NCT00979459

Brief 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 MK-1006 will be similar.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
12

participants targeted

Target at below P25 for phase_1 type-2-diabetes

Timeline
Completed

Started Sep 2009

Shorter than P25 for phase_1 type-2-diabetes

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2009

Completed
16 days until next milestone

First Submitted

Initial submission to the registry

September 17, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 18, 2009

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2009

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2009

Completed
2.7 years until next milestone

Results Posted

Study results publicly available

August 20, 2012

Completed
Last Updated

February 5, 2016

Status Verified

February 1, 2016

Enrollment Period

2 months

First QC Date

September 17, 2009

Results QC Date

July 12, 2012

Last Update Submit

February 4, 2016

Conditions

Type 2 Diabetes

Outcome Measures

Primary Outcomes (2)

  • 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

    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

    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

    Through 30 days post-dose

  • Number of Participants Who Discontinued Study Medication Due to an Adverse Event

    up to 8 days

Study Arms (2)

MK-1006 80 mg DFC

EXPERIMENTAL

Participants received a single dose of four 20 mg dry filled capsules of MK-1006

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

Drug: MK-1006 FCT

Interventions

MK-1006 DFCDRUG

Each dry filled capsule contains 20 mg MK-1006

MK-1006 80 mg DFC
MK-1006 FCTDRUG

Each film coated tablet contains 40 mg of MK-1006

MK-1006 80 mg FCT

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Results Point of Contact

Title
Senior Vice President, Global Clinical Development
Organization
Merck Sharp & Dohme Corp
ClinicalTrialsDisclosure@merck.com
1-800-672-6372

Study Officials

  • Medical Monitor

    Merck Sharp & Dohme LLC

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 17, 2009

First Posted

September 18, 2009

Study Start

September 1, 2009

Primary Completion

November 1, 2009

Study Completion

December 1, 2009

Last Updated

February 5, 2016

Results First Posted

August 20, 2012

Record last verified: 2016-02