Trial Outcomes & Findings for Single Rising Dose Study of MK-8723 in Healthy Participants and Participants With Immune Thrombocytopenia Purpura (MK-8723-001) (NCT NCT01963260)
NCT ID: NCT01963260
Last Updated: 2019-03-15
Results Overview
An AE is defined as any unfavorable and unintended medical occurrence in a clinical investigation participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
COMPLETED
PHASE1
50 participants
Up to 84 days
2019-03-15
Participant Flow
Amendment 3 specified a re-enrollment procedure for eligible participants in Part 2 to participate in more than one dosing panel.
2 participants that completed Part 2 10 mg/kg were re-enrolled in Part 2 100 mg/kg \& dosed. Both participants completed Part 2 100 mg/kg. 1 participant originally assigned to Part 2 30 mg/kg received placebo in error \& is included in Part 2 Placebo.
Participant milestones
| Measure |
Part 1: MK-8723 1 mg/kg in Healthy Participants
MK-8723 1 mg/kg administered as a single IV infusion to healthy participants in Part 1.
|
Part 1: MK-8723 3 mg/kg in Healthy Participants
MK-8723 3 mg/kg administered as a single IV infusion to healthy participants in Part 1.
|
Part 1: MK-8723 10 mg/kg in Healthy Participants
MK-8723 10 mg/kg administered as a single IV infusion to healthy participants in Part 1.
|
Part 1: MK-8723 30 mg/kg in Healthy Participants
MK-8723 30 mg/kg administered as a single IV infusion to healthy participants in Part 1.
|
Part 1: MK-8723 100 mg/kg in Healthy Participants
MK-8723 100 mg/kg administered as a single IV infusion to healthy participants in Part 1.
|
Part 1: Matching Placebo to MK-8723
Matching placebo to MK-8723 administered as a single IV infusion to healthy participants in Part 1.
|
Part 2: MK-8723 10 mg/kg in ITP Participants
MK-8723 10 mg/kg administered as a single IV infusion to participants with immune thrombocytopenia purpura (ITP) in Part 2. 2 participants were subsequently enrolled in Part 2 MK-8723 100 mg/kg.
|
Part 2: MK-8723 30 mg/kg in ITP Participants
MK-8723 30 mg/kg administered as a single IV infusion to participants with ITP in Part 2.
|
Part 2: MK-8723 100 mg/kg in ITP Participants
MK-8723 100 mg/kg administered as a single IV infusion to participants with ITP in Part 2. 2 participants with ITP from Part 2 MK-8723 10 mg/kg were re-enrolled into Part 2 100 mg/kg and dosed (not shown).
|
Part 2: Matching Placebo to MK-8723
Matching placebo to MK-8723 administered as a single IV infusion to participants with ITP in Part 2.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
6
|
6
|
6
|
6
|
6
|
10
|
3
|
2
|
1
|
4
|
|
Overall Study
Treated
|
6
|
6
|
6
|
6
|
6
|
10
|
3
|
2
|
1
|
4
|
|
Overall Study
COMPLETED
|
4
|
6
|
6
|
5
|
4
|
10
|
3
|
2
|
1
|
4
|
|
Overall Study
NOT COMPLETED
|
2
|
0
|
0
|
1
|
2
|
0
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
| Measure |
Part 1: MK-8723 1 mg/kg in Healthy Participants
MK-8723 1 mg/kg administered as a single IV infusion to healthy participants in Part 1.
|
Part 1: MK-8723 3 mg/kg in Healthy Participants
MK-8723 3 mg/kg administered as a single IV infusion to healthy participants in Part 1.
|
Part 1: MK-8723 10 mg/kg in Healthy Participants
MK-8723 10 mg/kg administered as a single IV infusion to healthy participants in Part 1.
|
Part 1: MK-8723 30 mg/kg in Healthy Participants
MK-8723 30 mg/kg administered as a single IV infusion to healthy participants in Part 1.
|
Part 1: MK-8723 100 mg/kg in Healthy Participants
MK-8723 100 mg/kg administered as a single IV infusion to healthy participants in Part 1.
|
Part 1: Matching Placebo to MK-8723
Matching placebo to MK-8723 administered as a single IV infusion to healthy participants in Part 1.
|
Part 2: MK-8723 10 mg/kg in ITP Participants
MK-8723 10 mg/kg administered as a single IV infusion to participants with immune thrombocytopenia purpura (ITP) in Part 2. 2 participants were subsequently enrolled in Part 2 MK-8723 100 mg/kg.
|
Part 2: MK-8723 30 mg/kg in ITP Participants
MK-8723 30 mg/kg administered as a single IV infusion to participants with ITP in Part 2.
|
Part 2: MK-8723 100 mg/kg in ITP Participants
MK-8723 100 mg/kg administered as a single IV infusion to participants with ITP in Part 2. 2 participants with ITP from Part 2 MK-8723 10 mg/kg were re-enrolled into Part 2 100 mg/kg and dosed (not shown).
|
Part 2: Matching Placebo to MK-8723
Matching placebo to MK-8723 administered as a single IV infusion to participants with ITP in Part 2.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
2
|
0
|
0
|
1
|
2
|
0
|
0
|
0
|
0
|
0
|
Baseline Characteristics
Single Rising Dose Study of MK-8723 in Healthy Participants and Participants With Immune Thrombocytopenia Purpura (MK-8723-001)
Baseline characteristics by cohort
| Measure |
Part 1: MK-8723 1 mg/kg in Healthy Participants
n=6 Participants
MK-8723 1 mg/kg administered as a single IV infusion to healthy participants in Part 1.
|
Part 1: MK-8723 3 mg/kg in Healthy Participants
n=6 Participants
MK-8723 3 mg/kg administered as a single IV infusion to healthy participants in Part 1.
|
Part 1: MK-8723 10 mg/kg in Healthy Participants
n=6 Participants
MK-8723 10 mg/kg administered as a single IV infusion to healthy participants in Part 1.
|
Part 1: MK-8723 30 mg/kg in Healthy Participants
n=6 Participants
MK-8723 30 mg/kg administered as a single IV infusion to healthy participants in Part 1.
|
Part 1: MK-8723 100 mg/kg in Healthy Participants
n=6 Participants
MK-8723 100 mg/kg administered as a single IV infusion to healthy participants in Part 1.
|
Part 1: Matching Placebo to MK-8723
n=10 Participants
Matching placebo to MK-8723 administered as a single IV infusion to healthy participants in Part 1.
|
Part 2: MK-8723 10 mg/kg in ITP Participants
n=3 Participants
MK-8723 10 mg/kg administered as a single IV infusion to participants with ITP in Part 2. 2 participants subsequently enrolled in Part 2 MK-8723 100 mg/kg.
|
Part 2: MK-8723 30 mg/kg in ITP Participants
n=2 Participants
MK-8723 30 mg/kg administered as a single IV infusion to participants with ITP in Part 2.
|
Part 2: MK-8723 100 mg/kg in ITP Participants
n=3 Participants
MK-8723 100 mg/kg administered as a single IV infusion to participants with ITP in Part 2. This group includes 2 participants that re-enrolled from Part 2 MK-8723 10 mg/kg.
|
Part 2: Matching Placebo to MK-8723
n=4 Participants
Matching placebo to MK-8723 administered as a single IV infusion to participants with ITP in Part 2.
|
Total
n=52 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
25.7 Years
STANDARD_DEVIATION 2.7 • n=5 Participants
|
32.7 Years
STANDARD_DEVIATION 13.0 • n=7 Participants
|
31.0 Years
STANDARD_DEVIATION 12.2 • n=5 Participants
|
25.7 Years
STANDARD_DEVIATION 4.2 • n=4 Participants
|
32.7 Years
STANDARD_DEVIATION 10.5 • n=21 Participants
|
30.1 Years
STANDARD_DEVIATION 9.5 • n=10 Participants
|
38.7 Years
STANDARD_DEVIATION 22.3 • n=115 Participants
|
53.0 Years
STANDARD_DEVIATION 4.2 • n=6 Participants
|
38.3 Years
STANDARD_DEVIATION 22.7 • n=6 Participants
|
50.3 Years
STANDARD_DEVIATION 13.5 • n=64 Participants
|
33.2 Years
STANDARD_DEVIATION 13.0 • n=17 Participants
|
|
Age, Customized
Between 18 and 65 years
|
6 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
6 Participants
n=21 Participants
|
10 Participants
n=10 Participants
|
3 Participants
n=115 Participants
|
2 Participants
n=6 Participants
|
3 Participants
n=6 Participants
|
3 Participants
n=64 Participants
|
51 Participants
n=17 Participants
|
|
Age, Customized
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
1 Participants
n=64 Participants
|
1 Participants
n=17 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
1 Participants
n=10 Participants
|
1 Participants
n=115 Participants
|
2 Participants
n=6 Participants
|
2 Participants
n=6 Participants
|
3 Participants
n=64 Participants
|
10 Participants
n=17 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
6 Participants
n=21 Participants
|
9 Participants
n=10 Participants
|
2 Participants
n=115 Participants
|
0 Participants
n=6 Participants
|
1 Participants
n=6 Participants
|
1 Participants
n=64 Participants
|
42 Participants
n=17 Participants
|
PRIMARY outcome
Timeframe: Up to 84 daysPopulation: The All Participants as Treated (APaT) population consisting of all participants who received at least one dose of study drug was used for the safety analysis.
An AE is defined as any unfavorable and unintended medical occurrence in a clinical investigation participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
Outcome measures
| Measure |
Part 1: MK-8723 1 mg/kg in Healthy Participants
n=6 Participants
MK-8723 1 mg/kg administered as a single IV infusion to healthy participants in Part 1.
|
Part 1: MK-8723 3 mg/kg in Healthy Participants
n=6 Participants
MK-8723 3 mg/kg administered as a single IV infusion to healthy participants in Part 1.
|
Part 1: MK-8723 10 mg/kg in Healthy Participants
n=6 Participants
MK-8723 10 mg/kg administered as a single IV infusion to healthy participants in Part 1.
|
Part 1: MK-8723 30 mg/kg in Healthy Participants
n=6 Participants
MK-8723 30 mg/kg administered as a single IV infusion to healthy participants in Part 1.
|
Part 1: MK-8723 100 mg/kg in Healthy Participants
n=6 Participants
MK-8723 100 mg/kg administered as a single IV infusion to healthy participants in Part 1.
|
Part 1: Matching Placebo to MK-8723
n=10 Participants
Matching placebo to MK-8723 administered as a single IV infusion to healthy participants in Part 1.
|
Part 2: MK-8723 10 mg/kg in ITP Participants
n=3 Participants
MK-8723 10 mg/kg administered as a single IV infusion to participants with ITP in Part 2. 2 participants subsequently enrolled in Part 2 MK-8723 100 mg/kg.
|
Part 2: MK-8723 30 mg/kg in ITP Participants
n=2 Participants
MK-8723 30 mg/kg administered as a single IV infusion to participants with ITP in Part 2.
|
Part 2: MK-8723 100 mg/kg in ITP Participants
n=3 Participants
MK-8723 100 mg/kg administered as a single IV infusion to participants with ITP in Part 2. This group includes 2 participants that re-enrolled from Part 2 MK-8723 10 mg/kg.
|
Part 2: Matching Placebo to MK-8723
n=4 Participants
Matching placebo to MK-8723 administered as a single IV infusion to participants with ITP in Part 2.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants Experiencing an Adverse Event
|
2 Participants
|
2 Participants
|
4 Participants
|
1 Participants
|
4 Participants
|
6 Participants
|
1 Participants
|
2 Participants
|
2 Participants
|
2 Participants
|
PRIMARY outcome
Timeframe: Up to 84 DaysPopulation: The APaT population consisting of all participants who received at least one dose of study drug was used for the safety analysis.
An AE is defined as any unfavorable and unintended medical occurrence in a clinical investigation participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
Outcome measures
| Measure |
Part 1: MK-8723 1 mg/kg in Healthy Participants
n=6 Participants
MK-8723 1 mg/kg administered as a single IV infusion to healthy participants in Part 1.
|
Part 1: MK-8723 3 mg/kg in Healthy Participants
n=6 Participants
MK-8723 3 mg/kg administered as a single IV infusion to healthy participants in Part 1.
|
Part 1: MK-8723 10 mg/kg in Healthy Participants
n=6 Participants
MK-8723 10 mg/kg administered as a single IV infusion to healthy participants in Part 1.
|
Part 1: MK-8723 30 mg/kg in Healthy Participants
n=6 Participants
MK-8723 30 mg/kg administered as a single IV infusion to healthy participants in Part 1.
|
Part 1: MK-8723 100 mg/kg in Healthy Participants
n=6 Participants
MK-8723 100 mg/kg administered as a single IV infusion to healthy participants in Part 1.
|
Part 1: Matching Placebo to MK-8723
n=10 Participants
Matching placebo to MK-8723 administered as a single IV infusion to healthy participants in Part 1.
|
Part 2: MK-8723 10 mg/kg in ITP Participants
n=3 Participants
MK-8723 10 mg/kg administered as a single IV infusion to participants with ITP in Part 2. 2 participants subsequently enrolled in Part 2 MK-8723 100 mg/kg.
|
Part 2: MK-8723 30 mg/kg in ITP Participants
n=2 Participants
MK-8723 30 mg/kg administered as a single IV infusion to participants with ITP in Part 2.
|
Part 2: MK-8723 100 mg/kg in ITP Participants
n=3 Participants
MK-8723 100 mg/kg administered as a single IV infusion to participants with ITP in Part 2. This group includes 2 participants that re-enrolled from Part 2 MK-8723 10 mg/kg.
|
Part 2: Matching Placebo to MK-8723
n=4 Participants
Matching placebo to MK-8723 administered as a single IV infusion to participants with ITP in Part 2.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants Discontinuing Study Due to an Adverse Event (AE)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Up to Day 14Population: The per protocol population consisting of all participants in compliance with the protocol (e.g., availability of measurements, absence of major protocol violations) was used for the pharmacodynamic (platelet response) analysis.
In participants with ITP, platelet response is a rapid, sensitive, and highly qualitative measure of response to anti-inflammatory therapy. A positive platelet response was defined as: 1) A doubling of platelet counts at the time point of maximum response (through Day 14) as compared to Day 0 AND an increase to an absolute level of ≥50,000/μL in participants with a baseline platelet count of \<50,000/μL, OR 2) A 50% increase in the platelet count at the time point of maximum response (through Day 14) as compared to Day 0 in participants with a baseline platelet count of ≥50,000/μL. The analysis was specified only for participants with ITP (Part 2) that received treatment with MK-8723 or matching placebo.
Outcome measures
| Measure |
Part 1: MK-8723 1 mg/kg in Healthy Participants
n=3 Participants
MK-8723 1 mg/kg administered as a single IV infusion to healthy participants in Part 1.
|
Part 1: MK-8723 3 mg/kg in Healthy Participants
n=2 Participants
MK-8723 3 mg/kg administered as a single IV infusion to healthy participants in Part 1.
|
Part 1: MK-8723 10 mg/kg in Healthy Participants
n=3 Participants
MK-8723 10 mg/kg administered as a single IV infusion to healthy participants in Part 1.
|
Part 1: MK-8723 30 mg/kg in Healthy Participants
n=4 Participants
MK-8723 30 mg/kg administered as a single IV infusion to healthy participants in Part 1.
|
Part 1: MK-8723 100 mg/kg in Healthy Participants
MK-8723 100 mg/kg administered as a single IV infusion to healthy participants in Part 1.
|
Part 1: Matching Placebo to MK-8723
Matching placebo to MK-8723 administered as a single IV infusion to healthy participants in Part 1.
|
Part 2: MK-8723 10 mg/kg in ITP Participants
MK-8723 10 mg/kg administered as a single IV infusion to participants with ITP in Part 2. 2 participants subsequently enrolled in Part 2 MK-8723 100 mg/kg.
|
Part 2: MK-8723 30 mg/kg in ITP Participants
MK-8723 30 mg/kg administered as a single IV infusion to participants with ITP in Part 2.
|
Part 2: MK-8723 100 mg/kg in ITP Participants
MK-8723 100 mg/kg administered as a single IV infusion to participants with ITP in Part 2. This group includes 2 participants that re-enrolled from Part 2 MK-8723 10 mg/kg.
|
Part 2: Matching Placebo to MK-8723
Matching placebo to MK-8723 administered as a single IV infusion to participants with ITP in Part 2.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With a Positive Platelet Response to MK-8723
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: All dose groups: Predose and 4 (end of infusion), 6, 12, 24 hrs postdose and Days 3, 4, 5, 7, 10, 14, 21, 28; 30 mg/kg and 100 mg/kg dose groups: Days 43, 56, 71, 84Population: The per protocol population consisting of all participants in compliance with the protocol (e.g., availability of measurements, absence of major protocol violations) was used for the pharmacokinetic (AUC0-∞) analysis.
AUC0-∞ is a measure of total body exposure to drug. Serum samples for determination of AUC0-∞ were collected at pre-specified time-points.
Outcome measures
| Measure |
Part 1: MK-8723 1 mg/kg in Healthy Participants
n=6 Participants
MK-8723 1 mg/kg administered as a single IV infusion to healthy participants in Part 1.
|
Part 1: MK-8723 3 mg/kg in Healthy Participants
n=6 Participants
MK-8723 3 mg/kg administered as a single IV infusion to healthy participants in Part 1.
|
Part 1: MK-8723 10 mg/kg in Healthy Participants
n=6 Participants
MK-8723 10 mg/kg administered as a single IV infusion to healthy participants in Part 1.
|
Part 1: MK-8723 30 mg/kg in Healthy Participants
n=6 Participants
MK-8723 30 mg/kg administered as a single IV infusion to healthy participants in Part 1.
|
Part 1: MK-8723 100 mg/kg in Healthy Participants
n=6 Participants
MK-8723 100 mg/kg administered as a single IV infusion to healthy participants in Part 1.
|
Part 1: Matching Placebo to MK-8723
n=3 Participants
Matching placebo to MK-8723 administered as a single IV infusion to healthy participants in Part 1.
|
Part 2: MK-8723 10 mg/kg in ITP Participants
n=2 Participants
MK-8723 10 mg/kg administered as a single IV infusion to participants with ITP in Part 2. 2 participants subsequently enrolled in Part 2 MK-8723 100 mg/kg.
|
Part 2: MK-8723 30 mg/kg in ITP Participants
n=3 Participants
MK-8723 30 mg/kg administered as a single IV infusion to participants with ITP in Part 2.
|
Part 2: MK-8723 100 mg/kg in ITP Participants
MK-8723 100 mg/kg administered as a single IV infusion to participants with ITP in Part 2. This group includes 2 participants that re-enrolled from Part 2 MK-8723 10 mg/kg.
|
Part 2: Matching Placebo to MK-8723
Matching placebo to MK-8723 administered as a single IV infusion to participants with ITP in Part 2.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Area Under the Concentration-time Curve of MK-8723 From Time 0 to Infinity (AUC0-∞) Among Healthy Participants and Participants With ITP
|
4830 hr*μg/mL
Geometric Coefficient of Variation 22.1
|
22300 hr*μg/mL
Geometric Coefficient of Variation 21.9
|
65800 hr*μg/mL
Geometric Coefficient of Variation 13.4
|
186000 hr*μg/mL
Geometric Coefficient of Variation 7.28
|
711000 hr*μg/mL
Geometric Coefficient of Variation 50.5
|
66200 hr*μg/mL
Geometric Coefficient of Variation 57.9
|
203000 hr*μg/mL
Geometric Coefficient of Variation 22.6
|
668000 hr*μg/mL
Geometric Coefficient of Variation 19.4
|
—
|
—
|
SECONDARY outcome
Timeframe: All dose groups: Predose and 4 (end of infusion), 6, 12, 24 hrs postdose and Days 3, 4, 5, 7, 10, 14, 21, 28; 30 mg/kg and 100 mg/kg dose groups: Days 43, 56, 71, 84Population: The per protocol population consisting of all participants in compliance with the protocol (e.g., availability of measurements, absence of major protocol violations) was used for this pharmacokinetic (Cmax) analysis.
Serum samples for determination of Cmax were collected at pre-specified time-points.
Outcome measures
| Measure |
Part 1: MK-8723 1 mg/kg in Healthy Participants
n=6 Participants
MK-8723 1 mg/kg administered as a single IV infusion to healthy participants in Part 1.
|
Part 1: MK-8723 3 mg/kg in Healthy Participants
n=6 Participants
MK-8723 3 mg/kg administered as a single IV infusion to healthy participants in Part 1.
|
Part 1: MK-8723 10 mg/kg in Healthy Participants
n=6 Participants
MK-8723 10 mg/kg administered as a single IV infusion to healthy participants in Part 1.
|
Part 1: MK-8723 30 mg/kg in Healthy Participants
n=6 Participants
MK-8723 30 mg/kg administered as a single IV infusion to healthy participants in Part 1.
|
Part 1: MK-8723 100 mg/kg in Healthy Participants
n=6 Participants
MK-8723 100 mg/kg administered as a single IV infusion to healthy participants in Part 1.
|
Part 1: Matching Placebo to MK-8723
n=3 Participants
Matching placebo to MK-8723 administered as a single IV infusion to healthy participants in Part 1.
|
Part 2: MK-8723 10 mg/kg in ITP Participants
n=2 Participants
MK-8723 10 mg/kg administered as a single IV infusion to participants with ITP in Part 2. 2 participants subsequently enrolled in Part 2 MK-8723 100 mg/kg.
|
Part 2: MK-8723 30 mg/kg in ITP Participants
n=3 Participants
MK-8723 30 mg/kg administered as a single IV infusion to participants with ITP in Part 2.
|
Part 2: MK-8723 100 mg/kg in ITP Participants
MK-8723 100 mg/kg administered as a single IV infusion to participants with ITP in Part 2. This group includes 2 participants that re-enrolled from Part 2 MK-8723 10 mg/kg.
|
Part 2: Matching Placebo to MK-8723
Matching placebo to MK-8723 administered as a single IV infusion to participants with ITP in Part 2.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Maximum Concentration (Cmax) of MK-8723 Among Healthy Participants and Participants With ITP
|
18.7 μg/mL
Geometric Coefficient of Variation 11.4
|
72.3 μg/mL
Geometric Coefficient of Variation 8.53
|
225 μg/mL
Geometric Coefficient of Variation 15.5
|
844 μg/mL
Geometric Coefficient of Variation 12.2
|
2160 μg/mL
Geometric Coefficient of Variation 23.9
|
195 μg/mL
Geometric Coefficient of Variation 11.7
|
741 μg/mL
Geometric Coefficient of Variation 24.8
|
2450 μg/mL
Geometric Coefficient of Variation 8.63
|
—
|
—
|
Adverse Events
Part 1: MK-8723 1 mg/kg in Healthy Participants
Part 1: MK-8723 3 mg/kg in Healthy Participants
Part 1: MK-8723 10 mg/kg in Healthy Participants
Part 1: MK-8723 30 mg/kg in Healthy Participants
Part 1: MK-8723 100 mg/kg in Healthy Participants
Part 1: Matching Placebo to MK-8723
Part 2: MK-8723 10 mg/kg in ITP Participants
Part 2: MK-8723 30 mg/kg in ITP Participants
Part 2: MK-8723 100 mg/kg in ITP Participants
Part 2: Matching Placebo to MK-8723
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Part 1: MK-8723 1 mg/kg in Healthy Participants
n=6 participants at risk
MK-8723 1 mg/kg administered as a single IV infusion to healthy participants in Part 1.
|
Part 1: MK-8723 3 mg/kg in Healthy Participants
n=6 participants at risk
MK-8723 3 mg/kg administered as a single IV infusion to healthy participants in Part 1.
|
Part 1: MK-8723 10 mg/kg in Healthy Participants
n=6 participants at risk
MK-8723 10 mg/kg administered as a single IV infusion to healthy participants in Part 1.
|
Part 1: MK-8723 30 mg/kg in Healthy Participants
n=6 participants at risk
MK-8723 30 mg/kg administered as a single IV infusion to healthy participants in Part 1.
|
Part 1: MK-8723 100 mg/kg in Healthy Participants
n=6 participants at risk
MK-8723 100 mg/kg administered as a single IV infusion to healthy participants in Part 1.
|
Part 1: Matching Placebo to MK-8723
n=10 participants at risk
Matching placebo to MK-8723 administered as a single IV infusion to healthy participants in Part 1.
|
Part 2: MK-8723 10 mg/kg in ITP Participants
n=3 participants at risk
MK-8723 10 mg/kg administered as a single IV infusion to participants with ITP in Part 2. 2 participants subsequently enrolled in Part 2 MK-8723 100 mg/kg.
|
Part 2: MK-8723 30 mg/kg in ITP Participants
n=2 participants at risk
MK-8723 30 mg/kg administered as a single IV infusion to participants with ITP in Part 2.
|
Part 2: MK-8723 100 mg/kg in ITP Participants
n=3 participants at risk
MK-8723 100 mg/kg administered as a single IV infusion to participants with ITP in Part 2. This group includes 2 participants that re-enrolled from Part 2 MK-8723 10 mg/kg.
|
Part 2: Matching Placebo to MK-8723
n=4 participants at risk
Matching placebo to MK-8723 administered as a single IV infusion to participants with ITP in Part 2.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/6 • Up to 84 days
The APaT population consisting of all participants who received at least one dose of study drug was used for the safety analysis. AEs are presented according to the actual treatment administered (i.e., as treated). 2 participants that completed Part 2 MK-8723 10 mg/kg were re-enrolled in Part 2 MK-8723 100 mg/kg \& dosed per protocol procedure.
|
0.00%
0/6 • Up to 84 days
The APaT population consisting of all participants who received at least one dose of study drug was used for the safety analysis. AEs are presented according to the actual treatment administered (i.e., as treated). 2 participants that completed Part 2 MK-8723 10 mg/kg were re-enrolled in Part 2 MK-8723 100 mg/kg \& dosed per protocol procedure.
|
16.7%
1/6 • Number of events 1 • Up to 84 days
The APaT population consisting of all participants who received at least one dose of study drug was used for the safety analysis. AEs are presented according to the actual treatment administered (i.e., as treated). 2 participants that completed Part 2 MK-8723 10 mg/kg were re-enrolled in Part 2 MK-8723 100 mg/kg \& dosed per protocol procedure.
|
0.00%
0/6 • Up to 84 days
The APaT population consisting of all participants who received at least one dose of study drug was used for the safety analysis. AEs are presented according to the actual treatment administered (i.e., as treated). 2 participants that completed Part 2 MK-8723 10 mg/kg were re-enrolled in Part 2 MK-8723 100 mg/kg \& dosed per protocol procedure.
|
0.00%
0/6 • Up to 84 days
The APaT population consisting of all participants who received at least one dose of study drug was used for the safety analysis. AEs are presented according to the actual treatment administered (i.e., as treated). 2 participants that completed Part 2 MK-8723 10 mg/kg were re-enrolled in Part 2 MK-8723 100 mg/kg \& dosed per protocol procedure.
|
0.00%
0/10 • Up to 84 days
The APaT population consisting of all participants who received at least one dose of study drug was used for the safety analysis. AEs are presented according to the actual treatment administered (i.e., as treated). 2 participants that completed Part 2 MK-8723 10 mg/kg were re-enrolled in Part 2 MK-8723 100 mg/kg \& dosed per protocol procedure.
|
0.00%
0/3 • Up to 84 days
The APaT population consisting of all participants who received at least one dose of study drug was used for the safety analysis. AEs are presented according to the actual treatment administered (i.e., as treated). 2 participants that completed Part 2 MK-8723 10 mg/kg were re-enrolled in Part 2 MK-8723 100 mg/kg \& dosed per protocol procedure.
|
0.00%
0/2 • Up to 84 days
The APaT population consisting of all participants who received at least one dose of study drug was used for the safety analysis. AEs are presented according to the actual treatment administered (i.e., as treated). 2 participants that completed Part 2 MK-8723 10 mg/kg were re-enrolled in Part 2 MK-8723 100 mg/kg \& dosed per protocol procedure.
|
0.00%
0/3 • Up to 84 days
The APaT population consisting of all participants who received at least one dose of study drug was used for the safety analysis. AEs are presented according to the actual treatment administered (i.e., as treated). 2 participants that completed Part 2 MK-8723 10 mg/kg were re-enrolled in Part 2 MK-8723 100 mg/kg \& dosed per protocol procedure.
|
0.00%
0/4 • Up to 84 days
The APaT population consisting of all participants who received at least one dose of study drug was used for the safety analysis. AEs are presented according to the actual treatment administered (i.e., as treated). 2 participants that completed Part 2 MK-8723 10 mg/kg were re-enrolled in Part 2 MK-8723 100 mg/kg \& dosed per protocol procedure.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/6 • Up to 84 days
The APaT population consisting of all participants who received at least one dose of study drug was used for the safety analysis. AEs are presented according to the actual treatment administered (i.e., as treated). 2 participants that completed Part 2 MK-8723 10 mg/kg were re-enrolled in Part 2 MK-8723 100 mg/kg \& dosed per protocol procedure.
|
0.00%
0/6 • Up to 84 days
The APaT population consisting of all participants who received at least one dose of study drug was used for the safety analysis. AEs are presented according to the actual treatment administered (i.e., as treated). 2 participants that completed Part 2 MK-8723 10 mg/kg were re-enrolled in Part 2 MK-8723 100 mg/kg \& dosed per protocol procedure.
|
0.00%
0/6 • Up to 84 days
The APaT population consisting of all participants who received at least one dose of study drug was used for the safety analysis. AEs are presented according to the actual treatment administered (i.e., as treated). 2 participants that completed Part 2 MK-8723 10 mg/kg were re-enrolled in Part 2 MK-8723 100 mg/kg \& dosed per protocol procedure.
|
0.00%
0/6 • Up to 84 days
The APaT population consisting of all participants who received at least one dose of study drug was used for the safety analysis. AEs are presented according to the actual treatment administered (i.e., as treated). 2 participants that completed Part 2 MK-8723 10 mg/kg were re-enrolled in Part 2 MK-8723 100 mg/kg \& dosed per protocol procedure.
|
0.00%
0/6 • Up to 84 days
The APaT population consisting of all participants who received at least one dose of study drug was used for the safety analysis. AEs are presented according to the actual treatment administered (i.e., as treated). 2 participants that completed Part 2 MK-8723 10 mg/kg were re-enrolled in Part 2 MK-8723 100 mg/kg \& dosed per protocol procedure.
|
0.00%
0/10 • Up to 84 days
The APaT population consisting of all participants who received at least one dose of study drug was used for the safety analysis. AEs are presented according to the actual treatment administered (i.e., as treated). 2 participants that completed Part 2 MK-8723 10 mg/kg were re-enrolled in Part 2 MK-8723 100 mg/kg \& dosed per protocol procedure.
|
0.00%
0/3 • Up to 84 days
The APaT population consisting of all participants who received at least one dose of study drug was used for the safety analysis. AEs are presented according to the actual treatment administered (i.e., as treated). 2 participants that completed Part 2 MK-8723 10 mg/kg were re-enrolled in Part 2 MK-8723 100 mg/kg \& dosed per protocol procedure.
|
50.0%
1/2 • Number of events 1 • Up to 84 days
The APaT population consisting of all participants who received at least one dose of study drug was used for the safety analysis. AEs are presented according to the actual treatment administered (i.e., as treated). 2 participants that completed Part 2 MK-8723 10 mg/kg were re-enrolled in Part 2 MK-8723 100 mg/kg \& dosed per protocol procedure.
|
0.00%
0/3 • Up to 84 days
The APaT population consisting of all participants who received at least one dose of study drug was used for the safety analysis. AEs are presented according to the actual treatment administered (i.e., as treated). 2 participants that completed Part 2 MK-8723 10 mg/kg were re-enrolled in Part 2 MK-8723 100 mg/kg \& dosed per protocol procedure.
|
0.00%
0/4 • Up to 84 days
The APaT population consisting of all participants who received at least one dose of study drug was used for the safety analysis. AEs are presented according to the actual treatment administered (i.e., as treated). 2 participants that completed Part 2 MK-8723 10 mg/kg were re-enrolled in Part 2 MK-8723 100 mg/kg \& dosed per protocol procedure.
|
|
Gastrointestinal disorders
Frequent bowel movements
|
0.00%
0/6 • Up to 84 days
The APaT population consisting of all participants who received at least one dose of study drug was used for the safety analysis. AEs are presented according to the actual treatment administered (i.e., as treated). 2 participants that completed Part 2 MK-8723 10 mg/kg were re-enrolled in Part 2 MK-8723 100 mg/kg \& dosed per protocol procedure.
|
0.00%
0/6 • Up to 84 days
The APaT population consisting of all participants who received at least one dose of study drug was used for the safety analysis. AEs are presented according to the actual treatment administered (i.e., as treated). 2 participants that completed Part 2 MK-8723 10 mg/kg were re-enrolled in Part 2 MK-8723 100 mg/kg \& dosed per protocol procedure.
|
0.00%
0/6 • Up to 84 days
The APaT population consisting of all participants who received at least one dose of study drug was used for the safety analysis. AEs are presented according to the actual treatment administered (i.e., as treated). 2 participants that completed Part 2 MK-8723 10 mg/kg were re-enrolled in Part 2 MK-8723 100 mg/kg \& dosed per protocol procedure.
|
0.00%
0/6 • Up to 84 days
The APaT population consisting of all participants who received at least one dose of study drug was used for the safety analysis. AEs are presented according to the actual treatment administered (i.e., as treated). 2 participants that completed Part 2 MK-8723 10 mg/kg were re-enrolled in Part 2 MK-8723 100 mg/kg \& dosed per protocol procedure.
|
0.00%
0/6 • Up to 84 days
The APaT population consisting of all participants who received at least one dose of study drug was used for the safety analysis. AEs are presented according to the actual treatment administered (i.e., as treated). 2 participants that completed Part 2 MK-8723 10 mg/kg were re-enrolled in Part 2 MK-8723 100 mg/kg \& dosed per protocol procedure.
|
10.0%
1/10 • Number of events 1 • Up to 84 days
The APaT population consisting of all participants who received at least one dose of study drug was used for the safety analysis. AEs are presented according to the actual treatment administered (i.e., as treated). 2 participants that completed Part 2 MK-8723 10 mg/kg were re-enrolled in Part 2 MK-8723 100 mg/kg \& dosed per protocol procedure.
|
0.00%
0/3 • Up to 84 days
The APaT population consisting of all participants who received at least one dose of study drug was used for the safety analysis. AEs are presented according to the actual treatment administered (i.e., as treated). 2 participants that completed Part 2 MK-8723 10 mg/kg were re-enrolled in Part 2 MK-8723 100 mg/kg \& dosed per protocol procedure.
|
0.00%
0/2 • Up to 84 days
The APaT population consisting of all participants who received at least one dose of study drug was used for the safety analysis. AEs are presented according to the actual treatment administered (i.e., as treated). 2 participants that completed Part 2 MK-8723 10 mg/kg were re-enrolled in Part 2 MK-8723 100 mg/kg \& dosed per protocol procedure.
|
0.00%
0/3 • Up to 84 days
The APaT population consisting of all participants who received at least one dose of study drug was used for the safety analysis. AEs are presented according to the actual treatment administered (i.e., as treated). 2 participants that completed Part 2 MK-8723 10 mg/kg were re-enrolled in Part 2 MK-8723 100 mg/kg \& dosed per protocol procedure.
|
0.00%
0/4 • Up to 84 days
The APaT population consisting of all participants who received at least one dose of study drug was used for the safety analysis. AEs are presented according to the actual treatment administered (i.e., as treated). 2 participants that completed Part 2 MK-8723 10 mg/kg were re-enrolled in Part 2 MK-8723 100 mg/kg \& dosed per protocol procedure.
|
|
Gastrointestinal disorders
Toothache
|
0.00%
0/6 • Up to 84 days
The APaT population consisting of all participants who received at least one dose of study drug was used for the safety analysis. AEs are presented according to the actual treatment administered (i.e., as treated). 2 participants that completed Part 2 MK-8723 10 mg/kg were re-enrolled in Part 2 MK-8723 100 mg/kg \& dosed per protocol procedure.
|
16.7%
1/6 • Number of events 1 • Up to 84 days
The APaT population consisting of all participants who received at least one dose of study drug was used for the safety analysis. AEs are presented according to the actual treatment administered (i.e., as treated). 2 participants that completed Part 2 MK-8723 10 mg/kg were re-enrolled in Part 2 MK-8723 100 mg/kg \& dosed per protocol procedure.
|
0.00%
0/6 • Up to 84 days
The APaT population consisting of all participants who received at least one dose of study drug was used for the safety analysis. AEs are presented according to the actual treatment administered (i.e., as treated). 2 participants that completed Part 2 MK-8723 10 mg/kg were re-enrolled in Part 2 MK-8723 100 mg/kg \& dosed per protocol procedure.
|
0.00%
0/6 • Up to 84 days
The APaT population consisting of all participants who received at least one dose of study drug was used for the safety analysis. AEs are presented according to the actual treatment administered (i.e., as treated). 2 participants that completed Part 2 MK-8723 10 mg/kg were re-enrolled in Part 2 MK-8723 100 mg/kg \& dosed per protocol procedure.
|
0.00%
0/6 • Up to 84 days
The APaT population consisting of all participants who received at least one dose of study drug was used for the safety analysis. AEs are presented according to the actual treatment administered (i.e., as treated). 2 participants that completed Part 2 MK-8723 10 mg/kg were re-enrolled in Part 2 MK-8723 100 mg/kg \& dosed per protocol procedure.
|
0.00%
0/10 • Up to 84 days
The APaT population consisting of all participants who received at least one dose of study drug was used for the safety analysis. AEs are presented according to the actual treatment administered (i.e., as treated). 2 participants that completed Part 2 MK-8723 10 mg/kg were re-enrolled in Part 2 MK-8723 100 mg/kg \& dosed per protocol procedure.
|
0.00%
0/3 • Up to 84 days
The APaT population consisting of all participants who received at least one dose of study drug was used for the safety analysis. AEs are presented according to the actual treatment administered (i.e., as treated). 2 participants that completed Part 2 MK-8723 10 mg/kg were re-enrolled in Part 2 MK-8723 100 mg/kg \& dosed per protocol procedure.
|
0.00%
0/2 • Up to 84 days
The APaT population consisting of all participants who received at least one dose of study drug was used for the safety analysis. AEs are presented according to the actual treatment administered (i.e., as treated). 2 participants that completed Part 2 MK-8723 10 mg/kg were re-enrolled in Part 2 MK-8723 100 mg/kg \& dosed per protocol procedure.
|
0.00%
0/3 • Up to 84 days
The APaT population consisting of all participants who received at least one dose of study drug was used for the safety analysis. AEs are presented according to the actual treatment administered (i.e., as treated). 2 participants that completed Part 2 MK-8723 10 mg/kg were re-enrolled in Part 2 MK-8723 100 mg/kg \& dosed per protocol procedure.
|
0.00%
0/4 • Up to 84 days
The APaT population consisting of all participants who received at least one dose of study drug was used for the safety analysis. AEs are presented according to the actual treatment administered (i.e., as treated). 2 participants that completed Part 2 MK-8723 10 mg/kg were re-enrolled in Part 2 MK-8723 100 mg/kg \& dosed per protocol procedure.
|
|
General disorders
Fatigue
|
0.00%
0/6 • Up to 84 days
The APaT population consisting of all participants who received at least one dose of study drug was used for the safety analysis. AEs are presented according to the actual treatment administered (i.e., as treated). 2 participants that completed Part 2 MK-8723 10 mg/kg were re-enrolled in Part 2 MK-8723 100 mg/kg \& dosed per protocol procedure.
|
0.00%
0/6 • Up to 84 days
The APaT population consisting of all participants who received at least one dose of study drug was used for the safety analysis. AEs are presented according to the actual treatment administered (i.e., as treated). 2 participants that completed Part 2 MK-8723 10 mg/kg were re-enrolled in Part 2 MK-8723 100 mg/kg \& dosed per protocol procedure.
|
0.00%
0/6 • Up to 84 days
The APaT population consisting of all participants who received at least one dose of study drug was used for the safety analysis. AEs are presented according to the actual treatment administered (i.e., as treated). 2 participants that completed Part 2 MK-8723 10 mg/kg were re-enrolled in Part 2 MK-8723 100 mg/kg \& dosed per protocol procedure.
|
0.00%
0/6 • Up to 84 days
The APaT population consisting of all participants who received at least one dose of study drug was used for the safety analysis. AEs are presented according to the actual treatment administered (i.e., as treated). 2 participants that completed Part 2 MK-8723 10 mg/kg were re-enrolled in Part 2 MK-8723 100 mg/kg \& dosed per protocol procedure.
|
0.00%
0/6 • Up to 84 days
The APaT population consisting of all participants who received at least one dose of study drug was used for the safety analysis. AEs are presented according to the actual treatment administered (i.e., as treated). 2 participants that completed Part 2 MK-8723 10 mg/kg were re-enrolled in Part 2 MK-8723 100 mg/kg \& dosed per protocol procedure.
|
0.00%
0/10 • Up to 84 days
The APaT population consisting of all participants who received at least one dose of study drug was used for the safety analysis. AEs are presented according to the actual treatment administered (i.e., as treated). 2 participants that completed Part 2 MK-8723 10 mg/kg were re-enrolled in Part 2 MK-8723 100 mg/kg \& dosed per protocol procedure.
|
0.00%
0/3 • Up to 84 days
The APaT population consisting of all participants who received at least one dose of study drug was used for the safety analysis. AEs are presented according to the actual treatment administered (i.e., as treated). 2 participants that completed Part 2 MK-8723 10 mg/kg were re-enrolled in Part 2 MK-8723 100 mg/kg \& dosed per protocol procedure.
|
0.00%
0/2 • Up to 84 days
The APaT population consisting of all participants who received at least one dose of study drug was used for the safety analysis. AEs are presented according to the actual treatment administered (i.e., as treated). 2 participants that completed Part 2 MK-8723 10 mg/kg were re-enrolled in Part 2 MK-8723 100 mg/kg \& dosed per protocol procedure.
|
0.00%
0/3 • Up to 84 days
The APaT population consisting of all participants who received at least one dose of study drug was used for the safety analysis. AEs are presented according to the actual treatment administered (i.e., as treated). 2 participants that completed Part 2 MK-8723 10 mg/kg were re-enrolled in Part 2 MK-8723 100 mg/kg \& dosed per protocol procedure.
|
25.0%
1/4 • Number of events 1 • Up to 84 days
The APaT population consisting of all participants who received at least one dose of study drug was used for the safety analysis. AEs are presented according to the actual treatment administered (i.e., as treated). 2 participants that completed Part 2 MK-8723 10 mg/kg were re-enrolled in Part 2 MK-8723 100 mg/kg \& dosed per protocol procedure.
|
|
General disorders
Feeling abnormal
|
0.00%
0/6 • Up to 84 days
The APaT population consisting of all participants who received at least one dose of study drug was used for the safety analysis. AEs are presented according to the actual treatment administered (i.e., as treated). 2 participants that completed Part 2 MK-8723 10 mg/kg were re-enrolled in Part 2 MK-8723 100 mg/kg \& dosed per protocol procedure.
|
0.00%
0/6 • Up to 84 days
The APaT population consisting of all participants who received at least one dose of study drug was used for the safety analysis. AEs are presented according to the actual treatment administered (i.e., as treated). 2 participants that completed Part 2 MK-8723 10 mg/kg were re-enrolled in Part 2 MK-8723 100 mg/kg \& dosed per protocol procedure.
|
0.00%
0/6 • Up to 84 days
The APaT population consisting of all participants who received at least one dose of study drug was used for the safety analysis. AEs are presented according to the actual treatment administered (i.e., as treated). 2 participants that completed Part 2 MK-8723 10 mg/kg were re-enrolled in Part 2 MK-8723 100 mg/kg \& dosed per protocol procedure.
|
0.00%
0/6 • Up to 84 days
The APaT population consisting of all participants who received at least one dose of study drug was used for the safety analysis. AEs are presented according to the actual treatment administered (i.e., as treated). 2 participants that completed Part 2 MK-8723 10 mg/kg were re-enrolled in Part 2 MK-8723 100 mg/kg \& dosed per protocol procedure.
|
0.00%
0/6 • Up to 84 days
The APaT population consisting of all participants who received at least one dose of study drug was used for the safety analysis. AEs are presented according to the actual treatment administered (i.e., as treated). 2 participants that completed Part 2 MK-8723 10 mg/kg were re-enrolled in Part 2 MK-8723 100 mg/kg \& dosed per protocol procedure.
|
10.0%
1/10 • Number of events 1 • Up to 84 days
The APaT population consisting of all participants who received at least one dose of study drug was used for the safety analysis. AEs are presented according to the actual treatment administered (i.e., as treated). 2 participants that completed Part 2 MK-8723 10 mg/kg were re-enrolled in Part 2 MK-8723 100 mg/kg \& dosed per protocol procedure.
|
0.00%
0/3 • Up to 84 days
The APaT population consisting of all participants who received at least one dose of study drug was used for the safety analysis. AEs are presented according to the actual treatment administered (i.e., as treated). 2 participants that completed Part 2 MK-8723 10 mg/kg were re-enrolled in Part 2 MK-8723 100 mg/kg \& dosed per protocol procedure.
|
0.00%
0/2 • Up to 84 days
The APaT population consisting of all participants who received at least one dose of study drug was used for the safety analysis. AEs are presented according to the actual treatment administered (i.e., as treated). 2 participants that completed Part 2 MK-8723 10 mg/kg were re-enrolled in Part 2 MK-8723 100 mg/kg \& dosed per protocol procedure.
|
0.00%
0/3 • Up to 84 days
The APaT population consisting of all participants who received at least one dose of study drug was used for the safety analysis. AEs are presented according to the actual treatment administered (i.e., as treated). 2 participants that completed Part 2 MK-8723 10 mg/kg were re-enrolled in Part 2 MK-8723 100 mg/kg \& dosed per protocol procedure.
|
0.00%
0/4 • Up to 84 days
The APaT population consisting of all participants who received at least one dose of study drug was used for the safety analysis. AEs are presented according to the actual treatment administered (i.e., as treated). 2 participants that completed Part 2 MK-8723 10 mg/kg were re-enrolled in Part 2 MK-8723 100 mg/kg \& dosed per protocol procedure.
|
|
General disorders
Influenza like illness
|
0.00%
0/6 • Up to 84 days
The APaT population consisting of all participants who received at least one dose of study drug was used for the safety analysis. AEs are presented according to the actual treatment administered (i.e., as treated). 2 participants that completed Part 2 MK-8723 10 mg/kg were re-enrolled in Part 2 MK-8723 100 mg/kg \& dosed per protocol procedure.
|
0.00%
0/6 • Up to 84 days
The APaT population consisting of all participants who received at least one dose of study drug was used for the safety analysis. AEs are presented according to the actual treatment administered (i.e., as treated). 2 participants that completed Part 2 MK-8723 10 mg/kg were re-enrolled in Part 2 MK-8723 100 mg/kg \& dosed per protocol procedure.
|
0.00%
0/6 • Up to 84 days
The APaT population consisting of all participants who received at least one dose of study drug was used for the safety analysis. AEs are presented according to the actual treatment administered (i.e., as treated). 2 participants that completed Part 2 MK-8723 10 mg/kg were re-enrolled in Part 2 MK-8723 100 mg/kg \& dosed per protocol procedure.
|
0.00%
0/6 • Up to 84 days
The APaT population consisting of all participants who received at least one dose of study drug was used for the safety analysis. AEs are presented according to the actual treatment administered (i.e., as treated). 2 participants that completed Part 2 MK-8723 10 mg/kg were re-enrolled in Part 2 MK-8723 100 mg/kg \& dosed per protocol procedure.
|
0.00%
0/6 • Up to 84 days
The APaT population consisting of all participants who received at least one dose of study drug was used for the safety analysis. AEs are presented according to the actual treatment administered (i.e., as treated). 2 participants that completed Part 2 MK-8723 10 mg/kg were re-enrolled in Part 2 MK-8723 100 mg/kg \& dosed per protocol procedure.
|
0.00%
0/10 • Up to 84 days
The APaT population consisting of all participants who received at least one dose of study drug was used for the safety analysis. AEs are presented according to the actual treatment administered (i.e., as treated). 2 participants that completed Part 2 MK-8723 10 mg/kg were re-enrolled in Part 2 MK-8723 100 mg/kg \& dosed per protocol procedure.
|
0.00%
0/3 • Up to 84 days
The APaT population consisting of all participants who received at least one dose of study drug was used for the safety analysis. AEs are presented according to the actual treatment administered (i.e., as treated). 2 participants that completed Part 2 MK-8723 10 mg/kg were re-enrolled in Part 2 MK-8723 100 mg/kg \& dosed per protocol procedure.
|
0.00%
0/2 • Up to 84 days
The APaT population consisting of all participants who received at least one dose of study drug was used for the safety analysis. AEs are presented according to the actual treatment administered (i.e., as treated). 2 participants that completed Part 2 MK-8723 10 mg/kg were re-enrolled in Part 2 MK-8723 100 mg/kg \& dosed per protocol procedure.
|
66.7%
2/3 • Number of events 2 • Up to 84 days
The APaT population consisting of all participants who received at least one dose of study drug was used for the safety analysis. AEs are presented according to the actual treatment administered (i.e., as treated). 2 participants that completed Part 2 MK-8723 10 mg/kg were re-enrolled in Part 2 MK-8723 100 mg/kg \& dosed per protocol procedure.
|
0.00%
0/4 • Up to 84 days
The APaT population consisting of all participants who received at least one dose of study drug was used for the safety analysis. AEs are presented according to the actual treatment administered (i.e., as treated). 2 participants that completed Part 2 MK-8723 10 mg/kg were re-enrolled in Part 2 MK-8723 100 mg/kg \& dosed per protocol procedure.
|
|
Infections and infestations
Infectious mononucleosis
|
0.00%
0/6 • Up to 84 days
The APaT population consisting of all participants who received at least one dose of study drug was used for the safety analysis. AEs are presented according to the actual treatment administered (i.e., as treated). 2 participants that completed Part 2 MK-8723 10 mg/kg were re-enrolled in Part 2 MK-8723 100 mg/kg \& dosed per protocol procedure.
|
0.00%
0/6 • Up to 84 days
The APaT population consisting of all participants who received at least one dose of study drug was used for the safety analysis. AEs are presented according to the actual treatment administered (i.e., as treated). 2 participants that completed Part 2 MK-8723 10 mg/kg were re-enrolled in Part 2 MK-8723 100 mg/kg \& dosed per protocol procedure.
|
0.00%
0/6 • Up to 84 days
The APaT population consisting of all participants who received at least one dose of study drug was used for the safety analysis. AEs are presented according to the actual treatment administered (i.e., as treated). 2 participants that completed Part 2 MK-8723 10 mg/kg were re-enrolled in Part 2 MK-8723 100 mg/kg \& dosed per protocol procedure.
|
16.7%
1/6 • Number of events 1 • Up to 84 days
The APaT population consisting of all participants who received at least one dose of study drug was used for the safety analysis. AEs are presented according to the actual treatment administered (i.e., as treated). 2 participants that completed Part 2 MK-8723 10 mg/kg were re-enrolled in Part 2 MK-8723 100 mg/kg \& dosed per protocol procedure.
|
0.00%
0/6 • Up to 84 days
The APaT population consisting of all participants who received at least one dose of study drug was used for the safety analysis. AEs are presented according to the actual treatment administered (i.e., as treated). 2 participants that completed Part 2 MK-8723 10 mg/kg were re-enrolled in Part 2 MK-8723 100 mg/kg \& dosed per protocol procedure.
|
0.00%
0/10 • Up to 84 days
The APaT population consisting of all participants who received at least one dose of study drug was used for the safety analysis. AEs are presented according to the actual treatment administered (i.e., as treated). 2 participants that completed Part 2 MK-8723 10 mg/kg were re-enrolled in Part 2 MK-8723 100 mg/kg \& dosed per protocol procedure.
|
0.00%
0/3 • Up to 84 days
The APaT population consisting of all participants who received at least one dose of study drug was used for the safety analysis. AEs are presented according to the actual treatment administered (i.e., as treated). 2 participants that completed Part 2 MK-8723 10 mg/kg were re-enrolled in Part 2 MK-8723 100 mg/kg \& dosed per protocol procedure.
|
0.00%
0/2 • Up to 84 days
The APaT population consisting of all participants who received at least one dose of study drug was used for the safety analysis. AEs are presented according to the actual treatment administered (i.e., as treated). 2 participants that completed Part 2 MK-8723 10 mg/kg were re-enrolled in Part 2 MK-8723 100 mg/kg \& dosed per protocol procedure.
|
0.00%
0/3 • Up to 84 days
The APaT population consisting of all participants who received at least one dose of study drug was used for the safety analysis. AEs are presented according to the actual treatment administered (i.e., as treated). 2 participants that completed Part 2 MK-8723 10 mg/kg were re-enrolled in Part 2 MK-8723 100 mg/kg \& dosed per protocol procedure.
|
0.00%
0/4 • Up to 84 days
The APaT population consisting of all participants who received at least one dose of study drug was used for the safety analysis. AEs are presented according to the actual treatment administered (i.e., as treated). 2 participants that completed Part 2 MK-8723 10 mg/kg were re-enrolled in Part 2 MK-8723 100 mg/kg \& dosed per protocol procedure.
|
|
Infections and infestations
Upper respiratory tract infection
|
33.3%
2/6 • Number of events 2 • Up to 84 days
The APaT population consisting of all participants who received at least one dose of study drug was used for the safety analysis. AEs are presented according to the actual treatment administered (i.e., as treated). 2 participants that completed Part 2 MK-8723 10 mg/kg were re-enrolled in Part 2 MK-8723 100 mg/kg \& dosed per protocol procedure.
|
0.00%
0/6 • Up to 84 days
The APaT population consisting of all participants who received at least one dose of study drug was used for the safety analysis. AEs are presented according to the actual treatment administered (i.e., as treated). 2 participants that completed Part 2 MK-8723 10 mg/kg were re-enrolled in Part 2 MK-8723 100 mg/kg \& dosed per protocol procedure.
|
16.7%
1/6 • Number of events 1 • Up to 84 days
The APaT population consisting of all participants who received at least one dose of study drug was used for the safety analysis. AEs are presented according to the actual treatment administered (i.e., as treated). 2 participants that completed Part 2 MK-8723 10 mg/kg were re-enrolled in Part 2 MK-8723 100 mg/kg \& dosed per protocol procedure.
|
16.7%
1/6 • Number of events 1 • Up to 84 days
The APaT population consisting of all participants who received at least one dose of study drug was used for the safety analysis. AEs are presented according to the actual treatment administered (i.e., as treated). 2 participants that completed Part 2 MK-8723 10 mg/kg were re-enrolled in Part 2 MK-8723 100 mg/kg \& dosed per protocol procedure.
|
50.0%
3/6 • Number of events 3 • Up to 84 days
The APaT population consisting of all participants who received at least one dose of study drug was used for the safety analysis. AEs are presented according to the actual treatment administered (i.e., as treated). 2 participants that completed Part 2 MK-8723 10 mg/kg were re-enrolled in Part 2 MK-8723 100 mg/kg \& dosed per protocol procedure.
|
50.0%
5/10 • Number of events 6 • Up to 84 days
The APaT population consisting of all participants who received at least one dose of study drug was used for the safety analysis. AEs are presented according to the actual treatment administered (i.e., as treated). 2 participants that completed Part 2 MK-8723 10 mg/kg were re-enrolled in Part 2 MK-8723 100 mg/kg \& dosed per protocol procedure.
|
0.00%
0/3 • Up to 84 days
The APaT population consisting of all participants who received at least one dose of study drug was used for the safety analysis. AEs are presented according to the actual treatment administered (i.e., as treated). 2 participants that completed Part 2 MK-8723 10 mg/kg were re-enrolled in Part 2 MK-8723 100 mg/kg \& dosed per protocol procedure.
|
50.0%
1/2 • Number of events 1 • Up to 84 days
The APaT population consisting of all participants who received at least one dose of study drug was used for the safety analysis. AEs are presented according to the actual treatment administered (i.e., as treated). 2 participants that completed Part 2 MK-8723 10 mg/kg were re-enrolled in Part 2 MK-8723 100 mg/kg \& dosed per protocol procedure.
|
0.00%
0/3 • Up to 84 days
The APaT population consisting of all participants who received at least one dose of study drug was used for the safety analysis. AEs are presented according to the actual treatment administered (i.e., as treated). 2 participants that completed Part 2 MK-8723 10 mg/kg were re-enrolled in Part 2 MK-8723 100 mg/kg \& dosed per protocol procedure.
|
50.0%
2/4 • Number of events 2 • Up to 84 days
The APaT population consisting of all participants who received at least one dose of study drug was used for the safety analysis. AEs are presented according to the actual treatment administered (i.e., as treated). 2 participants that completed Part 2 MK-8723 10 mg/kg were re-enrolled in Part 2 MK-8723 100 mg/kg \& dosed per protocol procedure.
|
|
Injury, poisoning and procedural complications
Wrist fracture
|
0.00%
0/6 • Up to 84 days
The APaT population consisting of all participants who received at least one dose of study drug was used for the safety analysis. AEs are presented according to the actual treatment administered (i.e., as treated). 2 participants that completed Part 2 MK-8723 10 mg/kg were re-enrolled in Part 2 MK-8723 100 mg/kg \& dosed per protocol procedure.
|
0.00%
0/6 • Up to 84 days
The APaT population consisting of all participants who received at least one dose of study drug was used for the safety analysis. AEs are presented according to the actual treatment administered (i.e., as treated). 2 participants that completed Part 2 MK-8723 10 mg/kg were re-enrolled in Part 2 MK-8723 100 mg/kg \& dosed per protocol procedure.
|
0.00%
0/6 • Up to 84 days
The APaT population consisting of all participants who received at least one dose of study drug was used for the safety analysis. AEs are presented according to the actual treatment administered (i.e., as treated). 2 participants that completed Part 2 MK-8723 10 mg/kg were re-enrolled in Part 2 MK-8723 100 mg/kg \& dosed per protocol procedure.
|
0.00%
0/6 • Up to 84 days
The APaT population consisting of all participants who received at least one dose of study drug was used for the safety analysis. AEs are presented according to the actual treatment administered (i.e., as treated). 2 participants that completed Part 2 MK-8723 10 mg/kg were re-enrolled in Part 2 MK-8723 100 mg/kg \& dosed per protocol procedure.
|
0.00%
0/6 • Up to 84 days
The APaT population consisting of all participants who received at least one dose of study drug was used for the safety analysis. AEs are presented according to the actual treatment administered (i.e., as treated). 2 participants that completed Part 2 MK-8723 10 mg/kg were re-enrolled in Part 2 MK-8723 100 mg/kg \& dosed per protocol procedure.
|
10.0%
1/10 • Number of events 1 • Up to 84 days
The APaT population consisting of all participants who received at least one dose of study drug was used for the safety analysis. AEs are presented according to the actual treatment administered (i.e., as treated). 2 participants that completed Part 2 MK-8723 10 mg/kg were re-enrolled in Part 2 MK-8723 100 mg/kg \& dosed per protocol procedure.
|
0.00%
0/3 • Up to 84 days
The APaT population consisting of all participants who received at least one dose of study drug was used for the safety analysis. AEs are presented according to the actual treatment administered (i.e., as treated). 2 participants that completed Part 2 MK-8723 10 mg/kg were re-enrolled in Part 2 MK-8723 100 mg/kg \& dosed per protocol procedure.
|
0.00%
0/2 • Up to 84 days
The APaT population consisting of all participants who received at least one dose of study drug was used for the safety analysis. AEs are presented according to the actual treatment administered (i.e., as treated). 2 participants that completed Part 2 MK-8723 10 mg/kg were re-enrolled in Part 2 MK-8723 100 mg/kg \& dosed per protocol procedure.
|
0.00%
0/3 • Up to 84 days
The APaT population consisting of all participants who received at least one dose of study drug was used for the safety analysis. AEs are presented according to the actual treatment administered (i.e., as treated). 2 participants that completed Part 2 MK-8723 10 mg/kg were re-enrolled in Part 2 MK-8723 100 mg/kg \& dosed per protocol procedure.
|
0.00%
0/4 • Up to 84 days
The APaT population consisting of all participants who received at least one dose of study drug was used for the safety analysis. AEs are presented according to the actual treatment administered (i.e., as treated). 2 participants that completed Part 2 MK-8723 10 mg/kg were re-enrolled in Part 2 MK-8723 100 mg/kg \& dosed per protocol procedure.
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/6 • Up to 84 days
The APaT population consisting of all participants who received at least one dose of study drug was used for the safety analysis. AEs are presented according to the actual treatment administered (i.e., as treated). 2 participants that completed Part 2 MK-8723 10 mg/kg were re-enrolled in Part 2 MK-8723 100 mg/kg \& dosed per protocol procedure.
|
0.00%
0/6 • Up to 84 days
The APaT population consisting of all participants who received at least one dose of study drug was used for the safety analysis. AEs are presented according to the actual treatment administered (i.e., as treated). 2 participants that completed Part 2 MK-8723 10 mg/kg were re-enrolled in Part 2 MK-8723 100 mg/kg \& dosed per protocol procedure.
|
0.00%
0/6 • Up to 84 days
The APaT population consisting of all participants who received at least one dose of study drug was used for the safety analysis. AEs are presented according to the actual treatment administered (i.e., as treated). 2 participants that completed Part 2 MK-8723 10 mg/kg were re-enrolled in Part 2 MK-8723 100 mg/kg \& dosed per protocol procedure.
|
16.7%
1/6 • Number of events 1 • Up to 84 days
The APaT population consisting of all participants who received at least one dose of study drug was used for the safety analysis. AEs are presented according to the actual treatment administered (i.e., as treated). 2 participants that completed Part 2 MK-8723 10 mg/kg were re-enrolled in Part 2 MK-8723 100 mg/kg \& dosed per protocol procedure.
|
0.00%
0/6 • Up to 84 days
The APaT population consisting of all participants who received at least one dose of study drug was used for the safety analysis. AEs are presented according to the actual treatment administered (i.e., as treated). 2 participants that completed Part 2 MK-8723 10 mg/kg were re-enrolled in Part 2 MK-8723 100 mg/kg \& dosed per protocol procedure.
|
0.00%
0/10 • Up to 84 days
The APaT population consisting of all participants who received at least one dose of study drug was used for the safety analysis. AEs are presented according to the actual treatment administered (i.e., as treated). 2 participants that completed Part 2 MK-8723 10 mg/kg were re-enrolled in Part 2 MK-8723 100 mg/kg \& dosed per protocol procedure.
|
0.00%
0/3 • Up to 84 days
The APaT population consisting of all participants who received at least one dose of study drug was used for the safety analysis. AEs are presented according to the actual treatment administered (i.e., as treated). 2 participants that completed Part 2 MK-8723 10 mg/kg were re-enrolled in Part 2 MK-8723 100 mg/kg \& dosed per protocol procedure.
|
0.00%
0/2 • Up to 84 days
The APaT population consisting of all participants who received at least one dose of study drug was used for the safety analysis. AEs are presented according to the actual treatment administered (i.e., as treated). 2 participants that completed Part 2 MK-8723 10 mg/kg were re-enrolled in Part 2 MK-8723 100 mg/kg \& dosed per protocol procedure.
|
0.00%
0/3 • Up to 84 days
The APaT population consisting of all participants who received at least one dose of study drug was used for the safety analysis. AEs are presented according to the actual treatment administered (i.e., as treated). 2 participants that completed Part 2 MK-8723 10 mg/kg were re-enrolled in Part 2 MK-8723 100 mg/kg \& dosed per protocol procedure.
|
0.00%
0/4 • Up to 84 days
The APaT population consisting of all participants who received at least one dose of study drug was used for the safety analysis. AEs are presented according to the actual treatment administered (i.e., as treated). 2 participants that completed Part 2 MK-8723 10 mg/kg were re-enrolled in Part 2 MK-8723 100 mg/kg \& dosed per protocol procedure.
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/6 • Up to 84 days
The APaT population consisting of all participants who received at least one dose of study drug was used for the safety analysis. AEs are presented according to the actual treatment administered (i.e., as treated). 2 participants that completed Part 2 MK-8723 10 mg/kg were re-enrolled in Part 2 MK-8723 100 mg/kg \& dosed per protocol procedure.
|
0.00%
0/6 • Up to 84 days
The APaT population consisting of all participants who received at least one dose of study drug was used for the safety analysis. AEs are presented according to the actual treatment administered (i.e., as treated). 2 participants that completed Part 2 MK-8723 10 mg/kg were re-enrolled in Part 2 MK-8723 100 mg/kg \& dosed per protocol procedure.
|
0.00%
0/6 • Up to 84 days
The APaT population consisting of all participants who received at least one dose of study drug was used for the safety analysis. AEs are presented according to the actual treatment administered (i.e., as treated). 2 participants that completed Part 2 MK-8723 10 mg/kg were re-enrolled in Part 2 MK-8723 100 mg/kg \& dosed per protocol procedure.
|
16.7%
1/6 • Number of events 1 • Up to 84 days
The APaT population consisting of all participants who received at least one dose of study drug was used for the safety analysis. AEs are presented according to the actual treatment administered (i.e., as treated). 2 participants that completed Part 2 MK-8723 10 mg/kg were re-enrolled in Part 2 MK-8723 100 mg/kg \& dosed per protocol procedure.
|
0.00%
0/6 • Up to 84 days
The APaT population consisting of all participants who received at least one dose of study drug was used for the safety analysis. AEs are presented according to the actual treatment administered (i.e., as treated). 2 participants that completed Part 2 MK-8723 10 mg/kg were re-enrolled in Part 2 MK-8723 100 mg/kg \& dosed per protocol procedure.
|
0.00%
0/10 • Up to 84 days
The APaT population consisting of all participants who received at least one dose of study drug was used for the safety analysis. AEs are presented according to the actual treatment administered (i.e., as treated). 2 participants that completed Part 2 MK-8723 10 mg/kg were re-enrolled in Part 2 MK-8723 100 mg/kg \& dosed per protocol procedure.
|
0.00%
0/3 • Up to 84 days
The APaT population consisting of all participants who received at least one dose of study drug was used for the safety analysis. AEs are presented according to the actual treatment administered (i.e., as treated). 2 participants that completed Part 2 MK-8723 10 mg/kg were re-enrolled in Part 2 MK-8723 100 mg/kg \& dosed per protocol procedure.
|
0.00%
0/2 • Up to 84 days
The APaT population consisting of all participants who received at least one dose of study drug was used for the safety analysis. AEs are presented according to the actual treatment administered (i.e., as treated). 2 participants that completed Part 2 MK-8723 10 mg/kg were re-enrolled in Part 2 MK-8723 100 mg/kg \& dosed per protocol procedure.
|
0.00%
0/3 • Up to 84 days
The APaT population consisting of all participants who received at least one dose of study drug was used for the safety analysis. AEs are presented according to the actual treatment administered (i.e., as treated). 2 participants that completed Part 2 MK-8723 10 mg/kg were re-enrolled in Part 2 MK-8723 100 mg/kg \& dosed per protocol procedure.
|
0.00%
0/4 • Up to 84 days
The APaT population consisting of all participants who received at least one dose of study drug was used for the safety analysis. AEs are presented according to the actual treatment administered (i.e., as treated). 2 participants that completed Part 2 MK-8723 10 mg/kg were re-enrolled in Part 2 MK-8723 100 mg/kg \& dosed per protocol procedure.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/6 • Up to 84 days
The APaT population consisting of all participants who received at least one dose of study drug was used for the safety analysis. AEs are presented according to the actual treatment administered (i.e., as treated). 2 participants that completed Part 2 MK-8723 10 mg/kg were re-enrolled in Part 2 MK-8723 100 mg/kg \& dosed per protocol procedure.
|
0.00%
0/6 • Up to 84 days
The APaT population consisting of all participants who received at least one dose of study drug was used for the safety analysis. AEs are presented according to the actual treatment administered (i.e., as treated). 2 participants that completed Part 2 MK-8723 10 mg/kg were re-enrolled in Part 2 MK-8723 100 mg/kg \& dosed per protocol procedure.
|
0.00%
0/6 • Up to 84 days
The APaT population consisting of all participants who received at least one dose of study drug was used for the safety analysis. AEs are presented according to the actual treatment administered (i.e., as treated). 2 participants that completed Part 2 MK-8723 10 mg/kg were re-enrolled in Part 2 MK-8723 100 mg/kg \& dosed per protocol procedure.
|
0.00%
0/6 • Up to 84 days
The APaT population consisting of all participants who received at least one dose of study drug was used for the safety analysis. AEs are presented according to the actual treatment administered (i.e., as treated). 2 participants that completed Part 2 MK-8723 10 mg/kg were re-enrolled in Part 2 MK-8723 100 mg/kg \& dosed per protocol procedure.
|
0.00%
0/6 • Up to 84 days
The APaT population consisting of all participants who received at least one dose of study drug was used for the safety analysis. AEs are presented according to the actual treatment administered (i.e., as treated). 2 participants that completed Part 2 MK-8723 10 mg/kg were re-enrolled in Part 2 MK-8723 100 mg/kg \& dosed per protocol procedure.
|
0.00%
0/10 • Up to 84 days
The APaT population consisting of all participants who received at least one dose of study drug was used for the safety analysis. AEs are presented according to the actual treatment administered (i.e., as treated). 2 participants that completed Part 2 MK-8723 10 mg/kg were re-enrolled in Part 2 MK-8723 100 mg/kg \& dosed per protocol procedure.
|
0.00%
0/3 • Up to 84 days
The APaT population consisting of all participants who received at least one dose of study drug was used for the safety analysis. AEs are presented according to the actual treatment administered (i.e., as treated). 2 participants that completed Part 2 MK-8723 10 mg/kg were re-enrolled in Part 2 MK-8723 100 mg/kg \& dosed per protocol procedure.
|
0.00%
0/2 • Up to 84 days
The APaT population consisting of all participants who received at least one dose of study drug was used for the safety analysis. AEs are presented according to the actual treatment administered (i.e., as treated). 2 participants that completed Part 2 MK-8723 10 mg/kg were re-enrolled in Part 2 MK-8723 100 mg/kg \& dosed per protocol procedure.
|
0.00%
0/3 • Up to 84 days
The APaT population consisting of all participants who received at least one dose of study drug was used for the safety analysis. AEs are presented according to the actual treatment administered (i.e., as treated). 2 participants that completed Part 2 MK-8723 10 mg/kg were re-enrolled in Part 2 MK-8723 100 mg/kg \& dosed per protocol procedure.
|
25.0%
1/4 • Number of events 1 • Up to 84 days
The APaT population consisting of all participants who received at least one dose of study drug was used for the safety analysis. AEs are presented according to the actual treatment administered (i.e., as treated). 2 participants that completed Part 2 MK-8723 10 mg/kg were re-enrolled in Part 2 MK-8723 100 mg/kg \& dosed per protocol procedure.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/6 • Up to 84 days
The APaT population consisting of all participants who received at least one dose of study drug was used for the safety analysis. AEs are presented according to the actual treatment administered (i.e., as treated). 2 participants that completed Part 2 MK-8723 10 mg/kg were re-enrolled in Part 2 MK-8723 100 mg/kg \& dosed per protocol procedure.
|
0.00%
0/6 • Up to 84 days
The APaT population consisting of all participants who received at least one dose of study drug was used for the safety analysis. AEs are presented according to the actual treatment administered (i.e., as treated). 2 participants that completed Part 2 MK-8723 10 mg/kg were re-enrolled in Part 2 MK-8723 100 mg/kg \& dosed per protocol procedure.
|
16.7%
1/6 • Number of events 1 • Up to 84 days
The APaT population consisting of all participants who received at least one dose of study drug was used for the safety analysis. AEs are presented according to the actual treatment administered (i.e., as treated). 2 participants that completed Part 2 MK-8723 10 mg/kg were re-enrolled in Part 2 MK-8723 100 mg/kg \& dosed per protocol procedure.
|
0.00%
0/6 • Up to 84 days
The APaT population consisting of all participants who received at least one dose of study drug was used for the safety analysis. AEs are presented according to the actual treatment administered (i.e., as treated). 2 participants that completed Part 2 MK-8723 10 mg/kg were re-enrolled in Part 2 MK-8723 100 mg/kg \& dosed per protocol procedure.
|
0.00%
0/6 • Up to 84 days
The APaT population consisting of all participants who received at least one dose of study drug was used for the safety analysis. AEs are presented according to the actual treatment administered (i.e., as treated). 2 participants that completed Part 2 MK-8723 10 mg/kg were re-enrolled in Part 2 MK-8723 100 mg/kg \& dosed per protocol procedure.
|
0.00%
0/10 • Up to 84 days
The APaT population consisting of all participants who received at least one dose of study drug was used for the safety analysis. AEs are presented according to the actual treatment administered (i.e., as treated). 2 participants that completed Part 2 MK-8723 10 mg/kg were re-enrolled in Part 2 MK-8723 100 mg/kg \& dosed per protocol procedure.
|
0.00%
0/3 • Up to 84 days
The APaT population consisting of all participants who received at least one dose of study drug was used for the safety analysis. AEs are presented according to the actual treatment administered (i.e., as treated). 2 participants that completed Part 2 MK-8723 10 mg/kg were re-enrolled in Part 2 MK-8723 100 mg/kg \& dosed per protocol procedure.
|
0.00%
0/2 • Up to 84 days
The APaT population consisting of all participants who received at least one dose of study drug was used for the safety analysis. AEs are presented according to the actual treatment administered (i.e., as treated). 2 participants that completed Part 2 MK-8723 10 mg/kg were re-enrolled in Part 2 MK-8723 100 mg/kg \& dosed per protocol procedure.
|
0.00%
0/3 • Up to 84 days
The APaT population consisting of all participants who received at least one dose of study drug was used for the safety analysis. AEs are presented according to the actual treatment administered (i.e., as treated). 2 participants that completed Part 2 MK-8723 10 mg/kg were re-enrolled in Part 2 MK-8723 100 mg/kg \& dosed per protocol procedure.
|
0.00%
0/4 • Up to 84 days
The APaT population consisting of all participants who received at least one dose of study drug was used for the safety analysis. AEs are presented according to the actual treatment administered (i.e., as treated). 2 participants that completed Part 2 MK-8723 10 mg/kg were re-enrolled in Part 2 MK-8723 100 mg/kg \& dosed per protocol procedure.
|
|
Musculoskeletal and connective tissue disorders
Myalgia intercostal
|
0.00%
0/6 • Up to 84 days
The APaT population consisting of all participants who received at least one dose of study drug was used for the safety analysis. AEs are presented according to the actual treatment administered (i.e., as treated). 2 participants that completed Part 2 MK-8723 10 mg/kg were re-enrolled in Part 2 MK-8723 100 mg/kg \& dosed per protocol procedure.
|
0.00%
0/6 • Up to 84 days
The APaT population consisting of all participants who received at least one dose of study drug was used for the safety analysis. AEs are presented according to the actual treatment administered (i.e., as treated). 2 participants that completed Part 2 MK-8723 10 mg/kg were re-enrolled in Part 2 MK-8723 100 mg/kg \& dosed per protocol procedure.
|
0.00%
0/6 • Up to 84 days
The APaT population consisting of all participants who received at least one dose of study drug was used for the safety analysis. AEs are presented according to the actual treatment administered (i.e., as treated). 2 participants that completed Part 2 MK-8723 10 mg/kg were re-enrolled in Part 2 MK-8723 100 mg/kg \& dosed per protocol procedure.
|
0.00%
0/6 • Up to 84 days
The APaT population consisting of all participants who received at least one dose of study drug was used for the safety analysis. AEs are presented according to the actual treatment administered (i.e., as treated). 2 participants that completed Part 2 MK-8723 10 mg/kg were re-enrolled in Part 2 MK-8723 100 mg/kg \& dosed per protocol procedure.
|
16.7%
1/6 • Number of events 1 • Up to 84 days
The APaT population consisting of all participants who received at least one dose of study drug was used for the safety analysis. AEs are presented according to the actual treatment administered (i.e., as treated). 2 participants that completed Part 2 MK-8723 10 mg/kg were re-enrolled in Part 2 MK-8723 100 mg/kg \& dosed per protocol procedure.
|
0.00%
0/10 • Up to 84 days
The APaT population consisting of all participants who received at least one dose of study drug was used for the safety analysis. AEs are presented according to the actual treatment administered (i.e., as treated). 2 participants that completed Part 2 MK-8723 10 mg/kg were re-enrolled in Part 2 MK-8723 100 mg/kg \& dosed per protocol procedure.
|
0.00%
0/3 • Up to 84 days
The APaT population consisting of all participants who received at least one dose of study drug was used for the safety analysis. AEs are presented according to the actual treatment administered (i.e., as treated). 2 participants that completed Part 2 MK-8723 10 mg/kg were re-enrolled in Part 2 MK-8723 100 mg/kg \& dosed per protocol procedure.
|
0.00%
0/2 • Up to 84 days
The APaT population consisting of all participants who received at least one dose of study drug was used for the safety analysis. AEs are presented according to the actual treatment administered (i.e., as treated). 2 participants that completed Part 2 MK-8723 10 mg/kg were re-enrolled in Part 2 MK-8723 100 mg/kg \& dosed per protocol procedure.
|
0.00%
0/3 • Up to 84 days
The APaT population consisting of all participants who received at least one dose of study drug was used for the safety analysis. AEs are presented according to the actual treatment administered (i.e., as treated). 2 participants that completed Part 2 MK-8723 10 mg/kg were re-enrolled in Part 2 MK-8723 100 mg/kg \& dosed per protocol procedure.
|
0.00%
0/4 • Up to 84 days
The APaT population consisting of all participants who received at least one dose of study drug was used for the safety analysis. AEs are presented according to the actual treatment administered (i.e., as treated). 2 participants that completed Part 2 MK-8723 10 mg/kg were re-enrolled in Part 2 MK-8723 100 mg/kg \& dosed per protocol procedure.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/6 • Up to 84 days
The APaT population consisting of all participants who received at least one dose of study drug was used for the safety analysis. AEs are presented according to the actual treatment administered (i.e., as treated). 2 participants that completed Part 2 MK-8723 10 mg/kg were re-enrolled in Part 2 MK-8723 100 mg/kg \& dosed per protocol procedure.
|
0.00%
0/6 • Up to 84 days
The APaT population consisting of all participants who received at least one dose of study drug was used for the safety analysis. AEs are presented according to the actual treatment administered (i.e., as treated). 2 participants that completed Part 2 MK-8723 10 mg/kg were re-enrolled in Part 2 MK-8723 100 mg/kg \& dosed per protocol procedure.
|
0.00%
0/6 • Up to 84 days
The APaT population consisting of all participants who received at least one dose of study drug was used for the safety analysis. AEs are presented according to the actual treatment administered (i.e., as treated). 2 participants that completed Part 2 MK-8723 10 mg/kg were re-enrolled in Part 2 MK-8723 100 mg/kg \& dosed per protocol procedure.
|
0.00%
0/6 • Up to 84 days
The APaT population consisting of all participants who received at least one dose of study drug was used for the safety analysis. AEs are presented according to the actual treatment administered (i.e., as treated). 2 participants that completed Part 2 MK-8723 10 mg/kg were re-enrolled in Part 2 MK-8723 100 mg/kg \& dosed per protocol procedure.
|
0.00%
0/6 • Up to 84 days
The APaT population consisting of all participants who received at least one dose of study drug was used for the safety analysis. AEs are presented according to the actual treatment administered (i.e., as treated). 2 participants that completed Part 2 MK-8723 10 mg/kg were re-enrolled in Part 2 MK-8723 100 mg/kg \& dosed per protocol procedure.
|
10.0%
1/10 • Number of events 1 • Up to 84 days
The APaT population consisting of all participants who received at least one dose of study drug was used for the safety analysis. AEs are presented according to the actual treatment administered (i.e., as treated). 2 participants that completed Part 2 MK-8723 10 mg/kg were re-enrolled in Part 2 MK-8723 100 mg/kg \& dosed per protocol procedure.
|
0.00%
0/3 • Up to 84 days
The APaT population consisting of all participants who received at least one dose of study drug was used for the safety analysis. AEs are presented according to the actual treatment administered (i.e., as treated). 2 participants that completed Part 2 MK-8723 10 mg/kg were re-enrolled in Part 2 MK-8723 100 mg/kg \& dosed per protocol procedure.
|
0.00%
0/2 • Up to 84 days
The APaT population consisting of all participants who received at least one dose of study drug was used for the safety analysis. AEs are presented according to the actual treatment administered (i.e., as treated). 2 participants that completed Part 2 MK-8723 10 mg/kg were re-enrolled in Part 2 MK-8723 100 mg/kg \& dosed per protocol procedure.
|
0.00%
0/3 • Up to 84 days
The APaT population consisting of all participants who received at least one dose of study drug was used for the safety analysis. AEs are presented according to the actual treatment administered (i.e., as treated). 2 participants that completed Part 2 MK-8723 10 mg/kg were re-enrolled in Part 2 MK-8723 100 mg/kg \& dosed per protocol procedure.
|
0.00%
0/4 • Up to 84 days
The APaT population consisting of all participants who received at least one dose of study drug was used for the safety analysis. AEs are presented according to the actual treatment administered (i.e., as treated). 2 participants that completed Part 2 MK-8723 10 mg/kg were re-enrolled in Part 2 MK-8723 100 mg/kg \& dosed per protocol procedure.
|
|
Nervous system disorders
Headache
|
16.7%
1/6 • Number of events 1 • Up to 84 days
The APaT population consisting of all participants who received at least one dose of study drug was used for the safety analysis. AEs are presented according to the actual treatment administered (i.e., as treated). 2 participants that completed Part 2 MK-8723 10 mg/kg were re-enrolled in Part 2 MK-8723 100 mg/kg \& dosed per protocol procedure.
|
16.7%
1/6 • Number of events 1 • Up to 84 days
The APaT population consisting of all participants who received at least one dose of study drug was used for the safety analysis. AEs are presented according to the actual treatment administered (i.e., as treated). 2 participants that completed Part 2 MK-8723 10 mg/kg were re-enrolled in Part 2 MK-8723 100 mg/kg \& dosed per protocol procedure.
|
33.3%
2/6 • Number of events 2 • Up to 84 days
The APaT population consisting of all participants who received at least one dose of study drug was used for the safety analysis. AEs are presented according to the actual treatment administered (i.e., as treated). 2 participants that completed Part 2 MK-8723 10 mg/kg were re-enrolled in Part 2 MK-8723 100 mg/kg \& dosed per protocol procedure.
|
0.00%
0/6 • Up to 84 days
The APaT population consisting of all participants who received at least one dose of study drug was used for the safety analysis. AEs are presented according to the actual treatment administered (i.e., as treated). 2 participants that completed Part 2 MK-8723 10 mg/kg were re-enrolled in Part 2 MK-8723 100 mg/kg \& dosed per protocol procedure.
|
0.00%
0/6 • Up to 84 days
The APaT population consisting of all participants who received at least one dose of study drug was used for the safety analysis. AEs are presented according to the actual treatment administered (i.e., as treated). 2 participants that completed Part 2 MK-8723 10 mg/kg were re-enrolled in Part 2 MK-8723 100 mg/kg \& dosed per protocol procedure.
|
0.00%
0/10 • Up to 84 days
The APaT population consisting of all participants who received at least one dose of study drug was used for the safety analysis. AEs are presented according to the actual treatment administered (i.e., as treated). 2 participants that completed Part 2 MK-8723 10 mg/kg were re-enrolled in Part 2 MK-8723 100 mg/kg \& dosed per protocol procedure.
|
33.3%
1/3 • Number of events 1 • Up to 84 days
The APaT population consisting of all participants who received at least one dose of study drug was used for the safety analysis. AEs are presented according to the actual treatment administered (i.e., as treated). 2 participants that completed Part 2 MK-8723 10 mg/kg were re-enrolled in Part 2 MK-8723 100 mg/kg \& dosed per protocol procedure.
|
0.00%
0/2 • Up to 84 days
The APaT population consisting of all participants who received at least one dose of study drug was used for the safety analysis. AEs are presented according to the actual treatment administered (i.e., as treated). 2 participants that completed Part 2 MK-8723 10 mg/kg were re-enrolled in Part 2 MK-8723 100 mg/kg \& dosed per protocol procedure.
|
0.00%
0/3 • Up to 84 days
The APaT population consisting of all participants who received at least one dose of study drug was used for the safety analysis. AEs are presented according to the actual treatment administered (i.e., as treated). 2 participants that completed Part 2 MK-8723 10 mg/kg were re-enrolled in Part 2 MK-8723 100 mg/kg \& dosed per protocol procedure.
|
25.0%
1/4 • Number of events 1 • Up to 84 days
The APaT population consisting of all participants who received at least one dose of study drug was used for the safety analysis. AEs are presented according to the actual treatment administered (i.e., as treated). 2 participants that completed Part 2 MK-8723 10 mg/kg were re-enrolled in Part 2 MK-8723 100 mg/kg \& dosed per protocol procedure.
|
|
Nervous system disorders
Lethargy
|
0.00%
0/6 • Up to 84 days
The APaT population consisting of all participants who received at least one dose of study drug was used for the safety analysis. AEs are presented according to the actual treatment administered (i.e., as treated). 2 participants that completed Part 2 MK-8723 10 mg/kg were re-enrolled in Part 2 MK-8723 100 mg/kg \& dosed per protocol procedure.
|
0.00%
0/6 • Up to 84 days
The APaT population consisting of all participants who received at least one dose of study drug was used for the safety analysis. AEs are presented according to the actual treatment administered (i.e., as treated). 2 participants that completed Part 2 MK-8723 10 mg/kg were re-enrolled in Part 2 MK-8723 100 mg/kg \& dosed per protocol procedure.
|
16.7%
1/6 • Number of events 1 • Up to 84 days
The APaT population consisting of all participants who received at least one dose of study drug was used for the safety analysis. AEs are presented according to the actual treatment administered (i.e., as treated). 2 participants that completed Part 2 MK-8723 10 mg/kg were re-enrolled in Part 2 MK-8723 100 mg/kg \& dosed per protocol procedure.
|
0.00%
0/6 • Up to 84 days
The APaT population consisting of all participants who received at least one dose of study drug was used for the safety analysis. AEs are presented according to the actual treatment administered (i.e., as treated). 2 participants that completed Part 2 MK-8723 10 mg/kg were re-enrolled in Part 2 MK-8723 100 mg/kg \& dosed per protocol procedure.
|
0.00%
0/6 • Up to 84 days
The APaT population consisting of all participants who received at least one dose of study drug was used for the safety analysis. AEs are presented according to the actual treatment administered (i.e., as treated). 2 participants that completed Part 2 MK-8723 10 mg/kg were re-enrolled in Part 2 MK-8723 100 mg/kg \& dosed per protocol procedure.
|
0.00%
0/10 • Up to 84 days
The APaT population consisting of all participants who received at least one dose of study drug was used for the safety analysis. AEs are presented according to the actual treatment administered (i.e., as treated). 2 participants that completed Part 2 MK-8723 10 mg/kg were re-enrolled in Part 2 MK-8723 100 mg/kg \& dosed per protocol procedure.
|
0.00%
0/3 • Up to 84 days
The APaT population consisting of all participants who received at least one dose of study drug was used for the safety analysis. AEs are presented according to the actual treatment administered (i.e., as treated). 2 participants that completed Part 2 MK-8723 10 mg/kg were re-enrolled in Part 2 MK-8723 100 mg/kg \& dosed per protocol procedure.
|
0.00%
0/2 • Up to 84 days
The APaT population consisting of all participants who received at least one dose of study drug was used for the safety analysis. AEs are presented according to the actual treatment administered (i.e., as treated). 2 participants that completed Part 2 MK-8723 10 mg/kg were re-enrolled in Part 2 MK-8723 100 mg/kg \& dosed per protocol procedure.
|
0.00%
0/3 • Up to 84 days
The APaT population consisting of all participants who received at least one dose of study drug was used for the safety analysis. AEs are presented according to the actual treatment administered (i.e., as treated). 2 participants that completed Part 2 MK-8723 10 mg/kg were re-enrolled in Part 2 MK-8723 100 mg/kg \& dosed per protocol procedure.
|
0.00%
0/4 • Up to 84 days
The APaT population consisting of all participants who received at least one dose of study drug was used for the safety analysis. AEs are presented according to the actual treatment administered (i.e., as treated). 2 participants that completed Part 2 MK-8723 10 mg/kg were re-enrolled in Part 2 MK-8723 100 mg/kg \& dosed per protocol procedure.
|
|
Nervous system disorders
Presyncope
|
0.00%
0/6 • Up to 84 days
The APaT population consisting of all participants who received at least one dose of study drug was used for the safety analysis. AEs are presented according to the actual treatment administered (i.e., as treated). 2 participants that completed Part 2 MK-8723 10 mg/kg were re-enrolled in Part 2 MK-8723 100 mg/kg \& dosed per protocol procedure.
|
0.00%
0/6 • Up to 84 days
The APaT population consisting of all participants who received at least one dose of study drug was used for the safety analysis. AEs are presented according to the actual treatment administered (i.e., as treated). 2 participants that completed Part 2 MK-8723 10 mg/kg were re-enrolled in Part 2 MK-8723 100 mg/kg \& dosed per protocol procedure.
