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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02434835
Recruitment Status : Completed
First Posted : May 5, 2015
Last Update Posted : April 18, 2016
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Healthy Male Subject Drug: [14C]KWA-0711 Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Primary Completion Date : May 2015

Arm Intervention/treatment
Experimental: [14C]KWA-0711 Drug: [14C]KWA-0711



Primary Outcome Measures :
  1. Area under the plasma concentration-time curve (AUC) of total radioactivity, unchanged drug substance and its major metabolites [ Time Frame: 240 hours ]
  2. Maximum observed plasma concentration (Cmax) of total radioactivity, unchanged drug substance and its major metabolites [ Time Frame: 240 hours ]
  3. Cumulative radioactivity recovery in urine and feces [ Time Frame: 240 hours ]
  4. Profiles of metabolites in plasma, urine and faeces [ Time Frame: 240 hours ]

Secondary Outcome Measures :
  1. Number of adverse events [ Time Frame: 240 hours ]


Information from the National Library of Medicine

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Ages Eligible for Study:   35 Years to 55 Years   (Adult)
Sexes Eligible for Study:   Male
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02434835


Locations
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United Kingdom
Leeds, United Kingdom
Sponsors and Collaborators
Kissei Pharmaceutical Co., Ltd.
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Responsible Party: Kissei Pharmaceutical Co., Ltd.
ClinicalTrials.gov Identifier: NCT02434835    
Other Study ID Numbers: KWA1101
First Posted: May 5, 2015    Key Record Dates
Last Update Posted: April 18, 2016
Last Verified: April 2016