Trial Outcomes & Findings for A Study to Evaluate Molnupiravir (MK-4482; MOV) in Participants With Severe Renal Impairment (MK-4482-003) (NCT NCT05386758)
NCT ID: NCT05386758
Last Updated: 2025-01-28
Results Overview
Blood for plasma samples was collected at pre-specified time points to determine the AUC0-inf of NHC.
COMPLETED
PHASE1
16 participants
Predose, 0.5,1.5, 2, 4, 6, 8, 12, 24, 48 and 72 hours postdose
2025-01-28
Participant Flow
Participant milestones
| Measure |
Participants With Severe Renal Impairment
Participants with severe renal impairment received a single oral 800 mg dose of molnupiravir.
|
Healthy Participants With Normal Renal Function
Participants in the healthy mean matched control group received a single oral 800 mg dose of molnupiravir.
|
|---|---|---|
|
Overall Study
STARTED
|
8
|
8
|
|
Overall Study
COMPLETED
|
8
|
8
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Study to Evaluate Molnupiravir (MK-4482; MOV) in Participants With Severe Renal Impairment (MK-4482-003)
Baseline characteristics by cohort
| Measure |
Participants With Severe Renal Impairment
n=8 Participants
Participants with severe renal impairment received a single oral 800 mg dose of molnupiravir.
|
Healthy Participants With Normal Renal Function
n=8 Participants
Participants in the healthy mean matched control group received a single oral 800 mg dose of molnupiravir.
|
Total
n=16 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
63.5 Years
STANDARD_DEVIATION 7.9 • n=99 Participants
|
59.6 Years
STANDARD_DEVIATION 2.0 • n=107 Participants
|
61.6 Years
STANDARD_DEVIATION 5.9 • n=206 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=99 Participants
|
7 Participants
n=107 Participants
|
15 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
4 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
8 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
4 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
8 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
5 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
6 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
11 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: Predose, 0.5,1.5, 2, 4, 6, 8, 12, 24, 48 and 72 hours postdosePopulation: 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.
Blood for plasma samples was collected at pre-specified time points to determine the AUC0-inf of NHC.
Outcome measures
| Measure |
Participants With Severe Renal Impairment
n=8 Participants
Participants with severe renal impairment received a single oral 800 mg dose of molnupiravir.
|
Healthy Participants With Normal Renal Function
n=8 Participants
Participants in the healthy mean matched control group received a single oral 800 mg dose of molnupiravir.
|
|---|---|---|
|
Area Under the Curve From Time 0 to Infinity (AUC0-inf) of N-hydroxycytidine (NHC)
|
11100 hr*ng/mL
Interval 7990.0 to 15400.0
|
8960 hr*ng/mL
Interval 7660.0 to 10500.0
|
PRIMARY outcome
Timeframe: Predose, 0.5,1.5, 2, 4, 6, 8, 12, 24, 48 and 72 hours postdosePopulation: 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.
Blood for plasma samples was collected at pre-specified time points to determine the Cmax of NHC.
Outcome measures
| Measure |
Participants With Severe Renal Impairment
n=8 Participants
Participants with severe renal impairment received a single oral 800 mg dose of molnupiravir.
|
Healthy Participants With Normal Renal Function
n=8 Participants
Participants in the healthy mean matched control group received a single oral 800 mg dose of molnupiravir.
|
|---|---|---|
|
Maximum Plasma Concentration (Cmax) of NHC
|
3920 ng/mL
Interval 2810.0 to 5460.0
|
3240 ng/mL
Interval 2630.0 to 4000.0
|
PRIMARY outcome
Timeframe: Up to Day 15Population: All participants who received at least 1 dose of study intervention.
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.
Outcome measures
| Measure |
Participants With Severe Renal Impairment
n=8 Participants
Participants with severe renal impairment received a single oral 800 mg dose of molnupiravir.
|
Healthy Participants With Normal Renal Function
n=8 Participants
Participants in the healthy mean matched control group received a single oral 800 mg dose of molnupiravir.
|
|---|---|---|
|
Number of Participants Who Experienced an Adverse Event (AE)
|
2 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Predose, 4, 8, 12 and 24 hours postdosePopulation: 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.
Urine was collected at pre-specified time points to determine the amount of dose Administered excreted in urine (Ae) of NHC.
Outcome measures
| Measure |
Participants With Severe Renal Impairment
n=8 Participants
Participants with severe renal impairment received a single oral 800 mg dose of molnupiravir.
|
Healthy Participants With Normal Renal Function
n=8 Participants
Participants in the healthy mean matched control group received a single oral 800 mg dose of molnupiravir.
|
|---|---|---|
|
Amount of Dose Administered Excreted in Urine (Ae) of N-hydroxycytidine (NHC)
|
3.72 mg
Geometric Coefficient of Variation 50.9
|
14.6 mg
Geometric Coefficient of Variation 172
|
SECONDARY outcome
Timeframe: Predose, 4, 8, 12 and 24 hours postdosePopulation: 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.
Urine was collected at pre-specified time points to determine the Fraction of the dose administered excreted in urine (Fe) of NHC.
Outcome measures
| Measure |
Participants With Severe Renal Impairment
n=8 Participants
Participants with severe renal impairment received a single oral 800 mg dose of molnupiravir.
|
Healthy Participants With Normal Renal Function
n=8 Participants
Participants in the healthy mean matched control group received a single oral 800 mg dose of molnupiravir.
|
|---|---|---|
|
Fraction of the Dose Administered Excreted in Urine (Fe) of NHC
|
0.591 % of administered dose
Geometric Coefficient of Variation 50.9
|
2.33 % of administered dose
Geometric Coefficient of Variation 172
|
SECONDARY outcome
Timeframe: Predose, 4, 8, 12 and 24 hours postdosePopulation: 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.
Urine will be collected at pre-specified time points to determine the Renal Clearance (CLr) of NHC
Outcome measures
| Measure |
Participants With Severe Renal Impairment
n=8 Participants
Participants with severe renal impairment received a single oral 800 mg dose of molnupiravir.
|
Healthy Participants With Normal Renal Function
n=8 Participants
Participants in the healthy mean matched control group received a single oral 800 mg dose of molnupiravir.
|
|---|---|---|
|
Renal Clearance (CLr) of NHC
|
0.338 L/hr
Geometric Coefficient of Variation 62.1
|
1.64 L/hr
Geometric Coefficient of Variation 162
|
Adverse Events
Participants With Severe Renal Impairment
Healthy Participants With Normal Renal Function
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Participants With Severe Renal Impairment
n=8 participants at risk
Participants with severe renal impairment received a single oral 800 mg dose of molnupiravir.
|
Healthy Participants With Normal Renal Function
n=8 participants at risk
Participants in the healthy mean matched control group received a single oral 800 mg dose of molnupiravir.
|
|---|---|---|
|
Gastrointestinal disorders
Constipation
|
12.5%
1/8 • Number of events 1 • 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.
|
0.00%
0/8 • 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.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
12.5%
1/8 • Number of events 1 • 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.
|
0.00%
0/8 • 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.
|
Additional Information
Senior Vice President, Global Clinical Development
Merck Sharp & Dohme LLC
Results disclosure agreements
- Principal investigator is a sponsor employee 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.
- Publication restrictions are in place
Restriction type: OTHER