A Drug-Drug Interaction Study of Warfarin and PA21
A Single-centre, Open-label, Three-period Study of the Pharmacokinetic Effect of PA21 on Warfarin in Healthy Male and Female Adults
1 other identifier
interventional
45
1 country
1
Brief Summary
The purpose of this study is to determine if Warfarin is affected by PA21.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1
Started Nov 2011
Shorter than P25 for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2011
CompletedFirst Submitted
Initial submission to the registry
November 16, 2011
CompletedFirst Posted
Study publicly available on registry
November 22, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2012
CompletedFebruary 16, 2012
February 1, 2012
3 months
November 16, 2011
February 14, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
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
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
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
Study Arms (3)
PA21 and Warfarin with food
EXPERIMENTALThe maximum dose of PA21 will be 15.0 g/day. The maximum dose of Warfarin will be 10 mg/day
No PA21; Warfarin with food
EXPERIMENTALThe maximum dosage of Warfarin will be 10 mg/day
PA21 with food and Warfarin 2hrs later
EXPERIMENTALThe maximum dose of PA21 will be 15 g/day. The maximum dose of Warfarin will be 10 mg/day
Interventions
Eligibility Criteria
You may qualify if:
- Healthy volunteers
- Written informed consent
You may not qualify if:
- No significant medical conditions
- Pregnancy
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Vifor Pharmalead
Study Sites (1)
PRA International - Clinical Pharmacology Center
Lenexa, Kansas, 66219, United States
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Sandra K Willsie, MD
PRA International - Clinical Pharmacology Center
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- BASIC SCIENCE
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 16, 2011
First Posted
November 22, 2011
Study Start
November 1, 2011
Primary Completion
February 1, 2012
Study Completion
February 1, 2012
Last Updated
February 16, 2012
Record last verified: 2012-02