Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

November 16, 2011
January 17, 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 ] [ 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 ]
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
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Crossover Assignment
Masking: 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
Both
20 Years to 50 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01477411
PA-DDI-004
No
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