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CompletedNCT01786382Updated Mar 26, 2013

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

A Phase 1 interventional study of PPI-668 and Midazolam in Pharmacokinetic Assessments in Healthy Volunteers, sponsored by Presidio Pharmaceuticals, Inc.. Completed at 1 site in United States. Open to participants aged 18 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2013-03-26.

Sponsored by Presidio Pharmaceuticals, Inc. · Phase 1, Interventional, and Basic science

Phase
Phase 1
Study type
Interventional
Enrollment
24
Allocation
Non-randomized
Ages
18 Years to 50 Years
Sex
All
01

Study 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
02

Conditions studied

  • Pharmacokinetic Assessments in Healthy Volunteers
03

Who can participate

Ages eligible
18 Years to 50 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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.)
04

Study design

Phase
Phase 1
Primary purpose
Basic science
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
24 participants (actual)

Study arms

  • 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

Interventions

  • DrugPPI-668
  • DrugMidazolam
  • DrugOmeprazole
  • DrugTelaprevir
05

What researchers measure

Primary outcomes

  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 outcomes

  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

06

Study locations

1 site
  • Spaulding Clinical Research
    West Bend, Wisconsin 53095, United States
07

Registry details

Key details

Study ID
NCT01786382
Lead sponsor
Presidio Pharmaceuticals, Inc.
Responsible party
Sponsor
First posted
Feb 8, 2013
Start date
Feb 2013
Primary completion
Mar 2013
Completion
Mar 2013
Last update
Mar 26, 2013

Study contacts

Paul Rice, MD
principal investigator · Spaulding Clinical

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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