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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01477411
Other study ID # PA-DDI-004
Secondary ID
Status Completed
Phase Phase 1
First received November 16, 2011
Last updated January 17, 2012
Start date November 2011
Est. completion date January 2012

Study information

Verified date January 2012
Source Vifor Inc.
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial Summary

The purpose of this study is to determine if Digoxin is affected by PA21.


Recruitment information / eligibility

Status Completed
Enrollment 42
Est. completion date January 2012
Est. primary completion date January 2012
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 20 Years to 50 Years
Eligibility Inclusion Criteria:

- Healthy volunteers

- Written informed consent

Exclusion Criteria:

- No significant medical conditions

- Pregnancy

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Basic Science


Related Conditions & MeSH terms


Intervention

Drug:
PA21
The maximum dose of PA21 will be 15.0 g/day.
Digoxin
The maximum dosage of Digoxin will be 0.5 mg/day

Locations

Country Name City State
United States ACRI - Phase 1 Anaheim California

Sponsors (1)

Lead Sponsor Collaborator
Vifor Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 No
Primary 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 No
Primary 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 No
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