An open-label, single-arm study to determine the excretion balance and metabolic disposition of [14C]GW642444 administered as a single dose of an oral solution to healthy male volunteers

An open-label, single-arm study to determine the excretion balance and metabolic disposition of [14C]GW642444 administered as a single dose of an oral solution to healthy male volunteers - [14C]-GW642444 ADME study

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON34294

Enrollment

Registered

2010-04-29

Start date

2010-05-18

Completion date

Unknown

Last updated

2024-05-06

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

Conditions

Asthma COPD

Interventions

Active substance: GW642444 and [14C]-GW642444

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: 1.Healthy male aged between 30 and 55 years inclusive, at the time of signing the informed consent. 2.Body Mass Index (BMI) within the range 18.5-29.0 kg/m2. 3.Subjects who are current non-smokers, who have not used any tobacco products in the 12 month period preceding the screening visit, and have a pack history of * 5 pack years.

Exclusion criteria

Exclusion criteria: 1.Suffering from: hepatitis B, cancer or HIV/AIDS. In case of participation in another drug study within 60 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
Pharmacokinetics Safety	—

Secondary

Measure	Time frame
n.a.	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)