A Phase I open-label study to investigate the mass balance and biotransformation of a single oral 160 mg (100 µCi) dose of 14C-MDV3100 (ASP9785) in healthy male subjects

A Phase I open-label study to investigate the mass balance and biotransformation of a single oral 160 mg (100 µCi) dose of 14C-MDV3100 (ASP9785) in healthy male subjects - [14C]- MDV3100 tracer label study

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON35823

Enrollment

Registered

2011-03-18

Start date

2011-04-12

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

prostate cancer prostate carcinoom

Interventions

active substance MDV3100 and [14C]- MDV3100

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: -Healthy male subjects -18 to 55 years inclusive. -BMI 18.5 to 30.0 kg/m2 -Non-smoker, or not more than 10 cigarettes for at least three months before drug administration

Exclusion criteria

Exclusion criteria: Suffering from: hepatitis B, 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 90 days from the start of the study. In case of donating more than 1.5 liters of blood in the 12 months prior the start of this study. Participation is also not permitted when participated in more than 3 other drug studies in the 10 months prior to the start of this study.

Design outcomes

Primary

Measure	Time frame
- radiokinetics - pharmacokinetics - safety - tolerability	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)