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CompletedNCT02666053Updated Sep 11, 2017

A Study to Assess the Effect of High Fat Meal and Increased Gastric pH on the Bioavailability of an Extended Release Formulation of BMS-663068 in Healthy Subjects

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 2017-09-11.

Sponsored by ViiV Healthcare (part of GlaxoSmithKline) · Phase 1, Interventional, and Other

From the registry’s dates

  • Primary completion was Feb 2016, 10 years 8 months ago, and no results have been posted to the registry.
Phase
Phase 1
Study type
Interventional
Enrollment
72
Allocation
Randomized
Ages
18 Years to 50 Years
Sex
All
01

Study summary

The purpose of this study is to estimate the effect of high fat meal and increased gastric pH on BMS-663068 bioavailability

02

Conditions studied

  • Infection, Human Immunodeficiency Virus
03

In context

Infections

6,702 studies on the registry are indexed under Infections; 801 are open to participants now.

This study's enrollment of 72 is below the median of 120 across 4,205 interventional studies indexed under Infections.

Browse Infections studies →

Lead sponsor

ViiV Healthcare is the lead sponsor of 265 studies on the registry; 16 are open to participants now.

Of its 71 completed or terminated interventional studies of FDA-regulated products, 53 (75%) have results posted.

Browse ViiV Healthcare studies →All GlaxoSmithKline studies →

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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Signed Informed Consent
  2. Target population: Healthy males and females.
  3. Males and females
  4. Women of child bearing potential (WOCBP) with negative serum or urine pregnancy test
  5. Women must not be breastfeeding
  6. Men and WOCBP must agree to follow instructions for contraception

Exclusion criteria

Exclusion Criteria:

  1. History of any chronic or acute illness or gastrointestinal disease
  2. Any major surgery within 4 weeks of study drug administration
  3. Evidence of organ dysfunction or any clinically significant deviation from normal in physical examination, vital signs, ECG or clinical laboratory determinations beyond what is consistent with the target population.
  4. History of allergy to HIV attachment inhibitors, famotidine or high fat meal
  5. History of smoking
05

Study design

Phase
Phase 1
Primary purpose
Other
Allocation
Randomized
Intervention model
Crossover assignment
Enrollment
72 participants (actual)

Study arms

  • Experimental
    Treatment A

    Single BMS-663068 tablet under fasted conditions

    Drug: BMS-663068

  • Experimental
    Treatment B

    Single BMS-663068 tablet with a high fat meal

    Drug: BMS-663068

  • Experimental
    Treatment C

    Single BMS-663068 tablet after a single famotidine tablet under fasted conditions

    Drug: BMS-663068

Interventions

06

What researchers measure

Primary outcomes

  1. Maximum observed plasma concentration (Cmax)

    Time frame: Days 1-12

  2. Area under the plasma concentration-time curve from time zero extrapolated to infinity, AUC (INF)

    Time frame: Days 1-12

Secondary outcomes

  1. Safety endpoints include incidence of nonserious AEs, serious AEs, AEs leading to discontinuation

    Adverse events (both serious and nonserious) will be listed and tabulated by system organ class, preferred term, and treatment.

    Time frame: Days 1-12; for SAEs up to 30 days post discontinuation of dosing

07

Study locations

1 site
  • GSK Investigational Site
    Austin, Texas 78744, United States
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Jan 2016 to primary completion in Feb 2016, 0 months.

Of 83 industry-sponsored phase 1 interventional studies under Infections, half reached primary completion within 11 months of starting (the median), counting those still running; a quarter within 6 and three quarters within 21. This study's 0 months is below that.

Counting every sponsor, half of 166 studies reached it within 16 months; a quarter within 7 and three quarters within 29.

Infections covers many different conditions, not one, so the studies compared here vary widely. Read these figures as a rough guide.

How these figures are worked out, and which studies are left out of them.

Registered
Jan 7, 2016
First posted
Jan 28, 2016
StartActual
Jan 27, 2016
Primary completionActual
Feb 22, 2016
CompletionActual
Feb 22, 2016
Last update
Sep 11, 2017
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Sep 11, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02666053
Lead sponsor
ViiV Healthcare
Collaborators
GlaxoSmithKline
Responsible party
Sponsor
First posted
Jan 28, 2016
Start date
Jan 27, 2016
Primary completion
Feb 22, 2016
Completion
Feb 22, 2016
Last update
Sep 11, 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 ↗

Not currently enrolling

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

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Discussion

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