A Drug-Drug Interaction Study of Omeprazole and PA21

A Single-centre, Open-label, Three-period Study of the Pharmacokinetic Effect of PA21 on Omeprazole in Healthy Male and Female Adults

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

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Drug: PA21 and Omeprazole with food; Drug: No PA21; Omeprazole with food; Drug: PA21 with food, Omeprazole 2hrs later

• Study Type: Interventional
• Enrollment (Actual): 45
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • California
    • Anaheim, California, United States, 92801
      • ACRI - Phase 1

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 50 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Healthy Volunteers
• Written informed consent

Exclusion Criteria:

• No significant medical conditions
• Pregnancy

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

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)	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, 3.5, 4, 5, 6, 8, 12, 24 hours post omeprazole 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, 3.5, 4, 5, 6, 8, 12, 24, 48 hours post omeprazole dose on days 0, 11, 22
Maximum observed plasma concentration (Cmax)		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

Collaborators and Investigators

• Sponsor: Vifor Pharma
• Investigators: Principal Investigator: Peter J Winkle, MD, ACRI - Phase 1 (Advanced Clinical Research Institute)

Study record dates

Study Major Dates

• Study Start: September 1, 2011
• Primary Completion (Actual): December 1, 2011
• Study Completion (Actual): December 1, 2011

Study Registration Dates

• First Submitted: September 22, 2011
• First Submitted That Met QC Criteria: October 12, 2011
• First Posted (Estimate): October 17, 2011

Study Record Updates

• Last Update Posted (Estimate): December 12, 2011
• Last Update Submitted That Met QC Criteria: December 8, 2011
• Last Verified: December 1, 2011

More Information

Terms related to this study

• Keywords: Pharmacokinetics; Drug-drug interaction; PA21; Drug Interaction Potentiation
• Additional Relevant MeSH Terms: Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Gastrointestinal Agents; Anti-Ulcer Agents; Proton Pump Inhibitors; Omeprazole
• Other Study ID Numbers: PA-DDI-003