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CompletedNCT02164045Updated Jul 27, 2017

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

A Phase 1 interventional study of BMS-663068 in Infection, Human Immunodeficiency Virus, sponsored by ViiV Healthcare. Completed at 1 site in United States. Open to participants aged 18 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-07-27.

Sponsored by ViiV Healthcare · Phase 1, Interventional, and Other

From the registry’s dates

  • Primary completion was Jul 2014, 12 years 2 months ago, and no results have been posted to the registry.
Phase
Phase 1
Study type
Interventional
Enrollment
38
Allocation
Randomized
Ages
18 Years to 50 Years
Sex
All
01

Study 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.

Read the 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)

02

Conditions studied

  • Infection, Human Immunodeficiency Virus
03

In context

Acquired Immunodeficiency Syndrome

2,040 studies on the registry are indexed under Acquired Immunodeficiency Syndrome; 272 are open to participants now.

This study's enrollment of 38 is below the median of 105 across 1,543 interventional studies indexed under Acquired Immunodeficiency Syndrome.

Browse Acquired Immunodeficiency Syndrome studies →

Lead sponsor

ViiV Healthcare is the lead sponsor of 261 studies on the registry; 16 are open to participants now.

Of its 66 completed or terminated interventional studies of FDA-regulated products, 50 (76%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 50 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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

Inclusion criteria

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

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
05

Study design

Phase
Phase 1
Primary purpose
Other
Allocation
Randomized
Intervention model
Crossover assignment
Masking
None (open label)
Enrollment
38 participants (actual)

Study arms

  • 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

Interventions

  • DrugBMS-663068

    BMS-663068

06

What researchers measure

Primary outcomes

  1. Maximum observed concentration (Cmax) for BMS-626529 in the presence and absence of food

    Time frame: 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

    Time frame: Days 1-4 of Periods 1 and 2

Secondary outcomes

  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

    Time frame: Approximately up to 41 days

  2. Time of maximum observed plasma concentration (Tmax) of BMS-626529

    Time frame: Day 4 of each period

  3. Plasma concentration observed at 12 hours postdose (C12) of BMS-626529

    Time frame: Day 4 of each period

  4. Trough observed plasma concentration (Ctrough) of BMS-626529

    Time frame: Days 1-4 of each period

07

Study locations

1 site
  • GSK Investigational Site
    San Antonio, Texas 78209, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 27, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02164045
Lead sponsor
ViiV Healthcare
Collaborators
GlaxoSmithKline
Responsible party
Sponsor
First posted
Jun 16, 2014
Start date
Jun 24, 2014
Primary completion
Jul 25, 2014
Completion
Jul 25, 2014
Last update
Jul 27, 2017

Study contacts

GSK Clinical Trials
study director · ViiV Healthcare

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jul 2017. You cannot join it, but the record below documents what was studied.

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