Status:
COMPLETED
A Study to Assess the Safety, Tolerability, and Effects in and on the Body of Healthy Young and Elderly Male and Female Subjects of Ascending Multiple Oral Doses of ASP3652
Lead Sponsor:
Astellas Pharma Europe B.V.
Conditions:
Healthy Subjects
Pharmacokinetics of ASP3652
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
The study investigates how safe ASP3652 is and how well it is tolerated when taken as multiple doses. The study also assesses how quickly and to what extent it is absorbed and eliminated from the body...
Detailed Description
This is a Multiple Ascending Dose (MAD) study with two parts. Screening for both parts takes place between Days -28 and -3. Subjects are admitted to the clinic on Day -2, and discharged on Day 16. The...
Eligibility Criteria
Inclusion
- Body Mass Index (BMI) between 18.5-30.0 kg/m2 for both male and female subjects.
- Male subject is non-fertile, i.e. surgically sterilized or practices an adequate contraceptive method to prevent pregnancies.
- Female subject is of non-child bearing potential, i.e. post menopausal, surgically sterilized, hysterectomy in medical history, or practices adequate (double barrier) non-hormonal contraceptive method to prevent pregnancies.
Exclusion
- Pregnant or breast feeding within 6 months before screening assessment.
- Presence or history of any clinically significant psychiatric disorder such as mania, depression or schizophrenia.
- Regular use of any inducer of liver metabolism (e.g. barbiturates, rifampin) in the 3 months prior to admission to the Clinical Unit.
Key Trial Info
Start Date :
May 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2010
Estimated Enrollment :
101 Patients enrolled
Trial Details
Trial ID
NCT02243657
Start Date
May 1 2009
End Date
May 1 2010
Last Update
September 18 2014
Active Locations (1)
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1
PRA International
Groningen, Netherlands, 9713GZ