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

Infection, Human Immunodeficiency Virus Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02164045
• Other study ID #: 206283
• Secondary ID: AI438-042
• Status: Completed
• Phase: Phase 1
• First received: June 12, 2014
• Last updated: July 25, 2017
• Start date: June 24, 2014
• Est. completion date: July 25, 2014

Study information

• Verified date: July 2017
• Source: ViiV Healthcare
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 38
• Est. completion date: July 25, 2014
• Est. primary completion date: July 25, 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Acquired Immunodeficiency Syndrome
• HIV Infections
• Immunologic Deficiency Syndromes
• Infection, Human Immunodeficiency Virus

Intervention

Drug:
• BMS-663068
BMS-663068

Locations

Country	Name	City	State
United States	GSK Investigational Site	San Antonio	Texas

Sponsors (2)

Lead Sponsor	Collaborator
ViiV Healthcare	GlaxoSmithKline

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maximum observed concentration (Cmax) for BMS-626529 in the presence and absence of food		Days 1-4 of Periods 1 and 2
Primary	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	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
Secondary	Time of maximum observed plasma concentration (Tmax) of BMS-626529		Day 4 of each period
Secondary	Plasma concentration observed at 12 hours postdose (C12) of BMS-626529		Day 4 of each period
Secondary	Trough observed plasma concentration (Ctrough) of BMS-626529		Days 1-4 of each period