Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| MK-4482-016 | Other Identifier | MSD |
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 pharmacokinetics (PK) of N-hydroxycytidine (NHC) following a single oral dose of molnupiravir in participants 18 to 75 years (inclusive) with moderate hepatic impairment and healthy matched controls.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Moderate Hepatic Impairment | Experimental | Participants with moderate hepatic impairment received a single oral dose of molnupiravir 800 mg on Day 1. |
|
| Healthy-Matched Control Group | Experimental | Healthy matched participants received a single oral dose of molnupiravir 800 mg on Day 1. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Molnupiravir | Drug | Four 200 mg capsules administered orally as a single dose |
|
| Measure | Description | Time Frame |
|---|---|---|
| Area Under the Plasma Concentration-Time Curve From Time Zero to Infinity (AUC0-∞) of Plasma N-Hydroxycitidine (NHC) | The plasma AUC0-∞ of NHC is reported. | Day 1: Predose and 0.5, 1.5, 2, 4, 6, 8, 12, 24, 48, and 72 hours postdose |
| Maximum Plasma Concentration (Cmax) of NHC | The plasma Cmax of NHC is reported. | Day 1: Predose and 0.5, 1.5, 2, 4, 6, 8, 12, 24, 48, and 72 hours postdose |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Experiencing ≥1 Adverse Event (AE) | An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. | Up to ~ 14 days |
Not provided
The key inclusion and exclusion criteria include but are not limited to the following:
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 |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Centers of America ( Hollywood ) ( Site 0002) | Hollywood | Florida | 33024 | United States | ||
| Clinical Pharmacology of Miami ( Site 0003) |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39601078 | Result | Duncan KE, Carstens RP, Butterfield KL, Jin Y, Inbody LR, Schaeffer AK, Matthews CZ, Zhao T, Patel S, Maas BM, Cheng MH, Stoch SA. Assessment of pharmacokinetics and tolerability following single-dose administration of molnupiravir in participants with hepatic or renal impairment. Clin Transl Sci. 2024 Dec;17(12):e70073. doi: 10.1111/cts.70073. |
| Label | URL |
|---|---|
| Merck Clinical Trials Information | View source |
Not provided
Not provided
Not provided
Not provided
This study was conducted at 3 sites in the United States.
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Moderate Hepatic Impairment | Participants with moderate hepatic impairment will receive a single oral 800mg dose of molnupiravir. |
| FG001 | Healthy-Matched Control Group | Healthy matched participants will receive a single oral 800mg dose of molnupiravir. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Moderate Hepatic Impairment | Participants with moderate hepatic impairment will receive a single oral 800mg dose of molnupiravir. |
| BG001 | Healthy-Matched Control Group | Healthy matched participants will receive a single oral 800mg dose of molnupiravir. |
| 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 | Area Under the Plasma Concentration-Time Curve From Time Zero to Infinity (AUC0-∞) of Plasma N-Hydroxycitidine (NHC) | The plasma AUC0-∞ of NHC is reported. | All participants are included. | Posted | Geometric Mean | 95% Confidence Interval | hr*ng/mL | Day 1: Predose and 0.5, 1.5, 2, 4, 6, 8, 12, 24, 48, and 72 hours postdose |
|
Up to ~14 days
All participants are included.
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 | Moderate Hepatic Impairment | Participants with moderate hepatic impairment will receive a single oral 800mg dose of molnupiravir. |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Respiratory disorder | Respiratory, thoracic and mediastinal disorders | MedDRA 25.1 | Systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Senior Vice President, Global Clinical Development | Merck Sharp & Dohme LLC | 1-800-672-6372 | ClinicalTrialsDisclosure@msd.com |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Aug 18, 2022 | Dec 1, 2023 | Prot_SAP_000.pdf |
Not provided
| ID | Term |
|---|---|
| C000656703 | molnupiravir |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Miami |
| Florida |
| 33014 |
| United States |
| Thomas Jefferson University - Pharmacology and Experimental Therapeutics ( Site 0001) | Philadelphia | Pennsylvania | 19107 | United States |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
|
|
| Primary | Maximum Plasma Concentration (Cmax) of NHC | The plasma Cmax of NHC is reported. | All participants are included. | Posted | Geometric Mean | 95% Confidence Interval | ng/mL | Day 1: Predose and 0.5, 1.5, 2, 4, 6, 8, 12, 24, 48, and 72 hours postdose |
|
|
|
| Secondary | Number of Participants Experiencing ≥1 Adverse Event (AE) | An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. | All participants are included. | Posted | Count of Participants | Participants | Up to ~ 14 days |
|
|
|
| 0 |
| 7 |
| 0 |
| 7 |
| 0 |
| 7 |
| EG001 | Healthy-Matched Control Group | Healthy matched participants will receive a single oral 800mg dose of molnupiravir. | 0 | 7 | 0 | 7 | 1 | 7 |
If publication activity is not directed by the Sponsor, the investigator agrees to submit all manuscripts or abstracts to the Sponsor before submission.