A Drug-Drug Interaction Study of Digoxin and PA21

Drug Interaction Potentiation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01477411
• Other study ID #: PA-DDI-004
• Status: Completed
• Phase: Phase 1
• First received: November 16, 2011
• Last updated: January 17, 2012
• Start date: November 2011
• Est. completion date: January 2012

Study information

• Verified date: January 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 Digoxin is affected by PA21.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 42
• Est. completion date: January 2012
• Est. primary completion date: January 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

• Drug Interaction Potentiation

Intervention

Drug:
• PA21
The maximum dose of PA21 will be 15.0 g/day.
• Digoxin
The maximum dosage of Digoxin will be 0.5 mg/day

Locations

Country	Name	City	State
United States	ACRI - Phase 1	Anaheim	California

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 and 96 hours post digoxin 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 and 96 hours post Digoxin 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 and 96 hours post Digoxin dose on days 0, 11, 22	No