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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
14
Four 200 mg capsules administered orally as a single dose
Research Centers of America ( Hollywood ) ( Site 0002)
Hollywood, Florida, United States
Clinical Pharmacology of Miami ( Site 0003)
Miami, Florida, United States
Thomas Jefferson University - Pharmacology and Experimental Therapeutics ( Site 0001)
Philadelphia, Pennsylvania, United States
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.
Time frame: 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.
Time frame: Day 1: Predose and 0.5, 1.5, 2, 4, 6, 8, 12, 24, 48, and 72 hours postdose
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.
Time frame: Up to ~ 14 days
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