Clincosm LogoSign in Get a demo

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

Sponsor
Astellas Pharma Inc (Industry)
Overall Status
Completed
CT.gov ID
NCT01115985
Collaborator
(none)
24
Enrollment
1
Location
2
Arms
1
Duration (Months)
23.6
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
Phase 1

Study Design

Study Type:
Interventional
Actual Enrollment :
24 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
None (Open Label)
Official Title:
ASP1585 Pharmacokinetic Interaction Study - Pharmacokinetic Interaction With Atorvastatin -
Study Start Date :
Mar 1, 2010
Actual Primary Completion Date :
Apr 1, 2010
Actual Study Completion Date :
Apr 1, 2010

Arms and Interventions

Arm Intervention/Treatment
Experimental: single-add first group

single administration first, then concomitant administration

Drug: ASP1585
oral

Drug: atorvastatin
oral
Other Names:
  • Lipitor

    		•
    Experimental: combi-add first group

    concomitant administration first, then single administration

    Drug: ASP1585
    oral

    Drug: atorvastatin
    oral
    Other Names:
  • Lipitor

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Plasma concentration of atorvastatin [48 hours after administration]

    Secondary Outcome Measures

    1. Safety assessed by AE, vital signs 12-lead ECG and lab tests [7 days after administration]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    20 Years to 44 Years
    Sexes Eligible for Study:
    Male
    Accepts Healthy Volunteers:
    Yes
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Tokyo Japan

    Sponsors and Collaborators

    • Astellas Pharma Inc

    Investigators

    • Study Chair: Use Central Contact, Astellas Pharma Inc

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT01115985
    Other Study ID Numbers:
    • 1585-CL-0010
    First Posted:
    May 4, 2010
    Last Update Posted:
    May 27, 2010
    Last Verified:
    May 1, 2010
    Keywords provided by , ,
    ASP1585
    Drug-drug interaction
    Atorvastatin
    Healthy volunteer
    Additional relevant MeSH terms:
    Atorvastatin

    Study Results

    No Results Posted as of May 27, 2010