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Mass Balance Study of ASP1941

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

Status
Completed
Phases
Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01302132
Enrollment
6
Registered
2011-02-23
Start date
2008-05-31
Completion date
2008-10-31
Last updated
2011-02-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy Subjects

Keywords

Mass Balance, ASP1941, Pharmacokinetics

Brief summary

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

Interventions

DRUGASP1941

Oral solution

Sponsors

Astellas Pharma Inc
Lead SponsorINDUSTRY

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Masking
NONE

Eligibility

Sex/Gender
MALE
Age
18 Years to 55 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frame
Pharmacokinetics of ASP1941 to evaluate metabolism and excretionup to 216 hours

Secondary

MeasureTime frame
Identification of metabolic profile of ASP1941up to 216 hours

Countries

Netherlands

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026