| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT02392494 | Evaluation of MK-1075 in Participants With Hepatitis C Virus (HCV) Infection (MK-1075-002) | PHASE1 | COMPLETED | 9 | — | — | Apr 28, 2015 | Aug 10, 2015 | Jan 22, 2019 | - | — |
An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. An AE could therefore be any unfavourable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a pre-existing condition that was temporally associated with the use of the Sponsor's product, was also an AE. The percentage of participants that experienced an AE was reported for each treatment panel.
An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. An AE could therefore be any unfavourable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a pre-existing condition that was temporally associated with the use of the Sponsor's product, was also an AE. The percentage of participants that discontinued the study due to an AE was reported for each treatment panel.
For assessment of antiviral activity of MK-1075 at each study dose, baseline and post-dose HCV ribonucleic acid (RNA) (log10) were measured at pre-dose and 2, 4, 8, 12, 16, 24, 32, 48, 72, and 120 hours post-dose. For each participant, baseline measurement was defined as the measurement obtained pre-dose on the first day of dosing. The estimated change from baseline in HCV RNA VL (log10) was calculated for each participant by time point after each single dose, and the maximum change (reduction) in HCV RNA was determined and reported for each treatment arm using an Analysis of Variance (ANOVA) model.
| Arm | Type | Description |
|---|---|---|
| MK-1075 100 mg (Panel A) | EXPERIMENTAL | HCV-infected participants receive a single 100 mg dose of MK-1075. |
| MK-1075 200 mg (Panel B) | EXPERIMENTAL | HCV-infected participants receive a single 200 mg dose of MK-1075. |
| MK-1075 400 mg (Panel C) | EXPERIMENTAL | HCV-infected participants receive a single 400 mg dose of MK-1075. |
| MK-1075 800 mg (Panel D) | EXPERIMENTAL | HCV-infected participants receive a single 800 mg dose of MK-1075. |
| Name | Type | Description |
|---|---|---|
| MK-1075 | DRUG | MK-1075 supplied as 10 mg or 100 mg tablets for oral administration. |
Inclusion Criteria: * Male or female of non-child bearing potential * In good health other than HCV genotype (GT) 1 infection Exclusion Criteria: * Is mentally incapacitated or legally institutionalized * Has a history of clinically significant and not stably controlled endocrine, gastrointestina...
| 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 |