Phase 1
Completed N=15
Study to Evaluate the Pharmacokinetics & Food Effect of MK-0941 in Adults With Type 2 Diabetes (MK-0941-009)
Source: ClinicalTrials.gov NCT00567112 ↗Enrolled (actual)
15
Serious AEs
0.0%
Results posted
Sep 2012
Primary outcomePrimary: Area Under the Curve (AUC)(0-∞) for Oral Compressed Tablet (OCT) (Fasted) and Dry Filled Capsule (DFC) (Fasted) — 763.76; 776.41 nM*hr — p=>0.200
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Area Under the Curve (AUC)(0-∞) for Oral Compressed Tablet (OCT) (Fasted) and Dry Filled Capsule (DFC) (Fasted) |
763.76; 776.41 | >0.200 |
| PRIMARY Maximum Concentration (Cmax) for OCT (Fasted) and DFC (Fasted) |
241.37; 246.92 | >0.200 |
| PRIMARY Time to Reach Cmax (Tmax) for OCT (Fasted) and DFC (Fasted) |
1.00; 1.00 | >0.200 |
| PRIMARY Half Life (t½) for OCT (Fasted) and DFC (Fasted) |
9.85; 8.05 | >0.200 |
| SECONDARY AUC(0-∞) for OCT (Fasted) and OCT (After Meal) |
763.76; 702.08 | 0.026 sig |
| SECONDARY Cmax of OCT (Fasted) and OCT (After Meal) |
241.37; 143.51 | <0.001 sig |
| SECONDARY Tmax for OCT (Fasted) and OCT (After Meal) |
1.00; 2.00 | <0.001 sig |
| SECONDARY t1/2 for OCT (Fasted) and OCT (After Meal) |
9.85; 9.60 | >0.200 |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT00567112). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.