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A phase 1, open-label study to characterize the absorption, metabolism, and excretion of 14C-JNJ-53718678 after a single oral dose in healthy adult male subjects

A phase 1, open-label study to characterize the absorption, metabolism, and excretion of 14C-JNJ-53718678 after a single oral dose in healthy adult male subjects - JNJ-53718678 ADME study

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON43122
Enrollment
6
Registered
2016-12-19
Start date
2017-01-27
Completion date
Unknown
Last updated
2025-09-08

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

Conditions

RSV

Interventions

The volunteer will receive a single dose of 500 mg radiolabeled JNJ-53718678 as an oral solution (50 milliliter).

Sponsors

Janssen Sciences Ireland UC
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: - healthy male subjects - 18 - 55 yrs, inclusive - BMI: 18.0 to 30.0 kg/m2, extremes included

Exclusion criteria

Exclusion criteria: Suffering from hepatitis B, hepatitis C, cancer or HIV/AIDS. Subject has received an experimental drug or experimental vaccine, or has used an experimental medical device within 1 month or within a period less than 10 times the drug*s half-life, whichever is longer, before scheduled study drug administration. Subject has donated blood or blood products or has had substantial loss of blood within 3 months before study drug administration or intention to donate blood or blood products during the study.

Design outcomes

Primary

MeasureTime frame
- to determine the routes of excretion for JNJ-53718678 and its metabolites after administration of a single oral dose of 14C-JNJ-53718678 in healthy adult male subjects - to explore the metabolic pathways of JNJ-53718678 after administration of a single oral dose of 14C-JNJ-53718678 in healthy adult male subjects - to determine the chemical structure of predominant metabolites

Secondary

MeasureTime frame
To determine safety and tolerability of a single oral dose of 14CJNJ- 53718678 in healthy adult male subjects.

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)