A Drug-Drug Interaction Study of Losartan and PA21

December 19, 2012 updated by: Vifor Pharma

A Single-centre, Open-label, Three-period Study of the Pharmacokinetic Effect of PA21 on Losartan Potassium in Healthy Male and Female Adults

The purpose of this study is to determine if Losartan potassium is affected by PA21.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

36

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Anaheim, California, United States, 92801
        • ACRI- Phase 1

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 50 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Healthy volunteers
  • Written informed consent

Exclusion Criteria:

  • No significant medical conditions
  • Pregnancy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: PA21 and Losartan with food
Drug: PA21 and Losartan with Food
The maximum dose of PA21 will be 15.0 g/day. The maximum dose of Losartan will be 100 mg/day.
Experimental: No PA21; Losartan with food
Drug: No PA21; Losartan with food
The maximum dose of Losartan will be 100 mg/day.
Experimental: PA21 with food and Losartan 2 hrs later
Drug: PA21 with food and Losartan 2 hours later
The maximum dose of PA21 will be 15.0 g/day. The maximum dose of Losartan will be 100 mg/day.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Effect of PA21 on Losartan potassium
Time Frame: PK assessment on Day 0, 11, 22
To assess the effect, if any, of PA21 on Losartan potassium exposure
PK assessment on Day 0, 11, 22

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Effect of PA21 on the active metabolite of Losartan potassium
Time Frame: PK assessment on Day 0, 11, 22
To assess the effect, if any, of PA21 on the active metabolite of Losartan potassium
PK assessment on Day 0, 11, 22

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Vifor Pharma

Investigators

  • Principal Investigator: Peter J Winkle, MD, ACRI - Phase 1 (Advanced Clinical Research Institute)

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2011

Primary Completion (Actual)

June 1, 2011

Study Completion (Actual)

June 1, 2011

Study Registration Dates

First Submitted

March 25, 2011

First Submitted That Met QC Criteria

March 28, 2011

First Posted (Estimate)

March 29, 2011

Study Record Updates

Last Update Posted (Estimate)

December 21, 2012

Last Update Submitted That Met QC Criteria

December 19, 2012

Last Verified

December 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PA-DDI-001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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