Trial Outcomes & Findings for Study to Evaluate the Pharmacokinetics & Food Effect of MK-0941 in Adults With Type 2 Diabetes (MK-0941-009) (NCT NCT00567112)
NCT ID: NCT00567112
Last Updated: 2015-03-23
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
18 participants
Primary outcome timeframe
From study drug administration to 72 hours post-administration
Results posted on
2015-03-23
Participant Flow
Participant milestones
| Measure |
Treatment Group ABCD
* Period 1: Dry Filled Capsule (DFC) (fasted)
* Period 2: Oral Compressed Tablet (OCT) (fasted)
* Period 3: OCT (after meal)
* Period 4: OCT (before meal)
|
Treatment Group BACD
* Period 1: OCT (fasted)
* Period 2: DFC (fasted)
* Period 3: OCT (after meal)
* Period 4: OCT (before meal)
|
Treatment Group BCD
* Period 1: Not Applicable
* Period 2: OCT (fasted)
* Period 3: OCT (after meal)
* Period 4: OCT (before meal)
|
|---|---|---|---|
|
Treatment Period 1 (3 Days)
STARTED
|
7
|
8
|
0
|
|
Treatment Period 1 (3 Days)
COMPLETED
|
7
|
8
|
0
|
|
Treatment Period 1 (3 Days)
NOT COMPLETED
|
0
|
0
|
0
|
|
Washout Period 1 (3 Days)
STARTED
|
7
|
8
|
0
|
|
Washout Period 1 (3 Days)
COMPLETED
|
7
|
8
|
0
|
|
Washout Period 1 (3 Days)
NOT COMPLETED
|
0
|
0
|
0
|
|
Treatment Period 2 (3 Days)
STARTED
|
7
|
8
|
3
|
|
Treatment Period 2 (3 Days)
COMPLETED
|
7
|
7
|
3
|
|
Treatment Period 2 (3 Days)
NOT COMPLETED
|
0
|
1
|
0
|
|
Washout Period 2 (3 Days)
STARTED
|
7
|
7
|
3
|
|
Washout Period 2 (3 Days)
COMPLETED
|
7
|
7
|
3
|
|
Washout Period 2 (3 Days)
NOT COMPLETED
|
0
|
0
|
0
|
|
Treatment Period 3 (3 Days)
STARTED
|
7
|
7
|
3
|
|
Treatment Period 3 (3 Days)
COMPLETED
|
7
|
7
|
3
|
|
Treatment Period 3 (3 Days)
NOT COMPLETED
|
0
|
0
|
0
|
|
Washout Period 3 (3 Days)
STARTED
|
7
|
7
|
3
|
|
Washout Period 3 (3 Days)
COMPLETED
|
4
|
7
|
3
|
|
Washout Period 3 (3 Days)
NOT COMPLETED
|
3
|
0
|
0
|
|
Treatment Period 4 (3 Days)
STARTED
|
4
|
7
|
3
|
|
Treatment Period 4 (3 Days)
COMPLETED
|
4
|
7
|
3
|
|
Treatment Period 4 (3 Days)
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
| Measure |
Treatment Group ABCD
* Period 1: Dry Filled Capsule (DFC) (fasted)
* Period 2: Oral Compressed Tablet (OCT) (fasted)
* Period 3: OCT (after meal)
* Period 4: OCT (before meal)
|
Treatment Group BACD
* Period 1: OCT (fasted)
* Period 2: DFC (fasted)
* Period 3: OCT (after meal)
* Period 4: OCT (before meal)
|
Treatment Group BCD
* Period 1: Not Applicable
* Period 2: OCT (fasted)
* Period 3: OCT (after meal)
* Period 4: OCT (before meal)
|
|---|---|---|---|
|
Treatment Period 2 (3 Days)
Protocol Violation
|
0
|
1
|
0
|
|
Washout Period 3 (3 Days)
Lost to Follow-up
|
2
|
0
|
0
|
|
Washout Period 3 (3 Days)
Protocol Violation
|
1
|
0
|
0
|
Baseline Characteristics
Study to Evaluate the Pharmacokinetics & Food Effect of MK-0941 in Adults With Type 2 Diabetes (MK-0941-009)
Baseline characteristics by cohort
| Measure |
All Randomized
n=18 Participants
Includes the 15 participants who were randomized and started the study in Treatment Period 1 (Baseline) and the 3 additional participants who were subsequently randomized and started the study in Treatment Period 2.
