A Drug-Drug Interaction Study of Warfarin and PA21

• Sponsor: Vifor Pharma (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01477424
• Collaborator: (none)
• Enrollment: 45
• Location: 1
• Arms: 3
• Duration (Months): 3
• Patients Per Site Per Month: 14.9

Study Details

Study Description

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 Design

• Study Type: Interventional
• 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: Nov 1, 2011
• Actual Primary Completion Date: Feb 1, 2012
• Actual Study Completion Date: Feb 1, 2012

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Area Under the Curve from time zero to 24 hours (AUC0-24) [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) [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) [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]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 20 Years to 50 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• Healthy volunteers

• Written informed consent

Exclusion Criteria:

• No significant medical conditions

• Pregnancy

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	PRA International - Clinical Pharmacology Center	Lenexa	Kansas	United States	66219

Sponsors and Collaborators

• Vifor Pharma

Investigators

• Principal Investigator: Sandra K Willsie, MD, PRA International - Clinical Pharmacology Center

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Vifor Pharma
• ClinicalTrials.gov Identifier: NCT01477424
• Other Study ID Numbers: PA-DDI-005
• First Posted: Nov 22, 2011
• Last Update Posted: Feb 16, 2012
• Last Verified: Feb 1, 2012

• Keywords provided by Vifor Pharma: Drug-drug interaction; Pharmacokinetics; PA21
• Additional relevant MeSH terms: Warfarin

Study Results

No Results Posted as of Feb 16, 2012