NCT01115972

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at P25-P50 for phase_1 healthy

Timeline
Completed

Started Mar 2010

Shorter than P25 for phase_1 healthy

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2010

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2010

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

May 3, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 4, 2010

Completed
Last Updated

May 27, 2010

Status Verified

May 1, 2010

Enrollment Period

1 month

First QC Date

May 3, 2010

Last Update Submit

May 26, 2010

Conditions

HealthyPharmacokinetics of Valsartan

Keywords

ASP1585Drug-drug interactionvalsartanHealthy volunteer

Outcome Measures

Primary Outcomes (1)

  • Plasma concentration of valsartan

    for 48 hours after administration

Secondary Outcomes (1)

  • Safety assessed by AE, vital signs 12-lead ECG and lab tests

    for 5 days after administration

Study Arms (2)

single-add first group

EXPERIMENTAL

single administration first, then concomitant administration

Drug: ASP1585Drug: valsartan

combi-add first group

EXPERIMENTAL

concomitant administration first, then single administration

Drug: ASP1585Drug: valsartan

Interventions

ASP1585DRUG

oral

combi-add first groupsingle-add first group
valsartanDRUG

oral

Also known as: Diovan
combi-add first groupsingle-add first group

Eligibility Criteria

Age20 Years - 44 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Unknown Facility

Tokyo, Japan

Location

MeSH Terms

Interventions

Valsartan

Intervention Hierarchy (Ancestors)

TetrazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsValineAmino Acids, Branched-ChainAmino AcidsAmino Acids, Peptides, and ProteinsAmino Acids, Essential

Study Officials

  • Use Central Contact

    Astellas Pharma Inc

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

May 3, 2010

First Posted

May 4, 2010

Study Start

March 1, 2010

Primary Completion

April 1, 2010

Study Completion

April 1, 2010

Last Updated

May 27, 2010

Record last verified: 2010-05

Locations

JP(1)