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

An Open-label, Single-sequence Study to Investigate the Effects of Cytochrome P450 1A2 Induction by Ritonavir on the Pharmacokinetics of BMS-986165 in Healthy Participants

Sponsors

Lead Sponsor: Bristol-Myers Squibb

Source Bristol-Myers Squibb
Brief Summary

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

Overall Status Completed
Start Date August 14, 2019
Completion Date September 21, 2019
Primary Completion Date September 21, 2019
Phase Phase 1
Study Type Interventional
Primary Outcome
Measure Time Frame
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 extrapolated to infinite time in BMS-986165 Day 1
Maximum observed plasma concentration of BMS-986165 in combination with steady-state ritonavir Day 15
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
Secondary Outcome
Measure Time Frame
Incidence of Adverse Events (AEs) initial dose up to day 29
vital signs of blood pressure initial dose up to day 29
Vital signs of body temperature initial dose up to day 29
Vital signs of respiratory rate 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 blood initial dose up to day 29
Number of Clinically significant changes in the lab assessment of urine initial dose up to day 29
Enrollment 16
Condition
Intervention

Intervention Type: Drug

Intervention Name: BMS-986165

Description: Dose 1

Arm Group Label: Combination Therapy

Intervention Type: Drug

Intervention Name: Ritonavir

Description: 100 mg

Arm Group Label: Combination Therapy

Eligibility

Criteria:

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

Gender: All

Minimum Age: 18 Years

Maximum Age: 50 Years

Healthy Volunteers: Accepts Healthy Volunteers

Overall Official
Last Name Role Affiliation
Bristol-Myers Squibb Study Director Bristol-Myers Squibb
Location
Facility: PRA Health Sciences - Salt Lake
Location Countries

United States

Verification Date

June 2020

Responsible Party

Type: Sponsor

Has Expanded Access No
Number Of Arms 1
Arm Group

Label: Combination Therapy

Type: Experimental

Study Design Info

Allocation: N/A

Intervention Model: Single Group Assignment

Primary Purpose: Health Services Research

Masking: None (Open Label)

Source: ClinicalTrials.gov