Trial Outcomes & Findings for Evaluation of Omarigliptin (MK-3102) in Obese Participants and in Participants With Type 2 Diabetes (MK-3102-004) (NCT NCT01088711)
NCT ID: NCT01088711
Last Updated: 2018-09-10
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
32 participants
Primary outcome timeframe
Up to Day 36
Results posted on
2018-09-10
Participant Flow
Participant milestones
| Measure |
Healthy Participants - Omarigliptin
Obese healthy participants received once-weekly omarigliptin for 4 weeks.
|
Healthy - Placebo
Obese healthy participants received once-weekly placebo for 4 weeks.
|
T2D - Omarigliptin
Obese T2D participants received once-weekly omarigliptin for 4 weeks.
|
T2D - Placebo
Obese T2D participants received once-weekly placebo for 4 weeks.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
18
|
6
|
6
|
2
|
|
Overall Study
COMPLETED
|
18
|
6
|
6
|
2
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Evaluation of Omarigliptin (MK-3102) in Obese Participants and in Participants With Type 2 Diabetes (MK-3102-004)
Baseline characteristics by cohort
| Measure |
Healthy Participants - Omarigliptin
n=18 Participants
Obese healthy participants received once-weekly omarigliptin for 4 weeks.
|
T2D Participants (Panel B)
n=6 Participants
Obese participants with T2D received once-weekly omarigliptin or placebo for 4 weeks.
|
T2D - Omarigliptin
n=6 Participants
Obese T2D participants received once-weekly omarigliptin for 4 weeks.
|
T2D - Placebo
n=2 Participants
Obese T2D participants received once-weekly placebo for 4 weeks.
|
Total
n=32 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
52.3 Years
STANDARD_DEVIATION 5.1 • n=99 Participants
|
56.2 Years
STANDARD_DEVIATION 7.6 • n=107 Participants
|
55.4 Years
STANDARD_DEVIATION 4.4 • n=206 Participants
|
61.0 Years
STANDARD_DEVIATION 8.5 • n=7 Participants
|
54.2 Years
STANDARD_DEVIATION 5.9 • n=31 Participants
|
|
Sex: Female, Male
Female
|
12 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
1 Participants
n=7 Participants
|
20 Participants
n=31 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
1 Participants
n=7 Participants
|
12 Participants
n=31 Participants
|
PRIMARY outcome
Timeframe: Up to Day 36Population: AEs were monitored in all obese healthy (Panel A) and Type 2 diabetes (T2D) (Panel B) participants who received omarigliptin 50 mg or placebo.
Outcome measures
| Measure |
Healthy Omarigliptin
n=18 Participants
Obese healthy participants received once-weekly omarigliptin 50 mg for 4 weeks (Panel A).
|
Healthy Placebo
n=6 Participants
Obese healthy participants received once-weekly placebo for 4 weeks (Panel A).
|
T2D Omarigliptin
n=6 Participants
Obese participants with T2D received once-weekly omarigliptin 50 mg for 4 weeks (Panel B).
|
T2D Placebo
n=2 Participants
Obese participants with T2D received once-weekly placebo for 4 weeks (Panel B).
|
|---|---|---|---|---|
|
Number of Participants Experiencing an Adverse Event (AE)
|
12 Participants
|
2 Participants
|
4 Participants
|
2 Participants
|
PRIMARY outcome
Timeframe: Up to Day 22Population: AEs were monitored in all obese healthy (Panel A) and T2D (Panel B) participants who received omarigliptin 50 mg or placebo.
Outcome measures
| Measure |
Healthy Omarigliptin
n=18 Participants
Obese healthy participants received once-weekly omarigliptin 50 mg for 4 weeks (Panel A).
|
Healthy Placebo
n=6 Participants
Obese healthy participants received once-weekly placebo for 4 weeks (Panel A).
|
T2D Omarigliptin
n=6 Participants
Obese participants with T2D received once-weekly omarigliptin 50 mg for 4 weeks (Panel B).
|
T2D Placebo
n=2 Participants
Obese participants with T2D received once-weekly placebo for 4 weeks (Panel B).
|
|---|---|---|---|---|
|
Number of Participants Withdrawing From Study Therapy Due to an AE
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 168 hours post-dose on Day 15Population: Data from obese healthy participants (Panel A) and obese T2D participants (Panel B) 168 hours post-dose on Day 15 were pooled according to treatment. Predose data from Day 1 were missing from 2 participants.
Percent DPP-4 inhibition at 168 hours after the Day 15 dose (from baseline \[pre-dose on Day 1\]) was compared in healthy and T2D participants receiving omarigliptin or placebo.
Outcome measures
| Measure |
Healthy Omarigliptin
n=22 Participants
Obese healthy participants received once-weekly omarigliptin 50 mg for 4 weeks (Panel A).
|
Healthy Placebo
n=8 Participants
Obese healthy participants received once-weekly placebo for 4 weeks (Panel A).
|
T2D Omarigliptin
Obese participants with T2D received once-weekly omarigliptin 50 mg for 4 weeks (Panel B).
|
T2D Placebo
Obese participants with T2D received once-weekly placebo for 4 weeks (Panel B).
|
|---|---|---|---|---|
|
Percent Inhibition of Dipeptidyl Peptidase-4 (DPP-4) After Day 15
|
91.92 Percent DPP-4 inhibition
Interval 89.78 to 93.61
|
1.16 Percent DPP-4 inhibition
Interval -7.55 to 9.17
|
—
|
—
|
SECONDARY outcome
Timeframe: 168 hours post dose on Day 22Population: No data from obese healthy participants (Panel A) were collected after pre-dose on Day 22. Therefore, data are presented only for obese T2D participants (Panel B) 168 hours post-dose on Day 22.
Percent DPP-4 inhibition at 168 hours after the Day 22 dose (from baseline \[pre-dose on Day 1\]) was compared in healthy and T2D participants receiving omarigliptin or placebo.
Outcome measures
| Measure |
Healthy Omarigliptin
n=6 Participants
Obese healthy participants received once-weekly omarigliptin 50 mg for 4 weeks (Panel A).
|
Healthy Placebo
n=2 Participants
Obese healthy participants received once-weekly placebo for 4 weeks (Panel A).
|
T2D Omarigliptin
Obese participants with T2D received once-weekly omarigliptin 50 mg for 4 weeks (Panel B).
|
T2D Placebo
Obese participants with T2D received once-weekly placebo for 4 weeks (Panel B).
|
|---|---|---|---|---|
|
Percent Inhibition of DPP-4 After Day 22
|
89.62 Percent DPP-4 inhibition
Interval 86.8 to 91.84
|
-8.59 Percent DPP-4 inhibition
Interval -65.56 to 28.78
|
—
|
—
|
SECONDARY outcome
Timeframe: Through 4 hours post dose on Day 21Population: Data from obese healthy participants (Panel A) and obese T2D participants (Panel B) 4 hours post dose on Day 21 were pooled according to treatment. All participants who received omarigliptin or placebo are included.
Weighted average augmentation (WAA) active GLP-1 concentration was based on the 0.25, 0.5, 1, 2, and 4 hour timepoints. WAA was calculated as area under the curve (AUC) for the 4-hr post-dose time period (AUC0-4 hrs); this AUC was then divided by the time interval of 4 hours to obtain WAA. Log scale data were then back-transformed to obtain LS means.
Outcome measures
| Measure |
Healthy Omarigliptin
n=24 Participants
Obese healthy participants received once-weekly omarigliptin 50 mg for 4 weeks (Panel A).
|
Healthy Placebo
n=8 Participants
Obese healthy participants received once-weekly placebo for 4 weeks (Panel A).
|
T2D Omarigliptin
Obese participants with T2D received once-weekly omarigliptin 50 mg for 4 weeks (Panel B).
|
T2D Placebo
Obese participants with T2D received once-weekly placebo for 4 weeks (Panel B).
|
|---|---|---|---|---|
|
WAA Active Glucagon-like Peptide-1 (GLP-1) Concentration
|
3.84 pmol/L
Interval 3.38 to 4.36
|
2.0 pmol/L
Interval 1.6 to 2.5
|
—
|
—
|
SECONDARY outcome
Timeframe: Through 4 hours post dose on Day 21Population: Data from obese healthy participants (Panel A) and obese T2D participants (Panel B) 4 hours post dose on Day 21 were pooled according to treatment. All participants who received omarigliptin or placebo are included.
WAA total GLP-1 concentration was based on the 0.25, 0.5, 1, 2, and 4 hour timepoints. WAA was calculated as AUC0-4 hrs; this AUC was then divided by the time interval of 4 hours to obtain WAA. Log scale data were then back-transformed to obtain LS means.
Outcome measures
| Measure |
Healthy Omarigliptin
n=24 Participants
Obese healthy participants received once-weekly omarigliptin 50 mg for 4 weeks (Panel A).
|
Healthy Placebo
n=8 Participants
Obese healthy participants received once-weekly placebo for 4 weeks (Panel A).
|
T2D Omarigliptin
Obese participants with T2D received once-weekly omarigliptin 50 mg for 4 weeks (Panel B).
|
T2D Placebo
Obese participants with T2D received once-weekly placebo for 4 weeks (Panel B).
|
|---|---|---|---|---|
|
WAA Total GLP-1 Concentration
|
2.11 pmol/L
Interval 1.82 to 2.44
|
2.31 pmol/L
Interval 1.79 to 2.98
|
—
|
—
|
SECONDARY outcome
Timeframe: Through 4 hours post dose on Day 21Population: Data from obese healthy participants (Panel A) and obese T2D participants (Panel B) 4 hours post dose on Day 21 were pooled according to treatment. All participants who received omarigliptin or placebo are included.
Post-prandial glucose concentration is presented as a weighted average of the 0.25, 0.5, 1, 2, and 4 hour post-dose time points. Glucose concentration was calculated as area under the curve (AUC) for the 4-hr post-dose time period (AUC0-4 hrs); this AUC was then divided by the time interval of 4 hours to obtain weighted average glucose concentration. Log scale data were then back-transformed to obtain LS means.
Outcome measures
| Measure |
Healthy Omarigliptin
n=24 Participants
Obese healthy participants received once-weekly omarigliptin 50 mg for 4 weeks (Panel A).
|
Healthy Placebo
n=8 Participants
Obese healthy participants received once-weekly placebo for 4 weeks (Panel A).
|
T2D Omarigliptin
Obese participants with T2D received once-weekly omarigliptin 50 mg for 4 weeks (Panel B).
|
T2D Placebo
Obese participants with T2D received once-weekly placebo for 4 weeks (Panel B).
|
|---|---|---|---|---|
|
Plasma Glucose Concentration
|
8.34 mg/dL
Interval 3.17 to 13.5
|
20.84 mg/dL
Interval 11.9 to 29.78
|
—
|
—
|
Adverse Events
Omarigliptin 50 mg Healthy (Panel A)
Serious events: 0 serious events
Other events: 12 other events
Deaths: 0 deaths
Placebo Healthy (Panel A)
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Omarigliptin 50 mg T2D (Panel B)
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Placebo T2D (Panel B)
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Omarigliptin 50 mg Healthy (Panel A)
n=18 participants at risk
Obese healthy participants received once-weekly omarigliptin 50 mg for 4 weeks.
|
Placebo Healthy (Panel A)
n=6 participants at risk
Obese healthy participants received once-weekly placebo for 4 weeks.
|
Omarigliptin 50 mg T2D (Panel B)
n=6 participants at risk
Obese T2D participants received once-weekly omarigliptin 50 mg for 4 weeks.
|
Placebo T2D (Panel B)
n=2 participants at risk
Obese T2D participants received once-weekly placebo for 4 weeks.
|
|---|---|---|---|---|
|
Ear and labyrinth disorders
Ear pruritus
|
5.6%
1/18 • Number of events 1 • Up to Day 36
AEs were monitored up to 14 days after the final dose of study drug on Day 22.
|
0.00%
0/6 • Up to Day 36
AEs were monitored up to 14 days after the final dose of study drug on Day 22.
|
0.00%
0/6 • Up to Day 36
AEs were monitored up to 14 days after the final dose of study drug on Day 22.
|
0.00%
0/2 • Up to Day 36
AEs were monitored up to 14 days after the final dose of study drug on Day 22.
|
|
Eye disorders
Eye pruritus
|
5.6%
1/18 • Number of events 1 • Up to Day 36
AEs were monitored up to 14 days after the final dose of study drug on Day 22.
|
0.00%
0/6 • Up to Day 36
AEs were monitored up to 14 days after the final dose of study drug on Day 22.
|
0.00%
0/6 • Up to Day 36
AEs were monitored up to 14 days after the final dose of study drug on Day 22.
|
0.00%
0/2 • Up to Day 36
AEs were monitored up to 14 days after the final dose of study drug on Day 22.
|
|
Eye disorders
Foreign body sensation in eyes
|
5.6%
1/18 • Number of events 1 • Up to Day 36
AEs were monitored up to 14 days after the final dose of study drug on Day 22.
|
0.00%
0/6 • Up to Day 36
AEs were monitored up to 14 days after the final dose of study drug on Day 22.
|
0.00%
0/6 • Up to Day 36
AEs were monitored up to 14 days after the final dose of study drug on Day 22.
|
0.00%
0/2 • Up to Day 36
AEs were monitored up to 14 days after the final dose of study drug on Day 22.
|
|
Eye disorders
Scintillating scotoma
|
0.00%
0/18 • Up to Day 36
AEs were monitored up to 14 days after the final dose of study drug on Day 22.
|
16.7%
1/6 • Number of events 1 • Up to Day 36
AEs were monitored up to 14 days after the final dose of study drug on Day 22.
|
0.00%
0/6 • Up to Day 36
AEs were monitored up to 14 days after the final dose of study drug on Day 22.
|
0.00%
0/2 • Up to Day 36
AEs were monitored up to 14 days after the final dose of study drug on Day 22.
|
|
Eye disorders
Vision blurred
|
0.00%
0/18 • Up to Day 36
AEs were monitored up to 14 days after the final dose of study drug on Day 22.
|
0.00%
0/6 • Up to Day 36
AEs were monitored up to 14 days after the final dose of study drug on Day 22.
|
0.00%
0/6 • Up to Day 36
AEs were monitored up to 14 days after the final dose of study drug on Day 22.
|
50.0%
1/2 • Number of events 1 • Up to Day 36
AEs were monitored up to 14 days after the final dose of study drug on Day 22.
|
|
Gastrointestinal disorders
Abdominal pain
|
5.6%
1/18 • Number of events 1 • Up to Day 36
AEs were monitored up to 14 days after the final dose of study drug on Day 22.
|
0.00%
0/6 • Up to Day 36
AEs were monitored up to 14 days after the final dose of study drug on Day 22.
|
0.00%
0/6 • Up to Day 36
AEs were monitored up to 14 days after the final dose of study drug on Day 22.
|
0.00%
0/2 • Up to Day 36
AEs were monitored up to 14 days after the final dose of study drug on Day 22.
|
|
Gastrointestinal disorders
Diarrhoea
|
5.6%
1/18 • Number of events 1 • Up to Day 36
AEs were monitored up to 14 days after the final dose of study drug on Day 22.
|
0.00%
0/6 • Up to Day 36
AEs were monitored up to 14 days after the final dose of study drug on Day 22.
|
0.00%
0/6 • Up to Day 36
AEs were monitored up to 14 days after the final dose of study drug on Day 22.
|
0.00%
0/2 • Up to Day 36
AEs were monitored up to 14 days after the final dose of study drug on Day 22.
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/18 • Up to Day 36
AEs were monitored up to 14 days after the final dose of study drug on Day 22.
|
0.00%
0/6 • Up to Day 36
AEs were monitored up to 14 days after the final dose of study drug on Day 22.
|
16.7%
1/6 • Number of events 2 • Up to Day 36
AEs were monitored up to 14 days after the final dose of study drug on Day 22.
|
0.00%
0/2 • Up to Day 36
AEs were monitored up to 14 days after the final dose of study drug on Day 22.
|
|
Gastrointestinal disorders
Nausea
|
11.1%
2/18 • Number of events 3 • Up to Day 36
AEs were monitored up to 14 days after the final dose of study drug on Day 22.
|
0.00%
0/6 • Up to Day 36
AEs were monitored up to 14 days after the final dose of study drug on Day 22.
|
0.00%
0/6 • Up to Day 36
AEs were monitored up to 14 days after the final dose of study drug on Day 22.
|
50.0%
1/2 • Number of events 1 • Up to Day 36
AEs were monitored up to 14 days after the final dose of study drug on Day 22.
|
|
Gastrointestinal disorders
Toothache
|
0.00%
0/18 • Up to Day 36
AEs were monitored up to 14 days after the final dose of study drug on Day 22.
|
0.00%
0/6 • Up to Day 36
AEs were monitored up to 14 days after the final dose of study drug on Day 22.
|
16.7%
1/6 • Number of events 1 • Up to Day 36
AEs were monitored up to 14 days after the final dose of study drug on Day 22.
|
0.00%
0/2 • Up to Day 36
AEs were monitored up to 14 days after the final dose of study drug on Day 22.
|
|
Gastrointestinal disorders
Vomiting
|
5.6%
1/18 • Number of events 1 • Up to Day 36
AEs were monitored up to 14 days after the final dose of study drug on Day 22.
|
0.00%
0/6 • Up to Day 36
AEs were monitored up to 14 days after the final dose of study drug on Day 22.
|
33.3%
2/6 • Number of events 3 • Up to Day 36
AEs were monitored up to 14 days after the final dose of study drug on Day 22.
|
0.00%
0/2 • Up to Day 36
AEs were monitored up to 14 days after the final dose of study drug on Day 22.
|
|
General disorders
Asthenia
|
5.6%
1/18 • Number of events 1 • Up to Day 36
AEs were monitored up to 14 days after the final dose of study drug on Day 22.
|
0.00%
0/6 • Up to Day 36
AEs were monitored up to 14 days after the final dose of study drug on Day 22.
|
0.00%
0/6 • Up to Day 36
AEs were monitored up to 14 days after the final dose of study drug on Day 22.
|
0.00%
0/2 • Up to Day 36
AEs were monitored up to 14 days after the final dose of study drug on Day 22.
|
|
General disorders
Chills
|
11.1%
2/18 • Number of events 2 • Up to Day 36
AEs were monitored up to 14 days after the final dose of study drug on Day 22.
|
0.00%
0/6 • Up to Day 36
AEs were monitored up to 14 days after the final dose of study drug on Day 22.
|
0.00%
0/6 • Up to Day 36
AEs were monitored up to 14 days after the final dose of study drug on Day 22.
|
0.00%
0/2 • Up to Day 36
AEs were monitored up to 14 days after the final dose of study drug on Day 22.
|
|
General disorders
Vessel puncture site haematoma
|
5.6%
1/18 • Number of events 1 • Up to Day 36
AEs were monitored up to 14 days after the final dose of study drug on Day 22.
|
0.00%
0/6 • Up to Day 36
AEs were monitored up to 14 days after the final dose of study drug on Day 22.
|
0.00%
0/6 • Up to Day 36
AEs were monitored up to 14 days after the final dose of study drug on Day 22.
|
0.00%
0/2 • Up to Day 36
AEs were monitored up to 14 days after the final dose of study drug on Day 22.
|
|
General disorders
Vessel puncture site pain
|
5.6%
1/18 • Number of events 1 • Up to Day 36
AEs were monitored up to 14 days after the final dose of study drug on Day 22.
|
0.00%
0/6 • Up to Day 36
AEs were monitored up to 14 days after the final dose of study drug on Day 22.
|
0.00%
0/6 • Up to Day 36
AEs were monitored up to 14 days after the final dose of study drug on Day 22.
|
0.00%
0/2 • Up to Day 36
AEs were monitored up to 14 days after the final dose of study drug on Day 22.
|
|
Infections and infestations
Upper respiratory tract infection
|
5.6%
1/18 • Number of events 1 • Up to Day 36
AEs were monitored up to 14 days after the final dose of study drug on Day 22.
|
0.00%
0/6 • Up to Day 36
AEs were monitored up to 14 days after the final dose of study drug on Day 22.
|
0.00%
0/6 • Up to Day 36
AEs were monitored up to 14 days after the final dose of study drug on Day 22.
|
0.00%
0/2 • Up to Day 36
AEs were monitored up to 14 days after the final dose of study drug on Day 22.
|
|
Infections and infestations
Urinary tract infection
|
11.1%
2/18 • Number of events 2 • Up to Day 36
AEs were monitored up to 14 days after the final dose of study drug on Day 22.
|
0.00%
0/6 • Up to Day 36
AEs were monitored up to 14 days after the final dose of study drug on Day 22.
|
0.00%
0/6 • Up to Day 36
AEs were monitored up to 14 days after the final dose of study drug on Day 22.
|
0.00%
0/2 • Up to Day 36
AEs were monitored up to 14 days after the final dose of study drug on Day 22.
|
|
Injury, poisoning and procedural complications
Excoriation
|
0.00%
0/18 • Up to Day 36
AEs were monitored up to 14 days after the final dose of study drug on Day 22.
|
0.00%
0/6 • Up to Day 36
AEs were monitored up to 14 days after the final dose of study drug on Day 22.
|
16.7%
1/6 • Number of events 1 • Up to Day 36
AEs were monitored up to 14 days after the final dose of study drug on Day 22.
|
50.0%
1/2 • Number of events 1 • Up to Day 36
AEs were monitored up to 14 days after the final dose of study drug on Day 22.
|
|
Investigations
Blood glucose increased
|
0.00%
0/18 • Up to Day 36
AEs were monitored up to 14 days after the final dose of study drug on Day 22.
|
0.00%
0/6 • Up to Day 36
AEs were monitored up to 14 days after the final dose of study drug on Day 22.
|
16.7%
1/6 • Number of events 1 • Up to Day 36
AEs were monitored up to 14 days after the final dose of study drug on Day 22.
|
0.00%
0/2 • Up to Day 36
AEs were monitored up to 14 days after the final dose of study drug on Day 22.
|
|
Nervous system disorders
Dizziness
|
16.7%
3/18 • Number of events 4 • Up to Day 36
AEs were monitored up to 14 days after the final dose of study drug on Day 22.
|
16.7%
1/6 • Number of events 1 • Up to Day 36
AEs were monitored up to 14 days after the final dose of study drug on Day 22.
|
0.00%
0/6 • Up to Day 36
AEs were monitored up to 14 days after the final dose of study drug on Day 22.
|
0.00%
0/2 • Up to Day 36
AEs were monitored up to 14 days after the final dose of study drug on Day 22.
|
|
Nervous system disorders
Headache
|
27.8%
5/18 • Number of events 7 • Up to Day 36
AEs were monitored up to 14 days after the final dose of study drug on Day 22.
|
16.7%
1/6 • Number of events 2 • Up to Day 36
AEs were monitored up to 14 days after the final dose of study drug on Day 22.
|
33.3%
2/6 • Number of events 5 • Up to Day 36
AEs were monitored up to 14 days after the final dose of study drug on Day 22.
|
0.00%
0/2 • Up to Day 36
AEs were monitored up to 14 days after the final dose of study drug on Day 22.
|
|
Nervous system disorders
Presyncope
|
0.00%
0/18 • Up to Day 36
AEs were monitored up to 14 days after the final dose of study drug on Day 22.
|
0.00%
0/6 • Up to Day 36
AEs were monitored up to 14 days after the final dose of study drug on Day 22.
|
0.00%
0/6 • Up to Day 36
AEs were monitored up to 14 days after the final dose of study drug on Day 22.
|
50.0%
1/2 • Number of events 1 • Up to Day 36
AEs were monitored up to 14 days after the final dose of study drug on Day 22.
|
|
Renal and urinary disorders
Micturition urgency
|
5.6%
1/18 • Number of events 1 • Up to Day 36
AEs were monitored up to 14 days after the final dose of study drug on Day 22.
|
0.00%
0/6 • Up to Day 36
AEs were monitored up to 14 days after the final dose of study drug on Day 22.
|
0.00%
0/6 • Up to Day 36
AEs were monitored up to 14 days after the final dose of study drug on Day 22.
|
0.00%
0/2 • Up to Day 36
AEs were monitored up to 14 days after the final dose of study drug on Day 22.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
11.1%
2/18 • Number of events 2 • Up to Day 36
AEs were monitored up to 14 days after the final dose of study drug on Day 22.
|
16.7%
1/6 • Number of events 1 • Up to Day 36
AEs were monitored up to 14 days after the final dose of study drug on Day 22.
|
33.3%
2/6 • Number of events 2 • Up to Day 36
AEs were monitored up to 14 days after the final dose of study drug on Day 22.
|
0.00%
0/2 • Up to Day 36
AEs were monitored up to 14 days after the final dose of study drug on Day 22.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
5.6%
1/18 • Number of events 1 • Up to Day 36
AEs were monitored up to 14 days after the final dose of study drug on Day 22.
|
0.00%
0/6 • Up to Day 36
AEs were monitored up to 14 days after the final dose of study drug on Day 22.
|
0.00%
0/6 • Up to Day 36
AEs were monitored up to 14 days after the final dose of study drug on Day 22.
|
0.00%
0/2 • Up to Day 36
AEs were monitored up to 14 days after the final dose of study drug on Day 22.
|
|
Respiratory, thoracic and mediastinal disorders
Sneezing
|
5.6%
1/18 • Number of events 1 • Up to Day 36
AEs were monitored up to 14 days after the final dose of study drug on Day 22.
|
0.00%
0/6 • Up to Day 36
AEs were monitored up to 14 days after the final dose of study drug on Day 22.
|
0.00%
0/6 • Up to Day 36
AEs were monitored up to 14 days after the final dose of study drug on Day 22.
|
0.00%
0/2 • Up to Day 36
AEs were monitored up to 14 days after the final dose of study drug on Day 22.
|
|
Skin and subcutaneous tissue disorders
Dermatitis allergic
|
5.6%
1/18 • Number of events 1 • Up to Day 36
AEs were monitored up to 14 days after the final dose of study drug on Day 22.
|
0.00%
0/6 • Up to Day 36
AEs were monitored up to 14 days after the final dose of study drug on Day 22.
|
0.00%
0/6 • Up to Day 36
AEs were monitored up to 14 days after the final dose of study drug on Day 22.
|
0.00%
0/2 • Up to Day 36
AEs were monitored up to 14 days after the final dose of study drug on Day 22.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
5.6%
1/18 • Number of events 1 • Up to Day 36
AEs were monitored up to 14 days after the final dose of study drug on Day 22.
|
0.00%
0/6 • Up to Day 36
AEs were monitored up to 14 days after the final dose of study drug on Day 22.
|
0.00%
0/6 • Up to Day 36
AEs were monitored up to 14 days after the final dose of study drug on Day 22.
|
0.00%
0/2 • Up to Day 36
AEs were monitored up to 14 days after the final dose of study drug on Day 22.
|
|
Skin and subcutaneous tissue disorders
Pruritus generalised
|
5.6%
1/18 • Number of events 1 • Up to Day 36
AEs were monitored up to 14 days after the final dose of study drug on Day 22.
|
0.00%
0/6 • Up to Day 36
AEs were monitored up to 14 days after the final dose of study drug on Day 22.
|
0.00%
0/6 • Up to Day 36
AEs were monitored up to 14 days after the final dose of study drug on Day 22.
|
0.00%
0/2 • Up to Day 36
AEs were monitored up to 14 days after the final dose of study drug on Day 22.
|
|
Vascular disorders
Hot flush
|
0.00%
0/18 • Up to Day 36
AEs were monitored up to 14 days after the final dose of study drug on Day 22.
|
0.00%
0/6 • Up to Day 36
AEs were monitored up to 14 days after the final dose of study drug on Day 22.
|
16.7%
1/6 • Number of events 1 • Up to Day 36
AEs were monitored up to 14 days after the final dose of study drug on Day 22.
|
0.00%
0/2 • Up to Day 36
AEs were monitored up to 14 days after the final dose of study drug on Day 22.
|
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. SPONSOR review can be expedited to meet publication timelines.
- Publication restrictions are in place
Restriction type: OTHER