Not provided
Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2015-000127-93 | EudraCT Number | ||
| MK-1075-002 | Other Identifier | Merck Protocol Number |
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 evaluate the safety and pharmacokinetics of MK-1075, and to determine the ability of MK-1075 to reduce HCV viral load, following administration of a single dose in HCV-infected participants.
Per protocol, panels may be omitted if the objectives of the study are met in preceding panels.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MK-1075 | Drug | MK-1075 supplied as 10 mg or 100 mg tablets for oral administration. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Experiencing an Adverse Event (AE) | 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. | Up to Study Day 14 |
| Percentage of Participants Who Discontinued Study Due to an AE | 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. | Up to Study Day 14 |
| Maximum HCV Viral Load (VL) Change From Baseline Over Time Following Single-Dose MK-1075 | 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. |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Merck Sharp & Dohme LLC | Study Director |
Not provided
Not provided
Not provided
Not provided
Nine participants were enrolled and allocated to single doses of either 100, 200, or 400 mg of MK-1075. As per the protocol, planned Panel D (800 mg MK-1075) was not enrolled since the study objective was achieved in Panel C.
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | MK-1075 100 mg (Panel A) | HCV-infected participants receive a single 100 mg dose of MK-1075. |
| FG001 | MK-1075 200 mg (Panel B) | HCV-infected participants receive a single 200 mg dose of MK-1075. |
| FG002 | MK-1075 400 mg (Panel C) | HCV-infected participants receive a single 400 mg dose of MK-1075. |
| FG003 | MK-1075 800 mg (Panel D) | HCV-infected participants were to receive a single 800 mg dose of MK-1075. No participants were enrolled in this arm. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | MK-1075 100 mg (Panel A) | HCV-infected participants receive a single 100 mg dose of MK-1075. |
| BG001 | MK-1075 200 mg (Panel B) | HCV-infected participants receive a single 200 mg dose of MK-1075. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percentage of Participants Experiencing an Adverse Event (AE) | 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. | All Participants as Treated (APaT): all participants who received at least 1 dose of study drug. | Posted | Number | Percentage of Participants | Up to Study Day 14 |
|
Up to study day 14
APaT: all participants who received at least 1 dose of study drug.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | MK-1075 100 mg (Panel A) | HCV-infected participants receive a single 100 mg dose of MK-1075. |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal distension | Gastrointestinal disorders | MedDRA 18.0 | Systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Senior Vice President, Global Clinical Development | Merck Sharp & Dohme Corp. | 1-800-672-6372 | ClinicalTrialsDisclosure@merck.com |
| ID | Term |
|---|---|
| D006526 | Hepatitis C |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D006525 | Hepatitis, Viral, Human |
Not provided
Not provided
In each panel (A, B, C, and D), participants will receive a single dose of MK-1075 (100, 200, 400, and 800 mg, respectively) in a fasted state. Safety and viral load (VL) data from the previous panel will be assessed before dosing the subsequent panel.
Not provided
Not provided
Not provided
Not provided
| Pre-dose (baseline), 2, 4, 8, 12, 16, 24, 32, 48, 72, and 120 hours post-dose |
| BG002 | MK-1075 400 mg (Panel C) | HCV-infected participants receive a single 400 mg dose of MK-1075. |
| BG003 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| OG000 |
| MK-1075 100 mg (Panel A) |
HCV-infected participants receive a single 100 mg dose of MK-1075. |
| OG001 | MK-1075 200 mg (Panel B) | HCV-infected participants receive a single 200 mg dose of MK-1075. |
| OG002 | MK-1075 400 mg (Panel C) | HCV-infected participants receive a single 400 mg dose of MK-1075. |
|
|
| Primary | Percentage of Participants Who Discontinued Study Due to an AE | 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. | APaT: all participants who received at least 1 dose of study drug. | Posted | Number | Percentage of Participants | Up to Study Day 14 |
|
|
|
| Primary | Maximum HCV Viral Load (VL) Change From Baseline Over Time Following Single-Dose MK-1075 | 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. | Per Protocol (PP) Population: all participants who received at least 1 dose of study drug and who complied with the protocol | Posted | Mean | Standard Error | log(IU/ml) | Pre-dose (baseline), 2, 4, 8, 12, 16, 24, 32, 48, 72, and 120 hours post-dose |
|
|
|
| 0 |
| 3 |
| 0 |
| 3 |
| 2 |
| 3 |
| EG001 | MK-1075 200 mg (Panel B) | HCV-infected participants receive a single 200 mg dose of MK-1075. | 0 | 3 | 0 | 3 | 2 | 3 |
| EG002 | MK-1075 400 mg (Panel C) | HCV-infected participants receive a single 400 mg dose of MK-1075. | 0 | 3 | 0 | 3 | 1 | 3 |
| Nausea | Gastrointestinal disorders | MedDRA 18.0 | Systematic Assessment |
|
| Procedural pain | Injury, poisoning and procedural complications | MedDRA 18.0 | Systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA 18.0 | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA 18.0 | Systematic Assessment |
|
The Sponsor must have the opportunity to review all proposed abstracts, manuscripts or presentations regarding this trial 45 days prior to submission for publication/presentation. Any information identified by the Sponsor as confidential must be deleted prior to submission; this confidentiality does not include efficacy and safety results. Sponsor review can be expedited to meet publication timelines.
| D014777 |
| Virus Diseases |
| D018178 | Flaviviridae Infections |
| D012327 | RNA Virus Infections |
| D006505 | Hepatitis |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
|