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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
  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
Intervention Model: Crossover Assignment
Masking: Open Label
Official Title: ASP1585 Pharmacokinetic Interaction Study - Pharmacokinetic Interaction With Atorvastatin -

Resource links provided by NLM:


Further study details as provided by Astellas Pharma Inc:

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

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

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   (Adult)
Sexes 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

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

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

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

ClinicalTrials.gov processed this record on June 23, 2017