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

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

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

Study Overview

• Status: Completed
• Conditions: Malignancies Multiple
• Intervention / Treatment: Drug: Itraconazole; Drug: BMS-986205; Drug: Rifampin

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.

• Study Type: Interventional
• Enrollment (Actual): 53
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Texas
    • Austin, Texas, United States, 78744
      • PPD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / 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: Itraconazole; Oral solution; Drug: BMS-986205; BMS-986205
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Maximum observed plasma concentration (Cmax)	Measured by plasma concentration	Up to 25 days
AUC from time zero to time of last quantifiable concentration (AUC(0-T))	Measured by plasma concentration	Up to 25 days
AUC from time zero extrapolated to infinite time (AUC(INF))	Measured by plasma concentration	Up to 25 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of Adverse Events (AEs)	Safety and tolerability as measured by incidence of AEs	Up to 25 days
Incidence of Serious Adverse Events (SAEs)	Safety and tolerability as measured by incidence of SAEs	Up to 76 days
Number of participants with electrocardiogram abnormalities		Up to 25 days
Number of participants with physical examination findings abnormalities		Up to 25 days
Number of participants with clinical laboratory abnormalities		Up to 25 days

Collaborators and Investigators

• Sponsor: Bristol-Myers Squibb
• Investigators: Study Director: Bristol-Myers Squibb, Briston-Myers Squibb

Publications and helpful links

Helpful Links

• FDA Safety Alerts and Recalls

Study record dates

Study Major Dates

• Study Start (Actual): November 22, 2017
• Primary Completion (Actual): December 20, 2017
• Study Completion (Actual): December 20, 2017

Study Registration Dates

• First Submitted: November 6, 2017
• First Submitted That Met QC Criteria: November 15, 2017
• First Posted (Actual): November 17, 2017

Study Record Updates

• Last Update Posted (Actual): February 28, 2018
• Last Update Submitted That Met QC Criteria: February 26, 2018
• Last Verified: February 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Nucleic Acid Synthesis Inhibitors; Enzyme Inhibitors; Hormones, Hormone Substitutes, and Hormone Antagonists; Anti-Bacterial Agents; Cytochrome P-450 CYP3A Inhibitors; Cytochrome P-450 Enzyme Inhibitors; Leprostatic Agents; Hormone Antagonists; Cytochrome P-450 Enzyme Inducers; Antifungal Agents; Steroid Synthesis Inhibitors; Cytochrome P-450 CYP3A Inducers; Antitubercular Agents; 14-alpha Demethylase Inhibitors; Antibiotics, Antitubercular; Cytochrome P-450 CYP2B6 Inducers; Cytochrome P-450 CYP2C8 Inducers; Cytochrome P-450 CYP2C19 Inducers; Cytochrome P-450 CYP2C9 Inducers; Rifampin; Itraconazole; Linrodostat
• Other Study ID Numbers: CA017-051

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No