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

• ClinicalTrials.gov Identifier: NCT00790556
• Recruitment Status: Completed
• First Posted: November 13, 2008
• Results First Posted: January 20, 2011
• Last Update Posted: February 17, 2016
• Sponsor: Merck Sharp & Dohme Corp.
• Information provided by (Responsible Party): Merck Sharp & Dohme Corp.

Study Description

Brief Summary:

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

Condition or disease	Intervention/treatment	Phase
Type 2 Diabetes	Drug: MK8245; Drug: Comparator: Placebo	Phase 1

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 14 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• Official Title: A Multiple-Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of MK8245.
• Study Start Date: October 2008
• Actual Primary Completion Date: September 2009
• Actual Study Completion Date: September 2009

Arms and Interventions

Arm	Intervention/treatment
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.
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.

Outcome Measures

Primary Outcome Measures :

1. Number of Participants Experiencing Clinical and Laboratory Adverse Events (CAEs and LAEs) [ Time Frame: 56 days ]

   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.

2. Mean Change From Baseline in Hepatic Glucose Production (HGP) at Day 14 [ Time Frame: Day 14 of each 14-day Treatment Period ]
   Changes in HGP were determined during a euglycemic clamp procedure. HGP was evaluated as milligrams per kilogram of glucose produced per minute.

Other Outcome Measures:

1. Hepatic Glucose Production (HGP) at Baseline [ Time Frame: Baseline ]

Eligibility Criteria

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

Criteria

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

Contacts and Locations

Sponsors and Collaborators

Merck Sharp & Dohme Corp.

Investigators

• Study Director: Medical Monitor; Merck Sharp & Dohme Corp.

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

• Responsible Party: Merck Sharp & Dohme Corp.
• ClinicalTrials.gov Identifier: NCT00790556
• Other Study ID Numbers: 8245-004; 2008_582
• First Posted: November 13, 2008
• Results First Posted: January 20, 2011
• Last Update Posted: February 17, 2016
• Last Verified: February 2016