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

NCT01786382 | Completed Phase 1

• 1 other identifier: PPI-668-102
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (4)

• Midazolam area under the plasma concentration-time curve from time 0 to 24 hours after dosing (AUC0-24)

  Days 1-6

• Midazolam maximum observed plasma concentration (Cmax)

  Days 1-6

• Omeprazole area under the plasma concentration-time curve from time 0 to 24 hours after dosing (AUC0-24)

  Days 1-6

• Omeprazole maximum observed plasma concentration (Cmax)

  Days 1-6

Secondary Outcomes (2)

• Telaprevir area under the plasma concentration-time curve from time 0 to 24 hours after dosing (AUC0-24)

  Days 1-12

• Telaprevir maximum observed plasma concentration (Cmax)

  Days 1-12

Study Arms (3)

midazolam

EXPERIMENTAL

potential effects of PPI-668 on midazolam pharmacokinetics

Drug: PPI-668; Drug: Midazolam

omeprazole

EXPERIMENTAL

potential effects of PPI-668 on omeprazole pharmacokinetics

Drug: PPI-668; Drug: Omeprazole

telaprevir

EXPERIMENTAL

potential effects of PPI-668 on telaprevir pharmacokinetics

Drug: PPI-668; Drug: Telaprevir

Interventions

PPI-668 DRUG

midazolam; omeprazole; telaprevir

Midazolam DRUG

midazolam

Omeprazole DRUG

omeprazole

Telaprevir DRUG

telaprevir

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

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.)

Sponsors & Collaborators

• Presidio Pharmaceuticals, Inc.: lead

Study Sites (1)

Spaulding Clinical Research

West Bend, Wisconsin, 53095, United States

Location

MeSH Terms

Interventions

ravidasvir; Midazolam; Omeprazole; telaprevir

Intervention Hierarchy (Ancestors)

Benzodiazepines; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; 2-Pyridinylmethylsulfinylbenzimidazoles; Sulfoxides; Sulfur Compounds; Organic Chemicals; Pyridines; Heterocyclic Compounds, 1-Ring; Benzimidazoles

Study Officials

• Paul Rice, MD

  Spaulding Clinical

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 4, 2013
• First Posted: February 8, 2013
• Study Start: February 1, 2013
• Primary Completion: March 1, 2013
• Study Completion: March 1, 2013
• Last Updated: March 26, 2013

Record last verified: 2013-03

Locations

US (1)