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A Study to Evaluate the Effect of 2 Drugs on the Pharmacokinetics of BMS-986205 in Healthy Subjects

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ClinicalTrials.gov Identifier: NCT03346837
Recruitment Status : Completed
First Posted : November 17, 2017
Last Update Posted : February 28, 2018
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb

Brief Summary:
Assess the effects of itraconazole and rifampin on the pharmacokinetics, safety, and tolerability of BMS-986205.

Condition or disease Intervention/treatment Phase
Malignancies Multiple Drug: BMS-986205 Drug: Itraconazole Drug: Rifampin Phase 1

Detailed Description:
A randomized, open-label, parallel design study in healthy participants to assess the effects of itraconazole and rifampin on the single-dose pharmacokinetics of BMS-986205. Safety and tolerability data to be collected and assessed as well.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 53 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: A Randomized, Open-Label, Four-Cohort, Parallel Design Study to Evaluate the Effect of Itraconazole or Rifampin on the Single-Dose Pharmacokinetics of BMS-986205 in Normal Healthy Participants
Actual Study Start Date : November 22, 2017
Actual Primary Completion Date : December 20, 2017
Actual Study Completion Date : December 20, 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Inhibition (Cohort 1)
Single oral dose BMS-986205
Drug: BMS-986205
BMS-986205

Experimental: Inhibition (Cohort 2)
Daily oral itraconazole doses for 24 days; single oral dose BMS-986205 on day 4
Drug: BMS-986205
BMS-986205

Drug: Itraconazole
Oral solution

Experimental: Induction (Cohort 3)
Single oral dose BMS-986205
Drug: BMS-986205
BMS-986205

Experimental: Induction (Cohort 4)
Daily oral rifampin doses for21 days; single oral dose BMS-986205 on day 8
Drug: BMS-986205
BMS-986205

Drug: Rifampin
Tablet




Primary Outcome Measures :
  1. Maximum observed plasma concentration (Cmax) [ Time Frame: Up to 25 days ]
    Measured by plasma concentration

  2. AUC from time zero to time of last quantifiable concentration (AUC(0-T)) [ Time Frame: Up to 25 days ]
    Measured by plasma concentration

  3. AUC from time zero extrapolated to infinite time (AUC(INF)) [ Time Frame: Up to 25 days ]
    Measured by plasma concentration


Secondary Outcome Measures :
  1. Incidence of Adverse Events (AEs) [ Time Frame: Up to 25 days ]
    Safety and tolerability as measured by incidence of AEs

  2. Incidence of Serious Adverse Events (SAEs) [ Time Frame: Up to 76 days ]
    Safety and tolerability as measured by incidence of SAEs

  3. Number of participants with electrocardiogram abnormalities [ Time Frame: Up to 25 days ]
  4. Number of participants with physical examination findings abnormalities [ Time Frame: Up to 25 days ]
  5. Number of participants with clinical laboratory abnormalities [ Time Frame: Up to 25 days ]


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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Body mass index 18.0 to 32.0 kg/m2, inclusive
  • Must have normal renal function demonstrated by GFR, calculated by Chronic Kidney Disease Epidemiology Collaboration formula
  • Women must not be of childbearing potential (cannot become pregnant)

Exclusion Criteria:

  • Any significant acute or chronic medical illness
  • History of glucose-6-phosphodiesterase (G6PD) deficiency
  • Personal or family history of cytochrome b5 reductase deficiency

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): NCT03346837


Locations
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United States, Texas
PPD
Austin, Texas, United States, 78744
Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
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Study Director: Bristol-Myers Squibb Briston-Myers Squibb

Additional Information:
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Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT03346837     History of Changes
Other Study ID Numbers: CA017-051
First Posted: November 17, 2017    Key Record Dates
Last Update Posted: February 28, 2018
Last Verified: February 2018

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Itraconazole
Hydroxyitraconazole
Rifampin
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
Antibiotics, Antitubercular
Antitubercular Agents
Anti-Bacterial Agents
Leprostatic Agents
Nucleic Acid Synthesis Inhibitors
Cytochrome P-450 CYP2B6 Inducers
Cytochrome P-450 Enzyme Inducers
Cytochrome P-450 CYP2C8 Inducers
Cytochrome P-450 CYP2C19 Inducers
Cytochrome P-450 CYP2C9 Inducers
Cytochrome P-450 CYP3A Inducers