Single Ascending Dose (SAD)/Multiple Ascending Dose(MAD) Safety/Pharmacokinetic (PK) Study of KM-023
Primary Purpose
Human Immunodeficiency Virus
Status
Completed
Phase
Phase 1
Locations
Korea, Republic of
Study Type
Interventional
Intervention
KM-023
Placebo for KM-023
Sponsored by
About this trial
This is an interventional treatment trial for Human Immunodeficiency Virus focused on measuring HIV
Eligibility Criteria
Inclusion Criteria:
- Subject is informed of the investigational nature of this study and voluntarily agrees to participate in this study and signs an Institutional Review Board (IRB) - approved informed consent prior to performing any of the screening procedures
- Male or female between 20 and 45 years of age at the time of screening, inclusive
- A subject with body weight ≥ 45 kg and body mass index (BMI) between 18.5 and 25 (inclusive). - BMI (kg/m2) = weight (kg) / {height (m)}2
- Capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the consent form.
- Able to understand and comply with protocol requirements, instructions and protocol-stated restrictions.
Exclusion Criteria:
- A subject with a history of allergies to drugs (aspirin, antibiotics, etc.), or history of clinically significant allergies
- A subject with clinical evidence or history of hepatic (including carrier of hepatitis virus), renal, respiratory, endocrine, neurologic, immunologic, hematologic, oncologic, psychiatric, or cardiovascular disease
- A subject with a history of gastrointestinal disease or surgery (except simple appendectomy or repair of hernia), which can influence the absorption of the study drug
- A female subject who is pregnant, nursing mother, or sexually active females (childbearing potential)
- Patients who are taking any of the following medications; Bepridil, cisapride, midazolam, pimozide, triazolam, Ergot medications (e.g. Wigraine, cafergot, St. John's wort), Phenobarbitol
- Patients who have previously demonstrated hypersensitivity to Efavirenz or to one of the components of Stocrin or Sustiva
- A positive Hepatitis B surface antigen or positive Hepatitis C antibody at screening.
- A positive test for HIV antibody (as per local practice)
- A subject who has taken any prescribed medication or herbal compounds within 14 days prior to the study drug administration. In addition, a subject who has taken any over-the-counter drug or vitamin supplements within 7 days prior to the study drug administration.
- A subject who has participated in any other clinical trial either for investigational or marketed drugs within 8 weeks before the study drug administration
- A subject who has donated or had loss of ≥ 400 mL of blood within 8 weeks prior to start of administration of study drug
- The value of aspartate aminotransferase (AST) or alanine aminotransferase (ALT) is greater than 1.25 times the upper limit of the reference range.
- A subject who is unable to abstain from drinking alcoholic beverages throughout the study period.
- A subject with a history of drug abuse, or a positive urine drug screening test
- A subject who heavily takes caffeine or caffeine-containing products, or takes grapefruit, grapefruit juice, or grapefruit-containing products
- A subject who is unable to eat a standardized meal offered by the study center
- A subject who will be previously assigned to treatment during this study (except those who did not take any study medications)
- Systolic blood pressure outside the range of 80 to 140 mm Hg, or diastolic blood pressure outside the range of 60 to 85 mm Hg, or heart rate outside the range of 50 to 100 beats per minute (bpm) for females; outside and the range of 45 to 100 beats per minute (bpm) for male subjects. Blood pressure and heart rate should be taken after 10 minutes of rest.
- The investigator judges the subject not eligible for the study after reviewing clinical laboratory results or other reasons
Sites / Locations
- Clinical Trials Center, Seoul National University Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
KM-023
Placebo for KM-023
Arm Description
Outcomes
Primary Outcome Measures
Safety/ Tolerability Evaluation
-number of subjects with Adverse events, Physical examinations, Vital signs, electrocardiogram (ECG), Laboratory tests (including hematology, chemistry, coagulation, urinalysis), circulating immune complexes (CIC)
Secondary Outcome Measures
Pharmacokinetic Evaluation of KM-023, Area under the plasma concentration versus time curve (AUC) of KM-023
-Serial blood samples and urine collections for pharmacokinetic evaluations will be conducted pre-dose through post dose in order to evaluate AUC of KM-023
Pharmacokinetic Evaluation of KM-023, Peak Plasma Concentration (Cmax) of KM-023
-Serial blood samples and urine collections for pharmacokinetic evaluations will be conducted pre-dose through post dose in order to evaluate Cmax of KM-023
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01348516
Brief Title
Single Ascending Dose (SAD)/Multiple Ascending Dose(MAD) Safety/Pharmacokinetic (PK) Study of KM-023
Official Title
A Dose Block-randomized, Double-blind, Placebo-controlled, Single/Multiple Dosing, Dose-escalation Clinical Trial to Investigate the Safety, Tolerability, and Pharmacokinetic Characteristics of KM-023 After Oral Administration in Healthy Subjects
Study Type
Interventional
2. Study Status
Record Verification Date
July 2012
Overall Recruitment Status
Completed
Study Start Date
May 2011 (undefined)
Primary Completion Date
March 2012 (Actual)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Kainos Medicine Inc.
