Status:
COMPLETED
A Study to Assess the Effects of Single Ascending Doses (SAD) of ASP8477, the Effect That Food Has on the Drug, and the Interaction Between ASP8477 and Omeprazole in Healthy Postmenopausal Females and Healthy Young Vasectomized Males
Lead Sponsor:
Astellas Pharma Europe B.V.
Conditions:
Pharmacokinetics of ASP8477
Pharmacodynamics of ASP8477
Eligibility:
All Genders
18-65 years
Phase:
PHASE1
Brief Summary
This is a 4-part study. Part I assesses the safety and tolerability of single ascending doses of ASP8477 or a placebo under fasted conditions in postmenopausal subjects. Part II is similar to part I e...
Detailed Description
Part I (SAD) in healthy postmenopausal females evaluates the safety, and tolerability, and defines Maximum Tolerated Dose = MTD, pharmacokinetics, and pharmacodynamics of single ascending oral doses (...
Eligibility Criteria
Inclusion
- Healthy young (\<65 years of age at first planned dose) postmenopausal female (Parts I, III, and IV).
- Healthy young vasectomized male subject aged 18-55 years inclusive (Part II).
- Body Mass index between 18.5 and 30.0 kg/m2 inclusive.
Exclusion
- Known or suspected hypersensitivity to ASP8477 or any of the components of the formulations used.
- Any of the liver function tests above the upper limit of normal.
- A family history of psychiatric disorders.
- Use of grapefruit (more than 3 x 200 ml) or marmalade (more than three times) in the week prior to admission to the Clinical Unit, as reported by the subject.
- Use of xanthine-containing beverages within 48 hours before admission.
Key Trial Info
Start Date :
November 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2011
Estimated Enrollment :
72 Patients enrolled
Trial Details
Trial ID
NCT02220777
Start Date
November 1 2010
End Date
May 1 2011
Last Update
August 20 2014
Active Locations (2)
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1
SGS Belgium N.V.
Antwerp, Belgium, B-2060
2
SGS Aster
Paris, France, 75015