We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

A Drug-Drug Interaction Study of Digoxin and PA21

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01477411
First Posted: November 22, 2011
Last Update Posted: January 18, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Vifor Inc.
  Purpose
The purpose of this study is to determine if Digoxin is affected by PA21.

Condition Intervention Phase
Drug Interaction Potentiation Drug: PA21 Drug: Digoxin Phase 1

Study Type: Interventional
Study Design: 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 Digoxin in Healthy Male and Female Adults

Resource links provided by NLM:


Further study details as provided by Vifor Inc.:

Primary Outcome Measures:
  • Area Under the Curve from time zero to 24 hours (AUC0-24) [ Time Frame: 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) [ Time Frame: 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) [ Time Frame: 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 ]

Enrollment: 42
Study Start Date: November 2011
Study Completion Date: January 2012
Primary Completion Date: January 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: PA21 and Digoxin with food
The maximum dose of PA21 will be 15.0 g/day. The maximum dose of Digoxin will be 0.5 mg/day
Drug: PA21
The maximum dose of PA21 will be 15.0 g/day.
Drug: Digoxin
The maximum dosage of Digoxin will be 0.5 mg/day
Experimental: No PA21; Digoxin with food
The maximum dosage of Digoxin will be 0.5 mg/day
Drug: Digoxin
The maximum dosage of Digoxin will be 0.5 mg/day
Experimental: PA21 with food and Digoxin 2hrs later
The maximum dose of PA21 will be 15 g/day. The maximum dose of Digoxin will be 0.5 mg/day
Drug: PA21
The maximum dose of PA21 will be 15.0 g/day.
Drug: Digoxin
The maximum dosage of Digoxin will be 0.5 mg/day

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   20 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy volunteers
  • Written informed consent

Exclusion Criteria:

  • No significant medical conditions
  • Pregnancy
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01477411


Locations
United States, California
ACRI - Phase 1
Anaheim, California, United States, 92801
Sponsors and Collaborators
Vifor Inc.
Investigators
Principal Investigator: Peter Winkle, MD ACRI - Phase 1 (Advanced Clinical Research Institute)
  More Information

Responsible Party: Vifor Inc.
ClinicalTrials.gov Identifier: NCT01477411     History of Changes
Other Study ID Numbers: PA-DDI-004
First Submitted: November 16, 2011
First Posted: November 22, 2011
Last Update Posted: January 18, 2012
Last Verified: January 2012

Keywords provided by Vifor Inc.:
Drug-drug interaction
Pharmacokinetics
PA21

Additional relevant MeSH terms:
Digoxin
Anti-Arrhythmia Agents
Cardiotonic Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs