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

Merck Sharp & Dohme (MSD)

Status and phase: Completed; Phase 1

Conditions: Type 2 Diabetes Mellitus

Treatments: Drug: MK1006; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT00757601

2008_549

1006-002

Details and patient eligibility

About

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

Enrollment: 25 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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25 participants in 12 patient groups

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

Experimental group

Description:

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.

Treatment:

Drug: MK1006

Drug: Placebo

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

Experimental group

Description:

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.

Treatment:

Drug: MK1006

Drug: Placebo

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

Experimental group

Description:

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.

Treatment:

Drug: MK1006

Drug: Placebo

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

Experimental group

Description:

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.

Treatment:

Drug: MK1006

Drug: Placebo

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

Experimental group

Description:

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.

Treatment:

Drug: MK1006

Drug: Placebo

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

Experimental group

Description:

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

Treatment:

Drug: MK1006

Drug: Placebo

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

Experimental group

Description:

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.

Treatment:

Drug: MK1006

Drug: Placebo

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

Experimental group

Description:

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.

Treatment:

Drug: MK1006

Drug: Placebo

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

Experimental group

Description:

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.

Treatment:

Drug: MK1006

Drug: Placebo

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

Experimental group

Description:

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.

Treatment:

Drug: MK1006

Drug: Placebo

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

Experimental group

Description:

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

Treatment:

Drug: MK1006

Drug: Placebo

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

Experimental group

Description:

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.

Treatment:

Drug: MK1006

Drug: Placebo