Phase 1
Completed N=16
A Study to Evaluate Molnupiravir (MK-4482; MOV) in Participants With Severe Renal Impairment (MK-4482-003)
Source: ClinicalTrials.gov NCT05386758 ↗Enrolled (actual)
16
Serious AEs
0.0%
Results posted
Jul 2024
Primary outcomePrimary: Area Under the Curve From Time 0 to Infinity (AUC0-inf) of N-hydroxycytidine (NHC) — 11100; 8960 hr*ng/mL
Summary
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Area Under the Curve From Time 0 to Infinity (AUC0-inf) of N-hydroxycytidine (NHC) |
11100; 8960 | — |
| PRIMARY Maximum Plasma Concentration (Cmax) of NHC |
3920; 3240 | — |
| PRIMARY Number of Participants Who Experienced an Adverse Event (AE) |
2; 0 | — |
| SECONDARY Amount of Dose Administered Excreted in Urine (Ae) of N-hydroxycytidine (NHC) |
3.72; 14.6 | — |
| SECONDARY Fraction of the Dose Administered Excreted in Urine (Fe) of NHC |
0.591; 2.33 | — |
| SECONDARY Renal Clearance (CLr) of NHC |
0.338; 1.64 | — |
Eligibility Criteria
Inclusion Criteria
The key Inclusion Criteria include but are not limited to the following:
- Body mass index (BMI) ≥18.5 kg/m^2 and ≤35 kg/m^2
- Healthy participants: Baseline estimated glomerular filtration rate (eGFR) ≥90 mL/min based on the 2021 Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) Creatinine equation
- Severe renal impairment participants: Baseline estimated glomerular filtration rate (eGFR) <30 mL/min based on the 2021 CKD-EPI Creatinine equation
Exclusion Criteria
The key Exclusion Criteria include but are not limited to the following:
- Positive for hepatitis B surface antigen (HBsAg), hepatitis C antibodies or human immunodeficiency virus (HIV)
- History of major surgery, donated or lost 1 unit of blood (approximately 500 mL) within 4 weeks prior to the prestudy (screening) visit
Severe renal impairment participants:
- History or presence of renal artery stenosis
- Had a renal transplant
- Currently taking medications to treat chronic medical conditions associated with renal disease if participant has not been on a stable regimen for at least 1 month and/or is unable to withhold the use of medication(s) within 4 hours prior to and 8 hours after administration of the study drug
Data sourced from ClinicalTrials.gov (NCT05386758). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.