A Drug-Drug Interaction Study of Digoxin and PA21

Phase 1

Completed

• Conditions: Drug Interaction Potentiation
• Interventions: Drug: PA21; Drug: Digoxin

• Registration Number: NCT01477411
• Lead Sponsor: Vifor Pharma

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2011-11
• Study First Submitted: 2011-11-16
• Study First Submitted QC: 2011-11-18
• Study First Posted: 2011-11-22
• Status Verified: 2012-01
• Primary Completion: 2012-01
• Study Completion: 2012-01
• Last Update Submitted: 2012-01-17
• Last Update Posted: 2012-01-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 42

Inclusion Criteria

• Healthy volunteers
• Written informed consent

Exclusion Criteria

• No significant medical conditions
• Pregnancy

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
PA21 and Digoxin with food	PA21	The maximum dose of PA21 will be 15.0 g/day. The maximum dose of Digoxin will be 0.5 mg/day
PA21 with food and Digoxin 2hrs later	PA21	The maximum dose of PA21 will be 15 g/day. The maximum dose of Digoxin will be 0.5 mg/day
PA21 and Digoxin with food	Digoxin	The maximum dose of PA21 will be 15.0 g/day. The maximum dose of Digoxin will be 0.5 mg/day
No PA21; Digoxin with food	Digoxin	The maximum dosage of Digoxin will be 0.5 mg/day
PA21 with food and Digoxin 2hrs later	Digoxin	The maximum dose of PA21 will be 15 g/day. The maximum dose of Digoxin will be 0.5 mg/day

Primary Outcome Measures

Name	Time	Method
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 and 96 hours post digoxin dose on Days 0, 11, 22	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)	pre-dose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, 48, 72 and 96 hours post Digoxin dose on Days 0, 11, 22	Area under the plasma concentration versus time curve from time zero (pre-dose) to extrapolated infinite time
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 and 96 hours post Digoxin dose on days 0, 11, 22

Trial Locations

Locations (1)

ACRI - Phase 1; 🇺🇸 Anaheim, California, United States