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A Study to Investigate the Effects of Itraconazole on the Pharmacokinetics of BMS-986256 in Healthy Participants

Sponsor
Bristol-Myers Squibb (Industry)
Overall Status
Completed
CT.gov ID
NCT03950960
Collaborator
(none)
15
Enrollment
1
Location
1
Arm
3.2
Actual Duration (Months)
4.7
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this study is to evaluate the effect of cytochrome P450 3A4 inhibition by Itraconazole on the pharmacokinetics of BMS-986256.

Condition or Disease Intervention/Treatment Phase
Phase 1

Study Design

Study Type:
Interventional
Actual Enrollment :
15 participants
Intervention Model:
Sequential Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
An Open-label, Single-Sequence, 2-Treatment Period Study to Investigate the Effects of Cytochrome P450 3A4 Inhibition by Itraconazole on the Pharmacokinetics of BMS-986256 in Healthy Participants
Actual Study Start Date :
May 2, 2019
Actual Primary Completion Date :
Jul 31, 2019
Actual Study Completion Date :
Aug 7, 2019

Arms and Interventions

Arm Intervention/Treatment
Experimental: BMS-986256 +Itraconazole

Drug: BMS-986256
Specified dose on specified days

Drug: Itraconazole
Specified dose on specified days

Outcome Measures

Primary Outcome Measures

  1. Maximum Observed Plasma Concentration (Cmax) of BMS-986256 [After single dose on Days 1 and 29]

  2. Area Under the Plasma Concentration-time Curve from Time Zero to Time of Last Quantifiable Concentration (AUC[0-T]) of BMS986256 [After single dose on Days 1 and 29]

  3. Area Under the Plasma Concentration-time Curve From Time Zero Extrapolated to Infinite Time (AUC[INF]) of BMS-986256 [After single dose on Days 1 and 29]

Secondary Outcome Measures

  1. Percentage of Participants with Adverse Events (AEs) [From the time of study treatment administration through the final study visit (Up to 55 days)]

  2. Percentage of Participants with Serious Adverse Events (SAEs) [From the time ICF is signed through 30 days post dose, or the final study visit (Up to 60 days)]

  3. Percentage of Participants with Vital Signs, Electrocardiograms (ECGs), and Physical Examinations Abnormalities [From screening to follow-up (Up to 55 days)]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 55 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes

For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com

Inclusion Criteria:

  • Healthy participant, defined as having no clinically significant active or ongoing medical condition, physical examination abnormality, abnormal ECG finding, and abnormal clinical laboratory determinations that in the opinion of the Investigator would compromise the conduct, results, or interpretation of the study findings

  • A negative QuantiFERON®-TB Gold test result at screening or documentation of a negative result within 3 months of the screening visit

  • Weight greater than or equal to (>=) 50 kilogram (kg) and body mass index between 18.0 and 32.0 kilogram per meter square (kg/m^2) inclusive at screening

Exclusion Criteria:

  • Prior exposure to BMS-986256

  • Previous investigational drug or placebo exposure within 6 weeks before nonbiologic study drug administration or 12 weeks before biologic study drug administration

  • History or presence of malignancy including hematological malignancies. However, participants with a history of basal cell or squamous cell carcinoma that has been completely and successfully treated with no evidence of recurrence may not be excluded, at the discretion of the investigator

Other protocol defined inclusion/exclusion criteria could apply

Contacts and Locations

Locations

Site City State Country Postal Code
1 PRA Health Sciences - Lenexa Lenexa Kansas United States 66219

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:
NCT03950960
Other Study ID Numbers:
  • IM026-020
First Posted:
May 15, 2019
Last Update Posted:
Feb 25, 2020
Last Verified:
Feb 1, 2020
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Bristol-Myers Squibb
Cytochrome P450 3A4 Inhibition
Additional relevant MeSH terms:
Itraconazole

Study Results

No Results Posted as of Feb 25, 2020