Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 11:02 PM
Ignite Modification Date:
2025-12-24 @ 11:02 PM
NCT ID:
NCT01458769
Brief 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.
Study:
NCT01458769
Study Brief:
Protocol Section:
NCT01458769