An open-label, single-sequence study to investigate the effects of BMS-986165 on the single-dose pharmacokinetics of methotrexate in healty male subjects.

Completed

• Conditions: Autoimmune diseases; 10003816

• Registration Number: NL-OMON46408
• Lead Sponsor: Bristol-Myers Squibb Research and Development

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 15 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 12

Inclusion Criteria

- healthy male subjects
- 18-50 yrs, inclusive
- BMI: 18.0-32.0 kg/m2, inclusive
- non-smoking

Exclusion Criteria

Suffering from hepatitis B, hepatitis C, cancer or HIV/AIDS. In case of participation in another drug study within 90 days before the start of this study or being a blood donor within 60 days from the start of the study. In case of donating more than 1.5 liters of blood in the 10 months prior the start of this study.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>To evaluate the PK of MTX when administered alone and in combination with<br /><br>BMS-986165</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>To evaluate the safety and tolerability of MTX when administered alone and in<br /><br>combination with BMS-986165.</p><br>