Pharmacokinetics and metabolism of [14C] BMS-986195 in healthy male subjects

Pharmacokinetics and metabolism of [14C] BMS-986195 in healthy male subjects - BMS-986195 ADME study

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON44627

Enrollment

Registered

2017-08-02

Start date

2017-08-16

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

Rheumatoid arthritis

Interventions

The volunteer will receive a single dose of 10 mg radiolabeled BMS-986195 as oral solution of 1 milliliter (mL).

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: - healthy male subjects, - 18 - 55 years, inclusive - BMI: 18.0 - 32.0 kg/m2, inclusive

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 assess the PK, metabolism routes and extent of elimination of a single oral dose of 10 mg [14C] BMS-986195 containing approximately 80 µCi (3.0 MBq) total radioactivity (TRA) in healthy male subjects.	—

Secondary

Measure	Time frame
To assess the safety and tolerability of a single oral dose of 10 mg [14C] BMS-986195 containing approximately 80 µCi (3.0 MBq) TRA.	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)