Effects of BMS-986256 at Steady State on the Single Dose Pharmacokinetics of Mycophenolate Mofetil

Sponsor

Bristol-Myers Squibb (Industry)

Overall Status

Completed

CT.gov ID

NCT04039373

Collaborator

(none)

Enrollment

Location

Arm

2.8

Actual Duration (Months)

5.3

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

A Study to Investigate BMS-986256 at steady state and its effect on Mycophenolate Mofetil exposure in Healthy Male Participants

Condition or Disease	Intervention/Treatment	Phase
Healthy Participants	Drug: BMS-986256 Drug: Mycophenolate Mofetil	Phase 1

Study Design

Study Type:

Interventional

Actual Enrollment :

15 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Prevention

Official Title:

An Open-label, Single-sequence Study to Investigate the Effects of BMS-986256 at Steady State on the Single Dose Pharmacokinetics of Mycophenolate Mofetil in Healthy Male Participants

Actual Study Start Date :

Jul 22, 2019

Actual Primary Completion Date :

Sep 18, 2019

Actual Study Completion Date :

Oct 16, 2019

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Treatment Arm	Drug: BMS-986256 specified dose on specified days Drug: Mycophenolate Mofetil specified dose on specified days

Arm

Intervention/Treatment

Experimental: Treatment Arm

Drug: BMS-986256

specified dose on specified days

Drug: Mycophenolate Mofetil

specified dose on specified days

Outcome Measures

Primary Outcome Measures

Mycophenolic Acid (MPA) PK parameter: Maximum observed plasma concentration (Cmax) [days 1-5 and days 26 -30]
mycophenolic acid (MPA) PK parameter: area under the concentration-time curve from time zero to the time of the last quantifiable concentration AUC (0-T) [Days 1-5 and Days 26 -30]
Mycophenolic Acid (MPA) PK parameter:area under the concentration-time curve from time zero extrapolated to infinite time AUC (INF) [Days 1-5 and days 26 -30]

Secondary Outcome Measures

Incidence of Adverse Events (AEs) [up to 51 days]
Incidence of Serious Adverse Events (SAEs) [up to 51 days]
Number of Clinically significant changes in lab assessment of blood serum [up to 51 days]
Number of Clinically significant changes in assessment of blood [up to 51 days]
Number of Clinically significant changes in lab assessment of urine [up to 51 days]
Vital signs of blood pressure [up to 51 days]
Vital signs of body temperature [up to 51 days]
Vital signs of respiratory rate [up to 51 days]
Number of Participants with abnormal physical examination findings [up to 51 days]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 55 Years

Sexes Eligible for Study:

Male

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

Healthy participant, defined as having no clinically significant active or ongoing medical condition, physical examination abnormality, abnormal ECG finding, with no current use of tobacco
A negative QuantiFERON-TB Gold® test result at screening or documentation of a negative result within 3 months of the screening visit and a weight ≥ 50 kg and BMI between 18.0 and 32.0 kg/m2 inclusive at screening.
Participants must not be current users (within 6 months before screening) of tobacco or tobacco- or nicotine-containing products; they must also be willing to refrain from using any of these products during their participation in the study.
Men who are sexually active with women of childbearing potential (WOCBP) must agree to follow instructions for method(s) of contraception (APPENDIX 4) for the duration of treatment with BMS-986256 or MMF, plus 5 half-lives of BMS-986256 (19 days) plus an additional 90 days (duration of sperm turnover) for a total of 109 days post treatment. In addition, participants must be willing to refrain from sperm donation during this time.

Exclusion Criteria:

Any significant acute or chronic medical illness or condition, in the opinion of the investigator in addition to prior exposure to BMS-986256
Major surgery within 4 weeks before study treatment administration, drug abuse or drug addiction.
Participants who have smoked or used smoking cessation or other nicotine-containing products within 6 months before the first dose of study drug.
History or presence of malignancy including hematological malignancies. However,participants with a history of basal cell or squamous cell carcinoma of the skin that has been completely and successfully treated with no evidence of recurrence may not be excluded, at the discretion of the investigator.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	PRA Health Sciences - Salt Lake	Salt Lake City	Utah	United States	84124

Sponsors and Collaborators

Bristol-Myers Squibb

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

None provided.

Responsible Party:

Bristol-Myers Squibb

ClinicalTrials.gov Identifier:

NCT04039373

Other Study ID Numbers:

IM026-022

First Posted:

Jul 31, 2019

Last Update Posted:

Jun 16, 2020

Last Verified:

Jun 1, 2020

Studies a U.S. FDA-regulated Drug Product:

Yes

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Mycophenolic Acid

Study Results

No Results Posted as of Jun 16, 2020