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Also known as PPI-668 tablet, PPI-668 capsule
PPI-668 · 2 trials · 2 indications
| Arm | Type | Description |
|---|---|---|
| PPI-668, BI 207127 Dose 1, Faldaprevir, and Ribavirin | ACTIVE_COMPARATOR | PPI-668, BI 207127 Dose 1, Faldaprevir, and Ribavirin dosed in combination |
| PPI-668, BI 207127 Dose 2, Faldaprevir, and Ribavirin | ACTIVE_COMPARATOR | PPI-668, BI 207127 Dose 2, BI 207127 Placebo, Faldaprevir, and Ribavirin dosed in combination |
| PPI-668, BI 207127 Dose 1, and Faldaprevir | ACTIVE_COMPARATOR | PPI-668, BI 207127 Dose 1, and Faldaprevir dosed in combination |
| Part I: single dose escalation in healthy volunteers | EXPERIMENTAL | There will be three sequential single dose cohorts: Cohort A: PPI-668 dose D1 or placebo Cohort B: PPI-668 dose D2 or placebo Cohort C: PPI-668 dose D3 or placebo |
| Part I: multiple dose administration to healthy volunteers | EXPERIMENTAL | Upon completion of the single dose escalation phase, an additional cohort will receive repeat doses: Cohort D: highest well-tolerated dose from Cohorts A-C or placebo once daily for five days |
| Part II: multiple dose escalation in HCV subjects | EXPERIMENTAL | Upon completion of Part I, there will be 3, and potentially 4, sequential cohorts of HCV patients: Cohort E (genotype-1): PPI-668 dose E1 or placebo Cohort F (genotype-1): PPI-668 dose E2 or placebo Cohort G (genotype-1): PPI-668 dose E3 or placebo Cohort H (genotype-1): if necessary for dose-response assessment; dose to be determined Cohort I (genotype-2 or -3): PPI-668 dose E4 or placebo |
| Name | Type | Description |
|---|---|---|
| PPI-668 | DRUG | - |
| BI 207127 Dose 1 | DRUG | - |
| BI 207127 Dose 2 | DRUG | - |
| Faldaprevir | DRUG | - |
| Ribavirin | DRUG | - |
| BI 207127 Placebo | DRUG | - |
| Placebo | DRUG | capsules |
Inclusion Criteria: 1. Male or female, 18 to 65 years of age; if females are of childbearing potential, then they must be willing to use two non-hormonal methods of birth control 2. Body weight greater than 40 kg and less than 125 kg 3. Clinical diagnosis of chronic hepatitis C 4. Treatment-naïve f...
PPI-668 is an investigational small molecule developed for the treatment of chronic hepatitis C, a viral infection of the liver. It has been studied in clinical trials both as a single agent and in combination with other direct-acting antivirals, including BI 207127 and faldaprevir, with and without ribavirin.
PPI-668 is developed by BioCryst Pharmaceuticals, Inc., which trades on the Nasdaq under the ticker BCRX. The company sponsored the clinical studies of the compound in chronic hepatitis C, including a Phase 1 trial in healthy volunteers and HCV genotype 1 patients and a Phase 2 combination study.
PPI-668 has completed Phase 2 testing for chronic hepatitis C. Two trials have been run in the program, a Phase 1 study and a Phase 2 study, and both are listed as completed. No trials are currently active, and the drug has not been approved by the FDA.
PPI-668 has been evaluated in two completed trials. NCT01448200 was a Phase 1 study in healthy volunteers and patients with HCV genotype 1, enrolling 82 participants across the United States, Australia, and New Zealand. NCT01859962 was a Phase 2 study of PPI-668 with BI 207127 and faldaprevir, with and without ribavirin, enrolling 38 patients in the United States.
Yes. PPI-668 tablet and PPI-668 capsule are alternative names for the same investigational compound, PPI-668. Searches for any of these names refer to the small molecule developed by BioCryst Pharmaceuticals for chronic hepatitis C, so the trial and development information is the same regardless of which name is used.
PPI-668 was tested in randomized, double-blind, controlled trials. The Phase 2 study combined PPI-668 with BI 207127 and faldaprevir, with and without ribavirin, in chronic hepatitis C patients. Across the two completed trials, 120 participants were enrolled, and participants were 18 years or older.