A Study to Examine the Acceptable Taste and to Estimate the Amount of Atazanavir and Cobicistat in the Body When Taken as a Combination Product Versus When Taken as Separate Products at the Same Time

• Status: Not yet recruiting
• Trial end date: 2020-04-01
• Target enrollment: 0
• Participant gender: All

Summary

Atazanavir (ATV) and cobicistat (COBI) are approved for use with other drugs for the treatment of HIV-1 (human immunodeficiency virus Type 1) infection in adults. The positive effect of patients taking both these drugs led to the development of a combination tablet (EVOTAZ®), which can help reduce the number of pills a patient has to take and improves their adherence with HIV therapy. This study compares the amount of ATV and COBI in the bodies of healthy adult volunteers when taken as a combination formulation, and when ATV is administered as an oral powder at the same time as COBI administered as an oral tablet. The ATV/COBI combination formulation and ATV powder will be taken with food.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Bristol-Myers Squibb
• Treatments: Atazanavir Sulfate; Cobicistat

Criteria

Inclusion Criteria:

• Signed written informed consent form.

• Body mass index (BMI) of 18.0 to 32.0 kg/m^2, inclusive. BMI = weight (kg)/[height(m)]^2.

• Women who are not pregnant or breastfeeding and are not a woman of childbearing potential (WOCBP) or who is a WOCBP and using a method of contraception defined in the protocol during study treatment and at least until after the last dose of study treatment is administered.

• WOCBP must agree to follow instructions for method(s) of contraception as defined in the study protocol and in the Informed Consent Form (ICF). They are not permitted to use hormonal contraception methods alone.

• Male participants who are sexually active with WOCBP must agree to follow instructions for method(s) of contraception defined in the protocol (azoospermic males are exempt from contraceptive requirements).

Exclusion Criteria:

• Any significant acute or chronic medical illness.

• Current or recent (within 3 months of study drug administration) gastrointestinal disease that could impact absorption of study treatment.

• Any major surgery within 4 weeks of study treatment administration.

• Donation of blood to a blood bank or in a clinical study (except a screening visit) within 4 weeks of study treatment administration (within 2 weeks for plasma only).

• Use of tobacco-containing or nicotine-containing products (including but not limited to cigarettes, e-cigarettes/vape pens, pipes, cigars, chewing tobacco, nicotine patches, nicotine lozenges, or nicotine gum) within 6 months prior to study treatment administration.

• Women of childbearing potential (WOCBP) using oral, injectable, or implantable hormonal contraceptives within 3 months prior to study treatment administration.