Study on Effects of BMS-955176 on the Pharmacokinetics of Probe Substrates

HIV Infections Clinical Trial

Official title:

Effects of BMS-955176 on the Single-dose Pharmacokinetics of Probe Substrates (Caffeine, Metoprolol, Montelukast, Flurbiprofen, Omeprazole, Midazolam, Digoxin, and Pravastatin) in Healthy Subjects

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02578277
• Other study ID #: 206294
• Secondary ID: AI468-063
• Status: Completed
• Phase: Phase 1
• Start date: November 9, 2015
• Est. completion date: December 23, 2015

Study information

• Verified date: July 2018
• Source: ViiV Healthcare
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of the study is to study the effects of BMS-955176 on the single-dose PK parameters of probe substrates caffeine, metoprolol, montelukast, flurbiprofen, omeprazole, midazolam, digoxin, and pravastatin

Recruitment information / eligibility

• Status: Completed
• Enrollment: 59
• Est. completion date: December 23, 2015
• Est. primary completion date: December 23, 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

Inclusion Criteria:

1. Written Informed Consent

2. Healthy male and female (not of childbearing potential) subjects as determined by medical history, surgical history, physical examination, vital signs, ECGs, and clinical laboratory determinations

3. Body mass index (BMI) of 18.0 kg/m2 to 32.0 kg/m2, inclusive, at screening and Day 1. BMI = weight (kg)/[height(m)]

4. Women must have documented proof that they are not of childbearing potential (eg, surgically sterile, postmenopausal with a documented follicle-stimulating hormone (FSH) > 40 mIU/mL) and should not be breast feeding

5. Males who are sexually active with WOCBP must agree to follow instructions for method(s) of contraception for the duration of treatment with BMS-955176 in addition to a post-treatment completion period

Exclusion Criteria:

1. Any significant acute or chronic medical illness

2. Use of tobacco, excessive alcohol

3. Medical history indicative of an increased risk of a cardiac arrhythmia or cardiac disease and history of asthma, bronchospasm, sleep apnea, rhabdomyolysis, a bleeding disorder, a major depressive disorder within the past 6 months, peptic ulcer or significant GI bleed, Raynaud's disease, or any gastrointestinal surgery that could impact upon the absorption of study drug

4. 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

5. History of allergy to BMS-955176, digoxin (or any member of the digitalis glycosides class of drugs), caffeine, metoprolol, montelukast, flurbiprofen, omeprazole, midazolam, or pravastatin, or to any related compounds

Related Conditions & MeSH terms

• HIV Infections

Intervention

Drug:
• CYP and transporter probe substrates
Cocktail of CYP (cytochrome P450) and transporter probe substrates
• BMS-955176
BMS-955176
• BMS-955176 plus CYP and transporter probe substrates
BMS-955176 plus the cocktail of CYP and transporter probe substrates

Locations

Country	Name	City	State
United States	GSK Investigational Site	Austin	Texas

Sponsors (1)

Lead Sponsor	Collaborator
ViiV Healthcare

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cmax (maximum observed concentration)		Days 1 to 18
Primary	AUC(0-T), area under the concentration-time curve from time zero to the time of the last quantifiable concentration		Days 1 to 18
Primary	AUC(INF), area under the concentration-time curve from time zero extrapolated to infinite time		Days 1 to 18