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

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

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON46408

Enrollment

Registered

2017-12-18

Start date

2018-02-07

Completion date

Unknown

Last updated

2024-04-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Autoimmune diseases

Interventions

The volunteer receives 7.5 mg of methotraxate as a tablet on Day 1 and Day 12, 15 mg of leucovorin as a capsule on Day 2 and Day 13 and 12 mg BMS-986165 daily as capsules from the morning of Day 8 t

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

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

Exclusion criteria

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.

Design outcomes

Primary

Measure	Time frame
To evaluate the PK of MTX when administered alone and in combination with BMS-986165	—

Secondary

Measure	Time frame
To evaluate the safety and tolerability of MTX when administered alone and in combination with BMS-986165.	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)