Status:
COMPLETED
A Study to Investigate the Effects of Cytochrome P450 1A2 Induction by Ritonavir on BMS-986165 Drug Levels and Effects in Healthy Participants
Lead Sponsor:
Bristol-Myers Squibb
Conditions:
Healthy Participants
Eligibility:
All Genders
18-50 years
Phase:
PHASE1
Brief Summary
The Study of Cytochrome P450 1A2 Induction by Ritonavir on the drug effects of BMS-986165 in Healthy Participants
Eligibility Criteria
Inclusion
- Normal renal function at screening as evidenced by an estimated glomerular filtration rate (GFR) \> 80 mL/min/1.732 m2 calculated with the Chronic Kidney Disease Epidemiology Collaboration formula.
- 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 onadotropin) within 24 hours prior to the start of study treatment.
- Body mass index of 18.0 kg/m2 to 32.0 kg/m2, inclusive, and body weight ≥ 50 kg, at screening.
Exclusion
- Participants who currently smoke, as well as those who have stopped smoking less than 6 months prior to dosing on Day 1.
- 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.
- Prisoners or participants who are involuntarily incarcerated
- Any significant acute or chronic medical condition that presents a potential risk to the participant and/or may compromise the objectives of the study, including a history of or active liver disease
Key Trial Info
Start Date :
August 14 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 21 2019
Estimated Enrollment :
16 Patients enrolled
Trial Details
Trial ID
NCT04055506
Start Date
August 14 2019
End Date
September 21 2019
Last Update
June 18 2020
Active Locations (1)
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1
PRA Health Sciences - Salt Lake
Salt Lake City, Utah, United States, 84124