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

NCT01458769 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 47

Last updated 2013-05-24

No results posted yet for this study

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.

Conditions

  • Healthy Volunteers

Interventions

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

Sponsors & Collaborators

  • Concert Pharmaceuticals

    lead INDUSTRY

Principal Investigators

  • Sepehr Shakib, MD · Adelaide, SA 5000 Australia

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2010-12-31
Primary Completion
2011-04-30
Completion
2011-04-30

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01458769 on ClinicalTrials.gov