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Clinical Trial Details

Trial ID: L6677
Source ID: NCT01767688
Associated Drug: Mk-3102
Title: A Pharmacokinetic Study of MK-3102 in Participants With Impaired Hepatic Function (MK-3102-031)
Acronym:
Status: COMPLETED
Study Results: YES
Results: https://ClinicalTrials.gov/show/NCT01767688/results
Conditions: Diabetes Mellitus, Type 2
Interventions: DRUG: MK-3102
Outcome Measures: Primary: Area Under the Plasma Concentration Versus Time Curve (AUC) From Hour 0 to Infinity (AUC0-∞), Pre-dose and 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 96, and 168 hours post-dose | Secondary: Area Under the Concentration Versus Time Curve From Hour 0 to 168 Hours After Dosing (AUC0-168h), Pre-dose and 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 96, and 168 hours post-dose|Plasma Concentration at 168 Hours After Dosing (C168h), 168 hours post-dose|Maximum Observed Plasma Concentration (Cmax), Pre-dose and 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 96, and 168 hours post-dose|Time to Maximum Observed Plasma Drug Concentration (Tmax), Pre-dose and 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 96, and 168 hours post-dose|Apparent Terminal Phase Half-life (t½), Pre-dose and 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 96, and 168 hours post-dose|Number of Participants Experiencing Adverse Events (AEs), An adverse event is defined as any untoward medical occurrence in a patient or clinical investigation patient/subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment., Up to 14 days post-dose|Number of Participants Discontinued From Study Due to AEs, An adverse event is defined as any untoward medical occurrence in a patient or clinical investigation patient/subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment., Up to 14 days post-dose
Sponsor/Collaborators: Sponsor: Merck Sharp & Dohme LLC
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE1
Enrollment: 16
Study Type: INTERVENTIONAL
Study Designs: Allocation: NON_RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2013-01-16
Completion Date: 2013-03-07
Results First Posted: 2015-10-29
Last Update Posted: 2018-09-10
Locations:
URL: https://clinicaltrials.gov/show/NCT01767688