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

NCT04039373 | Completed Phase 1 FDA Drug

• 1 other identifier: IM026-022
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Healthy Participants

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (9)

• 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

Study Arms (1)

Treatment Arm

EXPERIMENTAL

Drug: BMS-986256; Drug: Mycophenolate Mofetil

Interventions

BMS-986256 DRUG

specified dose on specified days

Treatment Arm

Mycophenolate Mofetil DRUG

specified dose on specified days

Treatment Arm

Eligibility Criteria

• Age: 18 Years - 55 Years
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Bristol-Myers Squibb: lead

Study Sites (1)

PRA Health Sciences - Salt Lake

Salt Lake City, Utah, 84124, United States

Location

Related Links

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

MeSH Terms

Interventions

Mycophenolic Acid

Intervention Hierarchy (Ancestors)

Caproates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Fatty Acids; Lipids

Study Officials

• Bristol-Myers Squibb

  Bristol-Myers Squibb

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 22, 2019
• First Posted: July 31, 2019
• Study Start: July 22, 2019
• Primary Completion: September 18, 2019
• Study Completion: October 16, 2019
• Last Updated: June 16, 2020

Record last verified: 2020-06

Locations

US (1)