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

Type 2 Diabetes Mellitus Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00567112
• Other study ID #: 0941-009
• Secondary ID: 2007_652MK-0941-
• Status: Completed
• Phase: Phase 1
• First received: November 30, 2007
• Last updated: March 12, 2015
• Start date: November 2007
• Est. completion date: April 2008

Study information

• Verified date: March 2015
• Source: Merck Sharp & Dohme Corp.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: April 2008
• Est. primary completion date: February 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2
• Type 2 Diabetes Mellitus

Intervention

Drug:
• 10 mg MK-0941 DFC (fasted)
single dose of 10 mg MK-0941 dry filled capsules (DFC) administered in a fasted state
• 10 mg MK-0941 OCT (after meal)
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)
single dose of 10 mg MK-0941 oral compressed tablet (OCT) administered before consumption of a standard breakfast
• 10 mg MK-0941 OCT (fasted)
single dose of 10 mg MK-0941 oral compressed tablet (OCT) administered in a fasted state

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Merck Sharp & Dohme Corp.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Area Under the Curve (AUC)(0-8) for Oral Compressed Tablet (OCT) (Fasted) and Dry Filled Capsule (DFC) (Fasted)		From study drug administration to 72 hours post-administration	No
Primary	Maximum Concentration (Cmax) for OCT (Fasted) and DFC (Fasted)		From study drug administration to 72 hours post-administration	No
Primary	Time to Reach Cmax (Tmax) for OCT (Fasted) and DFC (Fasted)		From study drug administration to 72 hours post-administration	No
Primary	Half Life (t½) for OCT (Fasted) and DFC (Fasted)		From study drug administration to 72 hours post-administration	No
Secondary	AUC(0-8) for OCT (Fasted) and OCT (After Meal)		From study drug administration to 72 hours post-administration	No
Secondary	Cmax of OCT (Fasted) and OCT (After Meal)		From study drug administration to 72 hours post-administration	No
Secondary	Tmax for OCT (Fasted) and OCT (After Meal)		From study drug administration to 72 hours post-administration	No
Secondary	t1/2 for OCT (Fasted) and OCT (After Meal)		From study drug administration to 72 hours post-administration	No