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NCT01115985 Clinical Trial

A Study to Assess the Effect of ASP1585 on Pharmacokinetics of Atorvastatin in Healthy Volunteers

Healthy Clinical Trial

Official title:
ASP1585 Pharmacokinetic Interaction Study - Pharmacokinetic Interaction With Atorvastatin -

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01115985
Other study ID # 1585-CL-0010
Secondary ID
Status Completed
Phase Phase 1
First received May 3, 2010
Last updated May 26, 2010
Start date March 2010
Est. completion date April 2010

Study information
Verified date May 2010
Source Astellas Pharma Inc
Contact n/a
Is FDA regulated No
Health authority Japan: Pharmaceuticals and Medical Devices Agency
Study type Interventional

Clinical Trial Summary

This study is to assess the effect of ASP1585 on pharmacokinetics of atorvastatin in 2x2 crossover method.

Recruitment information / eligibility
Status Completed
Enrollment 24
Est. completion date April 2010
Est. primary completion date April 2010
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Male
Age group 20 Years to 44 Years
Eligibility Inclusion Criteria:

- Body weight: =<50.0kg, <80.0kg

- Body mass index: =<17.6, <26.4

- Healthy as judged by investigator or caregiver from subjective and objective symptoms and physical examination data

Exclusion Criteria:

- Attending another clinical trial within 120 days before the study

- Blood donation within 90 days (400ml) or 30 days (200ml) before the study

- Receiving any drugs within 7 days before the study

- History of allergy to drugs

- Having GI disorders

- History or complication of liver diseases

- History or complication of heart disease

- History or complication of respiratory diseases

- History or complication of renal diseases

- History or complication of cerebrovascular diseases

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Crossover Assignment, Masking: Open Label

Related Conditions & MeSH terms

Intervention

Drug:
• ASP1585
oral
• atorvastatin
oral

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Astellas Pharma Inc

Country where clinical trial is conducted

Japan, 

Outcome
Type Measure Description Time frame Safety issue
Primary Plasma concentration of atorvastatin 48 hours after administration No
Secondary Safety assessed by AE, vital signs 12-lead ECG and lab tests 7 days after administration No
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