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

Malignancies Multiple Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03346837
• Other study ID #: CA017-051
• Status: Completed
• Phase: Phase 1
• First received: November 6, 2017
• Last updated: February 26, 2018
• Start date: November 22, 2017
• Est. completion date: December 20, 2017

Study information

• Verified date: February 2018
• Source: Bristol-Myers Squibb
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 53
• Est. completion date: December 20, 2017
• Est. primary completion date: December 20, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Malignancies Multiple

Intervention

Drug:
• BMS-986205
BMS-986205
• Itraconazole
Oral solution
• Rifampin
Tablet

Locations

Country	Name	City	State
United States	PPD	Austin	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Bristol-Myers Squibb

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maximum observed plasma concentration (Cmax)	Measured by plasma concentration	Up to 25 days
Primary	AUC from time zero to time of last quantifiable concentration (AUC(0-T))	Measured by plasma concentration	Up to 25 days
Primary	AUC from time zero extrapolated to infinite time (AUC(INF))	Measured by plasma concentration	Up to 25 days
Secondary	Incidence of Adverse Events (AEs)	Safety and tolerability as measured by incidence of AEs	Up to 25 days
Secondary	Incidence of Serious Adverse Events (SAEs)	Safety and tolerability as measured by incidence of SAEs	Up to 76 days
Secondary	Number of participants with electrocardiogram abnormalities		Up to 25 days
Secondary	Number of participants with physical examination findings abnormalities		Up to 25 days
Secondary	Number of participants with clinical laboratory abnormalities		Up to 25 days

External Links

•   BMS Clinical Trial Information
•   FDA Safety Alerts and Recalls
•   Investigator Inquiry Form