- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01477411
A Drug-Drug Interaction Study of Digoxin and PA21
January 17, 2012 updated by: Vifor Pharma
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
42
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
California
-
Anaheim, California, United States, 92801
- ACRI - Phase 1
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
20 years to 50 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Healthy volunteers
- Written informed consent
Exclusion Criteria:
- No significant medical conditions
- Pregnancy
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
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
|
The maximum dose of PA21 will be 15.0 g/day.
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
|
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
|
The maximum dose of PA21 will be 15.0 g/day.
The maximum dosage of Digoxin will be 0.5 mg/day
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
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 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
|
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
|
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
|
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
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Peter Winkle, MD, ACRI - Phase 1 (Advanced Clinical Research Institute)
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
November 1, 2011
Primary Completion (Actual)
January 1, 2012
Study Completion (Actual)
January 1, 2012
Study Registration Dates
First Submitted
November 16, 2011
First Submitted That Met QC Criteria
November 18, 2011
First Posted (Estimate)
November 22, 2011
Study Record Updates
Last Update Posted (Estimate)
January 18, 2012
Last Update Submitted That Met QC Criteria
January 17, 2012
Last Verified
January 1, 2012
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- PA-DDI-004
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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