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

May 26, 2010 updated by: Astellas Pharma Inc

ASP1585 Pharmacokinetic Interaction Study - Pharmacokinetic Interaction With Atorvastatin -

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

24

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 44 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Plasma concentration of atorvastatin
Time Frame: 48 hours after administration
48 hours after administration

Secondary Outcome Measures

Outcome Measure
Time Frame
Safety assessed by AE, vital signs 12-lead ECG and lab tests
Time Frame: 7 days after administration
7 days after administration

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Astellas Pharma Inc

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2010

Primary Completion (Actual)

April 1, 2010

Study Completion (Actual)

April 1, 2010

Study Registration Dates

First Submitted

May 3, 2010

First Submitted That Met QC Criteria

May 3, 2010

First Posted (Estimate)

May 4, 2010

Study Record Updates

Last Update Posted (Estimate)

May 27, 2010

Last Update Submitted That Met QC Criteria

May 26, 2010

Last Verified

May 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1585-CL-0010

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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