Trial Outcomes & Findings for Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of MK-1029 in Participants With Mild to Moderate Asthma (NCT NCT01370317)
NCT ID: NCT01370317
Last Updated: 2019-01-25
Results Overview
An adverse event (AE) is any untoward medical occurrence in a study participant administered a pharmaceutical product that does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not related to the medicinal product.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
27 participants
Primary outcome timeframe
Up to 42 days after initial dose of study treatment
Results posted on
2019-01-25
Participant Flow
Participant milestones
| Measure |
MK-1029
Participants received five 100 mg MK-1029 capsules, taken orally, once daily for 28 days.
|
Placebo
Participants received five 100 mg placebo-matching MK-1029 capsules, taken orally, once daily for 28 days.
|
|---|---|---|
|
Overall Study
STARTED
|
18
|
9
|
|
Overall Study
COMPLETED
|
17
|
8
|
|
Overall Study
NOT COMPLETED
|
1
|
1
|
Reasons for withdrawal
| Measure |
MK-1029
Participants received five 100 mg MK-1029 capsules, taken orally, once daily for 28 days.
|
Placebo
Participants received five 100 mg placebo-matching MK-1029 capsules, taken orally, once daily for 28 days.
|
|---|---|---|
|
Overall Study
Participant withdrew consent
|
1
|
0
|
|
Overall Study
Protocol deviation
|
0
|
1
|
Baseline Characteristics
Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of MK-1029 in Participants With Mild to Moderate Asthma
Baseline characteristics by cohort
| Measure |
MK-1029
n=18 Participants
Participants received five 100 mg MK-1029 capsules, taken orally, once daily for 28 days.
|
Placebo
n=9 Participants
Participants received five 100 mg placebo-matching MK-1029 capsules, taken orally, once daily for 28 days.
|
Total
n=27 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
40.4 Years
STANDARD_DEVIATION 15.2 • n=5 Participants
|
41.6 Years
STANDARD_DEVIATION 13.5 • n=7 Participants
|
40.8 Years
STANDARD_DEVIATION 14.4 • n=5 Participants
|
|
Sex: Female, Male
Female
|
9 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
9 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Up to 42 days after initial dose of study treatmentPopulation: All participants who received at least one dose of study drug
An adverse event (AE) is any untoward medical occurrence in a study participant administered a pharmaceutical product that does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not related to the medicinal product.
Outcome measures
| Measure |
MK-1029
n=18 Participants
Participants received five 100 mg MK-1029 capsules, taken orally, once daily for 28 days.
|
Placebo
n=9 Participants
Participants received five 100 mg placebo-matching MK-1029 capsules, taken orally, once daily for 28 days.
|
|---|---|---|
|
Number of Participants Who Experienced One or More Adverse Events
|
9 Participants
|
3 Participants
|
PRIMARY outcome
Timeframe: Up to 28 days after initial dose of study treatmentPopulation: All participants who received at least one dose of study drug
An AE is any untoward medical occurrence in a study participant administered a pharmaceutical product that does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not related to the medicinal product.
Outcome measures
| Measure |
MK-1029
n=18 Participants
Participants received five 100 mg MK-1029 capsules, taken orally, once daily for 28 days.
|
Placebo
n=9 Participants
Participants received five 100 mg placebo-matching MK-1029 capsules, taken orally, once daily for 28 days.
|
|---|---|---|
|
Number of Participants Who Discontinued Study Treatment Due to An Adverse Event
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Day 1 and Day 28: Predose, 1, 2, 3, 4, and 6 hours postdosePopulation: All participants who received study drug and had evaluable concentration values for AUC0-6 hours on Day 1 and Day 28
Blood was collected on Day 1 and Day 28 at predose and 1, 2, 3, 4 and 6 hours postdose for determining the Cmax of MK-1026.
