A Study to Test the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of MK1006 (MK-1006-002)(COMPLETED)
A Single Dose Clinical Trial to Study the Safety, Tolerability, Pharmacodynamics, and Pharmacokinetics of MK1006.
2 other identifiers
interventional
25
0 countries
N/A
Brief Summary
This study will assess the safety, tolerability, pharmacokinetics, and pharmacodynamics of single doses of MK1006
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1 type-2-diabetes-mellitus
Started Apr 2008
Typical duration for phase_1 type-2-diabetes-mellitus
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2008
CompletedFirst Submitted
Initial submission to the registry
September 22, 2008
CompletedFirst Posted
Study publicly available on registry
September 23, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2008
CompletedResults Posted
Study results publicly available
September 7, 2012
CompletedFebruary 5, 2016
February 1, 2016
8 months
September 22, 2008
July 31, 2012
February 4, 2016
Conditions
Outcome Measures
Primary Outcomes (2)
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.
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.
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)
Secondary Outcomes (5)
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
Apparent Terminal Half-Life (T 1/2) of MK1006 After Single Dose
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
From pre-dose to 168 hours post-dose
Study Arms (12)
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 / Placebo
EXPERIMENTALParticipants 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 MK1006
EXPERIMENTALParticipants 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 MK1006
EXPERIMENTALParticipants 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 MK1006
EXPERIMENTALParticipants 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 / Placebo
EXPERIMENTALParticipants 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 MK1006
EXPERIMENTALParticipants 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 MK1006
EXPERIMENTALParticipants 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 MK1006
EXPERIMENTALParticipants 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
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
Eligibility Criteria
You may qualify if:
- 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 the screening visit
- Participant has type 2 diabetes and is being treated with either diet and exercise or a single oral anti-hyperglycemic medication. For Panels B and C, participant may be treated with combination oral anti-hyperglycemic medications
- Participant is willing to follow the American Heart Association (AHA) diet and exercise program throughout the study
- Participant is a nonsmoker or has not used nicotine-containing products for 6 months prior to study start
You may not qualify if:
- Participant has a history of stroke, seizures, or other neurological disorders
- Participant has a recent history of eye infection or other inflammatory eye conditions
- Participant has glaucoma or is blind
- Participant has had eye surgery within 6 months of study start (Lasik is permitted)
- Participant has type 1 diabetes
- Participant cannot stop taking any of their current prescription or non-prescription medications during the study
- Participant consumes more than 3 alcoholic beverages per day
- Participant consumes more than 6 caffeinated beverages per day
- Participant has had major surgery or has donated blood within 4 weeks of study start
- Participant has multiple and/or severe allergies to drugs or food
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Senior Vice President, Global Clinical Development
- Organization
- Merck Sharp & Dohme Corp
Study Officials
- STUDY DIRECTOR
Medical Monitor
Merck Sharp & Dohme LLC
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 22, 2008
First Posted
September 23, 2008
Study Start
April 1, 2008
Primary Completion
December 1, 2008
Study Completion
December 1, 2008
Last Updated
February 5, 2016
Results First Posted
September 7, 2012
Record last verified: 2016-02