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

Sponsor
Bristol-Myers Squibb (Industry)
Overall Status
Completed
CT.gov ID
NCT04055506
Collaborator
(none)
16
Enrollment
1
Location
1
Arm
1.2
Actual Duration (Months)
12.8
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
Phase 1

Study Design

Study Type:
Interventional
Actual Enrollment :
16 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Health Services Research
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
Actual Study Start Date :
Aug 14, 2019
Actual Primary Completion Date :
Sep 21, 2019
Actual Study Completion Date :
Sep 21, 2019

Arms and Interventions

Arm Intervention/Treatment
Experimental: Combination Therapy

Drug: BMS-986165
Dose 1

Drug: Ritonavir
100 mg

Outcome Measures

Primary Outcome Measures

  1. Maximum observed plasma concentration (Cmax) of BMS-986165 [Day 1]

  2. Area under the plasma concentration-time curve from time zero to the time of the last quantifiable concentration of BMS-986165 [Day 1]

  3. Area under the plasma concentration-time curve from time zero extrapolated to infinite time in BMS-986165 [Day 1]

  4. Maximum observed plasma concentration of BMS-986165 in combination with steady-state ritonavir [Day 15]

  5. 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]

  6. 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 Measures

  1. Incidence of Adverse Events (AEs) [initial dose up to day 29]

  2. vital signs of blood pressure [initial dose up to day 29]

  3. Vital signs of body temperature [initial dose up to day 29]

  4. Vital signs of respiratory rate [initial dose up to day 29]

  5. Number of Clinically significant changes in lab assessment of blood serum [initial dose up to day 29]

  6. Number of Clinically significant changes in the lab assessment of blood [initial dose up to day 29]

  7. Number of Clinically significant changes in the lab assessment of urine [initial dose up to day 29]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 50 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 PRA Health Sciences - Salt Lake Salt Lake City Utah United States 84124

Sponsors and Collaborators

  • Bristol-Myers Squibb

Investigators

  • Study Director: Bristol-Myers Squibb, Bristol-Myers Squibb

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

None provided.
Responsible Party:
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT04055506
Other Study ID Numbers:
  • IM011-087
First Posted:
Aug 13, 2019
Last Update Posted:
Jun 18, 2020
Last Verified:
Jun 1, 2020
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Ritonavir
BMS-986165

Study Results

No Results Posted as of Jun 18, 2020