Outcome measures
| Measure |
MK-1029
n=16 Participants
Participants received five 100 mg MK-1029 capsules, taken orally, once daily for 28 days.
|
Placebo
Participants received five 100 mg placebo-matching MK-1029 capsules, taken orally, once daily for 28 days.
|
|---|---|---|
|
Area Under the Concentration-Time Curve From Time 0 to 6 Hours (AUC0-6hr) of MK-1029
Day 1
|
745 ng*hr/mL
Geometric Coefficient of Variation 104
|
—
|
|
Area Under the Concentration-Time Curve From Time 0 to 6 Hours (AUC0-6hr) of MK-1029
Day 28
|
505 ng*hr/mL
Geometric Coefficient of Variation 275
|
—
|
SECONDARY outcome
Timeframe: Day 1 and Day 28: Predose, 1, 2, 3, 4, and 6 hours postdosePopulation: All participants who received study drug and had evaluable concentration values for Cmax on Day 1 and Day 28
Blood was collected on Day 1 and Day 28 at predose and 1, 2, 3, 4 and 6 hours postdose for determining the Cmax of MK-1026.
Outcome measures
| Measure |
MK-1029
n=16 Participants
Participants received five 100 mg MK-1029 capsules, taken orally, once daily for 28 days.
|
Placebo
Participants received five 100 mg placebo-matching MK-1029 capsules, taken orally, once daily for 28 days.
|
|---|---|---|
|
Maximum Plasma Concentration (Cmax) of MK-1029
Day 1
|
295 ng/mL
Geometric Coefficient of Variation 106
|
—
|
|
Maximum Plasma Concentration (Cmax) of MK-1029
Day 28
|
167 ng/mL
Geometric Coefficient of Variation 273
|
—
|
SECONDARY outcome
Timeframe: Day 1 and Day 28: Predose, 1, 2, 3, 4, and 6 hours postdosePopulation: All participants who received study drug and had evaluable concentration values for Tmax on Day 1 and Day 28
Blood was collected on Day 1 and Day 28 at predose and 1, 2, 3, 4 and 6 hours postdose for determining the Tmax of MK-1026.
Outcome measures
| Measure |
MK-1029
n=16 Participants
Participants received five 100 mg MK-1029 capsules, taken orally, once daily for 28 days.
|
Placebo
Participants received five 100 mg placebo-matching MK-1029 capsules, taken orally, once daily for 28 days.
|
|---|---|---|
|
Time to Maximum Plasma Concentration (Tmax) of MK-1029
Day 1
|
2.00 Hours
Interval 2.0 to 3.08
|
—
|
|
Time to Maximum Plasma Concentration (Tmax) of MK-1029
Day 28
|
3.00 Hours
Interval 1.98 to 4.0
|
—
|
Adverse Events
MK-1029
Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
MK-1029
n=18 participants at risk
Participants received five 100 mg MK-1029 capsules, taken orally, once daily for 28 days.
|
Placebo
n=9 participants at risk
Participants received five 100 mg placebo-matching MK-1029 capsules, taken orally, once daily for 28 days.
