NCT01786382CompletedPhase 1
A Phase 1, Open-Label Study to Evaluate the Potential Effects of PPI-668 on the Pharmacokinetics of Midazolam and Omeprazole, and Potentially Telaprevir, in Healthy Adult Subjects
Presidio Pharmaceuticals, Inc.1 site in 1 country24 target enrollmentStarted: February 2013Last updated:
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Enrollment
- 24
- Locations
- 1
- Primary Endpoint
- Omeprazole maximum observed plasma concentration (Cmax)
Study Overview
Brief 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
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Basic Science
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 50 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Subject or legally authorized representative signs an Institutional Review Board (IRB)-approved written informed consent and privacy language as per national regulations (e.g., Health Insurance Portability and Accountability Act [HIPAA] authorization for sites in the United States) before any study-related procedures (including withdrawal of prohibited medication, if applicable) are performed
- •Age 18 to 50 years
- •Body mass index (BMI) 18-32 kg/m2
- •Clinical and laboratory findings consistent with good health in the opinion of the investigator
- •Women of non-childbearing potential or men who agree to utilize adequate contraception throughout the study
- •Women of non-childbearing potential must be one of the following:
- •Postmenopausal (>2 years amenorrhea and postmenopausal status confirmed by follicle-stimulating hormone levels)
- •Surgically sterile (documentation of prior tubal ligation, hysterectomy, or oophorectomy is required)
- •Male subjects who are not surgically sterile must agree to use one of the following birth control methods if sexually active:
- •Double-barrier contraceptive (e.g., condom plus diaphragm, condom or diaphragm with spermicidal gel/foam)
- •Female partner is at least two years postmenopausal or surgically sterile
Exclusion Criteria
- •Positive results on any of the following tests at Screening or Day -1:
- •urine pregnancy (women only), urine drugs of abuse and alcohol, hepatitis B surface antigen, hepatitis C antibody, and human immunodeficiency virus antibody
- •Concurrent clinically significant medical diagnosis that would potentially interfere with the subject's study compliance or confound the study results
- •Concurrent social conditions (e.g., drug or alcohol abuse, transportation difficulties) that would potentially interfere with the subject's study compliance
- •Clinically significant illness within 30 days preceding entry into the study
- •Participation in an investigational drug study within 30 days or 5 half-lives, whichever is longer, before Screening
- •Use of prescription medications within 14 days before Day 1 and throughout the study. (The use of non-prescription or over-the-counter medications is prohibited within 7 days before Day 1 and throughout the study. This includes all herbal supplements or remedies and vitamins.)
Arms & Interventions
midazolam
Experimental
potential effects of PPI-668 on midazolam pharmacokinetics
Intervention: PPI-668 (Drug)
midazolam
Experimental
potential effects of PPI-668 on midazolam pharmacokinetics
Intervention: Midazolam (Drug)
omeprazole
Experimental
potential effects of PPI-668 on omeprazole pharmacokinetics
Intervention: PPI-668 (Drug)
omeprazole
Experimental
potential effects of PPI-668 on omeprazole pharmacokinetics
Intervention: Omeprazole (Drug)
telaprevir
Experimental
potential effects of PPI-668 on telaprevir pharmacokinetics
Intervention: PPI-668 (Drug)
telaprevir
Experimental
potential effects of PPI-668 on telaprevir pharmacokinetics
Intervention: Telaprevir (Drug)
Outcomes
Primary Outcomes
Omeprazole maximum observed plasma concentration (Cmax)
Time Frame: Days 1-6
Midazolam area under the plasma concentration-time curve from time 0 to 24 hours after dosing (AUC0-24)
Time Frame: Days 1-6
Midazolam maximum observed plasma concentration (Cmax)
Time Frame: Days 1-6
Omeprazole area under the plasma concentration-time curve from time 0 to 24 hours after dosing (AUC0-24)
Time Frame: Days 1-6
Secondary Outcomes
- Telaprevir area under the plasma concentration-time curve from time 0 to 24 hours after dosing (AUC0-24)(Days 1-12)
- Telaprevir maximum observed plasma concentration (Cmax)(Days 1-12)
Investigators
Study Sites (1)
Loading locations...
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