Mass Balance Study of ASP1941

This study investigates the pharmacokinetics, in particular the routes and extent of metabolism and excretion, of ASP1941 after a single oral dose.

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Key information

Conditions

Healthy Subjects

Age range

18 year–55 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Zuidlaren, 9470 AE, Netherlands

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Body weight between 60-100kg, BMI between 18.5-30 kg/m2, inclusive

Exclusion criteria

Pulse <40 or >90 bpm; Systolic Blood Pressure > 140 mmHg; Diastolic Blood Pressure >90 mmHg

Treatment and study plan

ASP1941

Drug

Oral solution

Primary outcomes

Pharmacokinetics of ASP1941 to evaluate metabolism and excretion

Time frame: up to 216 hours

Secondary outcomes

Identification of metabolic profile of ASP1941

Time frame: up to 216 hours

Sponsors and collaborators

Lead sponsor

Astellas Pharma Inc

Industry

Registry information

Official study title

An Open Label Study to Evaluate the Pharmacokinetics of ASP1941 After a Single Oral Dose of 14C-labeled ASP1941 in Healthy Male Subjects

Important dates

Study start: 2008
Primary completion: 2008
Study completion: 2008
First posted: Feb 23, 2011
Registry last updated: Feb 23, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed