Trial Outcomes & Findings for MK-8237 (SCH900237) Biomarker Study in Participants With Allergic Rhinitis or Rhinoconjunctivitis (MK-8237-009) (NCT NCT01852825)
NCT ID: NCT01852825
Last Updated: 2019-03-15
Results Overview
Blood was collected from participants treated with Dermatophagoides (D.) farinae HDM and then with MK-8237 or placebo, and the amount of HDM-specific IgG4 antibodies in serum at baseline and at week 12 were measured. Fold change from baseline was evaluated based on constrained longitudinal data analysis (cLDA) method with log transformed data. The model included time (categorical variable), treatment, and time by treatment interaction as fixed effects and participants as random effect. Least squares geometric means are presented. It is hypothesized that the change from baseline is statistically greater with MK-8237 treatment than with placebo. This hypothesis is supported if the lower bound of the two-sided 90% confidence interval for the geometric mean fold difference is \>1.0.
COMPLETED
PHASE1
26 participants
Baseline and 12 weeks
2019-03-15
Participant Flow
In Part 1, healthy participants aged 18-55 years were enrolled; In Part 2, participants with house dust mite (HDM)-induced allergic rhinitis or rhinoconjunctivitis, aged 18-55, were enrolled.
Participant milestones
| Measure |
NAC + MK-8237 (Part 2)
Nasal Allergen Challenge (NAC) treatment consisting of 1800 Biological Units (BU) of HDM extract on Days -14, 56 and 84; starting on Day 1 a single tablet of MK-8237 with 12 Development Units (DUs), administered sublingually, at approximately the same time each day for 84 days (+/- 5 days)
|
NAC + Placebo (Part 2)
NAC treatment consisting of 1800 BU of HDM extract on Days -14, 56 and 84; starting on Day 1 a single placebo tablet administered sublingually, at approximately the same time each day for 84 days (+/- 5 days)
|
NAC (Part 1)
Nasal Allergen Challenge (NAC) treatment consisting of 100 µl fixed volume of 10,000 biological units (BU) of HDM extract delivered with a Pfeiffer Bidose Nasal Delivery System (or equivalent) to each nostril for a total dose of 1800 BU at the start of Part 1
|
|---|---|---|---|
|
Overall Study
STARTED
|
16
|
7
|
3
|
|
Overall Study
COMPLETED
|
14
|
7
|
3
|
|
Overall Study
NOT COMPLETED
|
2
|
0
|
0
|
Reasons for withdrawal
| Measure |
NAC + MK-8237 (Part 2)
Nasal Allergen Challenge (NAC) treatment consisting of 1800 Biological Units (BU) of HDM extract on Days -14, 56 and 84; starting on Day 1 a single tablet of MK-8237 with 12 Development Units (DUs), administered sublingually, at approximately the same time each day for 84 days (+/- 5 days)
|
NAC + Placebo (Part 2)
NAC treatment consisting of 1800 BU of HDM extract on Days -14, 56 and 84; starting on Day 1 a single placebo tablet administered sublingually, at approximately the same time each day for 84 days (+/- 5 days)
|
NAC (Part 1)
Nasal Allergen Challenge (NAC) treatment consisting of 100 µl fixed volume of 10,000 biological units (BU) of HDM extract delivered with a Pfeiffer Bidose Nasal Delivery System (or equivalent) to each nostril for a total dose of 1800 BU at the start of Part 1
|
|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
2
|
0
|
0
|
Baseline Characteristics
MK-8237 (SCH900237) Biomarker Study in Participants With Allergic Rhinitis or Rhinoconjunctivitis (MK-8237-009)
Baseline characteristics by cohort
| Measure |
NAC + MK-8237 (Part 2)
n=16 Participants
Nasal Allergen Challenge (NAC) treatment consisting of 1800 Biological Units (BU) of HDM extract on Days -14, 56 and 84; starting on Day 1 a single tablet of MK-8237 with 12 Development Units (DUs), administered sublingually, at approximately the same time each day for 84 days (+/- 5 days)
|
NAC + Placebo (Part 2)
n=7 Participants
NAC treatment consisting of 1800 BU of HDM extract on Days -14, 56 and 84; starting on Day 1 a single placebo tablet administered sublingually, at approximately the same time each day for 84 days (+/- 5 days)
|
NAC (Part 1)
n=3 Participants
Nasal Allergen Challenge (NAC) treatment consisting of 100 µl fixed volume of 10,000 biological units (BU) of HDM extract delivered with a Pfeiffer Bidose Nasal Delivery System (or equivalent) to each nostril for a total dose of 1800 BU at the start of Part 1
|
Total
n=26 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
31.3 Years
STANDARD_DEVIATION 8.6 • n=5 Participants
|
36.1 Years
STANDARD_DEVIATION 13.2 • n=7 Participants
|
25.7 Years
STANDARD_DEVIATION 4.0 • n=5 Participants
|
31.9 Years
STANDARD_DEVIATION 9.9 • n=4 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
12 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
14 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Baseline and 12 weeksPopulation: All randomized participants from Part 2 who are compliant with the study procedures and have available data from at least one treatment. Participants from Part 1 were not analyzed because they were not treated with MK-8237 or placebo.
Blood was collected from participants treated with Dermatophagoides (D.) farinae HDM and then with MK-8237 or placebo, and the amount of HDM-specific IgG4 antibodies in serum at baseline and at week 12 were measured. Fold change from baseline was evaluated based on constrained longitudinal data analysis (cLDA) method with log transformed data. The model included time (categorical variable), treatment, and time by treatment interaction as fixed effects and participants as random effect. Least squares geometric means are presented. It is hypothesized that the change from baseline is statistically greater with MK-8237 treatment than with placebo. This hypothesis is supported if the lower bound of the two-sided 90% confidence interval for the geometric mean fold difference is \>1.0.
Outcome measures
| Measure |
NAC + MK-8237 (Part 2)
n=14 Participants
Nasal Allergen Challenge (NAC) treatment consisting of 1800 Biological Units (BU) of HDM extract on Days -14, 56 and 84; starting on Day 1 a single tablet of MK-8237 with 12 Development Units (DUs), administered sublingually, at approximately the same time each day for 84 days (+/- 5 days)
|
NAC + Placebo (Part 2)
n=7 Participants
NAC treatment consisting of 1800 BU of HDM extract on Days -14, 56 and 84; starting on Day 1 a single placebo tablet administered sublingually, at approximately the same time each day for 84 days (+/- 5 days)
|
NAC (Part 1)
Nasal Allergen Challenge (NAC) treatment consisting of 100 µl fixed volume of 10,000 biological units (BU) of HDM extract delivered with a Pfeiffer Bidose Nasal Delivery System (or equivalent) to each nostril for a total dose of 1800 BU at the start of Part 1
|
|---|---|---|---|
|
Change From Baseline in D. Farinae HDM-specific IgG4 Antibodies in Serum at 12 Weeks (Part 2)
|
0.392 Fold Change
Interval 0.249 to 0.615
|
0.166 Fold Change
Interval 0.097 to 0.285
|
—
|
PRIMARY outcome
Timeframe: Baseline and 12 weeksPopulation: All randomized participants from Part 2 who are compliant with the study procedures and have available data from at least one treatment. Participants from Part 1 were not analyzed because they were not treated with MK-8237 or placebo.
Blood was collected from participants treated with D. pteronyssinus HDM, and then with MK-8237 or placebo, and the amount of HDM-specific IgG4 antibodies in serum at baseline and at week 12 were measured. Fold change from baseline was evaluated based on cLDA method with log transformed data. The model included time (categorical variable), treatment, and time by treatment interaction as fixed effects and participants as random effect. Least squares geometric means are presented. It is hypothesized that the change from baseline is statistically greater with MK-8237 treatment than with placebo. This hypothesis is supported if the lower bound of the two-sided 90% confidence interval for the geometric mean fold difference is \>1.0.
Outcome measures
| Measure |
NAC + MK-8237 (Part 2)
n=14 Participants
Nasal Allergen Challenge (NAC) treatment consisting of 1800 Biological Units (BU) of HDM extract on Days -14, 56 and 84; starting on Day 1 a single tablet of MK-8237 with 12 Development Units (DUs), administered sublingually, at approximately the same time each day for 84 days (+/- 5 days)
|
NAC + Placebo (Part 2)
n=7 Participants
NAC treatment consisting of 1800 BU of HDM extract on Days -14, 56 and 84; starting on Day 1 a single placebo tablet administered sublingually, at approximately the same time each day for 84 days (+/- 5 days)
|
NAC (Part 1)
Nasal Allergen Challenge (NAC) treatment consisting of 100 µl fixed volume of 10,000 biological units (BU) of HDM extract delivered with a Pfeiffer Bidose Nasal Delivery System (or equivalent) to each nostril for a total dose of 1800 BU at the start of Part 1
|
|---|---|---|---|
|
Change From Baseline in D. Pteronyssinus HDM-specific IgG4 Antibodies in Serum at 12 Weeks (Part 2)
|
0.619 Fold Change
Interval 0.397 to 0.966
|
0.284 Fold Change
Interval 0.164 to 0.49
|
—
|
PRIMARY outcome
Timeframe: Baseline and 12 weeksPopulation: All randomized participants from Part 2 who are compliant with the study procedures and have available data from at least one treatment. Participants from Part 1 were not analyzed because they were not treated with MK-8237 or placebo.
Blood was collected from participants treated with D. pteronyssinus and D.farinae HDM and then with either MK-8237 or placebo, and the amount of IgE-BF in serum was measured based on an Ordinary IgE measurement and an assay in the presence of Competitors; with IgE-BF = 1 - (Competitive IgE/Ordinary IgE). This ranges from 0 (no IgE blocked) to 1 (all IgE blocked); and as it is based on a ratio there are no units. Change from baseline (12 weeks minus baseline) was evaluated based on cLDA method, and was analyzed based on the original scale. The model included time (categorical variable), treatment, and time by treatment interaction as fixed effects and participants as random effect. It is hypothesized that the change from baseline is statistically greater with MK-8237 treatment than with placebo. This hypothesis is supported if the lower bound of the 1-tailed 95% CI around the 12 week mean difference in change from baseline in HDM-specific IgE blocking factor response excludes zero.
Outcome measures
| Measure |
NAC + MK-8237 (Part 2)
n=14 Participants
Nasal Allergen Challenge (NAC) treatment consisting of 1800 Biological Units (BU) of HDM extract on Days -14, 56 and 84; starting on Day 1 a single tablet of MK-8237 with 12 Development Units (DUs), administered sublingually, at approximately the same time each day for 84 days (+/- 5 days)
|
NAC + Placebo (Part 2)
n=7 Participants
NAC treatment consisting of 1800 BU of HDM extract on Days -14, 56 and 84; starting on Day 1 a single placebo tablet administered sublingually, at approximately the same time each day for 84 days (+/- 5 days)
|
NAC (Part 1)
Nasal Allergen Challenge (NAC) treatment consisting of 100 µl fixed volume of 10,000 biological units (BU) of HDM extract delivered with a Pfeiffer Bidose Nasal Delivery System (or equivalent) to each nostril for a total dose of 1800 BU at the start of Part 1
|
|---|---|---|---|
|
Change From Baseline in HDM-specific IgE Blocking Factor (IgE-BF) in Serum at 12 Weeks
|
0.097 Ratio
Interval -0.032 to 0.226
|
-0.141 Ratio
Interval -0.317 to 0.035
|
—
|
SECONDARY outcome
Timeframe: Baseline and 12 weeksPopulation: All randomized participants from Part 2 who are compliant with the study procedures and have available data from at least one treatment. Participants from Part 1 were not analyzed because they were not treated with MK-8237 or placebo.
Blood was collected from participants treated with D. pteronyssinus and D.farinae HDM and then with either MK-8237 or placebo, and the levels of Il-5 protein 6.5 hours after NAC in serum at baseline and at week 12 were measured. Fold change from baseline and between-treatment comparison was evaluated based on cLDA method with log transformed data. IL-5 protein concentration was measured in nasal exudates collected both pre- and post-nasal challenge. Least squares geometric means are presented.
Outcome measures
| Measure |
NAC + MK-8237 (Part 2)
n=14 Participants
Nasal Allergen Challenge (NAC) treatment consisting of 1800 Biological Units (BU) of HDM extract on Days -14, 56 and 84; starting on Day 1 a single tablet of MK-8237 with 12 Development Units (DUs), administered sublingually, at approximately the same time each day for 84 days (+/- 5 days)
|
NAC + Placebo (Part 2)
n=6 Participants
NAC treatment consisting of 1800 BU of HDM extract on Days -14, 56 and 84; starting on Day 1 a single placebo tablet administered sublingually, at approximately the same time each day for 84 days (+/- 5 days)
|
NAC (Part 1)
Nasal Allergen Challenge (NAC) treatment consisting of 100 µl fixed volume of 10,000 biological units (BU) of HDM extract delivered with a Pfeiffer Bidose Nasal Delivery System (or equivalent) to each nostril for a total dose of 1800 BU at the start of Part 1
|
|---|---|---|---|
|
Change From Baseline in 6.5 Hours Post-NAC Interleukin-5 (IL-5) Protein Concentration in Nasal Exudates Following 12 Weeks of Treatment (Part 2)
|
9.444 Fold change
Interval 3.852 to 23.153
|
8.843 Fold change
Interval 2.245 to 34.836
|
—
|
SECONDARY outcome
Timeframe: Baseline and 12 weeksPopulation: All randomized participants from Part 2 who are compliant with the study procedures and have available data from at least one treatment. Participants from Part 1 were not analyzed because they were not treated with MK-8237 or placebo.
Blood was collected from participants treated with D. pteronyssinus and D.farinae HDM and then with either MK-8237 or placebo, and the levels of nasal epithelial eosinophil-related mRNA signature 6.5 hours after NAC in serum at baseline and at week 12 were measured. The mRNA signature is derived from nine gene transcripts which were measured using the NanoString nCounter Gene Expression Assay. Positive control and pre-specified housekeeping gene normalization methods recommended by nSolver were used to normalize the transcripts. The average of the expression level of the nine genes was used to describe the eosinophil mRNA signature. Fold change from baseline and between-treatment comparison was evaluated based on cLDA method with log transformed data. Least squares geometric means are presented.
Outcome measures
| Measure |
NAC + MK-8237 (Part 2)
n=9 Participants
Nasal Allergen Challenge (NAC) treatment consisting of 1800 Biological Units (BU) of HDM extract on Days -14, 56 and 84; starting on Day 1 a single tablet of MK-8237 with 12 Development Units (DUs), administered sublingually, at approximately the same time each day for 84 days (+/- 5 days)
|
NAC + Placebo (Part 2)
n=4 Participants
NAC treatment consisting of 1800 BU of HDM extract on Days -14, 56 and 84; starting on Day 1 a single placebo tablet administered sublingually, at approximately the same time each day for 84 days (+/- 5 days)
|
NAC (Part 1)
Nasal Allergen Challenge (NAC) treatment consisting of 100 µl fixed volume of 10,000 biological units (BU) of HDM extract delivered with a Pfeiffer Bidose Nasal Delivery System (or equivalent) to each nostril for a total dose of 1800 BU at the start of Part 1
|
|---|---|---|---|
|
Change From Baseline in 6.5 Hours Post-NAC Nasal Epithelial Eosinophil-related Messenger RNA (mRNA) Signature Following 12 Weeks of Treatment (Part 2)
|
2.618 Fold change
Interval 0.911 to 5.16
|
0.981 Fold change
Interval 0.267 to 3.61
|
—
|
SECONDARY outcome
Timeframe: Baseline and 12 weeksPopulation: All randomized participants from Part 2 who are compliant with the study procedures and have available data from at least one treatment. Participants from Part 1 were not analyzed because they were not treated with MK-8237 or placebo.
A visual analog scale (VAS) representing the spectrum of symptoms from absent (0) to extremely severe (100) for each of rhinorrhea, nasal blockage, sneezing and nasal itch were summed to obtain an overall score. The range of VAS overall score is 0 - 400, with higher numbers representing worse symptoms. The models for the time-weighted mean (TWA) of the summed scores over 1 hour pre-NAC through hour 1 following NAC were constructed at the original scale.
Outcome measures
| Measure |
NAC + MK-8237 (Part 2)
n=14 Participants
Nasal Allergen Challenge (NAC) treatment consisting of 1800 Biological Units (BU) of HDM extract on Days -14, 56 and 84; starting on Day 1 a single tablet of MK-8237 with 12 Development Units (DUs), administered sublingually, at approximately the same time each day for 84 days (+/- 5 days)
|
NAC + Placebo (Part 2)
n=6 Participants
NAC treatment consisting of 1800 BU of HDM extract on Days -14, 56 and 84; starting on Day 1 a single placebo tablet administered sublingually, at approximately the same time each day for 84 days (+/- 5 days)
|
NAC (Part 1)
Nasal Allergen Challenge (NAC) treatment consisting of 100 µl fixed volume of 10,000 biological units (BU) of HDM extract delivered with a Pfeiffer Bidose Nasal Delivery System (or equivalent) to each nostril for a total dose of 1800 BU at the start of Part 1
|
|---|---|---|---|
|
Change From Baseline in Time Weighted Average (TWA) Over 1 Hour Pre-NAC Through 1 Hour Post-NAC Visual Analog Score (VAS) for Sneezing, Rhinorrhea, Congestion and Nasal Itch Following 12 Weeks of Treatment (Part 2)
|
53.065 Score on a scale
Interval 25.797 to 80.334
|
114.180 Score on a scale
Interval 74.723 to 153.638
|
—
|
Adverse Events
NAC (Part 1)
NAC + MK-8237 (Part 2)
NAC + Placebo (Part 2)
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
NAC (Part 1)
n=3 participants at risk
Nasal Allergen Challenge (NAC) treatment consisting of 100 µl fixed volume of 10,000 biological units (BU) of HDM extract delivered with a Pfeiffer Bidose Nasal Delivery System (or equivalent) to each nostril for a total dose of 1800 BU at the start of Part 1
|
NAC + MK-8237 (Part 2)
n=16 participants at risk
Nasal Allergen Challenge (NAC) treatment consisting of 1800 Biological Units (BU) of HDM extract on Days -14, 56 and 84; starting on Day 1 a single tablet of MK-8237 with 12 Development Units (DUs), administered sublingually, at approximately the same time each day for 84 days (+/- 5 days)
|
NAC + Placebo (Part 2)
n=7 participants at risk
NAC treatment consisting of 1800 BU of HDM extract on Days -14, 56 and 84; starting on Day 1 a single placebo tablet administered sublingually, at approximately the same time each day for 84 days (+/- 5 days)
|
|---|---|---|---|
|
Ear and labyrinth disorders
Ear pruritus
|
0.00%
0/3 • Part 1: Up to 17 days after treatment; Part 2: Up to 101 days after treatment
All participants who received at least one dose of the investigational drug.
|
12.5%
2/16 • Number of events 2 • Part 1: Up to 17 days after treatment; Part 2: Up to 101 days after treatment
All participants who received at least one dose of the investigational drug.
|
0.00%
0/7 • Part 1: Up to 17 days after treatment; Part 2: Up to 101 days after treatment
All participants who received at least one dose of the investigational drug.
|
|
Eye disorders
Conjunctivitis allergic
|
0.00%
0/3 • Part 1: Up to 17 days after treatment; Part 2: Up to 101 days after treatment
All participants who received at least one dose of the investigational drug.
|
0.00%
0/16 • Part 1: Up to 17 days after treatment; Part 2: Up to 101 days after treatment
All participants who received at least one dose of the investigational drug.
|
14.3%
1/7 • Number of events 1 • Part 1: Up to 17 days after treatment; Part 2: Up to 101 days after treatment
All participants who received at least one dose of the investigational drug.
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/3 • Part 1: Up to 17 days after treatment; Part 2: Up to 101 days after treatment
All participants who received at least one dose of the investigational drug.
|
0.00%
0/16 • Part 1: Up to 17 days after treatment; Part 2: Up to 101 days after treatment
All participants who received at least one dose of the investigational drug.
|
14.3%
1/7 • Number of events 1 • Part 1: Up to 17 days after treatment; Part 2: Up to 101 days after treatment
All participants who received at least one dose of the investigational drug.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/3 • Part 1: Up to 17 days after treatment; Part 2: Up to 101 days after treatment
All participants who received at least one dose of the investigational drug.
|
12.5%
2/16 • Number of events 2 • Part 1: Up to 17 days after treatment; Part 2: Up to 101 days after treatment
All participants who received at least one dose of the investigational drug.
|
0.00%
0/7 • Part 1: Up to 17 days after treatment; Part 2: Up to 101 days after treatment
All participants who received at least one dose of the investigational drug.
|
|
Gastrointestinal disorders
Hypoaesthesia oral
|
0.00%
0/3 • Part 1: Up to 17 days after treatment; Part 2: Up to 101 days after treatment
All participants who received at least one dose of the investigational drug.
|
6.2%
1/16 • Number of events 1 • Part 1: Up to 17 days after treatment; Part 2: Up to 101 days after treatment
All participants who received at least one dose of the investigational drug.
|
0.00%
0/7 • Part 1: Up to 17 days after treatment; Part 2: Up to 101 days after treatment
All participants who received at least one dose of the investigational drug.
|
|
Gastrointestinal disorders
Lip pain
|
0.00%
0/3 • Part 1: Up to 17 days after treatment; Part 2: Up to 101 days after treatment
All participants who received at least one dose of the investigational drug.
|
12.5%
2/16 • Number of events 3 • Part 1: Up to 17 days after treatment; Part 2: Up to 101 days after treatment
All participants who received at least one dose of the investigational drug.
|
0.00%
0/7 • Part 1: Up to 17 days after treatment; Part 2: Up to 101 days after treatment
All participants who received at least one dose of the investigational drug.
|
|
Gastrointestinal disorders
Lip swelling
|
0.00%
0/3 • Part 1: Up to 17 days after treatment; Part 2: Up to 101 days after treatment
All participants who received at least one dose of the investigational drug.
|
18.8%
3/16 • Number of events 3 • Part 1: Up to 17 days after treatment; Part 2: Up to 101 days after treatment
All participants who received at least one dose of the investigational drug.
|
0.00%
0/7 • Part 1: Up to 17 days after treatment; Part 2: Up to 101 days after treatment
All participants who received at least one dose of the investigational drug.
|
|
Gastrointestinal disorders
Mouth swelling
|
0.00%
0/3 • Part 1: Up to 17 days after treatment; Part 2: Up to 101 days after treatment
All participants who received at least one dose of the investigational drug.
|
25.0%
4/16 • Number of events 8 • Part 1: Up to 17 days after treatment; Part 2: Up to 101 days after treatment
All participants who received at least one dose of the investigational drug.
|
0.00%
0/7 • Part 1: Up to 17 days after treatment; Part 2: Up to 101 days after treatment
All participants who received at least one dose of the investigational drug.
|
|
Gastrointestinal disorders
Oral pruritus
|
0.00%
0/3 • Part 1: Up to 17 days after treatment; Part 2: Up to 101 days after treatment
All participants who received at least one dose of the investigational drug.
|
12.5%
2/16 • Number of events 2 • Part 1: Up to 17 days after treatment; Part 2: Up to 101 days after treatment
All participants who received at least one dose of the investigational drug.
|
0.00%
0/7 • Part 1: Up to 17 days after treatment; Part 2: Up to 101 days after treatment
All participants who received at least one dose of the investigational drug.
|
|
Gastrointestinal disorders
Paraesthesia oral
|
0.00%
0/3 • Part 1: Up to 17 days after treatment; Part 2: Up to 101 days after treatment
All participants who received at least one dose of the investigational drug.
|
18.8%
3/16 • Number of events 6 • Part 1: Up to 17 days after treatment; Part 2: Up to 101 days after treatment
All participants who received at least one dose of the investigational drug.
