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MK1006

Phase 1

Type 2 Diabetes Mellitus | Small molecule | Metabolic |Merck & Company, Inc.|Last Updated: Feb 5, 2016

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
RandomizedDouble-BlindCONTROLLED
Total Trials1
Total Enrollment25
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00757601A Study to Test the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of MK1006 (MK-1006-002)(COMPLETED)PHASE1 COMPLETED 25 — — Apr 1, 2008Dec 1, 2008Feb 5, 2016 - —
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Study Endpoints
Primary Endpoints
Number of Participants Experiencing Adverse Events (AEs) On Study
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)

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.

Number of Participants Who Discontinued Treatment Due to an AE
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)

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.

Secondary Endpoints
Mean Area Under the Plasma Concentration Curve From Time Zero to Infinity (AUC[0-∞]) After Single Dose MK1006
From pre-dose to 168 hours post-dose
Mean Maximum Plasma Concentration (Cmax) of MK1006 After Single Dose
From pre-dose to 168 hours post-dose
Median Time of Maximum Plasma Concentration (Tmax) of MK1006 After Single Dose
From pre-dose to 168 hours post-dose
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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelCROSSOVER
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
15 mg MK1006/Placebo/45 mg MK1006/60 mg MK1006/Placebo (Fed)EXPERIMENTALParticipants received 15 mg MK1006 in Period 1, followed by placebo to MK1006 in Period 2, followed by 45 mg MK1006 in Period 3, followed by 60 mg MK1006 in Period 4, followed by placebo to MK1006 taken with food (Fed state) in Period 5.
Placebo/30mg MK1006/45mg MK1006/60mg MK1006/30mg MK1006 (Fed)EXPERIMENTALParticipants received placebo to MK1006 in Period 1, followed by 30 mg MK1006 in Period 2, followed by 45 mg MK1006 in Period 3, followed by 60 mg MK1006 in Period 4, followed by 30 mg MK1006 taken with food (Fed state) in Period 5.
15mg MK1006/30mg MK1006/Placebo/60mg MK1006/30mg MK1006 (Fed)EXPERIMENTALParticipants received 15 mg MK1006 in Period 1, followed by 30 mg MK1006 in Period 2, followed by placebo to MK1006 in Period 3, followed by 60 mg MK1006 in Period 4, followed by 30 mg MK1006 taken with food (Fed state) in Period 5.
15mg MK1006/30mg MK1006/45mg MK1006/Placebo/30mg MK1006 (Fed)EXPERIMENTALParticipants received 15 mg MK1006 in Period 1, followed by 30 mg MK1006 in Period 2, followed by 45 mg MK1006 in Period 3, followed by placebo to MK1006 in Period 4, followed by 30 mg MK1006 taken with food (Fed state) in Period 5.
60mg MK1006 / Placebo / 100mg MK1006 / 120mg MK1006 / PlaceboEXPERIMENTALParticipants received 60 mg MK1006 in Period 1, followed by placebo to MK1006 in Period 2, followed by 100 mg MK1006 in Period 3, followed by 120 mg MK1006 in Period 4, followed by placebo to MK1006 in Period 5.
Placebo/ 80mg MK1006/ 100mg MK1006/ 120mg MK1006/ 140mg MK1006EXPERIMENTALParticipants received placebo to MK1006 in Period 1, followed by 80 mg MK1006 in Period 2, followed by 100 mg MK1006 in Period 3, followed by 120 mg MK1006 in Period 4, followed by 140 mg MK1006 in Period 5
60mg MK1006/ 80mg MK1006/ Placebo/ 120mg MK1006/ 140mg MK1006EXPERIMENTALParticipants received 60 mg MK1006 in Period 1, followed by 80 mg MK1006 in Period 2, followed by placebo to MK1006 in Period 3, followed by 120 mg MK1006 in Period 4, followed by 140 mg MK1006 in Period 5.
60mg MK1006/ 80mg MK1006/ 100mg MK1006/ Placebo/ 140mg MK1006EXPERIMENTALParticipants received 60 mg MK1006 in Period 1, followed by 80 mg MK1006 in Period 2, followed by 100 mg MK1006 in Period 3, followed by placebo to MK1006 in Period 4, followed by 140 mg MK1006 in Period 5.
140mg MK1006 / Placebo / 200mg MK1006 / 230mg MK1006 / PlaceboEXPERIMENTALParticipants received 140 mg MK1006 in Period 1, followed by placebo to MK1006 in Period 2, followed by 200 mg MK1006 in Period 3, followed by 230 mg MK1006 in Period 4, followed by placebo to MK1006 in Period 5.
Placebo/170mg MK1006/ 200mg MK1006/ 230mg MK1006/ 260mg MK1006EXPERIMENTALParticipants received placebo to MK1006 in Period 1, followed by 170 mg MK1006 in Period 2, followed by 200 mg MK1006 in Period 3, followed by 230 mg MK1006 in Period 4, followed by 260 mg MK1006 in Period 5.
140mg MK1006/170mg MK1006/ Placebo/ 230mg MK1006/ 260mg MK1006EXPERIMENTALParticipants received 140 mg MK1006 in Period 1, followed by 170 mg MK1006 in Period 2, followed by placebo to MK1006 in Period 3, followed by 230 mg MK1006 in Period 4, followed by 260 mg MK1006 in Period 5
140mg MK1006/170mg MK1006/ 200mg MK1006/ Placebo/ 260mg MK1006EXPERIMENTALParticipants received 140 mg MK1006 in Period 1, followed by 170 mg MK1006 in Period 2, followed by 200 mg MK1006 in Period 3, followed by placebo to MK1006 in Period 4, followed by 260 mg MK1006 in Period 5.
Interventions
NameTypeDescription
MK1006DRUGMK1006 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
PlaceboDRUGPlacebo 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
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Eligibility Criteria
Age Range18 Years — 55 Years
SexALL
Healthy VolunteersNo

Inclusion Criteria: * Participant is between 18 and 55 years of age. Participants up to 65 years of age may be enrolled in Panels B and C * Female participants must be postmenopausal or otherwise unable to have children * Participant has a body mass index (BMI) less than or equal to 42 kg/m\^2 at t...

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