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

This study has been completed.
Sponsor:
Information provided by:
Astellas Pharma Inc
ClinicalTrials.gov Identifier:
NCT01115946
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 enalapril in 2x2 crossover method.


Condition Intervention Phase
Healthy
Pharmacokinetics of Enalapril
Drug: ASP1585
Drug: enalapril
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 Enalapril -

Resource links provided by NLM:


Further study details as provided by Astellas Pharma Inc:

Primary Outcome Measures:
  • Plasma concentration of enalapril [ Time Frame: for 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: for 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: enalapril
oral
Other Name: Renivace
Experimental: combi-add first group
concomitant administration first, then single administration
Drug: ASP1585
oral
Drug: enalapril
oral
Other Name: Renivace

  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
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: NCT01115946

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: NCT01115946     History of Changes
Other Study ID Numbers: 1585-CL-0008
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
enalapril
Healthy volunteer

Additional relevant MeSH terms:
Enalapril
Enalaprilat
Angiotensin-Converting Enzyme Inhibitors
Antihypertensive Agents
Cardiovascular Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Protease Inhibitors
Therapeutic Uses

ClinicalTrials.gov processed this record on October 20, 2014