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

Phase 1

Completed

• Conditions: Healthy Male Subject
• Interventions: Drug: [14C]KWA-0711

• Registration Number: NCT02434835
• Lead Sponsor: Kissei Pharmaceutical Co., Ltd.

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-04-21
• Primary Completion: 2015-05
• Study First Submitted QC: 2015-05-04
• Study First Posted: 2015-05-05
• Status Verified: 2016-04
• Last Update Submitted: 2016-04-15
• Last Update Posted: 2016-04-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: Not specified

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
[14C]KWA-0711	[14C]KWA-0711	-

Primary Outcome Measures

Name	Time	Method
Area under the plasma concentration-time curve (AUC) of total radioactivity, unchanged drug substance and its major metabolites	240 hours
Maximum observed plasma concentration (Cmax) of total radioactivity, unchanged drug substance and its major metabolites	240 hours
Cumulative radioactivity recovery in urine and feces	240 hours
Profiles of metabolites in plasma, urine and faeces	240 hours

Secondary Outcome Measures

Name	Time	Method
Number of adverse events	240 hours