CompletedNCT00790556Updated Feb 17, 2016Results posted

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

A Phase 1 interventional study of MK8245 and Comparator: Placebo in Type 2 Diabetes, sponsored by Merck Sharp & Dohme LLC. Completed. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2016-02-17.

Sponsored by Merck Sharp & Dohme LLC · Phase 1, Interventional, and Treatment

Phase: Phase 1
Study type: Interventional
Enrollment: 14
Allocation: Randomized
Ages: 18 Years to 65 Years
Sex: All

Study summary

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

Read the 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.

Conditions studied

Type 2 Diabetes

In context

Lead sponsor

Merck Sharp & Dohme LLC is the lead sponsor of 2,114 studies on the registry; 133 are open to participants now.

Of its 489 completed or terminated interventional studies of FDA-regulated products, 362 (74%) have results posted.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years to 65 Years
Sexes eligible: All
Accepts healthy volunteers: No

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

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

Phase: Phase 1
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover assignment
Masking: Double (Participant, Investigator)
Enrollment: 14 participants (actual)

Study arms

Experimental
1
MK8245
Drug: MK8245
Placebo comparator
2
Placebo Comparator
Drug: Comparator: Placebo

Interventions

DrugMK8245
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.
DrugComparator: 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.

What researchers measure

Primary outcomes

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.
Time frame: 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.
Time frame: Day 14 of each 14-day Treatment Period

Other outcomes

Hepatic Glucose Production (HGP) at Baseline
Time frame: Baseline

Results

Posted Jan 20, 2011

Limitations and caveats

Stat. analysis of HGP was not performed as insulin suppression lead to a near complete suppression of HGP in both placebo and MK-8245 treated subjects, making it impossible to determine if MK-8245 could lead to a greater insulin effect than placebo

Participant flow

Treatment Period 1

Participant flow — Treatment Period 1
Milestone	MK8245 Then Placebo	Placebo Then MK8245
Started	8	6
Completed	6	6
Not completed	2	0
Withdrew: Physician decision	1	0
Withdrew: Withdrawal by subject	1	0

Washout After Period 1

Participant flow — Washout After Period 1
Milestone	MK8245 Then Placebo	Placebo Then MK8245
Started	6	6
Completed	6	6
Not completed	0	0

Treatment Period 2

Participant flow — Treatment Period 2
Milestone	MK8245 Then Placebo	Placebo Then MK8245
Started	6	6
Completed	6	6
Not completed	0	0

Outcome measures

PrimaryNumber 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.

Time frame:: 56 days
Reported as:: Number · participants

Number of Participants Experiencing Clinical and Laboratory Adverse Events (CAEs and LAEs)
participants	MK8245	Placebo
With clinical adverse events (CAEs)	4	5
With drug-related CAEs	0	0
With Serious CAEs	0	0
With laboratory adverse events (LAEs)	0	0
With drug-related LAEs	0	0
With serious LAEs	0	0

PrimaryMean 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.

Time frame:: Day 14 of each 14-day Treatment Period
Reported as:: Mean · mg/kg/min

Mean Change From Baseline in Hepatic Glucose Production (HGP) at Day 14
mg/kg/min	MK8245	Placebo
Mean Change From Baseline in Hepatic Glucose Production (HGP) at Day 14	-1.09 ± 1.54	-0.87 ± 0.94

Other pre-specifiedHepatic Glucose Production (HGP) at Baseline

Time frame:: Baseline
Reported as:: Mean · mg/kg/min

Hepatic Glucose Production (HGP) at Baseline
mg/kg/min	MK8245	Placebo
Hepatic Glucose Production (HGP) at Baseline	1.87 ± 0.36	1.95 ± 0.36

Adverse events

Collected over Treatment Period 1, Days 1 to 14, 14 day washout, Treatment Period 2, Days 1 to 14, 14 days to post study.. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
MK8245	—	0/14 (0%)	4/14 (28.6%)
Placebo	—	0/14 (0%)	5/14 (35.7%)

Most frequent other events

Showing 10 of 19

Most frequent other events
Event	MK8245	Placebo
HeadacheNervous system disorders	3/14	0/14
CataractEye disorders	1/14	0/14
Lacrimation increasedEye disorders	1/14	0/14
FlatulenceGastrointestinal disorders	1/14	1/14
Chest painGeneral disorders	1/14	0/14
ChillsGeneral disorders	1/14	0/14
Feeling hotGeneral disorders	1/14	0/14
Infusion site haemorrhageGeneral disorders	1/14	0/14
MalaiseGeneral disorders	1/14	0/14
Body tineaInfections and infestations	0/14	1/14

Baseline characteristics

Age, Continuous
Age, Continuous(years)	All Participants
Mean	49.43 (30 to 62)

Sex: Female, Male
Sex: Female, Male(Participants)	All Participants
Female	2
Male	12

Study locations

No study locations are listed for this record.

References and documents

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. PubMed 27392483 ↗

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Feb 17, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT00790556
Lead sponsor: Merck Sharp & Dohme LLC
Responsible party: Sponsor
First posted: Nov 13, 2008
Start date: Oct 2008
Primary completion: Sep 2009
Completion: Sep 2009
Results posted: Jan 20, 2011
Last update: Feb 17, 2016

Study contacts

Medical Monitor

study director · Merck Sharp & Dohme LLC

View the source record on ClinicalTrials.gov ↗

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