is also a reliable barrier method, provided that the female subject has never given birth naturally. The combined use of a condom and spermicide constitute 2 forms of acceptable nonhormonal contraception, provided that they are both used properly. The use of spermicide alone and the improper use of condoms are inferior methods of contraception. Subjects with surgical sterilization, including tubal sterilization or partner's vasectomy, must use a form of nonhormonal contraception. A barrier method or sterilization plus spermatocide are acceptable. Women who are not currently sexually active must agree to use a medically accepted method of contraception should they become sexually active while participating in the study. Male subjects and/or their partners must use a medically acceptable form of contraception Exclusion Criteria: Female who is pregnant (positive pregnancy test), trying to become pregnant, or breast feeding. Received any investigational drug within 30 days of study day 1 or who are scheduled to receive an investigational drug other than the study product during the study. Used prescription drug therapy, over the counter (nonprescription) medications, recreational drugs, or herbal products within 30 days of dosing, unless agreed as not clinically relevant by the principal investigator and sponsor. Participated in a previous study of the same study product. Currently using any medication that, in the opinion of the investigator, may affect the evaluation of the study product or place the subject at undue risk. Currently suffering from any disease or condition that, in the opinion of the investigator, may affect the evaluation of the study product or place the subject at undue risk. Has a history of anemia, iron deficiency, or iron depletion. Has a history of any condition possibly affecting absorption of drug (eg, peptic ulcer disease, gastrectomy, intestinal malabsorption). Considered immunocompromised. History of drug, prescription medicine, or alcohol abuse within the past 2 years. Has a history of known or suspected intolerance to any of the ingredients of the study products. Has known drug allergies. Has a clinically relevant history or presence of respiratory, gastrointestinal, renal, hepatic, hematological, lymphatic, neurological, cardiovascular, psychiatric, musculoskeletal, genitourinary, immunological, dermatological, or connective tissue diseases or disorders. Intends to donate blood or blood components while receiving the study product or for the duration of the pharmacokinetic sampling period. Has donated blood or has had significant blood loss (≥250 mL) within 30 days before dosing or has donated plasma within 7 days before dosing. Has QT interval corrected for heart rate (Fridericia's correction formula) (QTcF) >450 ms or any ECG abnormality except for the following: Mild sinus bradycardia in younger, athletic subjects (heart rate down to 46 beats per minute allowed). Mild sinus arrhythmia. Mild first degree atrioventricular (A-V) block (P-R interval <0.23 sec). Mild right or left axis deviation. Incomplete right bundle branch block. Isolated left anterior fascicular block (left anterior hemiblock) in younger, athletic subjects. Early repolarization. Uncorrected QT interval or QT interval corrected for heart rate with Bazett's correction formula (QTcB) exceeding 450 ms, with a QTcF ≤450 ms. Considered unable or unlikely to attend the necessary visits. Employees of investigator/ clinical research organization or Stiefel involved in the study, or an immediate family member (partner, offspring, parents, siblings, or sibling's offspring) of an employee involved in the study.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
GSK Clinical Trials
Organizational Affiliation
GlaxoSmithKline
Official's Role
Study Director
Facility Information:
Facility Name
Buffalo Clinical Research Center
City
Buffalo
State/Province
New York
ZIP/Postal Code
14202
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
23390369
Citation
van Rossem K, Lowe JA. A Phase 1, randomized, open-label crossover study to evaluate the safety and pharmacokinetics of 400 mg albaconazole administered to healthy participants as a tablet formulation versus a capsule formulation. Clin Pharmacol. 2013;5:23-31. doi: 10.2147/CPAA.S39600. Epub 2013 Jan 30.
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A Study to Compare the Blood Levels of Albaconazole in Healthy Subjects Who Have Received a Single Dose of 400 mg Albaconazole as a Tablet Versus Albaconazole as a Capsule

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