Clinical trial NCT02164045: 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
Overall status: COMPLETED
Phase: PHASE1
Conditions: Infection, Human Immunodeficiency Virus
Lead sponsor: ViiV Healthcare
Sponsor class: INDUSTRY
Collaborators: name: GlaxoSmithKline
First posted: 2014-06-16
Enrollment: 38
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

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)

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

Primary outcomes:
measure: Maximum observed concentration (Cmax) for BMS-626529 in the presence and absence of food
timeFrame: Days 1-4 of Periods 1 and 2
measure: Area under the concentration-time curve in one dosing interval (AUC(TAU)) for BMS-626529 in the presence and absence of food
timeFrame: Days 1-4 of Periods 1 and 2
Secondary outcomes:
measure: 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
timeFrame: Approximately up to 41 days
measure: Time of maximum observed plasma concentration (Tmax) of BMS-626529
timeFrame: Day 4 of each period
measure: Plasma concentration observed at 12 hours postdose (C12) of BMS-626529
timeFrame: Day 4 of each period
measure: Trough observed plasma concentration (Ctrough) of BMS-626529
timeFrame: Days 1-4 of each period
Other outcomes:
Locations:
city: San Antonio
country: United States
facility: GSK Investigational Site
state: Texas
Study officials:
affiliation: ViiV Healthcare
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References: