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

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.

Study Overview

• Status: Completed
• Conditions: Healthy Male Subject
• Intervention / Treatment: Drug: [14C]KWA-0711

• Study Type: Interventional
• Phase: Phase 1

Contacts and Locations

Study Locations

• United Kingdom
  • Leeds, United Kingdom

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 35 years to 55 years (Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: Male

Description

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 Plan

How is the study designed?

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: [14C]KWA-0711	Drug: [14C]KWA-0711

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Outcome Measure	Time Frame
Number of adverse events	240 hours

Collaborators and Investigators

• Sponsor: Kissei Pharmaceutical Co., Ltd.

Study record dates

Study Major Dates

• Primary Completion (Actual): May 1, 2015

Study Registration Dates

• First Submitted: April 21, 2015
• First Submitted That Met QC Criteria: May 4, 2015
• First Posted (Estimate): May 5, 2015

Study Record Updates

• Last Update Posted (Estimate): April 18, 2016
• Last Update Submitted That Met QC Criteria: April 15, 2016
• Last Verified: April 1, 2016

More Information

Terms related to this study

• Other Study ID Numbers: KWA1101