A Phase 1 study to investigate the absorption, metabolism and excretion of 14C-Orteronel (TAK-700) following a single oral administration in healthy subjects

A Phase 1 study to investigate the absorption, metabolism and excretion of 14C-Orteronel (TAK-700) following a single oral administration in healthy subjects - [14C]-TAK-700 tracer label human ADME study

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON36117

Enrollment

Registered

2011-03-31

Start date

2011-04-19

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

Interventions

Treatment A single oral dose of 200 mg [14C]-TAK-700, containing approximately 18.5 kBq (500 nCi) radiocarbon, on Day 1 in the fasted state Study Medication Active substance : TAK-700 and [14C]-TA

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Healthy male subject 18-55 years, incl BMI 18-30 kg/m2, incl

Exclusion criteria

Exclusion criteria: Suffering from : hepatitis B, cancer or HIV/AIDS. In case of participation in another drug study within 60 days before the start of the study. In case of donating any blood or significant loss of blood within 60 days of the start of drug dosing.

Design outcomes

Primary

Measure	Time frame
safety tolerability absorption, distribution, metabolizing and elimination	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)