A Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of MK8245 (8245-004)(COMPLETED)

A Multiple-Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of MK8245.

A 2-period crossover study to assess the safety, tolerability and glucose-lowering effects of MK8245.

Study Overview

• Status: Completed
• Conditions: Type 2 Diabetes
• Intervention / Treatment: Drug: MK8245; Drug: Comparator: Placebo

Detailed Description

Hypothesis: Multiple doses of MK-8245 are sufficiently safe and well tolerated in patients with Type 2 diabetes based on an assessment of clinical and laboratory adverse experiences (AEs), to permit continued clinical investigation.

• Study Type: Interventional
• Enrollment (Actual): 14
• Phase: Phase 1

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Subject has a diagnosis of Type 2 Diabetes and is being treated with diet and exercise alone or a single oral anti-hyperglycemic agent
• Subject is willing to follow the weight-maintaining diet and exercise program or equivalent beginning 4 weeks before receiving study drug, throughout the study and until the post study visit
• Subject has been a nonsmoker and/or has not used nicotine-containing products for at least approximately 6 months

Exclusion Criteria:

• Subject has a history of stroke, chronic seizures, or major neurological disorder
• Subject has a history of neoplastic disease (except non-melanomatous skin carcinoma, carcinoma in situ of the cervix, other malignancies successfully treated at least 10 years prior to screening, or malignancies deemed highly unlikely to recur.)
• Subject has a history of Type 1 Diabetes Mellitus and/or history of ketoacidosis
• Subject has a history of contact lens use within approximately the previous 6 months
• Subject has been diagnosed with dry eye syndrome
• Subject has used lipid-lowering therapies in the past 3 months (Subjects on a stable monotherapy dose of statins may be included)
• Subject has had major surgery, donated or lost 1 unit of blood or participated in another investigational study within 4 weeks of starting in the study

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: 2; Placebo Comparator	Drug: Comparator: Placebo; MK8245 placebo capsules twice daily for 13 days. On Day 14, only the morning dose of study medication will be taken. There will be a 14 day washout period. Patients will then crossover to MK8245 50 mg capsules twice daily for 13 days. On Day 14, only the morning dose of study drug will be taken.
Experimental: 1; MK8245	Drug: MK8245; MK8245 50 mg capsules twice daily for 13 days. On Day 14, only the morning dose of study medication will be taken. There will be a 14 day washout period. Patients will then crossover to MK8245 placebo capsules twice daily for 13 days. On Day 14, only the morning dose of study drug will be taken.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants Experiencing Clinical and Laboratory Adverse Events (CAEs and LAEs)	An LAE is defined as any unfavorable & unintended change in the chemistry of the body temporally associated with the use of study product, whether or not considered related to the use of the product. A CAE is defined similarly but also includes changes in structure or function of the body. Serious AEs are those occuring that result in one or more of the pre-specified outcome(s) that meet the criteria of seriousness, including death, life-threatening, significant disability, or hospitalization, etc. Drug-relatedness was determined by the investigator based on clinical judgement.	56 days
Mean Change From Baseline in Hepatic Glucose Production (HGP) at Day 14	Changes in HGP were determined during a euglycemic clamp procedure. HGP was evaluated as milligrams per kilogram of glucose produced per minute.	Day 14 of each 14-day Treatment Period

Other Outcome Measures

Outcome Measure	Time Frame
Hepatic Glucose Production (HGP) at Baseline	Baseline

Collaborators and Investigators

• Sponsor: Merck Sharp & Dohme LLC

Publications and helpful links

General Publications

• Nio Y, Hasegawa H, Okamura H, Miyayama Y, Akahori Y, Hijikata M. Liver-specific mono-unsaturated fatty acid synthase-1 inhibitor for anti-hepatitis C treatment. Antiviral Res. 2016 Aug;132:262-7. doi: 10.1016/j.antiviral.2016.07.003. Epub 2016 Jul 5.

Study record dates

Study Major Dates

• Study Start: October 1, 2008
• Primary Completion (Actual): September 1, 2009
• Study Completion (Actual): September 1, 2009

Study Registration Dates

• First Submitted: November 7, 2008
• First Submitted That Met QC Criteria: November 11, 2008
• First Posted (Estimate): November 13, 2008

Study Record Updates

• Last Update Posted (Estimate): February 17, 2016
• Last Update Submitted That Met QC Criteria: February 11, 2016
• Last Verified: February 1, 2016

More Information

Terms related to this study

• Other Study ID Numbers: 8245-004; 2008_582