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

Type 2 Diabetes Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00790556
• Other study ID #: 8245-004
• Secondary ID: 2008_582
• Status: Completed
• Phase: Phase 1
• First received: November 7, 2008
• Last updated: February 11, 2016
• Start date: October 2008
• Est. completion date: September 2009

Study information

• Verified date: February 2016
• Source: Merck Sharp & Dohme Corp.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 14
• Est. completion date: September 2009
• Est. primary completion date: September 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Type 2 Diabetes

Intervention

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.
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Merck Sharp & Dohme Corp.

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Hepatic Glucose Production (HGP) at Baseline		Baseline	No
Primary	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	Yes
Primary	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	No