RecruitingPhase 1ACTRN12610001080011

An open-labeled, randomized, crossover, single-dose study in healthy male subjects to test the pharmacokinetics (how your body handles the drug e.g. how it absorbs it and how it eliminates it), safety, and tolerability of investigational drugs taken as single agents or as combinations of two investigational drugs, with a pharmacokinetics comparison to the marketed drug Reyataz(Registered Trademark)

An open-labeled, randomized, crossover, single-dose study in healthy male Participants to evaluate the pharmacokinetics, safety, and tolerability of stable isotopologs of atazanavir (ATV), administered as single agents or as combinations of two isotopologs, with a pharmacokinetic comparison to Reyataz(Registered Trademark)

Sponsor

Concert Pharmaceuticals, Inc

Enrollment

32 participants

Start Date

Nov 30, 2010

Study Type

Interventional

Conditions

treatment and prevention of HIV

Summary

In this 2-part study, a total of 48 healthy male subjects will be enrolled and will be randomized to 1 of 8 sequences (4 in each study part), in groups of 4 subjects each. Part A of the study will be a 3-way crossover design. Part A1 will evaluate two single ascending doses of the single agent C-10276 (an ATV isotopolog), and a dose of Reyataz. Part A2 will evaluate the single agent C-10276 at two dose levels and co-administration of CTP-518 and C-10276. Part B will consist of two subparts. In the first subpart, C-10297 and C-10299 will be administered in 200 mg doses, in two groups of 4 subjects each. The second subpart consists of three groups of 8 subjects that will participate in a 3-way partial crossover study design. C-10297 and C-10299 will be administered in 400 and 600 mg doses, C-10276 will be administered in 600 mg and Reyataz will be dosed in 400 and 600 mg doses. All study drug doses, including the comparator, Reyataz, will be administered as single, open-labeled doses to subjects after a light meal. There will be a 7-day washout between individual subjects’ doses.

Eligibility

Sex: MalesMin Age: 18 YearssMax Age: 50 Yearss

Plain Language Summary

Simplified for easier understanding

This study is testing new experimental HIV medications to see how the body absorbs and processes them. Healthy male volunteers will receive single doses of these investigational drugs — alone or in combination — and their blood levels will be measured. Results will be compared to the approved HIV drug Reyataz (atazanavir). This is an early-phase pharmacokinetics (drug behavior) study. You may be eligible if: - You are a healthy male between 18 and 50 years old - Your weight is at least 50 kg and your BMI is between 18 and 32 - You have no significant medical conditions - You do not smoke and test negative for drugs of abuse - Your eating habits are normal (not on unusual restrictive diets) You may NOT be eligible if: - You have heart, lung, kidney, liver, or gut conditions - You have HIV, hepatitis B, or hepatitis C - You have used tobacco in the past 3 months - You have used recreational drugs within the past 6 months - You are taking any prescription or herbal medications - You have donated blood within the past 8 weeks - You have consumed grapefruit, star fruit, or red wine within the past 7 days Talk to your doctor about whether this trial might be right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

Part A participants are permitted to participate in Part B of the study. Their participation is dependant upon availablility. Part A is divided into 3 periods. Each period is separated by a 7 day washout period. 16 Subjects are divided in to Group A1 and A2. Within each group 8 subjects will be randomised to recieve one of the following treatments. Group A1 the 8 subjects are separated into 2 groups of 4. For Period 1, 8 subjects receive C-10276 200mg. For Period 2, 4 subjects will receive C-10276 400mg and 4 subjects will receive Reyataz 400mg. For Period 3 the treatment will crossover and the 4 subjects receiving C-10276 400mg in Period 2 will receive Reyataz 400mg and the 4 subjects receiving Reyataz 400 mg in Period 2 will recieve C-10276 400mg. Group A2 the 8 subjects are separated into 2 groups of 4. For Period 1 8 subjects receive C-10276 300mg. For Period 2, 4 subjects will receive C-10276 400mg and 4 subjects will receive Co-Dose Ratio 1 CTP-518 (100mg): C-10276 (300mg). For Period 3 the treatment will crossover and the 4 subjects receiving C-10276 400mg in Period 2 will receive Co-dose ratio 1 and the 4 subjects receiving Co-dose ratio 1 in Period 2 will recieve C-10276 400mg. Part B is divided in to two sub-parts. The first sub-part consists of two Groups B1 and B2, each group consists of 4 subjects. 4 subjects will receive C-10297 (200 mg) and 4 subjects will receive C-10299 (200 mg). The second sub-part will consist of three groups, B3, B4 and B5. Each group will consist of 8 subjects. These subjects will be dosed over 3 periods. Each period is separated by a 7 day washout period. For Period 1, 8 subjects will receive C-10297 (400 mg), 8 subjects will receive C-10299 (400 mg) and 8 subjects will receive C-10276 (600 mg). For Period 2, all 3 groups of 8 subjects will receive Reyataz (400 mg). For Period 3, 8 subjects will receive C-10297 (600 mg), 8 subjects will receive C-10299 (600 mg) and 8 subjects will receive Reyataz (600 mg). All the Isotopologs will be administered via oral suspension. Reyataz will be administered via oral capsules.

Locations(1)

Australia

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ACTRN12610001080011