Ulonivirine
DrugFour ulonivirine 100 mg tablets (total dose 400 mg) taken by mouth.
Other names: MK-8507
NCT Number: NCT05093972
The purpose of this study is to evaluate pharmacokinetics (PK) and safety of a single oral dose of ulonivirine in participants with mild or moderate hepatic impairment (HI). It is hypothesized that the area under the plasma concentration-time curve from dosing to (extrapolated) infinity (AUC0-∞) in participants with mild or moderate HI is similar to that of healthy control participants.
Trial opening soon.
Get Notified18 year–75 year
All sexes
Interventional
Phase 1
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Mild and Moderate HI (Panels A and B):
Healthy Controls (Panel C):
All Participants (Panels A to C):
Exclusion criteria
Mild and Moderate HI (Panels A and B):
Healthy Controls (Panel C):
All Participants (Panel A to C):
Four ulonivirine 100 mg tablets (total dose 400 mg) taken by mouth.
Other names: MK-8507
Time frame: Predose and 1, 2, 4, 6, 8, 12, 24, 48, 96, 120, 168, 240, 336, and 504 hours postdose
The AUC0-∞ of ulonivirine will be determined in participants with mild or moderate HI and healthy controls.
Time frame: Predose and 1, 2, 4, 6, 8, 12, 24, 48, 96, 120, 168, 240, 336, and 504 hours postdose
The AUC0-last of ulonivirine will be determined in participants with mild or moderate HI and healthy controls.
Time frame: Predose and 1, 2, 4, 6, 8, 12, 24, 48, 96, 120, 168, 240, 336, and 504 hours postdose
The Cmax of ulonivirine will be determined in participants with mild or moderate HI and healthy controls.
Time frame: Predose and 1, 2, 4, 6, 8, 12, 24, 48, 96, 120, 168, 240, 336, and 504 hours postdose
The Tmax of ulonivirine will be determined in participants with mild or moderate HI and healthy controls.
Time frame: Predose and 1, 2, 4, 6, 8, 12, 24, 48, 96, 120, 168, 240, 336, and 504 hours postdose
The t½ of ulonivirine will be determined in participants with mild or moderate HI and healthy controls.
Time frame: Predose and 1, 2, 4, 6, 8, 12, 24, 48, 96, 120, 168, 240, 336, and 504 hours postdose
The CL/F of ulonivirine will be determined in participants with mild or moderate HI and healthy controls.
Time frame: Predose and 1, 2, 4, 6, 8, 12, 24, 48, 96, 120, 168, 240, 336, and 504 hours postdose
The Vz/F of ulonivirine will be determined in participants with mild or moderate HI and healthy controls.
Time frame: Up to 21 days
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.
Merck Sharp & Dohme LLC
Industry
An Open-Label, Single-Dose Clinical Study to Evaluate Pharmacokinetics of MK-8507 in Participants With Mild or Moderate Hepatic Impairment.
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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