|
14.3%
1/7 • Number of events 1 • Part 1: Up to 17 days after treatment; Part 2: Up to 101 days after treatment
All participants who received at least one dose of the investigational drug.
|
|
Gastrointestinal disorders
Swollen tongue
|
0.00%
0/3 • Part 1: Up to 17 days after treatment; Part 2: Up to 101 days after treatment
All participants who received at least one dose of the investigational drug.
|
12.5%
2/16 • Number of events 2 • Part 1: Up to 17 days after treatment; Part 2: Up to 101 days after treatment
All participants who received at least one dose of the investigational drug.
|
0.00%
0/7 • Part 1: Up to 17 days after treatment; Part 2: Up to 101 days after treatment
All participants who received at least one dose of the investigational drug.
|
|
Gastrointestinal disorders
Tongue pruritus
|
0.00%
0/3 • Part 1: Up to 17 days after treatment; Part 2: Up to 101 days after treatment
All participants who received at least one dose of the investigational drug.
|
25.0%
4/16 • Number of events 6 • Part 1: Up to 17 days after treatment; Part 2: Up to 101 days after treatment
All participants who received at least one dose of the investigational drug.
|
0.00%
0/7 • Part 1: Up to 17 days after treatment; Part 2: Up to 101 days after treatment
All participants who received at least one dose of the investigational drug.
|
|
General disorders
Chest discomfort
|
0.00%
0/3 • Part 1: Up to 17 days after treatment; Part 2: Up to 101 days after treatment
All participants who received at least one dose of the investigational drug.
|
6.2%
1/16 • Number of events 1 • Part 1: Up to 17 days after treatment; Part 2: Up to 101 days after treatment
All participants who received at least one dose of the investigational drug.
|
0.00%
0/7 • Part 1: Up to 17 days after treatment; Part 2: Up to 101 days after treatment
All participants who received at least one dose of the investigational drug.
|
|
Immune system disorders
Hypersensitivity
|
0.00%
0/3 • Part 1: Up to 17 days after treatment; Part 2: Up to 101 days after treatment
All participants who received at least one dose of the investigational drug.
|
12.5%
2/16 • Number of events 2 • Part 1: Up to 17 days after treatment; Part 2: Up to 101 days after treatment
All participants who received at least one dose of the investigational drug.
|
0.00%
0/7 • Part 1: Up to 17 days after treatment; Part 2: Up to 101 days after treatment
All participants who received at least one dose of the investigational drug.
|
|
Immune system disorders
Seasonal allergy
|
0.00%
0/3 • Part 1: Up to 17 days after treatment; Part 2: Up to 101 days after treatment
All participants who received at least one dose of the investigational drug.
|
6.2%
1/16 • Number of events 1 • Part 1: Up to 17 days after treatment; Part 2: Up to 101 days after treatment
All participants who received at least one dose of the investigational drug.
|
0.00%
0/7 • Part 1: Up to 17 days after treatment; Part 2: Up to 101 days after treatment
All participants who received at least one dose of the investigational drug.
|
|
Infections and infestations
Conjunctivitis
|
0.00%
0/3 • Part 1: Up to 17 days after treatment; Part 2: Up to 101 days after treatment
All participants who received at least one dose of the investigational drug.
|
12.5%
2/16 • Number of events 2 • Part 1: Up to 17 days after treatment; Part 2: Up to 101 days after treatment
All participants who received at least one dose of the investigational drug.
|
0.00%
0/7 • Part 1: Up to 17 days after treatment; Part 2: Up to 101 days after treatment
All participants who received at least one dose of the investigational drug.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/3 • Part 1: Up to 17 days after treatment; Part 2: Up to 101 days after treatment
All participants who received at least one dose of the investigational drug.
|
37.5%
6/16 • Number of events 7 • Part 1: Up to 17 days after treatment; Part 2: Up to 101 days after treatment
All participants who received at least one dose of the investigational drug.
|
57.1%
4/7 • Number of events 5 • Part 1: Up to 17 days after treatment; Part 2: Up to 101 days after treatment
All participants who received at least one dose of the investigational drug.
