This study will assess the safety, tolerability, pharmacokinetics, and pharmacodynamics of single doses of MK1006
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
25
MK1006 capsules: 1 mg, 10 mg, and 20 mg. Panel A: MK1006 capsules in five doses beginning at 15 mg and rising to 60 mg Panel B: MK1006 capsules in five doses beginning at 60 mg and rising to 140 mg. Panel C: MK1006 capsules in five doses beginning at 140 mg and rising to 260 mg. There will a 7-day interval between each dose
Placebo capsule to match MK1006 1, 10, and 20 mg. Panel A: Placebo to MK1006 capsules in five doses beginning at 15 mg and rising to 60 mg Panel B: Placebo to MK1006 capsules in five doses beginning at 60 mg and rising to 140 mg. Panel C: Placebo to MK1006 capsules in 5 doses beginning at 140 mg and rising to 260 mg. There will a 7-day interval between each dose
Number of Participants Experiencing Adverse Events (AEs) On Study
An adverse event was defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the treatment, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which was temporally associated with the use of the treatment, was also considered an adverse experience.
Time frame: From the time of the run-in period prior to the first dose of study drug through the end of the poststudy period (up to 3 weeks)
Number of Participants Who Discontinued Treatment Due to an AE
An adverse event was defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the treatment, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which was temporally associated with the use of the treatment, was also considered an adverse experience.
Time frame: From the time of the run-in period prior to the first dose of study drug through the end of the poststudy period (up to 3 weeks)
Mean Area Under the Plasma Concentration Curve From Time Zero to Infinity (AUC[0-∞]) After Single Dose MK1006
The AUC(0-∞) was estimated by determining the total area under the curve of the concentration versus time curve extrapolated to infinity.
Time frame: From pre-dose to 168 hours post-dose
Mean Maximum Plasma Concentration (Cmax) of MK1006 After Single Dose
Time frame: From pre-dose to 168 hours post-dose
Median Time of Maximum Plasma Concentration (Tmax) of MK1006 After Single Dose
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Time frame: From pre-dose to 168 hours post-dose
Apparent Terminal Half-Life (T 1/2) of MK1006 After Single Dose
The apparent terminal half-life was defined as the time required for the plasma concentration of MK1006 to decrease 50% in the final stage of its elimination
Time frame: From pre-dose to 168 hours post-dose
Mean Area Under The Plasma Concentration Curve From Time Zero to 24 Hours (AUC[0-24]) After Single Dose MK1006
The AUC(0-24) was estimated by determining the total area under the curve of the concentration versus time curve to 24 hours post dose.
Time frame: From pre-dose to 168 hours post-dose