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

Healthy Participants Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04055506
• Other study ID #: IM011-087
• Status: Completed
• Phase: Phase 1
• Start date: August 14, 2019
• Est. completion date: September 21, 2019

Study information

• Verified date: June 2020
• Source: Bristol-Myers Squibb
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: September 21, 2019
• Est. primary completion date: September 21, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Healthy Participants

Intervention

Drug:
• BMS-986165
Dose 1
• Ritonavir
100 mg

Locations

Country	Name	City	State
United States	PRA Health Sciences - Salt Lake	Salt Lake City	Utah

Sponsors (1)

Lead Sponsor	Collaborator
Bristol-Myers Squibb

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maximum observed plasma concentration (Cmax) of BMS-986165		Day 1
Primary	Area under the plasma concentration-time curve from time zero to the time of the last quantifiable concentration of BMS-986165		Day 1
Primary	Area under the plasma concentration-time curve from time zero extrapolated to infinite time in BMS-986165		Day 1
Primary	Maximum observed plasma concentration of BMS-986165 in combination with steady-state ritonavir		Day 15
Primary	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
Primary	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	Incidence of Adverse Events (AEs)		initial dose up to day 29
Secondary	vital signs of blood pressure		initial dose up to day 29
Secondary	Vital signs of body temperature		initial dose up to day 29
Secondary	Vital signs of respiratory rate		initial dose up to day 29
Secondary	Number of Clinically significant changes in lab assessment of blood serum		initial dose up to day 29
Secondary	Number of Clinically significant changes in the lab assessment of blood		initial dose up to day 29
Secondary	Number of Clinically significant changes in the lab assessment of urine		initial dose up to day 29

External Links

•   BMS Clinical Trial Information
•   BMS Clinical Trial Patient Recruiting
•   FDA Safety Alerts and Recalls
•   Investigator Inquiry Form