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A Drug-Drug Interaction Study of Furosemide and PA21

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Vifor Inc.
ClinicalTrials.gov Identifier:
NCT01438359
First received: September 16, 2011
Last updated: September 29, 2011
Last verified: September 2011
  Purpose

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


Condition Intervention Phase
Healthy
Drug: PA21 and Furosemide with food
Drug: No PA21; Furosemide with food
Drug: PA21 with food and Furosemide 2hrs later
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Basic Science
Official Title: A Single-centre, Open-label, Three-period Study of the Pharmacokinetic Effect of PA21 on Furosemide in Healthy Male and Female Adults

Resource links provided by NLM:


Further study details as provided by Vifor Inc.:

Primary Outcome Measures:
  • Effect of PA21 on Furosemide [ Time Frame: PK assessment on Day 0, 11, and 22: pre-dose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, 48 hrs post furosemide dose ] [ Designated as safety issue: No ]
    To assess the effect, if any, of PA21 on Furosemide exposure(AUC0-24; AUC0-infinity; Cmax; Tmax and t1/2).


Estimated Enrollment: 42
Study Start Date: July 2011
Study Completion Date: September 2011
Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: PA21 and Furosemide with food Drug: PA21 and Furosemide with food
The maximum dose of PA21 will be 15.0 g/day. The maximum dose of Furosemide will be 40 mg/day
Experimental: No PA21; Furosemide with food Drug: No PA21; Furosemide with food
The maximum dosage of Furosemide will be 40 mg/day
Experimental: PA21 with food and Furosemide 2hrs later Drug: PA21 with food and Furosemide 2hrs later
The maximum dose of PA21 will be 15 g/day. The maximum dose of Furosemide will be 40 mg/day

  Eligibility

Ages Eligible for Study:   20 Years to 50 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy volunteers
  • Written informed consent

Exclusion Criteria:

  • No significant medical conditions
  • Pregnancy
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01438359

Locations
United States, California
ACRI - Phase 1
Anaheim, California, United States, 92801
Sponsors and Collaborators
Vifor Inc.
Investigators
Principal Investigator: Peter J Winkle, MD ACRI - Phase 1 (Advanced Clinical Research Institute)
  More Information

No publications provided

Responsible Party: Vifor Inc.
ClinicalTrials.gov Identifier: NCT01438359     History of Changes
Other Study ID Numbers: PA-DDI-002
Study First Received: September 16, 2011
Last Updated: September 29, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by Vifor Inc.:
Drug-drug interaction
Pharmacokinetics
PA21
Drug Interaction Potentiation

Additional relevant MeSH terms:
Furosemide
Cardiovascular Agents
Diuretics
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Natriuretic Agents
Pharmacologic Actions
Physiological Effects of Drugs
Sodium Potassium Chloride Symporter Inhibitors
Therapeutic Uses

ClinicalTrials.gov processed this record on November 24, 2014