Study to Evaluate the Effect of Food on the Pharmacokinet... | NCT02164045

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

NCT02164045

Sponsor

ViiV Healthcare

Status

Completed

Last Update Posted

Jul 27, 2017Actual

Enrollment

38Actual

Phase

Phase 1

Conditions

Infection, Human Immunodeficiency Virus

Interventions

BMS-663068

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
AI438-042	Other Identifier	Bristol-Myers Squibb

Status Module

Record Verification Date

Jul 2017

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 24, 2014Actual

Primary Completion Date

Jul 25, 2014Actual

Completion Date

Jul 25, 2014Actual

First Submitted Date

Jun 12, 2014

First Submission Date that Met QC Criteria

Jun 12, 2014

First Posted Date

Jun 16, 2014Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 25, 2017

Last Update Posted Date

Jul 27, 2017Actual

Name	Class
GlaxoSmithKline	INDUSTRY

Description Module

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.

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)

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
BMS-663068	Drug	BMS-663068	BMS-663068- Fasted BMS-663068- Fed

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
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

Other Outcomes

Not provided

Eligibility Module

Eligibility 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:
- 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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

50 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

ID	Term
D007239	Infections
D000163	Acquired Immunodeficiency Syndrome

ID	Term
D015658	HIV Infections
D000086982	Blood-Borne Infections
D003141	Communicable Diseases
D015229	Sexually Transmitted Diseases, Viral