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
1 other identifier
interventional
42
1 country
1
Brief Summary
The purpose of this study is to determine if Digoxin is affected by PA21.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1
Started Nov 2011
Shorter than P25 for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2011
CompletedFirst Submitted
Initial submission to the registry
November 16, 2011
CompletedFirst Posted
Study publicly available on registry
November 22, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2012
CompletedJanuary 18, 2012
January 1, 2012
2 months
November 16, 2011
January 17, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Area Under the Curve from time zero to 24 hours (AUC0-24)
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)
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)
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
Study Arms (3)
PA21 and Digoxin with food
EXPERIMENTALThe maximum dose of PA21 will be 15.0 g/day. The maximum dose of Digoxin will be 0.5 mg/day
No PA21; Digoxin with food
EXPERIMENTALThe maximum dosage of Digoxin will be 0.5 mg/day
PA21 with food and Digoxin 2hrs later
EXPERIMENTALThe maximum dose of PA21 will be 15 g/day. The maximum dose of Digoxin will be 0.5 mg/day
Interventions
Eligibility Criteria
You may qualify if:
- Healthy volunteers
- Written informed consent
You may not qualify if:
- No significant medical conditions
- Pregnancy
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Vifor Pharmalead
Study Sites (1)
ACRI - Phase 1
Anaheim, California, 92801, United States
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Peter Winkle, MD
ACRI - Phase 1 (Advanced Clinical Research Institute)
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- BASIC SCIENCE
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 16, 2011
First Posted
November 22, 2011
Study Start
November 1, 2011
Primary Completion
January 1, 2012
Study Completion
January 1, 2012
Last Updated
January 18, 2012
Record last verified: 2012-01