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

Healthy Participants Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04039373
• Other study ID #: IM026-022
• Status: Completed
• Phase: Phase 1
• Start date: July 22, 2019
• Est. completion date: October 16, 2019

Study information

• Verified date: June 2020
• Source: Bristol-Myers Squibb
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: October 16, 2019
• Est. primary completion date: September 18, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 55 Years

Eligibility

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.

Related Conditions & MeSH terms

• Healthy Participants

Intervention

Drug:
• BMS-986256
specified dose on specified days
• Mycophenolate Mofetil
specified dose on specified days

Locations

Country	Name	City	State
United States	PRA Health Sciences - Salt Lake	Salt Lake City	Utah

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	Mycophenolic Acid (MPA) PK parameter: Maximum observed plasma concentration (Cmax)		days 1-5 and days 26 -30
Primary	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
Primary	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	Incidence of Adverse Events (AEs)		up to 51 days
Secondary	Incidence of Serious Adverse Events (SAEs)		up to 51 days
Secondary	Number of Clinically significant changes in lab assessment of blood serum		up to 51 days
Secondary	Number of Clinically significant changes in assessment of blood		up to 51 days
Secondary	Number of Clinically significant changes in lab assessment of urine		up to 51 days
Secondary	Vital signs of blood pressure		up to 51 days
Secondary	Vital signs of body temperature		up to 51 days
Secondary	Vital signs of respiratory rate		up to 51 days
Secondary	Number of Participants with abnormal physical examination findings		up to 51 days

External Links

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