Type 2 Diabetes
Conditions
Brief summary
A single dose, open label study to characterize the routes of elimination and determine the mass balance of MK-0941. A single 40 mg dose of MK-0941 will be given orally to male participants with type 2 diabetes. After drug administration, blood, urine, and fecal samples will be collected to determine relative quantities of 14C-labeled MK-0941.
Interventions
DRUGMK-0941
A single dose of 40 mg of \[14C\]MK-0941 (160 µCi), taken orally as eight 5-mg capsules
Sponsors
Merck Sharp & Dohme LLC
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Subject has been diagnosed with type 2 diabetes, and is being treated with diet and exercise or with an oral anti-hyperglycemic agent * Subject is willing to follow the American Heart Association diet and exercise program throughout the study * Subject is a nonsmoker and/or has not used nicotine products for at least 6 months
Exclusion criteria
* Subject has a history of stroke, seizures, or major neurological disorder * Subject has a history of neoplastic disease * Subject has recently had abnormal bowel habits, such as diarrhea, loose stools or constipation * Subject has a history of type 1 diabetes mellitus * Subject has received insulin within the past 12 weeks * Subject has a recent history of eye infection * Subject has been diagnosed with glaucoma or is blind * Subject consumes more than 3 alcoholic beverages per day * Subject consumes more than 6 servings of coffee, tea, cola per day * Subject has had major surgery, donated or lost blood in the past 4 weeks * Subject has multiple or severe allergies to any food or drugs
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean Percent of Dose Recovered in Urine and Feces Following a Single Oral Dose of [^14C]MK-0941 (160 µCi). | Up to 168 hours after study drug administration | Urine was collected at predose, 0 to 4, 4 to 8, 8 to 12, and 12 to 24 hr postdose, and at 24 hr intervals through subject discharge. Feces were collected at pre-dose and at 24 hr intervals through subject discharge. Subjects were discharged when the total recovery in urine and feces ≥90% of the administered dose or the recovery in urine and feces for two consecutive 24-hr intervals was ≤ 1%. |
Secondary
| Measure | Time frame |
|---|---|
| Number of Participants Who Experienced An Adverse Event | Up to 14 days after study drug administration |
| Number of Participants Who Discontinued the Study Due to An Adverse Event | Up to 14 days after study drug administration |
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| MK-0941 Oral administration of a single 40-mg dose of \[\^14C\]MK-0941 (160 µCi) to adult male subjects with type 2 diabetes. | 6 |
| Total | 6 |
Baseline characteristics
| Characteristic | MK-0941 |
|---|---|
| Age, Customized <29 years | 0 participants |
| Age, Customized 29 years to 55 years | 6 participants |
| Age, Customized >55 years | 0 participants |
| Sex: Female, Male Female | 0 Participants |
| Sex: Female, Male Male | 6 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 5 / 6 |
| serious Total, serious adverse events | 0 / 6 |
Outcome results
Primary
Mean Percent of Dose Recovered in Urine and Feces Following a Single Oral Dose of [^14C]MK-0941 (160 µCi).
Urine was collected at predose, 0 to 4, 4 to 8, 8 to 12, and 12 to 24 hr postdose, and at 24 hr intervals through subject discharge. Feces were collected at pre-dose and at 24 hr intervals through subject discharge. Subjects were discharged when the total recovery in urine and feces ≥90% of the administered dose or the recovery in urine and feces for two consecutive 24-hr intervals was ≤ 1%.
Time frame: Up to 168 hours after study drug administration
Population: All treated participants.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| MK-0941 | Mean Percent of Dose Recovered in Urine and Feces Following a Single Oral Dose of [^14C]MK-0941 (160 µCi). | In the Urine | 60.0 Percent Recovered | Standard Deviation 8.56 |
| MK-0941 | Mean Percent of Dose Recovered in Urine and Feces Following a Single Oral Dose of [^14C]MK-0941 (160 µCi). | In the Feces | 38.7 Percent Recovered | Standard Deviation 8.35 |
Secondary
Number of Participants Who Discontinued the Study Due to An Adverse Event
Time frame: Up to 14 days after study drug administration
Population: All treated participants.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| MK-0941 | Number of Participants Who Discontinued the Study Due to An Adverse Event | 0 participants |
Secondary
Number of Participants Who Experienced An Adverse Event
Time frame: Up to 14 days after study drug administration
Population: All treated participants.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| MK-0941 | Number of Participants Who Experienced An Adverse Event | 5 participants |