Study of Absorption, Metabolism and Excretion Following a Single Oral Dose of [14C]KWA-0711 to Healthy Male Subjects

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Study Classification

INTERVENTIONAL

Brief Summary

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The purpose of this study is to evaluate the absorption, metabolism and excretion following a single oral dose of \[14C\]KWA-0711 to healthy male subjects.

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Detailed Description

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Conditions

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Healthy Male Subject

Study Groups

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[14C]KWA-0711

Group Type EXPERIMENTAL

[14C]KWA-0711

Intervention Type DRUG

Interventions

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[14C]KWA-0711

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Subjects who are male, caucasian, and between 35 and 55 years of age, inclusive.
* Subjects who have a body mass index (BMI) between 18.5 and 30.0 kg/m2, inclusive.
* Subjects who have a body weight between 50 and 100 kg, inclusive.
* Subjects must have regular bowel movements.

Exclusion Criteria

* Subjects who have an abnormality in heart rate, blood pressure , temperature or 12-lead ECG.
* Subjects who are still participating in a clinical study or who have participated in a clinical study involving administration of an investigational drug in the 3 months prior to dose administration.
* Subjects who have had a clinically significant illness within 4 weeks of dose administration as determined by the Investigator.
* Subjects who have any clinically significant abnormal laboratory safety findings.
* Subjects who have had an X ray or who have participated in any clinical trial involving a radiolabelled investigational product or have been exposed to radiolabelled substances within 12 months prior to dose administration.

Minimum Eligible Age

35 Years

Maximum Eligible Age

55 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No