Text Size

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

This study has been completed.
Sponsor:
Information provided by:
Astellas Pharma Inc
ClinicalTrials.gov Identifier:
NCT01115985
First received: May 3, 2010
Last updated: May 26, 2010
Last verified: May 2010
History of Changes
  Purpose

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


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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Crossover Assignment
Masking: Open Label
Official Title: ASP1585 Pharmacokinetic Interaction Study - Pharmacokinetic Interaction With Atorvastatin -

Resource links provided by NLM:

MedlinePlus related topics: Drug Reactions
U.S. FDA Resources

Further study details as provided by Astellas Pharma Inc:

Primary Outcome Measures:
  • Plasma concentration of atorvastatin [ Time Frame: 48 hours after administration ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Safety assessed by AE, vital signs 12-lead ECG and lab tests [ Time Frame: 7 days after administration ] [ Designated as safety issue: No ]

Enrollment: 24
Study Start Date: March 2010
Study Completion Date: April 2010
Primary Completion Date: April 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: single-add first group
single administration first, then concomitant administration
 Drug: ASP1585
oral
Drug: atorvastatin
oral
Other Name: Lipitor
Experimental: combi-add first group
concomitant administration first, then single administration
 Drug: ASP1585
oral
Drug: atorvastatin
oral
Other Name: Lipitor

  Eligibility

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

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01115985

Locations
Japan
Tokyo, Japan
Sponsors and Collaborators
Astellas Pharma Inc
Investigators
Study Chair: Use Central Contact Astellas Pharma Inc
  More Information

No publications provided

Responsible Party: Director, Astellas Pharma, Inc
ClinicalTrials.gov Identifier: NCT01115985     History of Changes
Other Study ID Numbers: 1585-CL-0010
Study First Received: May 3, 2010
Last Updated: May 26, 2010
Health Authority: Japan: Pharmaceuticals and Medical Devices Agency

Keywords provided by Astellas Pharma Inc:
ASP1585
Drug-drug interaction
Atorvastatin
Healthy volunteer

Additional relevant MeSH terms:
Atorvastatin
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
 Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Enzyme Inhibitors
Lipid Regulating Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 23, 2013