|
|---|---|
|
Age, Customized
≥ 35 and ≤ 69 years
|
18 participants
n=99 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
11 Participants
n=99 Participants
|
PRIMARY outcome
Timeframe: From study drug administration to 72 hours post-administrationPopulation: Participants with AUC(0-∞) measurements
Outcome measures
| Measure |
OCT (Fasted)
n=18 Participants
Participants receiving a single dose of 10 mg MK-0941 OCT administered in a fasted state
|
DFC (Fasted)
n=14 Participants
Participants receiving a single dose of 10 mg MK-0941 DFC administered in a fasted state
|
|---|---|---|
|
Area Under the Curve (AUC)(0-∞) for Oral Compressed Tablet (OCT) (Fasted) and Dry Filled Capsule (DFC) (Fasted)
|
763.76 nM*hr
Interval 579.52 to 1681.47
|
776.41 nM*hr
Interval 470.04 to 1698.0
|
PRIMARY outcome
Timeframe: From study drug administration to 72 hours post-administrationPopulation: Participants with Cmax measurements
Outcome measures
| Measure |
OCT (Fasted)
n=18 Participants
Participants receiving a single dose of 10 mg MK-0941 OCT administered in a fasted state
|
DFC (Fasted)
n=15 Participants
Participants receiving a single dose of 10 mg MK-0941 DFC administered in a fasted state
|
|---|---|---|
|
Maximum Concentration (Cmax) for OCT (Fasted) and DFC (Fasted)
|
241.37 nM
Interval 96.84 to 607.42
|
246.92 nM
Interval 78.17 to 539.93
|
PRIMARY outcome
Timeframe: From study drug administration to 72 hours post-administrationPopulation: Participants with Tmax measurements
Outcome measures
| Measure |
OCT (Fasted)
n=18 Participants
Participants receiving a single dose of 10 mg MK-0941 OCT administered in a fasted state
|
DFC (Fasted)
n=15 Participants
Participants receiving a single dose of 10 mg MK-0941 DFC administered in a fasted state
|
|---|---|---|
|
Time to Reach Cmax (Tmax) for OCT (Fasted) and DFC (Fasted)
|
1.00 hours
Interval 0.5 to 4.0
|
1.00 hours
Interval 0.2 to 1.5
|
PRIMARY outcome
Timeframe: From study drug administration to 72 hours post-administrationPopulation: Participants with t1/2 measurements
Outcome measures
| Measure |
OCT (Fasted)
n=18 Participants
Participants receiving a single dose of 10 mg MK-0941 OCT administered in a fasted state
|
DFC (Fasted)
n=14 Participants
Participants receiving a single dose of 10 mg MK-0941 DFC administered in a fasted state
|
|---|---|---|
|
Half Life (t½) for OCT (Fasted) and DFC (Fasted)
|
9.85 hours
Interval 3.9 to 27.0
|
8.05 hours
Interval 5.3 to 38.4
|
SECONDARY outcome
Timeframe: From study drug administration to 72 hours post-administrationPopulation: Participants with AUC(0-∞) measurements
Outcome measures
| Measure |
OCT (Fasted)
n=18 Participants
Participants receiving a single dose of 10 mg MK-0941 OCT administered in a fasted state
|
DFC (Fasted)
n=17 Participants
Participants receiving a single dose of 10 mg MK-0941 DFC administered in a fasted state
|
|---|---|---|
|
AUC(0-∞) for OCT (Fasted) and OCT (After Meal)
|
763.76 nM*hr
Interval 579.52 to 1681.47
|
702.08 nM*hr
Interval 467.62 to 1375.86
|
SECONDARY outcome
Timeframe: From study drug administration to 72 hours post-administrationPopulation: Participants with Cmax measurements
Outcome measures
| Measure |
OCT (Fasted)
n=18 Participants
Participants receiving a single dose of 10 mg MK-0941 OCT administered in a fasted state
|
DFC (Fasted)
n=17 Participants
Participants receiving a single dose of 10 mg MK-0941 DFC administered in a fasted state
|
|---|---|---|
|
Cmax of OCT (Fasted) and OCT (After Meal)
|
241.37 nM
Interval 96.84 to 607.42
|
143.51 nM
Interval 64.13 to 268.08
|
SECONDARY outcome
Timeframe: From study drug administration to 72 hours post-administrationPopulation: Participants with Tmax measurements
Outcome measures
| Measure |
OCT (Fasted)
n=18 Participants
Participants receiving a single dose of 10 mg MK-0941 OCT administered in a fasted state
|
DFC (Fasted)
n=17 Participants
Participants receiving a single dose of 10 mg MK-0941 DFC administered in a fasted state
|
|---|---|---|
|
Tmax for OCT (Fasted) and OCT (After Meal)
|
1.00 hours
Interval 0.5 to 4.0
|
2.00 hours
Interval 1.0 to 4.0
|
SECONDARY outcome
Timeframe: From study drug administration to 72 hours post-administrationPopulation: Participants with t1/2 measurements
Outcome measures
| Measure |
OCT (Fasted)
n=18 Participants
Participants receiving a single dose of 10 mg MK-0941 OCT administered in a fasted state
|
DFC (Fasted)
