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A Drug Interaction Study of the Effects of PPI-668 on the Pharmacokinetics of Midazolam and Omeprazole

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ClinicalTrials.gov Identifier: NCT01786382
Recruitment Status : Completed
First Posted : February 8, 2013
Last Update Posted : March 26, 2013
Sponsor:
Information provided by (Responsible Party):
Presidio Pharmaceuticals, Inc.

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

Condition or disease Intervention/treatment Phase
Pharmacokinetic Assessments in Healthy Volunteers Drug: PPI-668 Drug: Midazolam Drug: Omeprazole Drug: Telaprevir Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 24 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: 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
Study Start Date : February 2013
Actual Primary Completion Date : March 2013
Actual Study Completion Date : March 2013

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: midazolam
potential effects of PPI-668 on midazolam pharmacokinetics
Drug: PPI-668
Drug: Midazolam
Experimental: omeprazole
potential effects of PPI-668 on omeprazole pharmacokinetics
Drug: PPI-668
Drug: Omeprazole
Experimental: telaprevir
potential effects of PPI-668 on telaprevir pharmacokinetics
Drug: PPI-668
Drug: Telaprevir



Primary Outcome Measures :
  1. Midazolam area under the plasma concentration-time curve from time 0 to 24 hours after dosing (AUC0-24) [ Time Frame: Days 1-6 ]
  2. Midazolam maximum observed plasma concentration (Cmax) [ Time Frame: Days 1-6 ]
  3. Omeprazole area under the plasma concentration-time curve from time 0 to 24 hours after dosing (AUC0-24) [ Time Frame: Days 1-6 ]
  4. Omeprazole maximum observed plasma concentration (Cmax) [ Time Frame: Days 1-6 ]

Secondary Outcome Measures :
  1. Telaprevir area under the plasma concentration-time curve from time 0 to 24 hours after dosing (AUC0-24) [ Time Frame: Days 1-12 ]
  2. Telaprevir maximum observed plasma concentration (Cmax) [ Time Frame: Days 1-12 ]


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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. 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
  2. Age 18 to 50 years
  3. Body mass index (BMI) 18-32 kg/m2
  4. Clinical and laboratory findings consistent with good health in the opinion of the investigator
  5. Women of non-childbearing potential or men who agree to utilize adequate contraception throughout the study

    1. 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)
    2. 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:

  1. 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

  2. Concurrent clinically significant medical diagnosis that would potentially interfere with the subject's study compliance or confound the study results
  3. Concurrent social conditions (e.g., drug or alcohol abuse, transportation difficulties) that would potentially interfere with the subject's study compliance
  4. Clinically significant illness within 30 days preceding entry into the study
  5. Participation in an investigational drug study within 30 days or 5 half-lives, whichever is longer, before Screening
  6. 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.)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01786382


Locations
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United States, Wisconsin
Spaulding Clinical Research
West Bend, Wisconsin, United States, 53095
Sponsors and Collaborators
Presidio Pharmaceuticals, Inc.
Investigators
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Principal Investigator: Paul Rice, MD Spaulding Clinical
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Responsible Party: Presidio Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT01786382    
Other Study ID Numbers: PPI-668-102
First Posted: February 8, 2013    Key Record Dates
Last Update Posted: March 26, 2013
Last Verified: March 2013
Additional relevant MeSH terms:
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Midazolam
Omeprazole
Adjuvants, Anesthesia
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Anti-Anxiety Agents
Tranquilizing Agents
Psychotropic Drugs
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
GABA Modulators
GABA Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Anti-Ulcer Agents
Gastrointestinal Agents
Proton Pump Inhibitors
Enzyme Inhibitors