Arizona Clinical Trials ( Site 0001)
Chandler, Arizona, 85225, United States
NCT Number: NCT07025551
The purpose of this study is to learn what happens to MK-8527 in a person's body over time (a pharmacokinetic [PK] study). Researchers will compare what happens to MK-8527 in the body when it is given to healthy participants and participants with mild and moderate hepatic (liver) impairment.
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Notify Me18 year–75 year
All sexes
Interventional
Phase 1
Chandler, Arizona, 85225, United States
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
The main inclusion criteria include but are not limited to the following:
All participants:
Participants with Mild HI (Group 1) and Moderate HI (Group 2):
Healthy Control Participants (Group 3):
Exclusion criteria
The main exclusion criteria include but are not limited to the following:
All participants:
Participants with Mild HI (Group 1) and Moderate HI (Group 2):
Oral administration
Time frame: Predose and at designated timepoints up to 168 hours post dose
Plasma samples will be collected at pre-specified timepoints to determine the AUC0-last of MK-8527.
Time frame: Predose and at designated timepoints up to 168 hours post dose
Plasma samples will be collected at pre-specified timepoints to determine the AUC0-inf of MK-8527.
Time frame: Predose and at designated timepoints up to 168 hours post dose
Plasma samples will be collected at pre-specified timepoints to determine the Cmax of MK-8527.
Time frame: Predose and at designated timepoints up to 168 hours post dose
Plasma samples will be collected at pre-specified timepoints to determine the Tmax of MK-8527.
Time frame: Predose and at designated timepoints up to 168 hours post dose
Plasma samples will be collected at pre-specified timepoints to determine the t1/2 of MK-8527.
Time frame: Predose and at designated timepoints up to 168 hours post dose
Plasma samples will be collected at pre-specified timepoints to determine the CL/F of MK-8527.
Time frame: Predose and at designated timepoints up to 168 hours post dose
Plasma samples will be collected at pre-specified timepoints to determine the Vz/F of MK-8527.
Time frame: Up to approximately 29 days
An AE is defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.
Time frame: Up to approximately 29 days
An AE is defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.
Time frame: Predose and at designated timepoints up to 672 hours post dose
Blood samples will be collected to determine the AUC0-inf of MK-8527-TP.
Time frame: At designated timepoints pre dose and up to approximately 672 hours post dose
Blood samples will be collected to determine the AUC0-672 of MK-8527-TP.
Time frame: Predose and at designated timepoints up to 672 hours post dose
Blood samples will be collected to determine the Cmax of MK-8527-TP.
Time frame: Predose and at designated timepoints up to 672 hours post dose
Blood samples will be collected to determine the C672 of MK-8527-TP.
Time frame: Predose and at designated timepoints up to 672 hours post dose
Blood samples will be collected to determine the Tmax of MK-8527-TP.
Time frame: Predose and at designated timepoints up to 672 hours post dose
Blood samples will be collected to determine the Tmax of MK-8527-TP.
Merck Sharp & Dohme LLC
Industry
An Open-Label, Single-Dose Study to Evaluate the Pharmacokinetics of MK-8527 in Participants With Mild and 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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