NCT01458769

Pharmacokinetics, Safety & Tolerability of Isotopologs of Atazanavir (ATV), With Pharmacokinetic Comparison to Reyataz

Open-labeled, Randomized, Crossover, Single-dose Study in Healthy Male Subjects to Evaluate the Pharmacokinetics, Safety & Tolerability of Stable Isotopologs of Atazanavir (ATV), Administered as Single Agents or as Combinations of Two Isotopologs, With a Pharmacokinetic Comparison to Reyataz®.

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 47 (actual)
• Sponsor: Concert Pharmaceuticals · Industry
• Sex: Male
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to assess the safety, tolerability and pharmacokinetics of isotopologs of Atazanavir both as single agents and as combinations.

Detailed description

There are two parts to this study. Part A is a three-period, crossover design. Eligible subjects will be randomized to 1 of 4 sequences, in groups of 4 subjects each. 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; that is, dosing will occur on the same day each week. Part B evaluations are based on the results of Part A. Part B will further consist of two subparts. In the first subpart, low single doses of 2 new isotopologs will be dosed to two groups of 4 subjects each, B1 and B2, respectively. Following assessment of safety and pharmacokinetics in the first subpart, the second subpart, which consists of three groups of 8 subjects (B3, B4, B5) each will be dosed. Subjects enrolled in B3, B4, and B5 will participate in a 3-way partial crossover study design. The objectives will be to compare the PK properties, in healthy male subjects after a light meal, of single oral doses of single agent ATV isotopologs or as combinations of two ATV isotopologs with the PK properties in the same subjects, after a light meal, of a single dose of either 400 mg or 600 mg Reyataz. The safety and tolerability will also be evaluated. Blood samples for pharmacokinetic analysis will be collected. Actual dosing and sampling times will be used for analysis.

Conditions

• Healthy Volunteers

Interventions

Type	Name	Description
DRUG	C-10276	C-10276 200 mg, C-10276 400 mg, Reyataz 400 mg oral, single dose
DRUG	C-10276	C-10276 300 mg, CTP-518 100 mg with C-10276 300 mg, C-10276 400 mg oral, single dose
DRUG	C-10297	C-10297 200 mg, oral, single dose
DRUG	C-10299	C-10299 200 mg, oral, single dose
DRUG	C-10297	C-10297 400 mg, Reyataz 400 mg, C-10297 600 mg, oral, single dose
DRUG	C-10299	C-10299 400 mg, Reyataz 400 mg, C-10299 600 mg, oral, single dose
DRUG	C-10276	C-10276 600 mg, Reyataz 400 mg, Reyataz 600 mg, oral, single dose
DRUG	Reyataz®	Reyataz 400 mg, oral, single dose Reyataz 600 mg, oral, single dose

Timeline

• Start date: 2010-12-01
• Primary completion: 2011-04-01
• Completion: 2011-04-01
• First posted: 2011-10-25
• Last updated: 2013-05-24