An open label, single oral dose study to investigate the pharamcokinetics - absorption, distribution, metabolism, and elimination - of 75 mg of 14C-labeled BCT197 in healthy male volunteers.

An open label, single oral dose study to investigate the pharamcokinetics - absorption, distribution, metabolism, and elimination - of 75 mg of 14C-labeled BCT197 in healthy male volunteers. - BCT197 ADME study

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON36837

Enrollment

Registered

2012-10-10

Start date

2012-10-22

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

chronic infection of the lungs chronic obstructive pulminonary disease

Interventions

a single oral 14C-radiolabeled dose of 75 mg BCT197 (1.85 MBq, 50 µCi) as three 25 mg capsules after an overnight fast of at least 10 hours

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Healthy male volunteers 18-45 years, inclusive BMI: 18-30 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 month prior to the start of this study

Design outcomes

Primary

Measure	Time frame
Pharmacokinetics: blood, plasma and skin concentrations of radioactivity plasma and skin concentrations of BCT197 metabolite patterns in plasma and skin excretion of radioactivity, metabolite patterns in urine and feces Pharmacogenetics Safety: adverse events, vital signs, ECG, clinical laboratory and physical examination.	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)