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Completed

NCT Number: NCT01477424

A Drug-Drug Interaction Study of Warfarin and PA21

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

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Key information

Conditions

Drug Interaction Potentiation

Age range

20 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

PRA International - Clinical Pharmacology Center

Lenexa, Kansas, 66219, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Healthy volunteers
  • Written informed consent

Exclusion criteria

  • No significant medical conditions
  • Pregnancy

Treatment and study plan

PA21

Drug

The maximum dose of PA21 will be 15.0 g/day.

Warfarin

Drug

The maximum dosage of Warfarin will be 10 mg/day

Primary outcomes

  1. Area Under the Curve from time zero to 24 hours (AUC0-24)

    Time frame: pre-dose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, 48, 72, 96, 120, 144 and 168 hours post Warfarin dose on Days 0, 11, 22

    Area under the plasma concentration versus time curve from time zero (pre-dose) to 24 hours

  2. Area Under the Curve from time zero to infinite (AUC0-infinity)

    Time frame: pre-dose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, 48, 72, 96, 120, 144 and 168 hours post Warfarin dose on Days 0, 11, 22

    Area under the plasma concentration versus time curve from time zero (pre-dose) to extrapolated infinite time

  3. Maximum observed plasma concentration (Cmax)

    Time frame: pre-dose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, 48, 72, 96, 120 and 168 hours post Warfarin dose on days 0, 11, 22

Sponsors and collaborators

Lead sponsor

Vifor Pharma

Industry

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Nov 22, 2011
Registry last updated
Feb 16, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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