A Drug-Drug Interaction Study of Omeprazole and PA21

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Vifor Inc.
ClinicalTrials.gov Identifier:
NCT01452906
First received: September 22, 2011
Last updated: December 8, 2011
Last verified: December 2011
  Purpose

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


Condition Intervention Phase
Healthy
Drug: PA21 and Omeprazole with food
Drug: No PA21; Omeprazole with food
Drug: PA21 with food, Omeprazole 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 Omeprazole in Healthy Male and Female Adults

Resource links provided by NLM:


Further study details as provided by Vifor Inc.:

Primary Outcome Measures:
  • 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, 3.5, 4, 5, 6, 8, 12, 24 hours post omeprazole 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, 3.5, 4, 5, 6, 8, 12, 24, 48 hours post omeprazole 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, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 24, 48 hours post omeprazole dose on days 0, 11, 22 ] [ Designated as safety issue: No ]

Enrollment: 45
Study Start Date: September 2011
Study Completion Date: December 2011
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: PA21 and Omeprazole with food Drug: PA21 and Omeprazole with food
The maximum dose of PA21 will be 15.0 g/day. The maximum dose of Omeprazole will be 40 mg/day
Experimental: No PA21; Omeprazole with food Drug: No PA21; Omeprazole with food
The maximum dosage of Omeprazole will be 40 mg/day
Experimental: PA21 with food, Omeprazole 2 hrs later Drug: PA21 with food, Omeprazole 2hrs later
The maximum dose of PA21 will be 15 g/day. The maximum dose of Omeprazole 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: NCT01452906

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: NCT01452906     History of Changes
Other Study ID Numbers: PA-DDI-003
Study First Received: September 22, 2011
Last Updated: December 8, 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:
Omeprazole
Anti-Ulcer Agents
Gastrointestinal Agents
Therapeutic Uses
Pharmacologic Actions
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on July 24, 2014