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Completed

NCT Number: NCT00567112

Study to Evaluate the Pharmacokinetics & Food Effect of MK-0941 in Adults With Type 2 Diabetes (MK-0941-009)

A study to compare the pharmacokinetics (PK) of the dry filled capsule (DFC) & oral compressed tablet (OCT) formulations of MK-0941-009 & to assess the effect of food on the OCT formulation.

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Key information

Conditions

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

Age range

18 year–70 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

  • Males or females (of non-childbearing potential) between the ages of 18 to 70
  • Participants have been diagnosed with Type 2 Diabetes
  • Participants are nonsmokers for at least 6 months

Exclusion criteria

  • Participant should not be diagnosed with Type 1 diabetes
  • Participant should not be receiving insulin or PPAR gamma agonists for 12 weeks prior to study start
  • Participant has a recent history of eye infection or other inflammatory eye condition within 2 weeks prior to study start
  • Participant has been diagnosed with glaucoma or is blind
  • Participant has had trauma to one or both eyes
  • Participant has had major surgery, donated blood or participated in another clinical study in the past 4 weeks
  • Participant is a regular user of illicit drugs or has a history of drug, including alcohol, abuse in the past 6 months

Treatment and study plan

10 mg MK-0941 DFC (fasted)

Drug

single dose of 10 mg MK-0941 dry filled capsules (DFC) administered in a fasted state

10 mg MK-0941 OCT (after meal)

Drug

single dose of 10 mg MK-0941 oral compressed tablet (OCT) administered after consumption of a high-fat meal

10 mg MK-0941 OCT (before meal)

Drug

single dose of 10 mg MK-0941 oral compressed tablet (OCT) administered before consumption of a standard breakfast

10 mg MK-0941 OCT (fasted)

Drug

single dose of 10 mg MK-0941 oral compressed tablet (OCT) administered in a fasted state

Primary outcomes

  1. Area Under the Curve (AUC)(0-∞) for Oral Compressed Tablet (OCT) (Fasted) and Dry Filled Capsule (DFC) (Fasted)

    Time frame: From study drug administration to 72 hours post-administration

  2. Maximum Concentration (Cmax) for OCT (Fasted) and DFC (Fasted)

    Time frame: From study drug administration to 72 hours post-administration

  3. Time to Reach Cmax (Tmax) for OCT (Fasted) and DFC (Fasted)

    Time frame: From study drug administration to 72 hours post-administration

  4. Half Life (t½) for OCT (Fasted) and DFC (Fasted)

    Time frame: From study drug administration to 72 hours post-administration

Secondary outcomes

  1. AUC(0-∞) for OCT (Fasted) and OCT (After Meal)

    Time frame: From study drug administration to 72 hours post-administration

  2. Cmax of OCT (Fasted) and OCT (After Meal)

    Time frame: From study drug administration to 72 hours post-administration

  3. Tmax for OCT (Fasted) and OCT (After Meal)

    Time frame: From study drug administration to 72 hours post-administration

  4. t1/2 for OCT (Fasted) and OCT (After Meal)

    Time frame: From study drug administration to 72 hours post-administration

Sponsors and collaborators

Lead sponsor

Merck Sharp & Dohme LLC

Industry

Registry information

Official study title

An Open-Label, Randomized, Partially Fixed-Sequence, 4-Period Crossover Study to Assess the Pharmacokinetics After Administration of the DFC and OCT Formulations and the Food Effect on the OCT Formulation of MK-0941 in Patients With Type 2 Diabetes

Important dates

Study start
2007
Primary completion
2008
Study completion
2008
First posted
Dec 4, 2007
Registry last updated
Mar 23, 2015

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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