|
|
Injury, poisoning and procedural complications
Burns first degree
|
0.00%
0/3 • Part 1: Up to 17 days after treatment; Part 2: Up to 101 days after treatment
All participants who received at least one dose of the investigational drug.
|
0.00%
0/16 • Part 1: Up to 17 days after treatment; Part 2: Up to 101 days after treatment
All participants who received at least one dose of the investigational drug.
|
14.3%
1/7 • Number of events 1 • Part 1: Up to 17 days after treatment; Part 2: Up to 101 days after treatment
All participants who received at least one dose of the investigational drug.
|
|
Investigations
Blood iron decreased
|
0.00%
0/3 • Part 1: Up to 17 days after treatment; Part 2: Up to 101 days after treatment
All participants who received at least one dose of the investigational drug.
|
6.2%
1/16 • Number of events 1 • Part 1: Up to 17 days after treatment; Part 2: Up to 101 days after treatment
All participants who received at least one dose of the investigational drug.
|
0.00%
0/7 • Part 1: Up to 17 days after treatment; Part 2: Up to 101 days after treatment
All participants who received at least one dose of the investigational drug.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.00%
0/3 • Part 1: Up to 17 days after treatment; Part 2: Up to 101 days after treatment
All participants who received at least one dose of the investigational drug.
|
6.2%
1/16 • Number of events 1 • Part 1: Up to 17 days after treatment; Part 2: Up to 101 days after treatment
All participants who received at least one dose of the investigational drug.
|
0.00%
0/7 • Part 1: Up to 17 days after treatment; Part 2: Up to 101 days after treatment
All participants who received at least one dose of the investigational drug.
|
|
Nervous system disorders
Headache
|
0.00%
0/3 • Part 1: Up to 17 days after treatment; Part 2: Up to 101 days after treatment
All participants who received at least one dose of the investigational drug.
|
6.2%
1/16 • Number of events 1 • Part 1: Up to 17 days after treatment; Part 2: Up to 101 days after treatment
All participants who received at least one dose of the investigational drug.
|
14.3%
1/7 • Number of events 1 • Part 1: Up to 17 days after treatment; Part 2: Up to 101 days after treatment
All participants who received at least one dose of the investigational drug.
|
|
Respiratory, thoracic and mediastinal disorders
Dry throat
|
0.00%
0/3 • Part 1: Up to 17 days after treatment; Part 2: Up to 101 days after treatment
All participants who received at least one dose of the investigational drug.
|
12.5%
2/16 • Number of events 2 • Part 1: Up to 17 days after treatment; Part 2: Up to 101 days after treatment
All participants who received at least one dose of the investigational drug.
|
0.00%
0/7 • Part 1: Up to 17 days after treatment; Part 2: Up to 101 days after treatment
All participants who received at least one dose of the investigational drug.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal dryness
|
0.00%
0/3 • Part 1: Up to 17 days after treatment; Part 2: Up to 101 days after treatment
All participants who received at least one dose of the investigational drug.
|
0.00%
0/16 • Part 1: Up to 17 days after treatment; Part 2: Up to 101 days after treatment
All participants who received at least one dose of the investigational drug.
|
14.3%
1/7 • Number of events 1 • Part 1: Up to 17 days after treatment; Part 2: Up to 101 days after treatment
All participants who received at least one dose of the investigational drug.
|
|
Respiratory, thoracic and mediastinal disorders
Throat irritation
|
0.00%
0/3 • Part 1: Up to 17 days after treatment; Part 2: Up to 101 days after treatment
All participants who received at least one dose of the investigational drug.
|
18.8%
3/16 • Number of events 5 • Part 1: Up to 17 days after treatment; Part 2: Up to 101 days after treatment
All participants who received at least one dose of the investigational drug.
|
42.9%
3/7 • Number of events 3 • Part 1: Up to 17 days after treatment; Part 2: Up to 101 days after treatment
All participants who received at least one dose of the investigational drug.
|
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 trial 45 days prior to submission for publication/presentation. Any information identified by the Sponsor as confidential must be deleted prior to submission; this confidentiality does not include efficacy and safety results.
- Publication restrictions are in place
Restriction type: OTHER