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

NCT ID: NCT01786382

Last Updated: 2013-03-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-02-28
• Study Completion Date: 2013-03-31

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

Conditions

Pharmacokinetic Assessments in Healthy Volunteers

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

midazolam

potential effects of PPI-668 on midazolam pharmacokinetics

Group Type: EXPERIMENTAL

PPI-668

Intervention Type: DRUG

Midazolam

Intervention Type: DRUG

omeprazole

potential effects of PPI-668 on omeprazole pharmacokinetics

Group Type: EXPERIMENTAL

PPI-668

Intervention Type: DRUG

Omeprazole

Intervention Type: DRUG

telaprevir

potential effects of PPI-668 on telaprevir pharmacokinetics

Group Type: EXPERIMENTAL

PPI-668

Intervention Type: DRUG

Telaprevir

Intervention Type: DRUG

Interventions

PPI-668

Intervention Type: DRUG

Midazolam

Intervention Type: DRUG

Omeprazole

Intervention Type: DRUG

Telaprevir

Intervention Type: DRUG

Eligibility 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.)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Presidio Pharmaceuticals, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Paul Rice, MD

Role: PRINCIPAL_INVESTIGATOR

Spaulding Clinical

Locations

Spaulding Clinical Research

West Bend, Wisconsin, United States

Countries

United States

Other Identifiers

PPI-668-102

Identifier Type: -

Identifier Source: org_study_id