Type 2 Diabetes
Conditions
Brief 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.
Interventions
DRUGMK-1006 DFC
Each dry filled capsule contains 20 mg MK-1006
DRUGMK-1006 FCT
Each film coated tablet contains 40 mg of MK-1006
Sponsors
Merck Sharp & Dohme LLC
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Area Under the Concentration Versus Time Curve (AUC(0-infinity)) for MK-1006 | Pre-dose, 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 16, 24, 48, 72, 96 and 120 hours post-dose | AUC (0-infinity) is the area under the curve for the plot showing plasma concentration against time from time zero to the time of the last quantifiable concentration for two formulations of MK-1006, FCT and DFC |
| Maximum Plasma Concentration (Cmax) for MK-1006 | Pre-dose, 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 16, 24, 48, 72, 96 and 120 hours post-dose | Maximum plasma concentration for 2 formulations of MK-1006, FCT and DFC |
Secondary
| Measure | Time frame |
|---|---|
| Number of Participants Who Experienced at Least One Adverse Event | Through 30 days post-dose |
| Number of Participants Who Discontinued Study Medication Due to an Adverse Event | up to 8 days |
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| All Participants Includes participants who were randomized to receive either a single dose of four 20 mg MK-1006 DFC followed by a single dose of two 40 mg MK-1006 FCT or a single dose of four 20 mg MK-1006 FCT followed by a single dose of two 40 mg MK-1006 DFC | 12 |
| Total | 12 |
Baseline characteristics
| Characteristic | All Participants |
|---|---|
| Age, Customized <35 years | 0 participants |
| Age, Customized >65 years | 0 participants |
| Age, Customized Between 35 and 65 years | 12 participants |
| Sex: Female, Male Female | 5 Participants |
| Sex: Female, Male Male | 7 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 7 / 12 | 6 / 12 |
| serious Total, serious adverse events | 0 / 12 | 0 / 12 |
Outcome results
Primary
Area Under the Concentration Versus Time Curve (AUC(0-infinity)) for MK-1006
AUC (0-infinity) is the area under the curve for the plot showing plasma concentration against time from time zero to the time of the last quantifiable concentration for two formulations of MK-1006, FCT and DFC
Time frame: Pre-dose, 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 16, 24, 48, 72, 96 and 120 hours post-dose
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| MK-1006 80 mg FCT | Area Under the Concentration Versus Time Curve (AUC(0-infinity)) for MK-1006 | 5171 nM*hr |
| MK-1006 80 mg DFC | Area Under the Concentration Versus Time Curve (AUC(0-infinity)) for MK-1006 | 5588 nM*hr |
90% CI: [0.86, 0.99]
Primary
Maximum Plasma Concentration (Cmax) for MK-1006
Maximum plasma concentration for 2 formulations of MK-1006, FCT and DFC
Time frame: Pre-dose, 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 16, 24, 48, 72, 96 and 120 hours post-dose
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| MK-1006 80 mg FCT | Maximum Plasma Concentration (Cmax) for MK-1006 | 554 nM |
| MK-1006 80 mg DFC | Maximum Plasma Concentration (Cmax) for MK-1006 | 519 nM |
90% CI: [0.92, 1.24]
Secondary
Number of Participants Who Discontinued Study Medication Due to an Adverse Event
Time frame: up to 8 days
Population: All participants received both formulations of MK-1006, FCT and DFC, and appear in both treatment groups.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| MK-1006 80 mg FCT | Number of Participants Who Discontinued Study Medication Due to an Adverse Event | 0 participants |
| MK-1006 80 mg DFC | Number of Participants Who Discontinued Study Medication Due to an Adverse Event | 0 participants |
Secondary
Number of Participants Who Experienced at Least One Adverse Event
Time frame: Through 30 days post-dose
Population: All participants received both formulations of MK-1006, FCT and DFC, and appear in both treatment groups.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| MK-1006 80 mg FCT | Number of Participants Who Experienced at Least One Adverse Event | 7 participants |
| MK-1006 80 mg DFC | Number of Participants Who Experienced at Least One Adverse Event | 6 participants |