NCT04055506

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
16

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Aug 2019

Shorter than P25 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 9, 2019

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 13, 2019

Completed
1 day until next milestone

Study Start

First participant enrolled

August 14, 2019

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 21, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 21, 2019

Completed
Last Updated

June 18, 2020

Status Verified

June 1, 2020

Enrollment Period

1 month

First QC Date

August 9, 2019

Last Update Submit

June 16, 2020

Conditions

Healthy Participants

Outcome Measures

Primary Outcomes (6)

  • 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 Outcomes (7)

  • 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

  • +2 more secondary outcomes

Study Arms (1)

Combination Therapy

EXPERIMENTAL
Drug: BMS-986165Drug: Ritonavir

Interventions

BMS-986165DRUG

Dose 1

Combination Therapy
RitonavirDRUG

100 mg

Combination Therapy

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

PRA Health Sciences - Salt Lake

Salt Lake City, Utah, 84124, United States

Location

Related Links

MeSH Terms

Interventions

deucravacitinibRitonavir

Intervention Hierarchy (Ancestors)

ThiazolesSulfur CompoundsOrganic ChemicalsAzolesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Bristol-Myers Squibb

    Bristol-Myers Squibb

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 9, 2019

First Posted

August 13, 2019

Study Start

August 14, 2019

Primary Completion

September 21, 2019

Study Completion

September 21, 2019

Last Updated

June 18, 2020

Record last verified: 2020-06

Locations

US(1)