A Study to Test the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of MK1006 (MK-1006-002)(COMPLETED)

NCT ID: NCT00757601

Last Updated: 2016-02-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 25 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-04-30
• Study Completion Date: 2008-12-31

Brief Summary

This study will assess the safety, tolerability, pharmacokinetics, and pharmacodynamics of single doses of MK1006

Conditions

Type 2 Diabetes Mellitus

Study Design

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

Study Groups

15 mg MK1006/Placebo/45 mg MK1006/60 mg MK1006/Placebo (Fed)

Participants 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.

Group Type: EXPERIMENTAL

MK1006

Intervention Type: DRUG

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

Intervention Type: DRUG

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

Placebo/30mg MK1006/45mg MK1006/60mg MK1006/30mg MK1006 (Fed)

Participants 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.

Group Type: EXPERIMENTAL

MK1006

Intervention Type: DRUG

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

Intervention Type: DRUG

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

15mg MK1006/30mg MK1006/Placebo/60mg MK1006/30mg MK1006 (Fed)

Participants 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.

Group Type: EXPERIMENTAL

MK1006

Intervention Type: DRUG

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

Intervention Type: DRUG

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

15mg MK1006/30mg MK1006/45mg MK1006/Placebo/30mg MK1006 (Fed)

Participants 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.

Group Type: EXPERIMENTAL

MK1006

Intervention Type: DRUG

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

Intervention Type: DRUG

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

60mg MK1006 / Placebo / 100mg MK1006 / 120mg MK1006 / Placebo

Participants 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.

Group Type: EXPERIMENTAL

MK1006

Intervention Type: DRUG

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

Intervention Type: DRUG

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

Placebo/ 80mg MK1006/ 100mg MK1006/ 120mg MK1006/ 140mg MK1006

Participants 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

Group Type: EXPERIMENTAL

MK1006

Intervention Type: DRUG

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

Intervention Type: DRUG

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

60mg MK1006/ 80mg MK1006/ Placebo/ 120mg MK1006/ 140mg MK1006

Participants 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.

Group Type: EXPERIMENTAL

MK1006

Intervention Type: DRUG

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

Intervention Type: DRUG

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

60mg MK1006/ 80mg MK1006/ 100mg MK1006/ Placebo/ 140mg MK1006

Participants 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.

Group Type: EXPERIMENTAL

MK1006

Intervention Type: DRUG

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

Intervention Type: DRUG

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

140mg MK1006 / Placebo / 200mg MK1006 / 230mg MK1006 / Placebo

Participants 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.

Group Type: EXPERIMENTAL

MK1006

Intervention Type: DRUG

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

Intervention Type: DRUG

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

Placebo/170mg MK1006/ 200mg MK1006/ 230mg MK1006/ 260mg MK1006

Participants 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.

Group Type: EXPERIMENTAL

MK1006

Intervention Type: DRUG

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

Intervention Type: DRUG

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

140mg MK1006/170mg MK1006/ Placebo/ 230mg MK1006/ 260mg MK1006

Participants 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

Group Type: EXPERIMENTAL

MK1006

Intervention Type: DRUG

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

Intervention Type: DRUG

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

140mg MK1006/170mg MK1006/ 200mg MK1006/ Placebo/ 260mg MK1006

Participants 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.

Group Type: EXPERIMENTAL

MK1006

Intervention Type: DRUG

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

Intervention Type: DRUG

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

Interventions

MK1006

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

Intervention Type: DRUG

Placebo

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

Intervention Type: DRUG

Eligibility Criteria

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 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

Exclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 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_549

Identifier Type: -

Identifier Source: secondary_id

1006-002

Identifier Type: -

Identifier Source: org_study_id