- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00334659
A Study to Investigate the Cardiovascular Safety of Apricitabine in Healthy Subjects
June 21, 2011 updated by: Avexa
A Double-blind, Placebo-controlled, Positive Controlled, Randomized, Crossover Study to Investigate the Cardiovascular Safety of Apricitabine in Healthy Subjects
The purpose of this study is to confirm that apricitabine does not induce any clinically significant effect upon electrocardiogram (ECG) parameters at doses consistent with the maximum exposure expected to occur in clinical practice.
Study Overview
Study Type
Interventional
Enrollment (Actual)
37
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Michigan
-
Kalamazoo, Michigan, United States, 49007
- Jasper Clinic Inc.
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
Male
Description
Inclusion Criteria:
- Healthy male subjects 18 - 65 years of age, inclusive.
- Body mass index (BMI) between 18-30 kg/m2, inclusive, and a total body weight > 50 kg.
- No clinically significant medical history.
- No clinically significant findings on complete physical examination, including blood pressure, pulse rate and 12-lead ECG.
- Normal clinical safety laboratory results at screening.
- Willing and able to sign an informed consent document indicating understanding the purpose of and procedures required for the study and willingness to participate in the study.
- Willing and able to stay in the clinic for the in-patient activities required by the protocol.
Exclusion Criteria:
- Evidence of clinically relevant pathology that could interfere with the study results or put the subject's safety at risk.
- Current or recurrent disease that may affect the action, absorption or disposition of the study treatment, or clinical or laboratory assessments.
- Current or relevant previous history of serious, severe or unstable (acute or progressive) physical or psychiatric illness, any medical disorder requiring treatment or that may make the subject unlikely to fully complete the study, or any condition that presents undue risk from the study treatment or procedures.
- History of febrile illness within the 5 days prior to the first dose.
- Positive Hepatitis B surface antigen, Hepatitis C antibody or HIV test result at screening visit.
- Use of any prescription medication within 7 days or 5 half-lives (whichever is longer) prior to the first dose of trial medication or during the study. As an exception, acetaminophen may be used at doses of ≤ 1 g/day.
- Use of any over-the-counter (OTC) medication within 7 days or 5 half-lives (whichever is longer) prior to or during the study. Herbal supplements (including herbal weight-loss or "metabolism booster" therapies) must be discontinued 28 days prior to the first dose of trial medication.
- Known or suspected intolerance or hypersensitivity to the study drugs, closely related compounds or any of their stated ingredients.
- Subjects with a history of regular alcohol consumption exceeding 14 drinks/week (1 drink = 5 ounces [150 ml] of wine, 12 ounces [360 ml] of beer or 1.5 ounces [45 ml] of hard liquor) or illicit substance abuse within 6 months of screening.
- Positive screen for alcohol or drugs of abuse during screening visit or at study check-in.
- History or evidence of routine use of tobacco or nicotine-containing products in excess of 5 cigarettes per day (or equivalent).
- Participated in a clinical study involving an investigational drug within 30 days or 5 half-lives (whichever is longer) prior to study drug administration.
- Blood donation of one pint or more within 56 days of the start of the study.
- Plasmapheresis or plasma donation within 30 days of the start of the study.
- Single 12-lead ECG demonstrating QTc > 450 msec at screen. A single repeat ECG may be done at the investigator's discretion.
- Any condition that in the opinion of the investigator would complicate or compromise the study, or the well-being of the subject.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Quadruple
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
QTc at individual Day 7 post-dose Tmax as determined by concurrent pharmacokinetic (PK) analysis for apricitabine
Time Frame: day 7
|
day 7
|
The maximum Day 7 QTc increase from baseline observed between 1 to 4 hours post-dose, using time-matched ECG assessments
Time Frame: day 7
|
day 7
|
The average Day 7 QTc observed between 1 to 4 hours post-dose
Time Frame: day 7
|
day 7
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Susan W Cox, PhD, Avexa
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
June 1, 2006
Primary Completion (Actual)
August 1, 2006
Study Completion (Actual)
August 1, 2006
Study Registration Dates
First Submitted
June 6, 2006
First Submitted That Met QC Criteria
June 6, 2006
First Posted (Estimate)
June 8, 2006
Study Record Updates
Last Update Posted (Estimate)
June 23, 2011
Last Update Submitted That Met QC Criteria
June 21, 2011
Last Verified
June 1, 2011
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- AVX-101
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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