A Drug Interaction Study of the Effects of PPI-668 on the Pharmacokinetics of Midazolam and Omeprazole
NCT01786382 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 24
Last updated 2013-03-26
Summary
The primary objectives of the study are to:
* Evaluate the potential effects of PPI-668 at steady state on the pharmacokinetic (PK) profile of midazolam following a single oral dose in human subjects.
* Evaluate the potential effects of PPI-668 at steady state on the PK profile of omeprazole following a single oral dose in human subject
Conditions
- Pharmacokinetic Assessments in Healthy Volunteers
Interventions
- DRUG
-
PPI-668
- DRUG
-
Midazolam
- DRUG
-
Omeprazole
- DRUG
-
Telaprevir
Sponsors & Collaborators
-
Presidio Pharmaceuticals, Inc.
lead INDUSTRY
Principal Investigators
-
Paul Rice, MD · Spaulding Clinical
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- BASIC_SCIENCE
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 50 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2013-02-28
- Primary Completion
- 2013-03-31
- Completion
- 2013-03-31
Countries
- United States
Study Locations
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