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

A Phase 1 study testing MK8245 in people with Type 2 Diabetes, run by Merck Sharp & Dohme LLC.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

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

Who is it for?: Ages 18 to 65 years
Conditions the study is for: Type 2 Diabetes
What is being tested?: MK8245
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 14 participants
Where: No sites listed yet
Study dates: Oct 2008to Sep 2009
Phase: Phase 1
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 65 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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

About this study

Official title: 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.

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: Type 2 Diabetes
Being tested: MK8245, Comparator: Placebo
Medical subject headings: Diabetes Mellitus, Type 2

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

MK8245Drug
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: PlaceboDrug
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.

Study groups in NCT00790556
Study group	Role	What they receive
1	Experimental	MK8245 Receives: Drug: MK8245
2	Placebo comparator	Placebo Comparator Receives: Drug: Comparator: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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.
Measured: Day 14 of each 14-day Treatment Period

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Oct 2008Sep 2009

First posted13 Nov 2008 (estimated)
Study startOct 2008
Primary completionSep 2009
Study completionSep 2009

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Type 2 DiabetesStudies of the same condition, open and under way.
More trials run by Merck Sharp & Dohme LLCThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 14 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00790556
Sponsor's protocol ID: 8245-004
Other IDs: 2008_582
Status last verified: Feb 2016
First submitted: 7 Nov 2008
Last updated: 17 Feb 2016
Results posted: Yes, on ClinicalTrials.gov

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

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

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All Type 2 Diabetes trials

Study at a glance

From the registry record, last updated by the sponsor on 17 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Multiple-Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of MK8245.
ClinicalTrials.gov ID: NCT00790556
Acronym / sponsor ID: 8245-004
Conditions: Type 2 Diabetes
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 14 participants (actual)
Lead sponsor: Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
Study start: Oct 2008
Primary completion: Sep 2009 (actual)
Study completion: Sep 2009 (actual)
First posted: 13 Nov 2008 (estimated)
Results: Posted 20 Jan 2011

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: Double blind (participant, investigator)
Number of arms: 2

Arm	Type	Receives
1	Experimental	Drug: MK8245MK8245
2	Placebo comparator	Drug: Comparator: PlaceboPlacebo Comparator

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

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

Key exclusion criteria (7 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
MK8245MK8245 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.	Drug	1
Comparator: PlaceboMK8245 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.	Drug	2

Primary outcome

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.
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.

Results and safety

Results posted to the registry on 20 Jan 2011, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
MK8245 Then Placebo	8	6
Placebo Then MK8245	6	6

Primary outcome: Number of Participants Experiencing Clinical and Laboratory Adverse Events (CAEs and LAEs)

Time frame: 56 days. Number. Unit: participants

Measure	MK8245 n = 14	Placebo n = 14
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

Population analysed: All 14 subjects enrolled in the study were included in the assessment of safety and tolerability (although only 12 subjects received placebo, our database includes all subjects in the analysis).

Primary outcome: Mean Change From Baseline in Hepatic Glucose Production (HGP) at Day 14

Time frame: Day 14 of each 14-day Treatment Period. Mean (Standard Deviation). Unit: mg/kg/min

Measure	MK8245 n = 12	Placebo n = 12
Value	-1.09 (1.54)	-0.87 (0.94)

Population analysed: Subjects who discontinued were not used in the analysis.

Adverse events

Time frame: Treatment Period 1, Days 1 to 14, 14 day washout, Treatment Period 2, Days 1 to 14, 14 days to post study.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
MK8245	0 of 14 (0%)	4 of 14 (28.6%)	Not reported
Placebo	0 of 14 (0%)	5 of 14 (35.7%)	Not reported

Limitations and caveats (from the sponsor): 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

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2016.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 27392483Nio 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.

Related trials for Type 2 Diabetes

Not yet recruitingPhase 3
Efficacy and Safety of Once-Weekly SHR-3167 Compared With Once-Daily Insulin Glargine in Adults With Insulin-Naive Type 2 Diabetes
Type 2 Diabetes
Active, not recruiting
Digital Reinforcement of Motivational Interviewing Micro-Skills Among Primary Care Healthcare Professionals
Hypertension (Without Type 2 Diabetes Mellitus)
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)
Not yet recruitingPhase 3
A Study to Evaluate the Effectiveness and Safety of the Drug AZD6234 for Managing Weight in Adults Who Are Obese or Overweight. These Participants May or May Not Also Have Type 2 Diabetes
Obesity, Overweight
Not yet recruiting
Impact of Endoscopic Sleeve Gastroplasty (ESG) in Obese Adults With Type 2 Diabetes (T2D)
Type 2 Diabetes Mellitus (T2D), Obesity (BMI>30)

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Medical Monitor study director

Merck Sharp & Dohme LLC

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing MK8245 in people with Type 2 Diabetes, run by Merck Sharp & Dohme LLC.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 17 Feb 2016. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 20 Jan 2011). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants Experiencing Clinical and Laboratory Adverse Events (CAEs and LAEs) (time frame: 56 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00790556, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Feb 2016.