MK-1064
DrugDose for each period administered as oral MK-1064 tablets (1, 10 and 50 mg strengths)
NCT Number: NCT02549014
The purpose of this randomized, double-blind, placebo-controlled study is to evaluate the safety, pharmacokinetics and pharmacodynamics of rising, single oral doses MK-1064 in healthy, young, male participants. The primary pharmacokinetic hypothesis is that at least one dose of MK-1064 that is generally safe and well tolerated produces an average MK-1064 plasma concentration from 0 to 4 hours of ≥2.2 μM. Since this is an early Phase I assessment of MK-1064 in humans, the study protocol allows for modifications to the outlined dose, dosing regimen and/or clinical or laboratory procedures, if required to address study objectives and/or to ensure appropriate safety monitoring of participants.
Looking for future studies?
Notify Me18 year–45 year
Male
Interventional
Phase 1
Two panels (Panels A and B), will receive alternating single rising oral doses of MK-1064/placebo (i.e., order of administration will be Panel A 5 mg, Panel B 10 mg, Panel A 25 mg, Panel B 50 mg, and continuing in this alternating sequence). Following dosing for a given treatment period, a minimum of 3 days will elapse before administration of the next scheduled dose. After administration of each dose, safety and tolerability will be reviewed. The decision to proceed to the next Panel/Period in the alternating sequence will be contingent on acceptable safety and tolerability data from the preceding Panels/Periods.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Dose for each period administered as oral MK-1064 tablets (1, 10 and 50 mg strengths)
Dose for each period administered as oral placebo tablets matching active MK-1064 tablets
Time frame: Up to 14 days after the last dose of study drug (Up to approximately 60 days)
An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of study drug, whether or not considered related to the use of study drug. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a pre-existing condition which is temporally associated with the use of study drug, is also an AE.
Time frame: Up to 14 days after the last dose of study drug (Up to approximately 60 days)
An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of study drug, whether or not considered related to the use of study drug. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a pre-existing condition which is temporally associated with the use of study drug, is also an AE.
Time frame: Pre-dose and 0.5, 1, 2, 3 and 4 hours post-dose
AUC0-4hr is the area under the plasma concentration-time curve from time 0 to 4 hours post-dose. This is a measure of the average amount of study drug (MK-1064) in the blood plasma over a period of 4 hours after the dose.
Time frame: Pre-dose and 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 16, 24 and 48 hours post dose (all Periods); 72 hours post-dose (Periods 3 and 4 only)
AUC0-last is the area under the plasma concentration-time curve from time zero to time of last measurable concentration. It is is a measure of the amount of study drug (MK-1064) in the blood plasma from pre-dose until the last measurable concentration of study drug could be determined.
Time frame: Pre-dose and 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 16, 24 and 48 hours post dose (all Periods); 72 hours post dose (Periods 3 and 4 only)
Cmax is the maximum (peak) concentration of study drug (MK-1064) observed in blood plasma.
Time frame: Pre-dose and 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 16, 24 and 48 hours post dose (all Periods); 72 hours post dose (Periods 3 and 4 only)
Tmax is the amount of time to reach maximum (peak) plasma drug concentration following drug administration.
Time frame: Pre-dose and 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 16, 24 and 48 hours post dose (all Periods); 72 hours post dose (Periods 3 and 4 only)
t1/2 is the elimination half-life of study drug. t1/2 is the time it takes for half of the study drug (MK-1064) in the blood plama to dissipate.
Merck Sharp & Dohme LLC
Industry
A Single Dose Study to Evaluate the Safety, Pharmacokinetics and Pharmacodynamics of MK-1064
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.
Published trials that share one or more normalized conditions with this study.
NCT07560150
Insulin Aspart, Pharmacodynamics
Chula Vista, California, United States
View Trial DetailsNCT05142592
Pharmacokinetics, Safety Issues
Portland, Oregon, United States
View Trial DetailsNCT03911050
Human Health, Pharmacokinetics
Kannapolis, North Carolina, United States
View Trial DetailsNCT05328778
Pharmacokinetics
Guangzhou, Guangdong, China
View Trial Details