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A Drug-Drug Interaction Study of Warfarin and PA21

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ClinicalTrials.gov Identifier: NCT01477424
Recruitment Status : Completed
First Posted : November 22, 2011
Last Update Posted : February 16, 2012
Sponsor:
Information provided by (Responsible Party):
Vifor Inc.

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

Condition or disease Intervention/treatment Phase
Drug Interaction Potentiation Drug: PA21 Drug: Warfarin Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 45 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: A Single-centre, Open-label, Three-period Study of the Pharmacokinetic Effect of PA21 on Warfarin in Healthy Male and Female Adults
Study Start Date : November 2011
Actual Primary Completion Date : February 2012
Actual Study Completion Date : February 2012

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: PA21 and Warfarin with food
The maximum dose of PA21 will be 15.0 g/day. The maximum dose of Warfarin will be 10 mg/day
Drug: PA21
The maximum dose of PA21 will be 15.0 g/day.
Drug: Warfarin
The maximum dosage of Warfarin will be 10 mg/day
Experimental: No PA21; Warfarin with food
The maximum dosage of Warfarin will be 10 mg/day
Drug: Warfarin
The maximum dosage of Warfarin will be 10 mg/day
Experimental: PA21 with food and Warfarin 2hrs later
The maximum dose of PA21 will be 15 g/day. The maximum dose of Warfarin will be 10 mg/day
Drug: PA21
The maximum dose of PA21 will be 15.0 g/day.
Drug: Warfarin
The maximum dosage of Warfarin will be 10 mg/day



Primary Outcome Measures :
  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 ]


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Ages Eligible for Study:   20 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy volunteers
  • Written informed consent

Exclusion Criteria:

  • No significant medical conditions
  • Pregnancy

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01477424


Locations
United States, Kansas
PRA International - Clinical Pharmacology Center
Lenexa, Kansas, United States, 66219
Sponsors and Collaborators
Vifor Inc.
Investigators
Principal Investigator: Sandra K Willsie, MD PRA International - Clinical Pharmacology Center

Responsible Party: Vifor Inc.
ClinicalTrials.gov Identifier: NCT01477424     History of Changes
Other Study ID Numbers: PA-DDI-005
First Posted: November 22, 2011    Key Record Dates
Last Update Posted: February 16, 2012
Last Verified: February 2012

Keywords provided by Vifor Inc.:
Drug-drug interaction
Pharmacokinetics
PA21

Additional relevant MeSH terms:
Warfarin
Anticoagulants