A Study of the Pharmacokinetics of Two Formulations of MK-1006 (MK-1006-010 AM1)(COMPLETED)

A Phase 1 study testing MK-1006 DFC and MK-1006 FCT 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

This study will assess the pharmacokinetics of two formulations of MK-1006. The primary hypothesis of this study is that the MK-1006 area under the curve (0 to infinity) and maximum concentration after administration of a single 80 mg dose of the dry filled capsule (DFC) and film coated tablet (FCT) formulations of… 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?: MK-1006 DFC and MK-1006 FCT
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 12 participants
Where: No sites listed yet
Study dates: Sep 2009to Dec 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

is a male or a female of non-child bearing potential
has type 2 diabetes (T2D) and is either being treated with diet and exercise alone or with a single or combination oral anti-hyperglycemic agent(s)
has been a nonsmoker for at least 6 months

Who cannot join

has a history of stroke, chronic seizures, or major neurological disorder
has a history of major endocrine (except T2D), gastrointestinal, cardiovascular, blood, liver, immune, kidney, respiratory, or genitourinary abnormalities or diseases
has a history of cancer, except certain skin or cervical cancers or cancer that was successfully treated more than 10 years prior to screening
has unstable or rapidly progressing diabetic retinopathy and/or neuropathy
has had an eye infection or other inflammation of the eye in the 2 weeks prior to screening
has glaucoma or is blind

Show all 10Show fewer

has had incisional eye surgery in the last 6 months or laser eye surgery in the last 3 months (Lasik is permitted)
has a history of type 1 diabetes
has symptomatic coronary artery disease
consumes excessive amounts of alcohol and/or caffeine

About this study

Official title: A Single Dose Study to Compare the Pharmacokinetics of Two Probe Formulations of MK-1006

Conditions: Type 2 Diabetes
Being tested: MK-1006 DFC, MK-1006 FCT
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.

MK-1006 DFCDrug
Each dry filled capsule contains 20 mg MK-1006
MK-1006 FCTDrug
Each film coated tablet contains 40 mg of MK-1006

Study groups in NCT00979459
Study group	Role	What they receive
MK-1006 80 mg DFC	Experimental	Participants received a single dose of four 20 mg dry filled capsules of MK-1006 Receives: Drug: MK-1006 DFC
MK-1006 80 mg FCT	Experimental	Participants received a single dose of two 40 mg film coated tablets of MK-1006 Receives: Drug: MK-1006 FCT

What is being measured

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

Area Under the Concentration Versus Time Curve (AUC(0-infinity)) for MK-1006
AUC (0-infinity) is the area under the curve for the plot showing plasma concentration against time from time zero to the time of the last quantifiable concentration for two formulations of MK-1006, FCT and DFC
Measured: Pre-dose, 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 16, 24, 48, 72, 96 and 120 hours post-dose
Maximum Plasma Concentration (Cmax) for MK-1006
Maximum plasma concentration for 2 formulations of MK-1006, FCT and DFC
Measured: Pre-dose, 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 16, 24, 48, 72, 96 and 120 hours post-dose

Secondary outcomes (2)

Number of Participants Who Experienced at Least One Adverse Event
Measured: Through 30 days post-dose
Number of Participants Who Discontinued Study Medication Due to an Adverse Event
Measured: up to 8 days

Timeline

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

Sep 2009Dec 2009

First posted18 Sep 2009 (estimated)
Study startSep 2009
Primary completionNov 2009
Study completionDec 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.
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: None (open label)
Enrolment: 12 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00979459
Sponsor's protocol ID: 1006-010
Other IDs: 2009_663
Status last verified: Feb 2016
First submitted: 17 Sep 2009
Last updated: 5 Feb 2016
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

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 5 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Single Dose Study to Compare the Pharmacokinetics of Two Probe Formulations of MK-1006
ClinicalTrials.gov ID: NCT00979459
Acronym / sponsor ID: 1006-010
Conditions: Type 2 Diabetes
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 12 participants (actual)
Lead sponsor: Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
Study start: Sep 2009
Primary completion: Nov 2009 (actual)
Study completion: Dec 2009 (actual)
First posted: 18 Sep 2009 (estimated)
Results: Posted 20 Aug 2012

