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| ID | Type | Description | Link |
|---|---|---|---|
| MK-4482-003 | Other Identifier | MSD |
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This purpose of this study is to evaluate the plasma pharmacokinetics (PK) of N-hydroxycytidine (NHC), the nucleoside metabolite of molnupiravir, after a single oral dose of 800 mg molnupiravir in participants with severe renal impairment compared to healthy mean matched control participants. This study will also assess the safety and tolerability of molnupiravir in participants with severe renal impairment and the urinary excretion of NHC after a single oral dose of 800 mg molnupiravir in participants with severe renal impairment compared to healthy mean matched control participants. The primary hypothesis is that the plasma PK participants with severe renal impairment will be similar to that observed in the healthy mean matched control participants.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Panel A - Severe Renal Impairment Group | Experimental | Participants with severe renal impairment will receive a single oral 800 mg dose of molnupiravir. |
|
| Panel B - Healthy Control Group | Experimental | Participants in the healthy mean matched control group will receive a single oral 800 mg dose of molnupiravir. |
|
| 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 Curve From Time 0 to Infinity (AUC0-inf) of N-hydroxycytidine (NHC) | Blood for plasma samples was collected at pre-specified time points to determine the AUC0-inf of NHC. | Predose, 0.5,1.5, 2, 4, 6, 8, 12, 24, 48 and 72 hours postdose |
| Maximum Plasma Concentration (Cmax) of NHC | Blood for plasma samples was collected at pre-specified time points to determine the Cmax of NHC. | Predose, 0.5,1.5, 2, 4, 6, 8, 12, 24, 48 and 72 hours postdose |
| Number of Participants Who Experienced an Adverse Event (AE) | An AE was 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. An AE was therefore any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention. The number of participants who experienced an AE were reported. | Up to Day 15 |
| Measure | Description | Time Frame |
|---|---|---|
| Amount of Dose Administered Excreted in Urine (Ae) of N-hydroxycytidine (NHC) | Urine was collected at pre-specified time points to determine the amount of dose Administered excreted in urine (Ae) of NHC. | Predose, 4, 8, 12 and 24 hours postdose |
| Fraction of the Dose Administered Excreted in Urine (Fe) of NHC |
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Inclusion Criteria:
The key Inclusion Criteria include but are not limited to the following:
Exclusion Criteria:
The key Exclusion Criteria include but are not limited to the following:
Severe renal impairment participants:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Merck Sharp & Dohme LLC | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Velocity Clinical Research, Hallandale Beach ( Site 0005) | Hallandale | Florida | 33009 | United States | ||
| 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 |
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| ID | Title | Description |
|---|---|---|
| FG000 | Participants With Severe Renal Impairment | Participants with severe renal impairment received a single oral 800 mg dose of molnupiravir. |
| FG001 | Healthy Participants With Normal Renal Function | Participants in the healthy mean matched control group received a single oral 800 mg dose of molnupiravir. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Participants With Severe Renal Impairment | Participants with severe renal impairment received a single oral 800 mg dose of molnupiravir. |
| BG001 | Healthy Participants With Normal Renal Function |
| 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 Curve From Time 0 to Infinity (AUC0-inf) of N-hydroxycytidine (NHC) | Blood for plasma samples was collected at pre-specified time points to determine the AUC0-inf of NHC. | All participants who complied with the protocol sufficiently to ensure that generated data likely exhibiting the effects of treatment, according to the underlying scientific model. | Posted | Geometric Mean | 95% Confidence Interval | hr*ng/mL | Predose, 0.5,1.5, 2, 4, 6, 8, 12, 24, 48 and 72 hours postdose |
|
Up to ~ Day 15
All-cause mortality (ACM) was analyzed in all allocated participants. Safety Analyses were conducted in all participants who received at least 1 dose of study intervention.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Participants With Severe Renal Impairment | Participants with severe renal impairment received a single oral 800 mg dose of molnupiravir. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Constipation | Gastrointestinal disorders | MedDRA 26.0 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Senior Vice President, Global Clinical Development | Merck Sharp & Dohme LLC | 1-800-672-6372 | ClinicalTrialsDisclosure@msd.com |
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| 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 | Oct 27, 2022 | Jan 19, 2024 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D051437 | Renal Insufficiency |
| ID | Term |
|---|---|
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
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| ID | Term |
|---|---|
| C000656703 | molnupiravir |
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|
Urine was collected at pre-specified time points to determine the Fraction of the dose administered excreted in urine (Fe) of NHC. |
| Predose, 4, 8, 12 and 24 hours postdose |
| Renal Clearance (CLr) of NHC | Urine will be collected at pre-specified time points to determine the Renal Clearance (CLr) of NHC | Predose, 4, 8, 12 and 24 hours postdose |
| Advanced Pharma CR, LLC ( Site 0004) |
| Miami |
| Florida |
| 33147 |
| United States |
| Genesis Clinical Research, LLC ( Site 0003) | Tampa | Florida | 33603 | United States |
| Thomas Jefferson University-Pharmacology, Physiology and Cancer Biology ( Site 0001) | Philadelphia | Pennsylvania | 19107 | United States |
Participants in the healthy mean matched control group received a single oral 800 mg dose of molnupiravir.
