A Drug-Drug Interaction Study of Digoxin and PA21

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Vifor Inc.
ClinicalTrials.gov Identifier:
NCT01477411
First received: November 16, 2011
Last updated: January 17, 2012
Last verified: January 2012
  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
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Crossover Assignment
Masking: 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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   20 Years to 50 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy volunteers
  • Written informed consent

Exclusion Criteria:

  • No significant medical conditions
  • Pregnancy
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Vifor Inc.
ClinicalTrials.gov Identifier: NCT01477411     History of Changes
Other Study ID Numbers: PA-DDI-004
Study First Received: November 16, 2011
Last Updated: January 17, 2012
Health Authority: United States: Food and Drug Administration

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

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

ClinicalTrials.gov processed this record on July 26, 2014