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

Healthy Male Subject Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02434835
• Other study ID #: KWA1101
• Status: Completed
• Phase: Phase 1
• First received: April 21, 2015
• Last updated: April 15, 2016

Study information

• Verified date: April 2016
• Source: Kissei Pharmaceutical Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Est. primary completion date: May 2015
• Gender: Male
• Age group: 35 Years to 55 Years

Eligibility

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

N/A

Related Conditions & MeSH terms

• Healthy Male Subject

Intervention

Drug:
• [14C]KWA-0711

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Kissei Pharmaceutical Co., Ltd.

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Area under the plasma concentration-time curve (AUC) of total radioactivity, unchanged drug substance and its major metabolites		240 hours
Primary	Maximum observed plasma concentration (Cmax) of total radioactivity, unchanged drug substance and its major metabolites		240 hours
Primary	Cumulative radioactivity recovery in urine and feces		240 hours
Primary	Profiles of metabolites in plasma, urine and faeces		240 hours
Secondary	Number of adverse events		240 hours