Infection, Human Immunodeficiency Virus
Conditions
Brief summary
A phase I absolute bioavailability study of BMS-626529 following oral and intravenous dosing
Interventions
DRUGBMS-663068
Single oral dose of BMS-663068
DRUGBMS-626529
Single intravenous dose of \[13C\]BMS 626529
Sponsors
GlaxoSmithKline
ViiV Healthcare
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to 50 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The absolute bioavailability of BMS-626529 after single oral (BMS-663068) and single intravenous dosing ([13C]-BMS-626529) by assessing the primary endpoints AUC(inf) | up to 11 days |
Secondary
| Measure | Time frame |
|---|---|
| Safety and tolerability of single oral dose of BMS-663068 as determined by medical review of adverse event reports, vital sign measurements, electrocardiograms (ECGs), and results of physical examination and laboratory tests | up to 31 days |
| Safety and tolerability of single intravenous dose of [13C]-BMS-626529 as determined by medical review of adverse event reports, vital sign measurements, electrocardiograms (ECGs), and results of physical examination and laboratory tests | up to 31 days |
Countries
United Kingdom
Outcome results
None listed