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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT02164045
First received: June 12, 2014
Last updated: September 2, 2014
Last verified: September 2014
  Purpose

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.


Condition Intervention Phase
HIV / AIDS
Drug: BMS-663068
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Crossover Assignment
Masking: Open Label
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

Further study details as provided by Bristol-Myers Squibb:

Primary Outcome Measures:
  • Maximum observed concentration (Cmax) for BMS-626529 in the presence and absence of food [ Time Frame: Days 1-4 of Periods 1 and 2 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]

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 Frame: Approximately up to 41 days ] [ Designated as safety issue: Yes ]
  • Time of maximum observed plasma concentration (Tmax) of BMS-626529 [ Time Frame: Day 4 of each period ] [ Designated as safety issue: No ]
  • Plasma concentration observed at 12 hours postdose (C12) of BMS-626529 [ Time Frame: Day 4 of each period ] [ Designated as safety issue: No ]
  • Trough observed plasma concentration (Ctrough) of BMS-626529 [ Time Frame: Days 1-4 of each period ] [ Designated as safety issue: No ]

Enrollment: 38
Study Start Date: June 2014
Study Completion Date: July 2014
Primary Completion Date: July 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: BMS-663068- Fasted
BMS-663068 tablet twice a day by mouth on specified days
Drug: BMS-663068
Experimental: BMS-663068- Fed
BMS-663068 tablet twice a day by mouth on specified days
Drug: BMS-663068

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

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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

    • i) PR ≥ 210 msec
    • ii) QRS ≥ 120 msec
    • iii) QT ≥ 500 msec
    • iv) QTcF ≥ 450 msec
    • b) 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
  Contacts and Locations
Choosing 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: NCT02164045

Locations
United States, Texas
Healthcare Discoveries, Llc D/B/A Icon Development Solutions
San Antonio, Texas, United States, 78209
Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
  More Information

Additional Information:
No publications provided

Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT02164045     History of Changes
Other Study ID Numbers: AI438-042
Study First Received: June 12, 2014
Last Updated: September 2, 2014
Health Authority: United States: Food and Drug Administration

ClinicalTrials.gov processed this record on September 16, 2014