NCT02164045

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
38

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Jun 2014

Shorter than P25 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 12, 2014

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 16, 2014

Completed
8 days until next milestone

Study Start

First participant enrolled

June 24, 2014

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 25, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 25, 2014

Completed
Last Updated

July 27, 2017

Status Verified

July 1, 2017

Enrollment Period

1 month

First QC Date

June 12, 2014

Last Update Submit

July 25, 2017

Conditions

Infection, Human Immunodeficiency Virus

Outcome Measures

Primary Outcomes (2)

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

    Days 1-4 of Periods 1 and 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 Outcomes (4)

  • 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

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

    Day 4 of each period

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

    Day 4 of each period

  • Trough observed plasma concentration (Ctrough) of BMS-626529

    Days 1-4 of each period

Study Arms (2)

BMS-663068- Fasted

EXPERIMENTAL

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

Drug: BMS-663068

BMS-663068- Fed

EXPERIMENTAL

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

Drug: BMS-663068

Interventions

BMS-663068DRUG

BMS-663068

BMS-663068- FastedBMS-663068- Fed

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

GSK Investigational Site

San Antonio, Texas, 78209, United States

Location

MeSH Terms

Conditions

InfectionsAcquired Immunodeficiency Syndrome

Interventions

fostemsavir

Condition Hierarchy (Ancestors)

HIV InfectionsBlood-Borne InfectionsCommunicable DiseasesSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesSlow Virus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System Diseases

Study Officials

  • GSK Clinical Trials

    ViiV Healthcare

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 12, 2014

First Posted

June 16, 2014

Study Start

June 24, 2014

Primary Completion

July 25, 2014

Study Completion

July 25, 2014

Last Updated

July 27, 2017

Record last verified: 2017-07

Locations

US(1)