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

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ClinicalTrials.gov Identifier: NCT01115985
Recruitment Status : Completed
First Posted : May 4, 2010
Last Update Posted : May 27, 2010
Information provided by:
Astellas Pharma Inc

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
Healthy Pharmacokinetics of Atorvastatin Drug: ASP1585 Drug: atorvastatin Phase 1

Study Type : Interventional  (Clinical Trial)
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 : March 2010
Primary Completion Date : April 2010
Study Completion Date : April 2010

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: single-add first group
single administration first, then concomitant administration
Drug: ASP1585
Drug: atorvastatin
Other Name: Lipitor
Experimental: combi-add first group
concomitant administration first, then single administration
Drug: ASP1585
Drug: atorvastatin
Other Name: Lipitor

Primary Outcome Measures :
  1. Plasma concentration of atorvastatin [ Time Frame: 48 hours after administration ]

Secondary Outcome Measures :
  1. Safety assessed by AE, vital signs 12-lead ECG and lab tests [ Time Frame: 7 days after administration ]

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 44 Years   (Adult)
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01115985

Tokyo, Japan
Sponsors and Collaborators
Astellas Pharma Inc
Study Chair: Use Central Contact Astellas Pharma Inc

Responsible Party: Director, Astellas Pharma, Inc
ClinicalTrials.gov Identifier: NCT01115985     History of Changes
Other Study ID Numbers: 1585-CL-0010
First Posted: May 4, 2010    Key Record Dates
Last Update Posted: May 27, 2010
Last Verified: May 2010

Keywords provided by Astellas Pharma Inc:
Drug-drug interaction
Healthy volunteer

Additional relevant MeSH terms:
Atorvastatin Calcium
Anticholesteremic Agents
Hypolipidemic Agents
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors