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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.
November 16, 2011
November 22, 2011
January 18, 2012
November 2011
January 2012   (Final data collection date for primary outcome measure)
  • 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 ]
Same as current
Complete list of historical versions of study NCT01477411 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
A Drug-Drug Interaction Study of Digoxin and PA21
A Single-centre, Open-label, Three-period Study of the Pharmacokinetic Effect of PA21 on Digoxin in Healthy Male and Female Adults
The purpose of this study is to determine if Digoxin is affected by PA21.
Not Provided
Interventional
Phase 1
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Drug Interaction Potentiation
  • 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: 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
    Interventions:
    • Drug: PA21
    • Drug: Digoxin
  • Experimental: No PA21; Digoxin with food
    The maximum dosage of Digoxin will be 0.5 mg/day
    Intervention: Drug: Digoxin
  • 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
    Interventions:
    • Drug: PA21
    • Drug: Digoxin
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
42
January 2012
January 2012   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Healthy volunteers
  • Written informed consent

Exclusion Criteria:

  • No significant medical conditions
  • Pregnancy
Sexes Eligible for Study: All
20 Years to 50 Years   (Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01477411
PA-DDI-004
No
Not Provided
Not Provided
Vifor Inc.
Vifor Inc.
Not Provided
Principal Investigator: Peter Winkle, MD ACRI - Phase 1 (Advanced Clinical Research Institute)
Vifor Inc.
January 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP