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

Sponsor
ViiV Healthcare (Industry)
Overall Status
Completed
CT.gov ID
NCT02164045
Collaborator
GlaxoSmithKline (Industry)
38
Enrollment
1
Location
2
Arms
1
Actual Duration (Months)
37.3
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
Phase 1

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)

Study Design

Study Type:
Interventional
Actual Enrollment :
38 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
None (Open Label)
Primary Purpose:
Other
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
Actual Study Start Date :
Jun 24, 2014
Actual Primary Completion Date :
Jul 25, 2014
Actual Study Completion Date :
Jul 25, 2014

Arms and Interventions

Arm Intervention/Treatment
Experimental: BMS-663068- Fasted

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

Drug: BMS-663068
BMS-663068
Experimental: BMS-663068- Fed

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

Drug: BMS-663068
BMS-663068

Outcome Measures

Primary Outcome Measures

  1. Maximum observed concentration (Cmax) for BMS-626529 in the presence and absence of food [Days 1-4 of Periods 1 and 2]

  2. Area under the concentration-time curve in one dosing interval (AUC(TAU)) for BMS-626529 in the presence and absence of food [Days 1-4 of Periods 1 and 2]

Secondary Outcome Measures

  1. 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 [Approximately up to 41 days]

  2. Time of maximum observed plasma concentration (Tmax) of BMS-626529 [Day 4 of each period]

  3. Plasma concentration observed at 12 hours postdose (C12) of BMS-626529 [Day 4 of each period]

  4. Trough observed plasma concentration (Ctrough) of BMS-626529 [Days 1-4 of each period]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 50 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes

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

Contacts and Locations

Locations

Site City State Country Postal Code
1 GSK Investigational Site San Antonio Texas United States 78209

Sponsors and Collaborators

  • ViiV Healthcare
  • GlaxoSmithKline

Investigators

  • Study Director: GSK Clinical Trials, ViiV Healthcare

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
ViiV Healthcare
ClinicalTrials.gov Identifier:
NCT02164045
Other Study ID Numbers:
  • 206283
  • AI438-042
First Posted:
Jun 16, 2014
Last Update Posted:
Jul 27, 2017
Last Verified:
Jul 1, 2017
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
HIV Infections
Fostemsavir

Study Results

No Results Posted as of Jul 27, 2017