Logo 1 Logo 2

Clinical Trial Details

Trial ID: L0197
Source ID: NCT01407276
Associated Drug: Omarigliptin
Title: A Study of Omarigliptin (MK-3102) in Participants With Impaired Renal Function (MK-3102-009)
Acronym:
Status: COMPLETED
Study Results: YES
Results: https://ClinicalTrials.gov/show/NCT01407276/results
Conditions: Chronic Renal Insufficiency|Type 2 Diabetes Mellitus
Interventions: DRUG: Omarigliptin
Outcome Measures: Primary: Area Under the Concentration-time Curve From Time 0 to Infinity (AUC0-∞) of Omarigliptin, AUC0-∞ is a measure of the mean concentration levels of drug in the plasma after the dose., Pre-dose and 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72 (Panel G only), 96, 168, 240, and 336 hours post-dose|Maximum Concentration (Cmax) of Omarigliptin, Cmax is a measure of the maximum amount of drug in the plasma after the dose is given., Pre-dose and 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72 (Panel G only), 96, 168, 240, and 336 hours post-dose|Area Under the Concentration-time Curve From Time 0 to 168 Hours Post Dose (AUC0-168h) of Omarigliptin, AUC0-168h is a measure of the total amount of drug in the plasma from the dose to 168 hours after the dose., Pre-dose and 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72 (Panel G only), 96, and 168 hours post-dose|Concentration at 168 Hours Post-dose (C168h) of Omarigliptin, C168h is a measure of the plasma drug concentration 168 hours post-dose., 168 hours post-dose|Apparent Volume of Distribution (Vd/F) of Omarigliptin, Vd/F is defined as the distribution of a medication between the plasma and the rest of the body after the dose. It is the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired blood concentration of the drug., Up to 336 hours post-dose|Apparent Total Body Clearance (CL/F) of Omarigliptin, CL/F is a calculation of the rate at which a drug is removed from the body via renal, hepatic, and other clearance pathways, expressed as volume (milliliters) per unit of time (minutes)., Up to 336 hours post-dose|Renal Clearance (CLr) of Omarigliptin, CLr is a calculation of the rate at which a drug is removed from the body via renal clearance pathways, expressed as volume (milliliters) per unit of time (minutes). CLr was only determined for Panels A-F., Up to 336 hours post-dose|Fraction of Dose Excreted Unchanged in Urine Through 48 Hours Post-dose (fe48h) of Omarigliptin, fe48h is expressed as percentage of omarigliptin not metabolized and excreted in urine. fe48h was only determined for Panels A-F., Up to 48 hours post-dose|Cumulative Amount of Drug Excreted in Urine Over 48 Hours (Ae0-48h) of Omarigliptin, Ae0-48h is a measure of the cumulative amount of drug excreted in the urine for 48 hours post-dose. Ae0-48h was only determined for Panels A-F., Up to 48 hours post-dose|Time to Maximum Concentration (Tmax) of Omarigliptin, Tmax is a measure of the time to reach the maximum drug plasma concentration post-dose., Pre-dose and 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72 (Panel G only), 96, 168, 240, and 336 hours post-dose|Apparent Terminal Half-life (t1/2) of Omarigliptin, T1/2 is the time required for the maximum concentration of a drug in the plasma to decrease by 50%., Pre-dose and 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72 (Panel G only), 96, 168, 240, and 336 hours post-dose | Secondary: Number of Participants Experiencing an Adverse Event (AE), An AE was defined as any unfavorable and unintended change in the structure (signs), function (symptoms), or chemistry (laboratory data) of the body temporally associated with any use of a Sponsor product, whether or not considered related to the use of the product., From pre-dose to 14 days post-dose (Up to Day 15)|Number of Participants Withdrawn From Study, Up to Day 15
Sponsor/Collaborators: Sponsor: Merck Sharp & Dohme LLC
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE1
Enrollment: 49
Study Type: INTERVENTIONAL
Study Designs: Allocation: NON_RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2011-08-08
Completion Date: 2012-03-23
Results First Posted: 2015-12-03
Last Update Posted: 2018-09-10
Locations:
URL: https://clinicaltrials.gov/show/NCT01407276