Clinical summary

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

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
MK-1006 80 mg DFC	Experimental	Drug: MK-1006 DFCParticipants received a single dose of four 20 mg dry filled capsules of MK-1006
MK-1006 80 mg FCT	Experimental	Drug: MK-1006 FCTParticipants received a single dose of two 40 mg film coated tablets of MK-1006

Who may qualify

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

Key inclusion criteria (3 listed)

is a male or a female of non-child bearing potential
has type 2 diabetes (T2D) and is either being treated with diet and exercise alone or with a single or combination oral anti-hyperglycemic agent(s)
has been a nonsmoker for at least 6 months

Key exclusion criteria (10 listed)

has a history of stroke, chronic seizures, or major neurological disorder
has a history of major endocrine (except T2D), gastrointestinal, cardiovascular, blood, liver, immune, kidney, respiratory, or genitourinary abnormalities or diseases
has a history of cancer, except certain skin or cervical cancers or cancer that was successfully treated more than 10 years prior to screening
has unstable or rapidly progressing diabetic retinopathy and/or neuropathy
has had an eye infection or other inflammation of the eye in the 2 weeks prior to screening

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
MK-1006 DFCEach dry filled capsule contains 20 mg MK-1006	Drug	MK-1006 80 mg DFC
MK-1006 FCTEach film coated tablet contains 40 mg of MK-1006	Drug	MK-1006 80 mg FCT

Primary outcome

Area Under the Concentration Versus Time Curve (AUC(0-infinity)) for MK-1006
Time frame: Pre-dose, 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 16, 24, 48, 72, 96 and 120 hours post-dose
AUC (0-infinity) is the area under the curve for the plot showing plasma concentration against time from time zero to the time of the last quantifiable concentration for two formulations of MK-1006, FCT and DFC
Maximum Plasma Concentration (Cmax) for MK-1006
Time frame: Pre-dose, 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 16, 24, 48, 72, 96 and 120 hours post-dose
Maximum plasma concentration for 2 formulations of MK-1006, FCT and DFC

2 secondary outcomes

Number of Participants Who Experienced at Least One Adverse Event
Time frame: Through 30 days post-dose
Number of Participants Who Discontinued Study Medication Due to an Adverse Event
Time frame: up to 8 days

Results and safety

Results posted to the registry on 20 Aug 2012, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
MK-1006 DFC, Then MK-1006 FCT	6	6
MK-1006 FCT, Then MK-1006 DFC	6	6

Primary outcome: Area Under the Concentration Versus Time Curve (AUC(0-infinity)) for MK-1006

Time frame: Pre-dose, 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 16, 24, 48, 72, 96 and 120 hours post-dose. Geometric mean (95% Confidence Interval). Unit: nM*hr

Measure	MK-1006 80 mg FCT n = 12	MK-1006 80 mg DFC n = 12
Value	5171 (4350 to 6147)	5588 (4593 to 6798)

MK-1006 80 mg FCT vs MK-1006 80 mg DFC: Geometric mean ratio: 0.93 (90% CI 0.86 to 0.99)

Primary outcome: Maximum Plasma Concentration (Cmax) for MK-1006

Time frame: Pre-dose, 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 16, 24, 48, 72, 96 and 120 hours post-dose. Geometric mean (95% Confidence Interval). Unit: nM

Measure	MK-1006 80 mg FCT n = 12	MK-1006 80 mg DFC n = 12
Value	554 (429 to 715)	519 (405 to 664)

MK-1006 80 mg FCT vs MK-1006 80 mg DFC: Geometric mean ratio: 1.07 (90% CI 0.92 to 1.24)

2 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
MK-1006 80 mg FCT	0 of 12 (0%)	7 of 12 (58.3%)	Not reported
MK-1006 80 mg DFC	0 of 12 (0%)	6 of 12 (50%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2016.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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
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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)
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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 MK-1006 DFC and MK-1006 FCT 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 10 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 5 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. 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 Aug 2012). 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?

Area Under the Concentration Versus Time Curve (AUC(0-infinity)) for MK-1006 (time frame: Pre-dose, 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 16, 24, 48, 72, 96 and 120 hours post-dose). 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 NCT00979459.

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 5 Feb 2016.