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OpenTrials
Completed

NCT Number: NCT03950960

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

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

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Key information

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

PRA Health Sciences - Lenexa

Lenexa, Kansas, 66219, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

BMS-986256

Drug

Specified dose on specified days

Itraconazole

Drug

Specified dose on specified days

Primary outcomes

  1. Maximum Observed Plasma Concentration (Cmax) of BMS-986256

    Time frame: 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

    Time frame: 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

    Time frame: After single dose on Days 1 and 29

Secondary outcomes

  1. Percentage of Participants with Adverse Events (AEs)

    Time frame: 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)

    Time frame: 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

    Time frame: From screening to follow-up (Up to 55 days)

Sponsors and collaborators

Lead sponsor

Bristol-Myers Squibb

Industry

Registry information

Official study 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

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
May 15, 2019
Registry last updated
Feb 25, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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