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NCT01477424 Clinical Trial

A Drug-Drug Interaction Study of Warfarin and PA21

Drug Interaction Potentiation Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01477424
Other study ID # PA-DDI-005
Secondary ID
Status Completed
Phase Phase 1
First received November 16, 2011
Last updated February 14, 2012
Start date November 2011
Est. completion date February 2012

Study information
Verified date February 2012
Source Vifor Inc.
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial Summary

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

Recruitment information / eligibility
Status Completed
Enrollment 45
Est. completion date February 2012
Est. primary completion date February 2012
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 20 Years to 50 Years
Eligibility Inclusion Criteria:

- Healthy volunteers

- Written informed consent

Exclusion Criteria:

- No significant medical conditions

- Pregnancy

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

Intervention

Drug:
• PA21
The maximum dose of PA21 will be 15.0 g/day.
• Warfarin
The maximum dosage of Warfarin will be 10 mg/day

Locations
Country Name City State
United States PRA International - Clinical Pharmacology Center Lenexa Kansas

Sponsors (1)
Lead Sponsor Collaborator
Vifor Inc.

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Area Under the Curve from time zero to 24 hours (AUC0-24) Area under the plasma concentration versus time curve from time zero (pre-dose) to 24 hours 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 No
Primary Area Under the Curve from time zero to infinite (AUC0-infinity) Area under the plasma concentration versus time curve from time zero (pre-dose) to extrapolated infinite time 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 No
Primary Maximum observed plasma concentration (Cmax) 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 No
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