Phase 1
Completed N=25
A Study to Test the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of MK1006 (MK-1006-002)(COMPLETED)
Source: ClinicalTrials.gov NCT00757601 ↗Enrolled (actual)
25
Serious AEs
0.0%
Results posted
Sep 2012
Primary outcomePrimary: Number of Participants Experiencing Adverse Events (AEs) On Study — 2; 3; 3; 2 participants
Summary
This study will assess the safety, tolerability, pharmacokinetics, and pharmacodynamics of single doses of MK1006
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants Experiencing Adverse Events (AEs) On Study |
2; 3; 3; 2; 2; 1 | — |
| PRIMARY Number of Participants Who Discontinued Treatment Due to an AE |
0; 0; 0; 0; 0; 0 | — |
| SECONDARY Mean Area Under the Plasma Concentration Curve From Time Zero to Infinity (AUC[0-∞]) After Single Dose MK1006 |
595; 1330; 1900; 2790; 4380; 6360 | — |
| SECONDARY Mean Maximum Plasma Concentration (Cmax) of MK1006 After Single Dose |
60.0; 123.0; 191.0; 251.0; 434.0; 614.0 | — |
| SECONDARY Median Time of Maximum Plasma Concentration (Tmax) of MK1006 After Single Dose |
1.5; 2.0; 3.0; 3.0; 3.0; 3.0 | — |
| SECONDARY Apparent Terminal Half-Life (T 1/2) of MK1006 After Single Dose |
17.0; 17.3; 17.6; 18.3; 20.0; 23.0 | — |
| SECONDARY Mean Area Under The Plasma Concentration Curve From Time Zero to 24 Hours (AUC[0-24]) After Single Dose MK1006 |
468; 1030; 1520; 2100; 3450; 4930 | — |
Eligibility Criteria
Inclusion Criteria
- Participant is between 18 and 55 years of age. Participants up to 65 years of age may be enrolled in Panels B and C
- Female participants must be postmenopausal or otherwise unable to have children
- Participant has a body mass index (BMI) less than or equal to 42 kg/m^2 at the screening visit
- Participant has type 2 diabetes and is being treated with either diet and exercise or a single oral anti-hyperglycemic medication. For Panels B and C, participant may be treated with combination oral anti-hyperglycemic medications
- Participant is willing to follow the American Heart Association (AHA) diet and exercise program throughout the study
- Participant is a nonsmoker or has not used nicotine-containing products for 6 months prior to study start
Exclusion Criteria
- Participant has a history of stroke, seizures, or other neurological disorders
- Participant has a recent history of eye infection or other inflammatory eye conditions
- Participant has glaucoma or is blind
- Participant has had eye surgery within 6 months of study start (Lasik is permitted)
- Participant has type 1 diabetes
- Participant cannot stop taking any of their current prescription or non-prescription medications during the study
- Participant consumes more than 3 alcoholic beverages per day
- Participant consumes more than 6 caffeinated beverages per day
- Participant has had major surgery or has donated blood within 4 weeks of study start
- Participant has multiple and/or severe allergies to drugs or food
Data sourced from ClinicalTrials.gov (NCT00757601). 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.