Infection, Human Immunodeficiency Virus Clinical Trial
Official title:
A Two-Part Study to Evaluate the Bioavailability of BMS-626529 Administered as Prodrug BMS-663068 From Prototype Low-Dose Extended-Release Tablets (Part 1) and Prototype Multi-Particulate Formulations (Part 2) Relative to the 600 mg Extended Release Tablet in Healthy Subjects
Verified date | September 2017 |
Source | ViiV Healthcare |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This 2-part study will determine the bioavailability of BMS-626529 in healthy subjects from prototype low dose extended release formulations (Part 1) of BMS-663068 and prototype extended release multi-particulate formulations (Part 2) of BMS-663068 relative to 600 mg extended release tablet of BMS-663068.
Status | Completed |
Enrollment | 27 |
Est. completion date | November 5, 2015 |
Est. primary completion date | November 5, 2015 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 50 Years |
Eligibility |
For more information regarding BMS clinical trial participation, please visit
www.BMSStudyConnect.com Inclusion Criteria: - Males and females, 18 to 50 years of age, inclusive - Healthy subjects as determined by no clinically significant deviation from normal in medical and surgical history, PE findings, vital sign measurements, 12-lead ECG measurements, physical measurements, and clinical laboratory test results - Women of childbearing potential (WOCBP) must have a negative urine pregnancy test (performed for all females; minimum sensitivity 25 IU/L or equivalent units of human chorionic gonadotropin) within 24 hours prior to the start of study drug Exclusion Criteria: - Any significant acute or chronic medical illness - Evidence of organ dysfunction or any clinically significant deviation from normal in PE, vital signs, ECG, or clinical laboratory determinations beyond what is consistent with the target population - Any of the following on 12-lead ECG prior to study drug administration, confirmed by repeat: i) PR = 210 msec ii) QRS = 120 msec iii) QT = 500 msec and iv) QTcF = 450 msec - Exposure to any investigational drug or placebo within 12 weeks of study drug administration - Positive blood screen for hepatitis C antibody (HCV Ab), hepatitis B surface antigen (HBsAg), or HIV-1 and HIV-2 antibody |
Country | Name | City | State |
---|---|---|---|
United Kingdom | GSK Investigational Site | Nottingham |
Lead Sponsor | Collaborator |
---|---|
ViiV Healthcare | GlaxoSmithKline |
United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Maximum observed concentration (Cmax) of BMS-626529 | Day 1 to Day 4 of each period | ||
Primary | Area under the concentration-time curve from time zero to the time of the last quantifiable concentration (AUC(0-T)) of BMS-626529 | Day 1 to Day 4 of each period | ||
Primary | Area under the concentration-time curve from time zero extrapolated to infinite time (AUC(INF)) of BMS-626529 | Day 1 to Day 4 of each period | ||
Secondary | Safety of BMS-663068 will be measured by incidence of Adverse events (AEs), Serious adverse events (SAEs), and AEs leading to discontinuation;, and results of clinical laboratory tests, vital signs, 12-lead ECGs, and Physical examination (PE) | Day 1 to Day 4 of each period; for SAEs up to 30 days post discontinuation of dosing | ||
Secondary | Tolerability of BMS-663068 will be measured by incidence of AEs, SAEs, and AEs leading to discontinuation; and results of clinical laboratory tests, vital signs and 12-lead ECGs | Day 1 to Day 4 of each period; for SAEs up to 30 days post discontinuation of dosing |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT01425099 -
Drug Interaction Study Between Dolutegravir and Prednisone
|
Phase 1 | |
Completed |
NCT01209117 -
A Study to Assess the Relative Bioavailability of Tablet Formulations of GSK2248761 in Healthy Adult Subjects. SGN114435
|
Phase 1 | |
Completed |
NCT03231943 -
GSK3640254 First Time in Human (FTIH) Study in Healthy Volunteers
|
Phase 1 | |
Terminated |
NCT01195974 -
A Study to Evaluate the Pharmacokinetics of an Oral Contraceptive When Co-administered With GSK2248761 in Healthy Adult Female Subjects.
|
Phase 1 | |
Completed |
NCT02893488 -
Relative Bioavailability Study of a Fixed-dose Combination Dolutegravir/Abacavir/Lamivudine Dispersible Tablet
|
Phase 1 | |
Terminated |
NCT01199731 -
Dose-finding Study of GSK2248761 in Antiretroviral Therapy-experienced Subjects With NNRTI-resistant HIV Infection
|
Phase 2 | |
Completed |
NCT01449929 -
Dolutegravir Compared to Darunavir/Ritonavir , Each in Combination With Dual Nucleoside Reverse Transcriptase Inhibitors (NRTIs) in ART-naive Subjects
|
Phase 3 | |
Active, not recruiting |
NCT02951052 -
Study Evaluating the Efficacy, Safety, and Tolerability of Switching to Long-acting Cabotegravir Plus Long-acting Rilpivirine From Current Antiretroviral Regimen in Virologically Suppressed HIV-1-infected Adults
|
Phase 3 | |
Completed |
NCT01231516 -
A Study of GSK1349572 Versus Raltegravir (RAL) With Investigator Selected Background Regimen in Antiretroviral-Experienced, Integrase Inhibitor-Naive Adults
|
Phase 3 | |
Completed |
NCT02273947 -
Food Effect Study With BMS-955176
|
Phase 1 | |
Completed |
NCT00071760 -
Study Of An Investigational Regimen Including FDA Approved HIV Drugs In HIV-Infected Pediatric Subjects
|
Phase 2 | |
Completed |
NCT02539576 -
Pharmacokinetics, Safety and Tolerability Study of Abacavir/ Dolutegravir/ Lamivudine Fixed-dose Combination Tablets in Healthy Japanese Subjects
|
Phase 1 | |
Completed |
NCT01967771 -
Effect of Carbamazepine on Dolutegravir Pharmacokinetics in Healthy Adult Subjects
|
Phase 1 | |
Completed |
NCT01077635 -
PENTA Fosamprenavir Study
|
N/A | |
Completed |
NCT00774735 -
GSK1349572 Drug Interaction Study With Protease Inhibitors
|
Phase 1 | |
Completed |
NCT00386347 -
A Study To Evaluate Formulations And Food Effect On GSK364735 In Healthy Subjects.
|
Phase 1 | |
Completed |
NCT00945282 -
Safety and Tolerability Study to Evaluate Lower Dose of GSK2248761 in Antiretroviral Treatment-Naive HIV-1 Infected Adults.
|
Phase 2 | |
Terminated |
NCT02576119 -
A Study to Determine the Effect of Multiple Doses of BMS-955176 on the Electrocardiograph of Healthy Subjects
|
Phase 1 | |
Completed |
NCT02277600 -
A Phase 1 Antiretroviral Drug-Drug Interaction Study in Healthy Volunteers (DDI)
|
Phase 1 | |
Completed |
NCT00398125 -
Monotherapy Versus Placebo Over 10 Days in Integrase Naive HIV-1 Infected Adults
|
Phase 2 |