search
Back to results

Study to Evaluate the Effect of Food on the Pharmacokinetics of BMS-626529

Primary Purpose

Infection, Human Immunodeficiency Virus

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
BMS-663068
Sponsored by
ViiV Healthcare
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Infection, Human Immunodeficiency Virus

Eligibility Criteria

18 Years - 50 Years (Adult)All SexesAccepts Healthy Volunteers

For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com

Inclusion Criteria:

  • Healthy subjects as determined by no clinically significant deviation from normal in medical and surgical history, physical examination findings, 12-lead ECG measurements, and clinical laboratory test results
  • Body mass index (BMI) of 18.0 to 32.0 kg/m2, inclusive
  • Males and Females, ages 18 to 50 years, inclusive
  • Women of childbearing potential (WOCBP) must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of human chorionic gonadotropin (HCG)) within 24 hours prior to the start of study drug

Exclusion Criteria:

  • Any significant acute or chronic medical illness as determined by the investigator
  • Current or recent (within 3 months of study drug administration) gastrointestinal disease that could impact upon the absorption of study drug
  • Any major surgery within 4 weeks of study drug administration
  • Any gastrointestinal surgery that could impact upon the absorption of study drug
  • Inability to tolerate oral medication
  • Recent (within 6 months of study drug administration) history of smoking or current smokers
  • Evidence of organ dysfunction or any clinically significant deviation from normal in physical examination, vital signs, electrocardiogram (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:

    • PR ≥ 210 msec
    • QRS ≥ 120 msec
    • QT ≥ 500 msec
    • QTcF ≥ 450 msec
    • Positive urine screen for drugs of abuse
  • Positive blood screen for hepatitis C antibody, hepatitis B surface antigen, or Human Immunodeficiency Virus-1 (HIV-1), -2 antibodies, and HIV-1 RNA

Sites / Locations

  • GSK Investigational Site

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

BMS-663068- Fasted

BMS-663068- Fed

Arm Description

BMS-663068 tablet twice a day by mouth on specified days

BMS-663068 tablet twice a day by mouth on specified days

Outcomes

Primary Outcome Measures

Maximum observed concentration (Cmax) for BMS-626529 in the presence and absence of food
Area under the concentration-time curve in one dosing interval (AUC(TAU)) for BMS-626529 in the presence and absence of food

Secondary Outcome Measures

Safety and tolerability endpoints including incidence of Adverse events (AEs), serious AEs, AEs leading to discontinuations, deaths, and the results of vital signs, ECGs, physical examinations, and clinical laboratory tests
Time of maximum observed plasma concentration (Tmax) of BMS-626529
Plasma concentration observed at 12 hours postdose (C12) of BMS-626529
Trough observed plasma concentration (Ctrough) of BMS-626529

Full Information

First Posted
June 12, 2014
Last Updated
July 25, 2017
Sponsor
ViiV Healthcare
Collaborators
GlaxoSmithKline
search

1. Study Identification

Unique Protocol Identification Number
NCT02164045
Brief Title
Study to Evaluate the Effect of Food on the Pharmacokinetics of BMS-626529
Official Title
Study to Evaluate the Effect of Food on the Pharmacokinetics of BMS-626529 From an Extended-Release Formulation of BMS-663068 in Healthy Subjects
Study Type
Interventional

2. Study Status

Record Verification Date
July 2017
Overall Recruitment Status
Completed
Study Start Date
June 24, 2014 (Actual)
Primary Completion Date
July 25, 2014 (Actual)
Study Completion Date
July 25, 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
ViiV Healthcare
Collaborators
GlaxoSmithKline

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The current food effect study is being performed to support a Phase 3 study with BMS 663068. Results from this study will inform whether patients in the upcoming Phase 3 study can be given the flexibility to dose BMS-663068 in the fasted state, if so desired.
Detailed Description
Primary Purpose: Other: To assess the effect of food on the steady-state exposure of BMS-626529 when administered as BMS 663068 600 mg twice daily (BID) to healthy subjects Acquired Immune Deficiency Syndrome (AIDS)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infection, Human Immunodeficiency Virus

7. Study Design

Primary Purpose
Other
Study Phase
Phase 1
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
38 (Actual)

8. Arms, Groups, and Interventions

Arm Title
BMS-663068- Fasted
Arm Type
Experimental
Arm Description
BMS-663068 tablet twice a day by mouth on specified days
Arm Title
BMS-663068- Fed
Arm Type
Experimental
Arm Description
BMS-663068 tablet twice a day by mouth on specified days
Intervention Type
Drug
Intervention Name(s)
BMS-663068
Intervention Description
BMS-663068
Primary Outcome Measure Information:
Title
Maximum observed concentration (Cmax) for BMS-626529 in the presence and absence of food
Time Frame
Days 1-4 of Periods 1 and 2
Title
Area under the concentration-time curve in one dosing interval (AUC(TAU)) for BMS-626529 in the presence and absence of food
Time Frame
Days 1-4 of Periods 1 and 2
Secondary Outcome Measure Information:
Title
Safety and tolerability endpoints including incidence of Adverse events (AEs), serious AEs, AEs leading to discontinuations, deaths, and the results of vital signs, ECGs, physical examinations, and clinical laboratory tests
Time Frame
Approximately up to 41 days
Title
Time of maximum observed plasma concentration (Tmax) of BMS-626529
Time Frame
Day 4 of each period
Title
Plasma concentration observed at 12 hours postdose (C12) of BMS-626529
Time Frame
Day 4 of each period
Title
Trough observed plasma concentration (Ctrough) of BMS-626529
Time Frame
Days 1-4 of each period

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com Inclusion Criteria: Healthy subjects as determined by no clinically significant deviation from normal in medical and surgical history, physical examination findings, 12-lead ECG measurements, and clinical laboratory test results Body mass index (BMI) of 18.0 to 32.0 kg/m2, inclusive Males and Females, ages 18 to 50 years, inclusive Women of childbearing potential (WOCBP) must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of human chorionic gonadotropin (HCG)) within 24 hours prior to the start of study drug Exclusion Criteria: Any significant acute or chronic medical illness as determined by the investigator Current or recent (within 3 months of study drug administration) gastrointestinal disease that could impact upon the absorption of study drug Any major surgery within 4 weeks of study drug administration Any gastrointestinal surgery that could impact upon the absorption of study drug Inability to tolerate oral medication Recent (within 6 months of study drug administration) history of smoking or current smokers Evidence of organ dysfunction or any clinically significant deviation from normal in physical examination, vital signs, electrocardiogram (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: PR ≥ 210 msec QRS ≥ 120 msec QT ≥ 500 msec QTcF ≥ 450 msec Positive urine screen for drugs of abuse Positive blood screen for hepatitis C antibody, hepatitis B surface antigen, or Human Immunodeficiency Virus-1 (HIV-1), -2 antibodies, and HIV-1 RNA
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
GSK Clinical Trials
Organizational Affiliation
ViiV Healthcare
Official's Role
Study Director
Facility Information:
Facility Name
GSK Investigational Site
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78209
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Study to Evaluate the Effect of Food on the Pharmacokinetics of BMS-626529

We'll reach out to this number within 24 hrs