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

• Sponsor: Presidio Pharmaceuticals, Inc. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01786382
• Collaborator: (none)
• Enrollment: 24
• Location: 1
• Arms: 3
• Duration (Days): 28
• Patients Per Site Per Month: 26.1

Study Details

Study Description

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

Study Design

• Study Type: Interventional
• 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: Feb 1, 2013
• Actual Primary Completion Date: Mar 1, 2013
• Actual Study Completion Date: Mar 1, 2013

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Midazolam area under the plasma concentration-time curve from time 0 to 24 hours after dosing (AUC0-24) [Days 1-6]

2. Midazolam maximum observed plasma concentration (Cmax) [Days 1-6]

3. Omeprazole area under the plasma concentration-time curve from time 0 to 24 hours after dosing (AUC0-24) [Days 1-6]

4. Omeprazole maximum observed plasma concentration (Cmax) [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) [Days 1-12]

2. Telaprevir maximum observed plasma concentration (Cmax) [Days 1-12]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 50 Years
• Sexes Eligible for Study: 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

6. 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)

1. 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

1. Concurrent clinically significant medical diagnosis that would potentially interfere with the subject's study compliance or confound the study results

2. Concurrent social conditions (e.g., drug or alcohol abuse, transportation difficulties) that would potentially interfere with the subject's study compliance

3. Clinically significant illness within 30 days preceding entry into the study

4. Participation in an investigational drug study within 30 days or 5 half-lives, whichever is longer, before Screening

5. 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.)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Spaulding Clinical Research	West Bend	Wisconsin	United States	53095

Sponsors and Collaborators

• Presidio Pharmaceuticals, Inc.

Investigators

• Principal Investigator: Paul Rice, MD, Spaulding Clinical

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Presidio Pharmaceuticals, Inc.
• ClinicalTrials.gov Identifier: NCT01786382
• Other Study ID Numbers: PPI-668-102
• First Posted: Feb 8, 2013
• Last Update Posted: Mar 26, 2013
• Last Verified: Mar 1, 2013

• Additional relevant MeSH terms: Midazolam; Omeprazole

Study Results

No Results Posted as of Mar 26, 2013