4. Oversight
5. Study Description
Brief Summary
The purpose of this study is to investigate the safety and pharmacokinetics of KM-023 after single/multiple dosing.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Human Immunodeficiency Virus
Keywords
HIV
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
83 (Actual)
8. Arms, Groups, and Interventions
Arm Title
KM-023
Arm Type
Experimental
Arm Title
Placebo for KM-023
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
KM-023
Intervention Description
-KM-023 is dosed orally via 75 mg tablets. Study doses are 75 mg, 150 mg, 300 mg, and 600 mg QD for 1 (SAD) or 7 (MAD) days.
Intervention Type
Drug
Intervention Name(s)
Placebo for KM-023
Intervention Description
-Placebo for KM-023 is dosed orally via Placebo for KM-023 tablets. Study doses are 1, 2, 3, and 4 placebo tablets QD for 1 (SAD) or 7 (MAD) days.
Primary Outcome Measure Information:
Title
Safety/ Tolerability Evaluation
Description
-number of subjects with Adverse events, Physical examinations, Vital signs, electrocardiogram (ECG), Laboratory tests (including hematology, chemistry, coagulation, urinalysis), circulating immune complexes (CIC)
Time Frame
participants will be followed for the duration of hospital stay, 8-10 days for SAD and 14-16 days for MAD
Secondary Outcome Measure Information:
Title
Pharmacokinetic Evaluation of KM-023, Area under the plasma concentration versus time curve (AUC) of KM-023
Description
-Serial blood samples and urine collections for pharmacokinetic evaluations will be conducted pre-dose through post dose in order to evaluate AUC of KM-023
Time Frame
participants will be followed for the duration of hospital stay, 8-10 days for SAD and 14-16 days for MAD
Title
Pharmacokinetic Evaluation of KM-023, Peak Plasma Concentration (Cmax) of KM-023
Description
-Serial blood samples and urine collections for pharmacokinetic evaluations will be conducted pre-dose through post dose in order to evaluate Cmax of KM-023
Time Frame
participants will be followed for the duration of hospital stay, 8-10 days for SAD and 14-16 days for MAD
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Subject is informed of the investigational nature of this study and voluntarily agrees to participate in this study and signs an Institutional Review Board (IRB) - approved informed consent prior to performing any of the screening procedures
Male or female between 20 and 45 years of age at the time of screening, inclusive
A subject with body weight ≥ 45 kg and body mass index (BMI) between 18.5 and 25 (inclusive). - BMI (kg/m2) = weight (kg) / {height (m)}2
Capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the consent form.
Able to understand and comply with protocol requirements, instructions and protocol-stated restrictions.
Exclusion Criteria:
A subject with a history of allergies to drugs (aspirin, antibiotics, etc.), or history of clinically significant allergies
A subject with clinical evidence or history of hepatic (including carrier of hepatitis virus), renal, respiratory, endocrine, neurologic, immunologic, hematologic, oncologic, psychiatric, or cardiovascular disease
A subject with a history of gastrointestinal disease or surgery (except simple appendectomy or repair of hernia), which can influence the absorption of the study drug
A female subject who is pregnant, nursing mother, or sexually active females (childbearing potential)
Patients who are taking any of the following medications; Bepridil, cisapride, midazolam, pimozide, triazolam, Ergot medications (e.g. Wigraine, cafergot, St. John's wort), Phenobarbitol
Patients who have previously demonstrated hypersensitivity to Efavirenz or to one of the components of Stocrin or Sustiva
A positive Hepatitis B surface antigen or positive Hepatitis C antibody at screening.
A positive test for HIV antibody (as per local practice)
A subject who has taken any prescribed medication or herbal compounds within 14 days prior to the study drug administration. In addition, a subject who has taken any over-the-counter drug or vitamin supplements within 7 days prior to the study drug administration.
A subject who has participated in any other clinical trial either for investigational or marketed drugs within 8 weeks before the study drug administration
A subject who has donated or had loss of ≥ 400 mL of blood within 8 weeks prior to start of administration of study drug
The value of aspartate aminotransferase (AST) or alanine aminotransferase (ALT) is greater than 1.25 times the upper limit of the reference range.
A subject who is unable to abstain from drinking alcoholic beverages throughout the study period.
A subject with a history of drug abuse, or a positive urine drug screening test
A subject who heavily takes caffeine or caffeine-containing products, or takes grapefruit, grapefruit juice, or grapefruit-containing products
A subject who is unable to eat a standardized meal offered by the study center
A subject who will be previously assigned to treatment during this study (except those who did not take any study medications)
Systolic blood pressure outside the range of 80 to 140 mm Hg, or diastolic blood pressure outside the range of 60 to 85 mm Hg, or heart rate outside the range of 50 to 100 beats per minute (bpm) for females; outside and the range of 45 to 100 beats per minute (bpm) for male subjects. Blood pressure and heart rate should be taken after 10 minutes of rest.
The investigator judges the subject not eligible for the study after reviewing clinical laboratory results or other reasons
Facility Information:
Facility Name
Clinical Trials Center, Seoul National University Hospital
City
Seoul
Country
Korea, Republic of
12. IPD Sharing Statement
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Single Ascending Dose (SAD)/Multiple Ascending Dose(MAD) Safety/Pharmacokinetic (PK) Study of KM-023
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