A Study to Investigate the Effects of Cytochrome P450 1A2 Induction by Ritonavir on BMS-986165 Drug Levels and Effects in Healthy Participants

Phase 1

Completed

• Conditions: Healthy Participants
• Interventions: Drug: BMS-986165; Drug: Ritonavir

• Registration Number: NCT04055506
• Lead Sponsor: Bristol-Myers Squibb

Brief Summary

The Study of Cytochrome P450 1A2 Induction by Ritonavir on the drug effects of BMS-986165 in Healthy Participants

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-08-09
• Study First Submitted QC: 2019-08-12
• Study First Posted: 2019-08-13
• Study Start: 2019-08-14
• Primary Completion: 2019-09-21
• Study Completion: 2019-09-21
• Status Verified: 2020-06
• Last Update Submitted: 2020-06-16
• Last Update Posted: 2020-06-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 16

Inclusion Criteria

• 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 Criteria

• 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Combination Therapy	BMS-986165	-
Combination Therapy	Ritonavir	-

Primary Outcome Measures

Name	Time	Method
Maximum observed plasma concentration of BMS-986165 in combination with steady-state ritonavir	Day 15
Maximum observed plasma concentration (Cmax) of BMS-986165	Day 1
Area under the plasma concentration-time curve from time zero to the time of the last quantifiable concentration of BMS-986165	Day 1
Area under the plasma concentration-time curve from time zero to the time of the last quantifiable concentration of BMS-986165 in combination with steady-state ritonavir	Day 15
Area under the plasma concentration-time curve from time zero extrapolated to infinite time in BMS-986165 in combination with steady-state ritonavir	Day 15
Area under the plasma concentration-time curve from time zero extrapolated to infinite time in BMS-986165	Day 1

Secondary Outcome Measures

Name	Time	Method
vital signs of blood pressure	initial dose up to day 29
Vital signs of respiratory rate	initial dose up to day 29
Number of Clinically significant changes in the lab assessment of blood	initial dose up to day 29
Number of Clinically significant changes in lab assessment of blood serum	initial dose up to day 29
Number of Clinically significant changes in the lab assessment of urine	initial dose up to day 29
Incidence of Adverse Events (AEs)	initial dose up to day 29
Vital signs of body temperature	initial dose up to day 29

Trial Locations

Locations (1)

PRA Health Sciences - Salt Lake; 🇺🇸 Salt Lake City, Utah, United States