Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of this study is to investigate the pharmacokinetics, safety, and tolerability of the co-administration of VCH-222 and telaprevir in healthy subjects.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1 | Experimental |
| |
| Cohort 2 | Experimental |
| |
| Cohort 3 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| VCH-222 | Drug | Capsules, Oral, 400 mg, q12h, Days 1-10 and Days 28-37 |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Safety and tolerability based on vital signs, 12-lead electrocardiograms (ECGs), physical examination, laboratory assessments, and adverse events | Day 47 safety assessment |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetic parameters (Cmax, tmax, C12 h, Cmin, and AUC0-12 h) of VCH-222 at steady-state in plasma in the presence and absence of telaprevir at steady-state | Day 37 pharmacokinetic assessment | |
| Pharmacokinetics parameters (Cmax, tmax, C12 h, Cmin, and AUC0-12 h) of telaprevir at steady-state in plasma in the presence and absence of VCH-222 at steady-state |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Medical Monitor | Vertex Pharmaceuticals Incorporated | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Christchurch | New Zealand |
Not provided
| ID | Term |
|---|---|
| D006526 | Hepatitis C |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D006525 | Hepatitis, Viral, Human |
Not provided
Not provided
| ID | Term |
|---|---|
| C000592793 | lomibuvir |
| C486464 | telaprevir |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| VCH-222 |
| Drug |
Capsules, Oral, 750 mg, q12h, Days 1-10 and Days 28-37 |
|
| VCH-222 | Drug | Capsules, Oral, 1000 mg, q12h, Days 1-10 and Days 28-37 |
|
| telaprevir | Drug | Tablet, Oral, 1125 mg, q12h, Days 18-37 |
|
| Day 37 pharmacokinetic assessment |
| D014777 |
| Virus Diseases |
| D018178 | Flaviviridae Infections |
| D012327 | RNA Virus Infections |
| D006505 | Hepatitis |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |