A Phase I Study to Investigate the Absorption, Metabolism, and Excretion of Radiolabeled [14C] R924548 Following Single Oral Dose Administration in Healthy Male Subjects

A Phase I Study to Investigate the Absorption, Metabolism, and Excretion of Radiolabeled [14C] R924548 Following Single Oral Dose Administration in Healthy Male Subjects - R548 ADME study

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON37118

Enrollment

Registered

2012-06-19

Start date

2012-06-28

Completion date

Unknown

Last updated

2024-04-29

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

Conditions

immune-mediated diseases rheuma

Interventions

Study Medication Active substance: R548 Activity: janus kinase 1 (JAK1) and janus kinase 3 (JAK3) Dosage form: aqueous suspension or aqueous solution Treatment: a single oral dose of 400 mg 14C-R548

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Healthy male volunteers 18-55 years of age BMI 18.0-31.0 kg/m2

Exclusion criteria

Exclusion criteria: Suffering from: hepatitis B, cancer or HIV/AIDS. Participation in another drug study within 3 months before the start of this study. Blood donation within 3 months from the start of this study or in case you have donated more than 1.5 liters of blood in the 10 months before the start of this study.

Design outcomes

Primary

Measure	Time frame
- Plasma PK of R507 and R689 - Total concentration radioactivity in plasma and whole blood over time - Total amount of radioactivity recovered in urine and feces - Characterized metabolites of R924548 (R548) in plasma, urine, and feces	—

Secondary

Measure	Time frame
Safety and tolerability: adverse events, vital signs, ECG-parameters, laboratory parameters, physical examination	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)