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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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on November 24, 2014