A phase 1, open-label study to characterize the absorption, metabolism and excretion of 14C-JNJ-63623872 after a single dose in healthy male subjects

A phase 1, open-label study to characterize the absorption, metabolism and excretion of 14C-JNJ-63623872 after a single dose in healthy male subjects - JNJ-63623872 ADME study

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON42724

Enrollment

Registered

2015-05-06

Start date

2015-05-18

Completion date

Unknown

Last updated

2024-04-23

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

Conditions

Influenza A RNA-virus

Interventions

The volunteer will receive a single 600 mg dose of JNJ-63623872 in the form of three capsules (200 mg per capsule).

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Healthy male subjects 18-60 years, inclusive BMI: 18.0-30.0 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 months prior the start of this study.

Design outcomes

Primary

Measure	Time frame
The primary objective is to characterize the absorption and metabolic pathways of JNJ-63623872, and the excretion of the compound and its metabolites, after single oral dosing of 14C-JNJ-63623872 in healthy adult male subjects.	—

Secondary

Measure	Time frame
The secondary objective of this study is to determine safety and tolerability for a single oral dose of 14C-JNJ-63623872 in healthy adult male subjects.	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)