|
|---|---|---|
|
Gastrointestinal disorders
Anorectal discomfort
|
5.6%
1/18 • Number of events 1 • Up to 42 days after initial dose of study treatment
All participants who received at least one dose of study drug
|
0.00%
0/9 • Up to 42 days after initial dose of study treatment
All participants who received at least one dose of study drug
|
|
Gastrointestinal disorders
Aphthous stomatitis
|
11.1%
2/18 • Number of events 2 • Up to 42 days after initial dose of study treatment
All participants who received at least one dose of study drug
|
0.00%
0/9 • Up to 42 days after initial dose of study treatment
All participants who received at least one dose of study drug
|
|
Gastrointestinal disorders
Stomatitis
|
5.6%
1/18 • Number of events 1 • Up to 42 days after initial dose of study treatment
All participants who received at least one dose of study drug
|
0.00%
0/9 • Up to 42 days after initial dose of study treatment
All participants who received at least one dose of study drug
|
|
Infections and infestations
Oral herpes
|
5.6%
1/18 • Number of events 1 • Up to 42 days after initial dose of study treatment
All participants who received at least one dose of study drug
|
0.00%
0/9 • Up to 42 days after initial dose of study treatment
All participants who received at least one dose of study drug
|
|
Infections and infestations
Otitis media viral
|
0.00%
0/18 • Up to 42 days after initial dose of study treatment
All participants who received at least one dose of study drug
|
11.1%
1/9 • Number of events 1 • Up to 42 days after initial dose of study treatment
All participants who received at least one dose of study drug
|
|
Infections and infestations
Pharyngitis
|
5.6%
1/18 • Number of events 1 • Up to 42 days after initial dose of study treatment
All participants who received at least one dose of study drug
|
11.1%
1/9 • Number of events 1 • Up to 42 days after initial dose of study treatment
All participants who received at least one dose of study drug
|
|
Infections and infestations
Upper respiratory tract infection
|
22.2%
4/18 • Number of events 4 • Up to 42 days after initial dose of study treatment
All participants who received at least one dose of study drug
|
22.2%
2/9 • Number of events 2 • Up to 42 days after initial dose of study treatment
All participants who received at least one dose of study drug
|
|
Injury, poisoning and procedural complications
Accidental overdose
|
5.6%
1/18 • Number of events 1 • Up to 42 days after initial dose of study treatment
All participants who received at least one dose of study drug
|
0.00%
0/9 • Up to 42 days after initial dose of study treatment
All participants who received at least one dose of study drug
|
|
Injury, poisoning and procedural complications
Excoriation
|
5.6%
1/18 • Number of events 1 • Up to 42 days after initial dose of study treatment
All participants who received at least one dose of study drug
|
0.00%
0/9 • Up to 42 days after initial dose of study treatment
All participants who received at least one dose of study drug
|
|
Injury, poisoning and procedural complications
Joint injury
|
5.6%
1/18 • Number of events 1 • Up to 42 days after initial dose of study treatment
All participants who received at least one dose of study drug
|
0.00%
0/9 • Up to 42 days after initial dose of study treatment
All participants who received at least one dose of study drug
|
|
Injury, poisoning and procedural complications
Ligament sprain
|
11.1%
2/18 • Number of events 2 • Up to 42 days after initial dose of study treatment
All participants who received at least one dose of study drug
|
0.00%
0/9 • Up to 42 days after initial dose of study treatment
All participants who received at least one dose of study drug
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
5.6%
1/18 • Number of events 1 • Up to 42 days after initial dose of study treatment
All participants who received at least one dose of study drug
|
0.00%
0/9 • Up to 42 days after initial dose of study treatment
All participants who received at least one dose of study drug
|
|
Nervous system disorders
Lethargy
|
11.1%
2/18 • Number of events 3 • Up to 42 days after initial dose of study treatment
All participants who received at least one dose of study drug
|
0.00%
0/9 • Up to 42 days after initial dose of study treatment
All participants who received at least one dose of study drug
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
5.6%
1/18 • Number of events 1 • Up to 42 days after initial dose of study treatment
All participants who received at least one dose of study drug
|
11.1%
1/9 • Number of events 1 • Up to 42 days after initial dose of study treatment
All participants who received at least one dose of study drug
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
5.6%
1/18 • Number of events 1 • Up to 42 days after initial dose of study treatment
All participants who received at least one dose of study drug
|
0.00%
0/9 • Up to 42 days after initial dose of study treatment
All participants who received at least one dose of study drug
|
|
Skin and subcutaneous tissue disorders
Ecchymosis
|
5.6%
1/18 • Number of events 1 • Up to 42 days after initial dose of study treatment
All participants who received at least one dose of study drug
|
0.00%
0/9 • Up to 42 days after initial dose of study treatment
All participants who received at least one dose of study drug
|
|
Skin and subcutaneous tissue disorders
Heat rash
|
5.6%
1/18 • Number of events 1 • Up to 42 days after initial dose of study treatment
All participants who received at least one dose of study drug
|
0.00%
0/9 • Up to 42 days after initial dose of study treatment
All participants who received at least one dose of study drug
|
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