Trial Outcomes & Findings for A Study of Absorption, Metabolism, Excretion and Mass Balance After a Single Dose Administration of MK-0941 (MK-0941-016)(COMPLETED) (NCT NCT00912002)
NCT ID: NCT00912002
Last Updated: 2015-07-03
Results Overview
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%.
COMPLETED
PHASE1
6 participants
Up to 168 hours after study drug administration
2015-07-03
Participant Flow
Participant milestones
| Measure |
MK-0941
Oral administration of a single 40-mg dose of \[\^14C\]MK-0941 (160 µCi) to adult male subjects with type 2 diabetes.
|
|---|---|
|
Overall Study
STARTED
|
6
|
|
Overall Study
COMPLETED
|
6
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Study of Absorption, Metabolism, Excretion and Mass Balance After a Single Dose Administration of MK-0941 (MK-0941-016)(COMPLETED)
Baseline characteristics by cohort
| Measure |
MK-0941
n=6 Participants
Oral administration of a single 40-mg dose of \[\^14C\]MK-0941 (160 µCi) to adult male subjects with type 2 diabetes.
|
|---|---|
|
Age, Customized
<29 years
|
0 participants
n=93 Participants
|
|
Age, Customized
29 years to 55 years
|
6 participants
n=93 Participants
|
|
Age, Customized
>55 years
|
0 participants
n=93 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=93 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=93 Participants
|
PRIMARY outcome
Timeframe: Up to 168 hours after study drug administrationPopulation: All treated participants.
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%.
Outcome measures
| Measure |
MK-0941
n=6 Participants
Oral administration of a single 40-mg dose of \[\^14C\]MK-0941 (160 µCi) to adult male subjects with type 2 diabetes as eight 5-mg capsules.
|
|---|---|
|
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
|
|
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 outcome
Timeframe: Up to 14 days after study drug administrationPopulation: All treated participants.
Outcome measures
| Measure |
MK-0941
n=6 Participants
Oral administration of a single 40-mg dose of \[\^14C\]MK-0941 (160 µCi) to adult male subjects with type 2 diabetes as eight 5-mg capsules.
|
|---|---|
|
Number of Participants Who Experienced An Adverse Event
|
5 participants
|
SECONDARY outcome
Timeframe: Up to 14 days after study drug administrationPopulation: All treated participants.
Outcome measures
| Measure |
MK-0941
n=6 Participants
Oral administration of a single 40-mg dose of \[\^14C\]MK-0941 (160 µCi) to adult male subjects with type 2 diabetes as eight 5-mg capsules.
|
|---|---|
|
Number of Participants Who Discontinued the Study Due to An Adverse Event
|
0 participants
|
Adverse Events
MK-0941
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
MK-0941
n=6 participants at risk
Oral administration of a single 40-mg dose of \[\^14C\]MK-0941 (160 µCi) to adult male subjects with type 2 diabetes.
|
|---|---|
|
Eye disorders
Cataract
|
16.7%
1/6 • Up to 14 days after study drug administration
|
|
Gastrointestinal disorders
Abdominal pain
|
16.7%
1/6 • Up to 14 days after study drug administration
|
|
Gastrointestinal disorders
Abdominal pain lower
|
16.7%
1/6 • Up to 14 days after study drug administration
|
|
Gastrointestinal disorders
Dyspepsia
|
16.7%
1/6 • Up to 14 days after study drug administration
|
|
Gastrointestinal disorders
Faecal incontinence
|
16.7%
1/6 • Up to 14 days after study drug administration
|
|
General disorders
Mucosal dryness
|
16.7%
1/6 • Up to 14 days after study drug administration
|
|
Metabolism and nutrition disorders
Decreased appetite
|
33.3%
2/6 • Up to 14 days after study drug administration
|
|
Nervous system disorders
Dizziness
|
16.7%
1/6 • Up to 14 days after study drug administration
|
|
Nervous system disorders
Headache
|
16.7%
1/6 • Up to 14 days after study drug administration
|
|
Nervous system disorders
Tremor
|
16.7%
1/6 • Up to 14 days after study drug administration
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
16.7%
1/6 • Up to 14 days after study drug administration
|
|
Skin and subcutaneous tissue disorders
Dermatitis contact
|
16.7%
1/6 • Up to 14 days after study drug administration
|
Additional Information
Senior Vice President, Global Clinical Development
Merck Sharp & Dohme Corp
Results disclosure agreements
- Principal investigator is a sponsor employee The sponsor must have the opportunity to review all proposed abstracts, manuscripts, or presentations regarding this study 60 days prior to submission for publication/presentation. Any information identified by the sponsor as confidential must be deleted prior to submission.
- Publication restrictions are in place
Restriction type: OTHER