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

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ClinicalTrials.gov Identifier: NCT03950960
Recruitment Status : Recruiting
First Posted : May 15, 2019
Last Update Posted : August 13, 2019
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb

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
Healthy Participants Drug: BMS-986256 Drug: Itraconazole Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 45 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 : July 31, 2019
Estimated Study Completion Date : August 7, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: BMS-986256 +Itraconazole Drug: BMS-986256
Specified dose on specified days

Drug: Itraconazole
Specified dose on specified days




Primary Outcome Measures :
  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 Outcome Measures :
  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) ]


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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03950960


Contacts
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Contact: Recruiting sites have contact information. Please contact the sites directly. If there is no contact information, please email: Clinical.Trials@bms.com
Contact: First line of the email MUST contain NCT# and Site #.

Locations
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United States, Kansas
PRA Health Sciences- Lenexa Recruiting
Lenexa, Kansas, United States, 66219
Contact: Gregory Appenfeller, Site 0001    913-410-2218      
Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
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Study Director: Bristol-Myers Squibb Bristol-Myers Squibb

Additional Information:
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Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT03950960     History of Changes
Other Study ID Numbers: IM026-020
First Posted: May 15, 2019    Key Record Dates
Last Update Posted: August 13, 2019
Last Verified: August 2019

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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:
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Itraconazole
Hydroxyitraconazole
Antifungal Agents
Anti-Infective Agents
14-alpha Demethylase Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Steroid Synthesis Inhibitors
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Cytochrome P-450 CYP3A Inhibitors