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

• Sponsor: Bristol-Myers Squibb (Industry)
• Overall Status: Completed
• CT.gov ID: NCT03346837
• Collaborator: (none)
• Enrollment: 53
• Location: 1
• Arms: 4
• Actual Duration (Days): 28
• Patients Per Site Per Month: 57.6

Study Details

Study Description

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.

Study Design

• Study Type: Interventional
• 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: Nov 22, 2017
• Actual Primary Completion Date: Dec 20, 2017
• Actual Study Completion Date: Dec 20, 2017

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Maximum observed plasma concentration (Cmax) [Up to 25 days]

   Measured by plasma concentration

2. AUC from time zero to time of last quantifiable concentration (AUC(0-T)) [Up to 25 days]

   Measured by plasma concentration

3. AUC from time zero extrapolated to infinite time (AUC(INF)) [Up to 25 days]

   Measured by plasma concentration

Secondary Outcome Measures

1. Incidence of Adverse Events (AEs) [Up to 25 days]

   Safety and tolerability as measured by incidence of AEs

2. Incidence of Serious Adverse Events (SAEs) [Up to 76 days]

   Safety and tolerability as measured by incidence of SAEs

3. Number of participants with electrocardiogram abnormalities [Up to 25 days]

4. Number of participants with physical examination findings abnormalities [Up to 25 days]

5. Number of participants with clinical laboratory abnormalities [Up to 25 days]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 50 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	PPD	Austin	Texas	United States	78744

Sponsors and Collaborators

• Bristol-Myers Squibb

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• FDA Safety Alerts and Recalls

Publications

None provided.

• Responsible Party: Bristol-Myers Squibb
• ClinicalTrials.gov Identifier: NCT03346837
• Other Study ID Numbers: CA017-051
• First Posted: Nov 17, 2017
• Last Update Posted: Feb 28, 2018
• Last Verified: Feb 1, 2018

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Neoplasms; Itraconazole; Rifampin; Linrodostat

Study Results

No Results Posted as of Feb 28, 2018