Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Ruzasvir · 1 trial · 1 indication
Blood was collected at baseline and on Days 1, 2, 3, 4 and 5 to determine HCV RNA levels. Least squares means (LSM) and confidence intervals (CI) were obtained from an analysis of variance (ANOVA) model with maximum log10 HCV RNA change from baseline as response and a fixed effect for treatment. The primary hypothesis was that the mean change from baseline would be a reduction of ≥3 log10. A positive change from baseline indicates a reduction from baseline in log10 HCV RNA.
An adverse event (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.
| Arm | Type | Description |
|---|---|---|
| Part I GT3 Participants | EXPERIMENTAL | Participants receive Ruzasvir capsules, orally, starting at a dose of 60 mg once per day (QD) x 5 days with doses increasing or decreasing as clinically indicated. |
| Part II GT1a Participants | EXPERIMENTAL | Participants receive Ruzasvir capsules, orally, starting at a dose of 60 mg once per day (QD) x 5 days with doses increasing or decreasing as clinically indicated. |
| Part III GT2b Participants | EXPERIMENTAL | Participants receive Ruzasvir capsules, orally, starting at a dose of 60 mg once per day (QD) x 5 days with doses increasing or decreasing as clinically indicated. |
| Name | Type | Description |
|---|---|---|
| Ruzasvir | DRUG | Ruzasvir capsules, orally, starting at a dose of 60 mg once per day (QD) x 5 days with doses increasing or decreasing as clinically indicated. |
Inclusion Criteria: * Body mass index (BMI) \>=18 to\<=37 kg/m\^2 * In general good health, except for HCV infection * Clinical diagnosis of chronic HCV infection exclusively GT3 (Panels A-D) or exclusively GT1a (Panels E-F), or exclusively GT2b (Panels G-H). * Must agree to follow the smoking rest...
Ruzasvir is an investigational small molecule being developed for the treatment of Hepatitis C Infection. It is currently in Phase 1 clinical development and has been studied in a completed clinical trial. Ruzasvir is not yet approved and remains under investigation for this indication.
Ruzasvir is being developed by Merck & Company, Inc., a pharmaceutical company traded on the New York Stock Exchange under the ticker symbol MRK. The drug is currently in Phase 1 clinical development for Hepatitis C Infection.
Ruzasvir is in Phase 1 clinical development. It has completed one Phase 1 clinical trial, which was a controlled study. Ruzasvir is an investigational drug and has not been approved for any use.
Ruzasvir has been studied in one clinical trial, identified as NCT02076100. This was a Phase 1 study titled "Safety, Pharmacokinetics, and Pharmacodynamics of Ruzasvir (MK-8408) in Participants With Hepatitis C Infection (MK-8408-003)." The trial enrolled 22 participants and has been completed.
Yes, Ruzasvir is also known as MK-8408. The clinical trial NCT02076100, which studied the drug in participants with Hepatitis C Infection, refers to it as MK-8408. This alternative name is used in the trial title and may appear in related research.