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Completed

NCT Number: NCT00979459

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

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.

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Key information

Conditions

Type 2 Diabetes Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

MK-1006 DFC

Drug

Each dry filled capsule contains 20 mg MK-1006

MK-1006 FCT

Drug

Each film coated tablet contains 40 mg of MK-1006

Primary outcomes

  1. 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

  2. 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

Secondary outcomes

  1. Number of Participants Who Experienced at Least One Adverse Event

    Time frame: Through 30 days post-dose

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

    Time frame: up to 8 days

Sponsors and collaborators

Lead sponsor

Merck Sharp & Dohme LLC

Industry

Registry information

Official study title

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

Important dates

Study start
2009
Primary completion
2009
Study completion
2009
First posted
Sep 18, 2009
Registry last updated
Feb 5, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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