| 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 |
|
Participants in the healthy mean matched control group received a single oral 800 mg dose of molnupiravir. |
|
|
|
| Primary | Maximum Plasma Concentration (Cmax) of NHC | Blood for plasma samples was collected at pre-specified time points to determine the Cmax of NHC. | All participants who complied with the protocol sufficiently to ensure that generated data likely exhibiting the effects of treatment, according to the underlying scientific model. | Posted | Geometric Mean | 95% Confidence Interval | ng/mL | Predose, 0.5,1.5, 2, 4, 6, 8, 12, 24, 48 and 72 hours postdose |
|
|
|
|
| Primary | Number of Participants Who Experienced an Adverse Event (AE) | An AE was 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. An AE was therefore any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention. The number of participants who experienced an AE were reported. | All participants who received at least 1 dose of study intervention. | Posted | Number | Participants | Up to Day 15 |
|
|
|
| Secondary | Amount of Dose Administered Excreted in Urine (Ae) of N-hydroxycytidine (NHC) | Urine was collected at pre-specified time points to determine the amount of dose Administered excreted in urine (Ae) of NHC. | All participants who complied with the protocol sufficiently to ensure that generated data likely exhibiting the effects of treatment, according to the underlying scientific model. | Posted | Geometric Mean | Geometric Coefficient of Variation | mg | Predose, 4, 8, 12 and 24 hours postdose |
|
|
|
| Secondary | Fraction of the Dose Administered Excreted in Urine (Fe) of NHC | Urine was collected at pre-specified time points to determine the Fraction of the dose administered excreted in urine (Fe) of NHC. | All participants who complied with the protocol sufficiently to ensure that generated data likely exhibiting the effects of treatment, according to the underlying scientific model. | Posted | Geometric Mean | Geometric Coefficient of Variation | % of administered dose | Predose, 4, 8, 12 and 24 hours postdose |
|
|
|
| Secondary | Renal Clearance (CLr) of NHC | Urine will be collected at pre-specified time points to determine the Renal Clearance (CLr) of NHC | All participants who complied with the protocol sufficiently to ensure that generated data likely exhibiting the effects of treatment, according to the underlying scientific model. | Posted | Geometric Mean | Geometric Coefficient of Variation | L/hr | Predose, 4, 8, 12 and 24 hours postdose |
|
|
|
| 0 |
| 8 |
| 0 |
| 8 |
| 2 |
| 8 |
| EG001 | Healthy Participants With Normal Renal Function | Participants in the healthy mean matched control group received a single oral 800 mg dose of molnupiravir. | 0 | 8 | 0 | 8 | 0 | 8 |
| Hyperkalaemia | Metabolism and nutrition disorders | MedDRA 26.0 | Systematic Assessment |
|
If publication activity is not directed by the Sponsor, the investigator agrees to submit all manuscripts or abstracts to the Sponsor before submission. This allows the Sponsor to protect proprietary information and to provide comments.
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |