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

Phase 1

Completed

• Conditions: Healthy; Pharmacokinetics of Valsartan
• Interventions: Drug: ASP1585; Drug: valsartan

• Registration Number: NCT01115972
• Lead Sponsor: Astellas Pharma Inc

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2010-03
• Primary Completion: 2010-04
• Study Completion: 2010-04
• Status Verified: 2010-05
• Study First Submitted: 2010-05-03
• Study First Submitted QC: 2010-05-03
• Study First Posted: 2010-05-04
• Last Update Submitted: 2010-05-26
• Last Update Posted: 2010-05-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 24

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
single-add first group	valsartan	single administration first, then concomitant administration
single-add first group	ASP1585	single administration first, then concomitant administration
combi-add first group	ASP1585	concomitant administration first, then single administration
combi-add first group	valsartan	concomitant administration first, then single administration

Primary Outcome Measures

Name	Time	Method
Plasma concentration of valsartan	for 48 hours after administration

Secondary Outcome Measures

Name	Time	Method
Safety assessed by AE, vital signs 12-lead ECG and lab tests	for 5 days after administration