A Multiple-Dose Study of MK-1006 (MK-1006-004)(TERMINATED)

NCT ID: NCT00758680

Last Updated: 2016-02-05

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE1
• Total Enrollment: 112 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-08-31
• Study Completion Date: 2010-03-31

Brief Summary

This study will asses the safety, tolerability, multiple-dose pharmacokinetics and pharmacodynamics of MK1006 in participants with type 2 diabetes.

Conditions

Type 2 Diabetes

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

MK-1006 20 mg Once Daily (Panel A)

After a 2-week run-in/wash-off period, participants received single daily doses (q.d.) of 20 mg MK-1006 over a 10-day multiple-dosing period while remaining domiciled in the Clinical Research Unit (CRU).

Group Type: EXPERIMENTAL

MK-1006

Intervention Type: DRUG

MK-1006 capsules (10 mg and 20 mg) administered orally from 20 mg to 120 mg per dose over a multiple dosing period.

MK-1006 40 mg Once Daily (Panel B)

After a 2-week run-in/wash-off period, participants received single daily doses of 40 mg MK-1006 over a 10-day multiple-dosing period while remaining domiciled in the CRU.

Group Type: EXPERIMENTAL

MK-1006

Intervention Type: DRUG

MK-1006 capsules (10 mg and 20 mg) administered orally from 20 mg to 120 mg per dose over a multiple dosing period.

MK-1006 80 mg Once Daily (Panel C)

After a 2-week run-in/wash-off period, participants received single daily doses of 80 mg MK-1006 over a 10-day multiple-dosing period while remaining domiciled in the CRU.

Group Type: EXPERIMENTAL

MK-1006

Intervention Type: DRUG

MK-1006 capsules (10 mg and 20 mg) administered orally from 20 mg to 120 mg per dose over a multiple dosing period.

MK-1006 120 mg Once Daily (Panel D)

After a 2-week run-in/wash-off period, participants received single daily doses of 120 mg MK-1006 over a 10-day multiple-dosing period while remaining domiciled in the CRU.

Group Type: EXPERIMENTAL

MK-1006

Intervention Type: DRUG

MK-1006 capsules (10 mg and 20 mg) administered orally from 20 mg to 120 mg per dose over a multiple dosing period.

MK-1006 20 mg Twice Daily (Panel E)

After a 2-week run-in/wash-off period, participants received twice-daily doses (b.i.d.) of 120 mg MK-1006 over a 10-day multiple-dosing period while remaining domiciled in the CRU.

Group Type: EXPERIMENTAL

MK-1006

Intervention Type: DRUG

MK-1006 capsules (10 mg and 20 mg) administered orally from 20 mg to 120 mg per dose over a multiple dosing period.

MK-1006 30 mg Twice Daily (Panel F)

After a 2-week run-in/wash-off period, participants received twice-daily doses of 30 mg MK-1006 over a 10-day multiple-dosing period while remaining domiciled in the CRU.

Group Type: EXPERIMENTAL

MK-1006

Intervention Type: DRUG

MK-1006 capsules (10 mg and 20 mg) administered orally from 20 mg to 120 mg per dose over a multiple dosing period.

MK-1006 50 mg Twice Daily (Panel G)

After a 2-week run-in/wash-off period, participants received twice-daily doses of 50 mg MK-1006 over a 10-day multiple-dosing period while remaining domiciled in the CRU.

Group Type: EXPERIMENTAL

MK-1006

Intervention Type: DRUG

MK-1006 capsules (10 mg and 20 mg) administered orally from 20 mg to 120 mg per dose over a multiple dosing period.

MK-1006 120 mg Once Daily Outpatient (Panel H)

After a 2-week run-in/wash-off period, participants received single daily doses of 120 mg MK-1006 over a 7-day multiple-dosing period while remaining domiciled in the CRU. Participants were then discharged from the CRU and continued daily dosing of MK-1006 for an additional 21 days as outpatients.

Group Type: EXPERIMENTAL

MK-1006

Intervention Type: DRUG

MK-1006 capsules (10 mg and 20 mg) administered orally from 20 mg to 120 mg per dose over a multiple dosing period.

MK-1006 50 mg Twice Daily Outpatient (Panel I)

After a 2-week run-in/wash-off period, participants received twice-daily doses of 50 mg MK-1006 over a 7-day multiple-dosing period while remaining domiciled in the CRU. Participants were then discharged from the CRU and continued daily dosing of MK-1006 for an additional 21 days as outpatients.

Group Type: EXPERIMENTAL

MK-1006

Intervention Type: DRUG

MK-1006 capsules (10 mg and 20 mg) administered orally from 20 mg to 120 mg per dose over a multiple dosing period.

Placebo

After a 2-week run-in/wash-off period, participants received dose-matched placebo to MK-1006 over a multiple-dosing period while remaining domiciled in the CRU.

Group Type: PLACEBO_COMPARATOR

Comparator: Placebo comparator

Intervention Type: DRUG

Dose-matched MK-1006 placebo capsules (1 mg, 10 mg and 20 mg) administered orally over a multiple dosing period.

Interventions

MK-1006

MK-1006 capsules (10 mg and 20 mg) administered orally from 20 mg to 120 mg per dose over a multiple dosing period.

Intervention Type: DRUG

Comparator: Placebo comparator

Dose-matched MK-1006 placebo capsules (1 mg, 10 mg and 20 mg) administered orally over a multiple dosing period.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Participant has a BMI less than or equal to 42 kg/m^2 at the screening visit
• Participant has been diagnosed with Type 2 Diabetes that is being treated either by diet and exercise alone or by single or combination oral anti-hyperglycemic medications
• Participant is willing to follow a diet containing approximately 50% carbohydrates, 20% protein, and 30% fat during the study
• Participant is a nonsmoker and has not used nicotine containing products for ~ 6 months before start of study

Exclusion Criteria

• Participant must not be treated with three or more oral anti-hyperglycemic medications, insulin, or PPAR-gamma agonists
• Participant has a history of stroke, chronic seizures, or a major neurological disorder
• Participant has had an eye infection or other inflammatory eye condition within 2 weeks of first dose of study drug
• Participant has glaucoma or is blind
• Participant has a condition known to be related to cataract development
• Participant has had or will have incisional eye surgery within 6 months before screening or has had laser surgery (other than Lasik) within 3 months of screening
• Participant has a history of type 1 diabetes or ketoacidosis
• Participant cannot stop taking certain current medications during the study
• Participant consumes greater than 3 alcoholic beverages per day
• Participant consumes more than 6 servings of caffeinated beverages per day (1 serving is ~ 120 mg caffeine)
• Participant has a history of significant multiple or severe allergies or has had a reaction to or is intolerant of prescription/non-prescription drugs or food
• Participant uses recreational drugs or has had a history of drug abuse within 6 months of start of study

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Medical Monitor

Role: STUDY_DIRECTOR

Merck Sharp & Dohme LLC

Other Identifiers

2008_550

Identifier Type: -

Identifier Source: secondary_id

1006-004

Identifier Type: -

Identifier Source: org_study_id