Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01593735 | A Multiple Dose Study to Evaluate the Safety and Efficacy of MK-2748 in Hepatitis C-Infected Participants (MK-2748-002 AM1) | PHASE1 | COMPLETED | 30 | — | — | May 1, 2012 | Feb 1, 2013 | Jan 22, 2015 | - | — |
| Arm | Type | Description |
|---|---|---|
| Panel A: GT1, low dose | EXPERIMENTAL | Participants with genotype 1 (GT1) Hepatitis C Virus (HCV) will receive low dose MK-2748 daily for 7 days. |
| Panel B: GT1, lower dose | EXPERIMENTAL | Participants with GT1 HCV will receive lower dose MK-2748 daily for 7 days. |
| Panel C: GT1, dose based on Panels A+B | EXPERIMENTAL | Participants with GT1 HCV will be dosed with MK-2748 daily for 7 days based on the safety, pharmacokinetic, and/or pharmacodynamic data from Panels A (low dose) and B (lower dose). |
| Panel G: GT1, dose based on Panels A+B+C | EXPERIMENTAL | Participants with GT1 HCV will be dosed with MK-2748 daily for 7 days based on the safety, pharmacokinetic, and/or pharmacodynamic data from Panels A (low dose), B (lower dose), and C. |
| Panel H: GT1, dose based on Panels A+B+C+G | EXPERIMENTAL | Participants with GT1 HCV will be dosed with MK-2748 daily for 7 days based on the safety, pharmacokinetic, and/or pharmacodynamic data from Panels A (low dose), B (lower dose), C, and G. |
| Panel D: GT3, low dose (Omitted) | EXPERIMENTAL | Participants with genotype 3 (GT3) HCV were to receive low dose MK-2748 daily for 7 days. Panel D was omitted from the study design and participants were not enrolled in this panel. |
| Panel E: GT3, high dose | EXPERIMENTAL | Participants with genotype 3 (GT3) HCV will receive high dose MK-2748 daily for 7 days. |
| Panel F: GT3, dose based on Panel E | EXPERIMENTAL | Participants with GT3 HCV will be dosed with MK-2748 daily for 7 days based on the safety, pharmacokinetic, and/or pharmacodynamic data from Panel E (high dose). |
| Panel I: GT3, dose based on Panels E+F | EXPERIMENTAL | Participants with GT3 HCV will be dosed with MK-2748 daily for 7 days based on the safety, pharmacokinetic, and/or pharmacodynamic data from Panels E (high dose) and F. |
| Panel J: GT3, dose based on Panels E+F+I | EXPERIMENTAL | Participants with GT3 HCV will be dosed with MK-2748 daily for 7 days based on the safety, pharmacokinetic, and/or pharmacodynamic data from Panels E (high dose), F, and I. |
| Name | Type | Description |
|---|---|---|
| MK-2748 | DRUG | MK-2748 tablets, orally, once daily for 7 days, dose level dependent on Panel assignment |
| Placebo | DRUG | Placebo tablets, orally, once daily for 7 days |
Inclusion criteria: * Clinical diagnosis of chronic HCV infection (GT1 or GT3) for at least 6 months and detectable HCV-RNA in peripheral blood * Body mass index (BMI) of 18 to 37 kg/m\^2 * No clinically significant abnormality on electrocardiogram (ECG) * Stable health * Willing to use appropriate...
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Atea Pharmaceuticals, Inc. | AVIR | 2 | PHASE3 | Bemnifosbuvir-Ruzasvir, Sofosbuvir-Velpatasvir |
| Abbott Laboratories | ABT | 2 | — | Undisclosed |
| AbbVie, Inc. | ABBV | 1 | — | Undisclosed |