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The primary objectives of the study are to:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| midazolam | Experimental | potential effects of PPI-668 on midazolam pharmacokinetics |
|
| omeprazole | Experimental | potential effects of PPI-668 on omeprazole pharmacokinetics |
|
| telaprevir | Experimental | potential effects of PPI-668 on telaprevir pharmacokinetics |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PPI-668 | Drug |
| ||
| Midazolam |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
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:
Male subjects who are not surgically sterile must agree to use one of the following birth control methods if sexually active:
Exclusion Criteria:
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.)
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| Name | Affiliation | Role |
|---|---|---|
| Paul Rice, MD | Spaulding Clinical | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Spaulding Clinical Research | West Bend | Wisconsin | 53095 | United States |
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| ID | Term |
|---|---|
| C000621711 | ravidasvir |
| D008874 | Midazolam |
| D009853 | Omeprazole |
| C486464 | telaprevir |
| ID | Term |
|---|---|
| D001569 | Benzodiazepines |
| D001552 | Benzazepines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
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| Drug |
|
| Omeprazole | Drug |
|
| Telaprevir | Drug |
|
| D006571 | Heterocyclic Compounds |
| D053799 | 2-Pyridinylmethylsulfinylbenzimidazoles |
| D013454 | Sulfoxides |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D001562 | Benzimidazoles |