Phase 1
Completed N=12
A Study of the Pharmacokinetics of Two Formulations of MK-1006 (MK-1006-010 AM1)(COMPLETED)
Source: ClinicalTrials.gov NCT00979459 ↗Enrolled (actual)
12
Serious AEs
0.0%
Results posted
Aug 2012
Primary outcomePrimary: Area Under the Concentration Versus Time Curve (AUC(0-infinity)) for MK-1006 — 5171; 5588 nM*hr
Summary
This study will assess the pharmacokinetics of two formulations of MK-1006. The primary hypothesis of this study is that the MK-1006 area under the curve (0 to infinity) and maximum concentration after administration of a single 80 mg dose of the dry filled capsule (DFC) and film coated tablet (FCT) formulations of MK-1006 will be similar.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Area Under the Concentration Versus Time Curve (AUC(0-infinity)) for MK-1006 |
5171; 5588 | — |
| PRIMARY Maximum Plasma Concentration (Cmax) for MK-1006 |
554; 519 | — |
| SECONDARY Number of Participants Who Experienced at Least One Adverse Event |
7; 6 | — |
| SECONDARY Number of Participants Who Discontinued Study Medication Due to an Adverse Event |
0; 0 | — |
Eligibility Criteria
Inclusion Criteria
- is a male or a female of non-child bearing potential
- has type 2 diabetes (T2D) and is either being treated with diet and exercise alone or with a single or combination oral anti-hyperglycemic agent(s)
- has been a nonsmoker for at least 6 months
Exclusion Criteria
- has a history of stroke, chronic seizures, or major neurological disorder
- has a history of major endocrine (except T2D), gastrointestinal, cardiovascular, blood, liver, immune, kidney, respiratory, or genitourinary abnormalities or diseases
- has a history of cancer, except certain skin or cervical cancers or cancer that was successfully treated more than 10 years prior to screening
- has unstable or rapidly progressing diabetic retinopathy and/or neuropathy
- has had an eye infection or other inflammation of the eye in the 2 weeks prior to screening
- has glaucoma or is blind
- has had incisional eye surgery in the last 6 months or laser eye surgery in the last 3 months (Lasik is permitted)
- has a history of type 1 diabetes
- has symptomatic coronary artery disease
- consumes excessive amounts of alcohol and/or caffeine
Data sourced from ClinicalTrials.gov (NCT00979459). 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.