Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
MK-1075 · 2 trials · 2 indications
An AE is any untoward medical occurrence in a participant administered a pharmaceutical product which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), 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 preexisting condition that is temporally associated with the use of the Sponsor's product, is also an AE.
An AE is any untoward medical occurrence in a participant administered a pharmaceutical product which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), 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 preexisting condition that is temporally associated with the use of the Sponsor's product, is also an AE.
Blood was collected on Days 1, 3, 4, 5, 6, 7, 21, 28 and 42, where baseline measurement was defined as the measurement obtained pre-dose on the first day of dosing. Change from baseline in log10 HCV RNA levels, was determined, and the maximum reduction in HCV RNA was analyzed by an ANOVA model with a fixed effect for treatment. The primary hypothesis is, with a posterior probability larger than 70%, there is at least a 3 log10 reduction from baseline in HCV RNA.
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 |
|---|---|---|
| GT1: 200 mg MK-1075 | EXPERIMENTAL | Fasted GT1 participants are administered 200 mg MK-1075 in tablet form, orally, once daily for 7 consecutive days |
| GT1: 400 mg MK-1075 | EXPERIMENTAL | Fasted GT1 participants are administered 400 mg MK-1075 in tablet form, orally, once daily for 7 consecutive days |
| GT1: 800 mg MK-1075 | EXPERIMENTAL | Fasted GT1 participants are administered 800 mg MK-1075 in tablet form, orally, once daily for 7 consecutive days |
| GT3: 200 mg MK-1075 | EXPERIMENTAL | Fasted GT3 participants are administered 200 mg MK-1075 in tablet form, orally, once daily for 7 consecutive days |
| GT3: 400 mg MK-1075 | EXPERIMENTAL | Fasted GT3 participants are administered 400 mg MK-1075 in tablet form, orally, once daily for 7 consecutive days |
| GT3: 800 mg MK-1075 | EXPERIMENTAL | Fasted GT3 participants are administered 800 mg MK-1075 in tablet form, orally, once daily for 7 consecutive days |
| 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 |
|---|---|---|
| 200 mg MK-1075 | DRUG | Two 100 mg tablets of MK-1075 administered orally, once daily for 7 consecutive days |
| 400 mg MK-1075 | DRUG | Four 100 mg tablets of MK-1075 administered orally, once daily for 7 consecutive days |
| 800 mg MK-1075 | DRUG | Eight 100 mg tablets of MK-1075 administered orally, once daily for 7 consecutive days |
| MK-1075 | DRUG | MK-1075 supplied as 10 mg or 100 mg tablets for oral administration. |
Inclusion Criteria: * Female of non-childbearing potential * Have a body mass index (BMI) \>=18 to =\< 37 kg/m\^2 * Excepting HCV infection, be in good health * Have a clinical diagnosis of chronic HCV infection, exclusively GT1 or exclusively GT3 * Agree to follow smoking restrictions Exclusion C...
Top 1 of 4 competitors
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Atea Pharmaceuticals, Inc. | AVIR | 2 | PHASE3 | Bemnifosbuvir-Ruzasvir |
MK-1075 is an investigational small molecule developed by Merck & Company, Inc. (MRK) for the treatment of hepatitis C and hepatitis C virus infection. It is in Phase 1 clinical development and has been studied in a small number of HCV-infected participants. MK-1075 is also known as 200 mg MK-1075.
MK-1075 is being developed for the treatment of hepatitis C and hepatitis C virus infection. It is an investigational therapy and has not been approved for any indication. Clinical testing has been conducted in adults with HCV infection, with the goal of evaluating the drug in that patient population.
MK-1075 is developed by Merck & Company, Inc., which trades on the New York Stock Exchange under the ticker MRK. Merck is the sponsor of the clinical studies evaluating MK-1075 in hepatitis C virus infection.
MK-1075 is in Phase 1 clinical development. It is an investigational drug and has not been approved by the FDA or any other regulatory agency. The Phase 1 program has evaluated the drug in adults with hepatitis C virus infection.
MK-1075 has been studied in two completed Phase 1 trials: NCT02461563, a multiple-dose study in HCV-infected participants that enrolled 12 people, and NCT02392494, a study in participants with hepatitis C that enrolled 9 people. Both trials are completed.