n=17 Participants
Participants receiving a single dose of 10 mg MK-0941 DFC administered in a fasted state
|
|---|---|---|
|
t1/2 for OCT (Fasted) and OCT (After Meal)
|
9.85 hours
Interval 3.9 to 27.0
|
9.60 hours
Interval 3.3 to 23.2
|
Adverse Events
OCT (Fasted)
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
OCT (After Meal)
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
OCT (Before Meal)
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
DFC (Fasted)
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
OCT (Fasted)
n=18 participants at risk
Participants receiving a single dose of 10 mg MK-0941 OCT administered in a fasted state
|
OCT (After Meal)
n=17 participants at risk
Participants receiving a single dose of 10 mg MK-0941 OCT administered after consumption of a high-fat meal
|
OCT (Before Meal)
n=14 participants at risk
Participants receiving a single dose of 10 mg MK-0941 OCT administered before consumption of a standard breakfast
|
DFC (Fasted)
n=15 participants at risk
Participants receiving a single dose of 10 mg MK-0941 DFC administered in a fasted state
|
|---|---|---|---|---|
|
General disorders
Asthenia
|
0.00%
0/18 • From first dose of study drug administration through to 72 hours post-administration
|
0.00%
0/17 • From first dose of study drug administration through to 72 hours post-administration
|
0.00%
0/14 • From first dose of study drug administration through to 72 hours post-administration
|
6.7%
1/15 • From first dose of study drug administration through to 72 hours post-administration
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/18 • From first dose of study drug administration through to 72 hours post-administration
|
0.00%
0/17 • From first dose of study drug administration through to 72 hours post-administration
|
7.1%
1/14 • From first dose of study drug administration through to 72 hours post-administration
|
0.00%
0/15 • From first dose of study drug administration through to 72 hours post-administration
|
|
General disorders
Catheter site pain
|
5.6%
1/18 • From first dose of study drug administration through to 72 hours post-administration
|
0.00%
0/17 • From first dose of study drug administration through to 72 hours post-administration
|
0.00%
0/14 • From first dose of study drug administration through to 72 hours post-administration
|
0.00%
0/15 • From first dose of study drug administration through to 72 hours post-administration
|
|
Gastrointestinal disorders
Diarrhoea
|
5.6%
1/18 • From first dose of study drug administration through to 72 hours post-administration
|
0.00%
0/17 • From first dose of study drug administration through to 72 hours post-administration
|
0.00%
0/14 • From first dose of study drug administration through to 72 hours post-administration
|
6.7%
1/15 • From first dose of study drug administration through to 72 hours post-administration
|
|
Nervous system disorders
Dizziness
|
0.00%
0/18 • From first dose of study drug administration through to 72 hours post-administration
|
0.00%
0/17 • From first dose of study drug administration through to 72 hours post-administration
|
7.1%
1/14 • From first dose of study drug administration through to 72 hours post-administration
|
0.00%
0/15 • From first dose of study drug administration through to 72 hours post-administration
|
|
Skin and subcutaneous tissue disorders
Erythema
|
5.6%
1/18 • From first dose of study drug administration through to 72 hours post-administration
|
5.9%
1/17 • From first dose of study drug administration through to 72 hours post-administration
|
0.00%
0/14 • From first dose of study drug administration through to 72 hours post-administration
|
0.00%
0/15 • From first dose of study drug administration through to 72 hours post-administration
|
|
Nervous system disorders
Headache
|
5.6%
1/18 • From first dose of study drug administration through to 72 hours post-administration
|
5.9%
1/17 • From first dose of study drug administration through to 72 hours post-administration
|
14.3%
2/14 • From first dose of study drug administration through to 72 hours post-administration
|
6.7%
1/15 • From first dose of study drug administration through to 72 hours post-administration
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
11.1%
2/18 • From first dose of study drug administration through to 72 hours post-administration
|
11.8%
2/17 • From first dose of study drug administration through to 72 hours post-administration
