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

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00567112

Enrollment

Registered

2007-12-04

Start date

2007-11-30

Completion date

2008-04-30

Last updated

2015-03-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Type 2 Diabetes Mellitus

Brief 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.

Interventions

DRUG10 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

DRUG10 mg MK-0941 DFC (fasted)

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

DRUG10 mg MK-0941 OCT (before meal)

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

DRUG10 mg MK-0941 OCT (fasted)

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

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 70 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Time to Reach Cmax (Tmax) for OCT (Fasted) and DFC (Fasted)	From study drug administration to 72 hours post-administration
Half Life (t½) for OCT (Fasted) and DFC (Fasted)	From study drug administration to 72 hours post-administration
Area Under the Curve (AUC)(0-∞) for Oral Compressed Tablet (OCT) (Fasted) and Dry Filled Capsule (DFC) (Fasted)	From study drug administration to 72 hours post-administration
Maximum Concentration (Cmax) for OCT (Fasted) and DFC (Fasted)	From study drug administration to 72 hours post-administration

Secondary

Measure	Time frame
AUC(0-∞) for OCT (Fasted) and OCT (After Meal)	From study drug administration to 72 hours post-administration
Cmax of OCT (Fasted) and OCT (After Meal)	From study drug administration to 72 hours post-administration
Tmax for OCT (Fasted) and OCT (After Meal)	From study drug administration to 72 hours post-administration
t1/2 for OCT (Fasted) and OCT (After Meal)	From study drug administration to 72 hours post-administration

Participant flow

Participants by arm

Arm	Count
All Randomized Includes the 15 participants who were randomized and started the study in Treatment Period 1 (Baseline) and the 3 additional participants who were subsequently randomized and started the study in Treatment Period 2.	18
Total	18

Withdrawals & dropouts

Period	Reason	FG000	FG001
Treatment Period 2 (3 Days)	Protocol Violation	0	1
Washout Period 3 (3 Days)	Lost to Follow-up	2	0
Washout Period 3 (3 Days)	Protocol Violation	1	0

Baseline characteristics

Characteristic	All Randomized
Age, Customized ≥ 35 and ≤ 69 years	18 participants
Sex: Female, Male Female	7 Participants
Sex: Female, Male Male	11 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk	EG002 affected / at risk	EG003 affected / at risk
deaths Total, all-cause mortality	— / —	— / —	— / —	— / —
other Total, other adverse events	6 / 18	7 / 17	3 / 14	4 / 15
serious Total, serious adverse events	0 / 18	0 / 17	0 / 14	0 / 15