Absolute Bioavailability of BMS-626529 After Oral and Intravenous Dosing

ViiV Healthcare

Status and phase: Completed; Phase 1

Conditions: Infection, Human Immunodeficiency Virus

Treatments: Drug: BMS-663068; Drug: BMS-626529

Study type: Interventional

Funder types: Industry

Identifiers

NCT02805556

206218

AI438-075 (Other Identifier)

Details and patient eligibility

About

A phase I absolute bioavailability study of BMS-626529 following oral and intravenous dosing

Enrollment: 36 patients

Sex: Male

Ages: 18 to 50 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Generally healthy
• BMI 18.0-32.0 kg/m2
• Men sexually active with women of childbearing potential must follow instructions for contraception for the duration of treatment plus 90 days
• Men must refrain from sperm donation for the length of the study and for 90 days
• Sign informed consent

Exclusion criteria

• Significant medical illness
• Tobacco use in the last 12 months
• Major surgery within 4 weeks of study administration
• Donation of blood within 4 weeks of study administration
• Current or recent (within 3 months of study administration) of gastrointestinal disease

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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36 participants in 1 patient group

Oral dose of BMS-663068 + intravenous dose of [13C]BMS 626529

Experimental group

Description:

Single oral dose of BMS-663068 followed by Single intravenous dose of \[13C\]BMS 626529

Treatment:

Drug: BMS-663068

Drug: BMS-626529