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

Completed · Phase 1

Conditions studied: Pharmacokinetic Assessments in Healthy Volunteers

In brief

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

Key facts

Study ID

NCT01786382

Run by

Presidio Pharmaceuticals, Inc.

People needed

24

Starts

2013-02-01

Expected to finish

2013-03-01

Last updated by the study team

2013-03-26

Who can join

Age: 18 and older, up to 50. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.)

Where it is running

• Spaulding Clinical Research — West Bend, Wisconsin, United States

Full record on ClinicalTrials.gov

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