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A Drug-Drug Interaction Study of Warfarin and PA21

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Vifor Inc.
ClinicalTrials.gov Identifier:
NCT01477424
First received: November 16, 2011
Last updated: February 14, 2012
Last verified: February 2012
History of Changes
  Purpose

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


Condition Intervention Phase
Drug Interaction Potentiation
 Drug: PA21
Drug: Warfarin
 Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Crossover Assignment
Masking: 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Vifor Inc.:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    Area under the plasma concentration versus time curve from time zero (pre-dose) to 24 hours

  • 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 ] [ Designated as safety issue: No ]
    Area under the plasma concentration versus time curve from time zero (pre-dose) to extrapolated infinite time

  • 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 ] [ Designated as safety issue: No ]

Enrollment: 45
Study Start Date: November 2011
Study Completion Date: February 2012
Primary Completion Date: February 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   20 Years to 50 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy volunteers
  • Written informed consent

Exclusion Criteria:

  • No significant medical conditions
  • Pregnancy
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

Responsible Party: Vifor Inc.
ClinicalTrials.gov Identifier: NCT01477424     History of Changes
Other Study ID Numbers: PA-DDI-005
Study First Received: November 16, 2011
Last Updated: February 14, 2012
Health Authority: United States: Food and Drug Administration

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

Additional relevant MeSH terms:
Warfarin
Anticoagulants
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 19, 2013