A Study of the Relative Bioavailability of BMS-626529 Administered as BMS-663068 From 150mg Low-dose Extended-release Tablets Compared to 600mg Reference Extended-release Tablets in Healthy Subjects
Information provided by (Responsible Party)
First received: July 28, 2016
Last updated: May 12, 2017
Last Verified: May 2017
History of Changes
An oral dose in healthy subjects to determine the relative bioavailabilty of BMS-626529 administered as BMS-663068
Infection, Human Immunodeficiency Virus
Drug : BMS-663068 (1 tablet at 600 mg)
Drug : BMS-663068 (4 tablets at 150 mg each tablet)
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
|Official Title:||Relative Bioavailability Study of BMS-626529 Administered as Prodrug BMS-663068 From 150-mg Low-dose Extended-release Tablets Compared to 600-mg Reference Extended-release Tablet in Healthy Subjects|
Further study details as provided by ViiV Healthcare:
Primary Outcome Measures
- Bioavailability of BMS-626529 from low-dose ER tablet formulation of BMS-663068 relative to the reference ER tablet formulation. [ Time Frame: Approximately 8 days ]
- Safety and Tolerability as assessed by the Incidence of Serious Adverse Events (SAEs), Adverse Events (AEs), AEs leading to discontinuation, and the results of electrocardiogram tests (ECGs), vital signs, physical exams, and clinical laboratory tests. [ Time Frame: Approximately 8 days ]
|Study Start Date:||August 12, 2016|
|Study Completion Date:||August 12, 2016|
|Primary Completion Date:||August 12, 2016 (Final data collection date for primary outcome measure)|
Treatment A: reference extended-release (ER) 1 tablet at 600mg
A single dose of BMS-663068 administered orally as specified
BMS-663068 (1 tablet at 600 mg)
BMS-663068 (1 tablet at 600 mg). A single dose of BMS-663068 administered orally as specified.
Treatment B: low-dose ER 4 tablets at 150mg
A single dose (4 tablets) of BMS-663068 administered orally as specified
BMS-663068 (4 tablets at 150 mg each tablet)
BMS-663068 (4 tablets at 150 mg each tablet). A single dose (4 tablets) of BMS-663068 administered orally as specified.
|Ages Eligible for Study:||18 Years to 50 Years|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||Yes|
- Signed Informed Consent
- Target Population: Healthy subjects as determined by no clinically significant deviation from normal in medical and surgical history, physical examination, vital sign measurements, 12-lead ECG measurements and clinical laboratory test results. Body mass index (BMI) of 18.0 to 32.0 kg/m².
- Subject Re-enrollment: This study permits the re-enrollment of a subject that has discontinued the study as a pre-treatment failure (i.e., subject has not been randomized/ has not been treated). If re-enrolled, the subject must be re-consented.
- Age: Males and Females, ages 18 or age of majority to 50 years, inclusive.
- Reproductive Status: Women of childbearing potential (WOCBP) must have a negative serum/urine (urine test not allowed at screening and Day -1 of Period 1) pregnancy test (minimum sensitivity 25 IU/L or equivalent units of human chorionic gonadotropin) within 24 hours prior to the start of study drug. Women must not be breastfeeding. Women of childbearing potential must agree to follow instructions for method(s) of contraception for the duration of treatment with study drug plus 5 half-lives of study drug (60 hours) plus 30 days (duration of ovulatory cycle) for a total of 33 days post-treatment completion. Males who are sexually active with WOCBP must agree to follow instructions for method(s) of contraception for the duration of treatment with study drug plus 5 half-lives of study drug (60 hours). In addition, male subjects must be willing to refrain from sperm donation during this time. Azoospermic males are exempt from contraceptive requirements. Women of childbearing potential who are continuously not heterosexually active are also exempt from contraceptive requirements, and still undergo pregnancy testing as described in this section.
- Medical History and Concurrent Diseases: History of any chronic or acute illness, gastrointestinal disease, gastrointestinal surgery within less than 4 weeks of dosing, blood donation within 4 weeks of dosing, blood transfusion within 4 weeks of dosing, smoking within less than 12 months prior to dosing, alcohol abuse, inability to tolerate oral medication, or inability to be venipunctured. Any other sound medical, psychiatric and/or social reason as determined by the investigator.
- Physical and Laboratory Test Findings: Evidence of organ dysfunction or any clinically significant deviation from normal in physical examination, vital signs measurements, ECGs, or clinical laboratory determinations beyond what is consistent with the target population.
- Exposure to any investigational drug or placebo within 4 weeks of study drug
Contacts and LocationsChoosing to participate in a study is an important personal decision.Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT02859259
Locations Show More
|United States, Texas|
|GSK Investigational Site|
|Dallas, Texas, United States, 75247|
Sponsors and CollaboratorsViiV Healthcare
|Study Director:||GSK Clinical Trials||ViiV Healthcare|
|Responsible Party:||ViiV Healthcare|
|ClinicalTrials.gov Identifier:||NCT02859259 History of Changes|
|Other Study ID Numbers:||206219|
|Study First Received:||July 28, 2016|
|Last Updated:||May 12, 2017|
|Individual Participant Data|
|Plan to Share IPD:||No|
|Studies a U.S. FDA-regulated Drug Product:||Yes|
|Studies a U.S. FDA-regulated Device Product:||No|
Additional relevant MeSH terms:
Acquired Immunodeficiency Syndrome
ClinicalTrials.gov processed this data on June 01, 2020
This information is provided by ClinicalTrials.gov.