|
0.00%
0/14 • From first dose of study drug administration through to 72 hours post-administration
|
6.7%
1/15 • From first dose of study drug administration through to 72 hours post-administration
|
|
General disorders
Infusion site erythema
|
5.6%
1/18 • From first dose of study drug administration through to 72 hours post-administration
|
11.8%
2/17 • From first dose of study drug administration through to 72 hours post-administration
|
0.00%
0/14 • From first dose of study drug administration through to 72 hours post-administration
|
0.00%
0/15 • From first dose of study drug administration through to 72 hours post-administration
|
|
General disorders
Infusion site pain
|
0.00%
0/18 • From first dose of study drug administration through to 72 hours post-administration
|
5.9%
1/17 • From first dose of study drug administration through to 72 hours post-administration
|
0.00%
0/14 • From first dose of study drug administration through to 72 hours post-administration
|
0.00%
0/15 • From first dose of study drug administration through to 72 hours post-administration
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.00%
0/18 • From first dose of study drug administration through to 72 hours post-administration
|
5.9%
1/17 • From first dose of study drug administration through to 72 hours post-administration
|
0.00%
0/14 • From first dose of study drug administration through to 72 hours post-administration
|
0.00%
0/15 • From first dose of study drug administration through to 72 hours post-administration
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/18 • From first dose of study drug administration through to 72 hours post-administration
|
0.00%
0/17 • From first dose of study drug administration through to 72 hours post-administration
|
0.00%
0/14 • From first dose of study drug administration through to 72 hours post-administration
|
6.7%
1/15 • From first dose of study drug administration through to 72 hours post-administration
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/18 • From first dose of study drug administration through to 72 hours post-administration
|
5.9%
1/17 • From first dose of study drug administration through to 72 hours post-administration
|
0.00%
0/14 • From first dose of study drug administration through to 72 hours post-administration
|
0.00%
0/15 • From first dose of study drug administration through to 72 hours post-administration
|
|
Cardiac disorders
Palpitations
|
0.00%
0/18 • From first dose of study drug administration through to 72 hours post-administration
|
0.00%
0/17 • From first dose of study drug administration through to 72 hours post-administration
|
7.1%
1/14 • From first dose of study drug administration through to 72 hours post-administration
|
0.00%
0/15 • From first dose of study drug administration through to 72 hours post-administration
|
|
Nervous system disorders
Somnolence
|
0.00%
0/18 • From first dose of study drug administration through to 72 hours post-administration
|
5.9%
1/17 • From first dose of study drug administration through to 72 hours post-administration
|
0.00%
0/14 • From first dose of study drug administration through to 72 hours post-administration
|
0.00%
0/15 • From first dose of study drug administration through to 72 hours post-administration
|
|
Gastrointestinal disorders
Tongue Blistering
|
0.00%
0/18 • From first dose of study drug administration through to 72 hours post-administration
|
5.9%
1/17 • From first dose of study drug administration through to 72 hours post-administration
|
0.00%
0/14 • From first dose of study drug administration through to 72 hours post-administration
|
0.00%
0/15 • From first dose of study drug administration through to 72 hours post-administration
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/18 • From first dose of study drug administration through to 72 hours post-administration
|
0.00%
0/17 • From first dose of study drug administration through to 72 hours post-administration
|
7.1%
1/14 • From first dose of study drug administration through to 72 hours post-administration
|
0.00%
0/15 • From first dose of study drug administration through to 72 hours post-administration
|
Additional Information
Senior Vice President, Global Clinical Development
Merck Sharp & Dohme Corp
Phone: 1-800-672-6372
Email: [email protected]
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