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

Kissei

Status and phase: Completed; Phase 1

Conditions: Healthy Male Subject

Treatments: Drug: [14C]KWA-0711

Study type: Interventional

Funder types: Industry

Identifiers

NCT02434835

KWA1101

Details and patient eligibility

About

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.

Sex: Male

Ages: 35 to 55 years old

Volunteers: No Healthy Volunteers

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.

Trial design

0 participants in 1 patient group

[14C]KWA-0711

Experimental group

Treatment:

Drug: [14C]KWA-0711