|
0.00%
0/6 • Up to 84 days
The APaT population consisting of all participants who received at least one dose of study drug was used for the safety analysis. AEs are presented according to the actual treatment administered (i.e., as treated). 2 participants that completed Part 2 MK-8723 10 mg/kg were re-enrolled in Part 2 MK-8723 100 mg/kg \& dosed per protocol procedure.
|
0.00%
0/6 • Up to 84 days
The APaT population consisting of all participants who received at least one dose of study drug was used for the safety analysis. AEs are presented according to the actual treatment administered (i.e., as treated). 2 participants that completed Part 2 MK-8723 10 mg/kg were re-enrolled in Part 2 MK-8723 100 mg/kg \& dosed per protocol procedure.
|
16.7%
1/6 • Number of events 1 • Up to 84 days
The APaT population consisting of all participants who received at least one dose of study drug was used for the safety analysis. AEs are presented according to the actual treatment administered (i.e., as treated). 2 participants that completed Part 2 MK-8723 10 mg/kg were re-enrolled in Part 2 MK-8723 100 mg/kg \& dosed per protocol procedure.
|
0.00%
0/10 • Up to 84 days
The APaT population consisting of all participants who received at least one dose of study drug was used for the safety analysis. AEs are presented according to the actual treatment administered (i.e., as treated). 2 participants that completed Part 2 MK-8723 10 mg/kg were re-enrolled in Part 2 MK-8723 100 mg/kg \& dosed per protocol procedure.
|
0.00%
0/3 • Up to 84 days
The APaT population consisting of all participants who received at least one dose of study drug was used for the safety analysis. AEs are presented according to the actual treatment administered (i.e., as treated). 2 participants that completed Part 2 MK-8723 10 mg/kg were re-enrolled in Part 2 MK-8723 100 mg/kg \& dosed per protocol procedure.
|
0.00%
0/2 • Up to 84 days
The APaT population consisting of all participants who received at least one dose of study drug was used for the safety analysis. AEs are presented according to the actual treatment administered (i.e., as treated). 2 participants that completed Part 2 MK-8723 10 mg/kg were re-enrolled in Part 2 MK-8723 100 mg/kg \& dosed per protocol procedure.
|
0.00%
0/3 • Up to 84 days
The APaT population consisting of all participants who received at least one dose of study drug was used for the safety analysis. AEs are presented according to the actual treatment administered (i.e., as treated). 2 participants that completed Part 2 MK-8723 10 mg/kg were re-enrolled in Part 2 MK-8723 100 mg/kg \& dosed per protocol procedure.
|
0.00%
0/4 • Up to 84 days
The APaT population consisting of all participants who received at least one dose of study drug was used for the safety analysis. AEs are presented according to the actual treatment administered (i.e., as treated). 2 participants that completed Part 2 MK-8723 10 mg/kg were re-enrolled in Part 2 MK-8723 100 mg/kg \& dosed per protocol procedure.
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/6 • Up to 84 days
The APaT population consisting of all participants who received at least one dose of study drug was used for the safety analysis. AEs are presented according to the actual treatment administered (i.e., as treated). 2 participants that completed Part 2 MK-8723 10 mg/kg were re-enrolled in Part 2 MK-8723 100 mg/kg \& dosed per protocol procedure.
|
0.00%
0/6 • Up to 84 days
The APaT population consisting of all participants who received at least one dose of study drug was used for the safety analysis. AEs are presented according to the actual treatment administered (i.e., as treated). 2 participants that completed Part 2 MK-8723 10 mg/kg were re-enrolled in Part 2 MK-8723 100 mg/kg \& dosed per protocol procedure.
|
0.00%
0/6 • Up to 84 days
The APaT population consisting of all participants who received at least one dose of study drug was used for the safety analysis. AEs are presented according to the actual treatment administered (i.e., as treated). 2 participants that completed Part 2 MK-8723 10 mg/kg were re-enrolled in Part 2 MK-8723 100 mg/kg \& dosed per protocol procedure.
|
0.00%
0/6 • Up to 84 days
The APaT population consisting of all participants who received at least one dose of study drug was used for the safety analysis. AEs are presented according to the actual treatment administered (i.e., as treated). 2 participants that completed Part 2 MK-8723 10 mg/kg were re-enrolled in Part 2 MK-8723 100 mg/kg \& dosed per protocol procedure.
|
0.00%
0/6 • Up to 84 days
The APaT population consisting of all participants who received at least one dose of study drug was used for the safety analysis. AEs are presented according to the actual treatment administered (i.e., as treated). 2 participants that completed Part 2 MK-8723 10 mg/kg were re-enrolled in Part 2 MK-8723 100 mg/kg \& dosed per protocol procedure.
|
10.0%
1/10 • Number of events 1 • Up to 84 days
The APaT population consisting of all participants who received at least one dose of study drug was used for the safety analysis. AEs are presented according to the actual treatment administered (i.e., as treated). 2 participants that completed Part 2 MK-8723 10 mg/kg were re-enrolled in Part 2 MK-8723 100 mg/kg \& dosed per protocol procedure.
|
0.00%
0/3 • Up to 84 days
The APaT population consisting of all participants who received at least one dose of study drug was used for the safety analysis. AEs are presented according to the actual treatment administered (i.e., as treated). 2 participants that completed Part 2 MK-8723 10 mg/kg were re-enrolled in Part 2 MK-8723 100 mg/kg \& dosed per protocol procedure.
|
0.00%
0/2 • Up to 84 days
The APaT population consisting of all participants who received at least one dose of study drug was used for the safety analysis. AEs are presented according to the actual treatment administered (i.e., as treated). 2 participants that completed Part 2 MK-8723 10 mg/kg were re-enrolled in Part 2 MK-8723 100 mg/kg \& dosed per protocol procedure.
|
0.00%
0/3 • Up to 84 days
The APaT population consisting of all participants who received at least one dose of study drug was used for the safety analysis. AEs are presented according to the actual treatment administered (i.e., as treated). 2 participants that completed Part 2 MK-8723 10 mg/kg were re-enrolled in Part 2 MK-8723 100 mg/kg \& dosed per protocol procedure.
|
0.00%
0/4 • Up to 84 days
The APaT population consisting of all participants who received at least one dose of study drug was used for the safety analysis. AEs are presented according to the actual treatment administered (i.e., as treated). 2 participants that completed Part 2 MK-8723 10 mg/kg were re-enrolled in Part 2 MK-8723 100 mg/kg \& dosed per protocol procedure.
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/6 • Up to 84 days
The APaT population consisting of all participants who received at least one dose of study drug was used for the safety analysis. AEs are presented according to the actual treatment administered (i.e., as treated). 2 participants that completed Part 2 MK-8723 10 mg/kg were re-enrolled in Part 2 MK-8723 100 mg/kg \& dosed per protocol procedure.
|
0.00%
0/6 • Up to 84 days
The APaT population consisting of all participants who received at least one dose of study drug was used for the safety analysis. AEs are presented according to the actual treatment administered (i.e., as treated). 2 participants that completed Part 2 MK-8723 10 mg/kg were re-enrolled in Part 2 MK-8723 100 mg/kg \& dosed per protocol procedure.
|
0.00%
0/6 • Up to 84 days
The APaT population consisting of all participants who received at least one dose of study drug was used for the safety analysis. AEs are presented according to the actual treatment administered (i.e., as treated). 2 participants that completed Part 2 MK-8723 10 mg/kg were re-enrolled in Part 2 MK-8723 100 mg/kg \& dosed per protocol procedure.
|
0.00%
0/6 • Up to 84 days
The APaT population consisting of all participants who received at least one dose of study drug was used for the safety analysis. AEs are presented according to the actual treatment administered (i.e., as treated). 2 participants that completed Part 2 MK-8723 10 mg/kg were re-enrolled in Part 2 MK-8723 100 mg/kg \& dosed per protocol procedure.
|
0.00%
0/6 • Up to 84 days
The APaT population consisting of all participants who received at least one dose of study drug was used for the safety analysis. AEs are presented according to the actual treatment administered (i.e., as treated). 2 participants that completed Part 2 MK-8723 10 mg/kg were re-enrolled in Part 2 MK-8723 100 mg/kg \& dosed per protocol procedure.
|
10.0%
1/10 • Number of events 1 • Up to 84 days
The APaT population consisting of all participants who received at least one dose of study drug was used for the safety analysis. AEs are presented according to the actual treatment administered (i.e., as treated). 2 participants that completed Part 2 MK-8723 10 mg/kg were re-enrolled in Part 2 MK-8723 100 mg/kg \& dosed per protocol procedure.
|
0.00%
0/3 • Up to 84 days
The APaT population consisting of all participants who received at least one dose of study drug was used for the safety analysis. AEs are presented according to the actual treatment administered (i.e., as treated). 2 participants that completed Part 2 MK-8723 10 mg/kg were re-enrolled in Part 2 MK-8723 100 mg/kg \& dosed per protocol procedure.
|
0.00%
0/2 • Up to 84 days
The APaT population consisting of all participants who received at least one dose of study drug was used for the safety analysis. AEs are presented according to the actual treatment administered (i.e., as treated). 2 participants that completed Part 2 MK-8723 10 mg/kg were re-enrolled in Part 2 MK-8723 100 mg/kg \& dosed per protocol procedure.
|
0.00%
0/3 • Up to 84 days
The APaT population consisting of all participants who received at least one dose of study drug was used for the safety analysis. AEs are presented according to the actual treatment administered (i.e., as treated). 2 participants that completed Part 2 MK-8723 10 mg/kg were re-enrolled in Part 2 MK-8723 100 mg/kg \& dosed per protocol procedure.
|
0.00%
0/4 • Up to 84 days
The APaT population consisting of all participants who received at least one dose of study drug was used for the safety analysis. AEs are presented according to the actual treatment administered (i.e., as treated). 2 participants that completed Part 2 MK-8723 10 mg/kg were re-enrolled in Part 2 MK-8723 100 mg/kg \& dosed per protocol procedure.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.00%
0/6 • Up to 84 days
The APaT population consisting of all participants who received at least one dose of study drug was used for the safety analysis. AEs are presented according to the actual treatment administered (i.e., as treated). 2 participants that completed Part 2 MK-8723 10 mg/kg were re-enrolled in Part 2 MK-8723 100 mg/kg \& dosed per protocol procedure.
|
0.00%
0/6 • Up to 84 days
The APaT population consisting of all participants who received at least one dose of study drug was used for the safety analysis. AEs are presented according to the actual treatment administered (i.e., as treated). 2 participants that completed Part 2 MK-8723 10 mg/kg were re-enrolled in Part 2 MK-8723 100 mg/kg \& dosed per protocol procedure.
|
0.00%
0/6 • Up to 84 days
The APaT population consisting of all participants who received at least one dose of study drug was used for the safety analysis. AEs are presented according to the actual treatment administered (i.e., as treated). 2 participants that completed Part 2 MK-8723 10 mg/kg were re-enrolled in Part 2 MK-8723 100 mg/kg \& dosed per protocol procedure.
|
0.00%
0/6 • Up to 84 days
The APaT population consisting of all participants who received at least one dose of study drug was used for the safety analysis. AEs are presented according to the actual treatment administered (i.e., as treated). 2 participants that completed Part 2 MK-8723 10 mg/kg were re-enrolled in Part 2 MK-8723 100 mg/kg \& dosed per protocol procedure.
|
0.00%
0/6 • Up to 84 days
The APaT population consisting of all participants who received at least one dose of study drug was used for the safety analysis. AEs are presented according to the actual treatment administered (i.e., as treated). 2 participants that completed Part 2 MK-8723 10 mg/kg were re-enrolled in Part 2 MK-8723 100 mg/kg \& dosed per protocol procedure.
|
10.0%
1/10 • Number of events 1 • Up to 84 days
The APaT population consisting of all participants who received at least one dose of study drug was used for the safety analysis. AEs are presented according to the actual treatment administered (i.e., as treated). 2 participants that completed Part 2 MK-8723 10 mg/kg were re-enrolled in Part 2 MK-8723 100 mg/kg \& dosed per protocol procedure.
|
0.00%
0/3 • Up to 84 days
The APaT population consisting of all participants who received at least one dose of study drug was used for the safety analysis. AEs are presented according to the actual treatment administered (i.e., as treated). 2 participants that completed Part 2 MK-8723 10 mg/kg were re-enrolled in Part 2 MK-8723 100 mg/kg \& dosed per protocol procedure.
|
0.00%
0/2 • Up to 84 days
The APaT population consisting of all participants who received at least one dose of study drug was used for the safety analysis. AEs are presented according to the actual treatment administered (i.e., as treated). 2 participants that completed Part 2 MK-8723 10 mg/kg were re-enrolled in Part 2 MK-8723 100 mg/kg \& dosed per protocol procedure.
|
0.00%
0/3 • Up to 84 days
The APaT population consisting of all participants who received at least one dose of study drug was used for the safety analysis. AEs are presented according to the actual treatment administered (i.e., as treated). 2 participants that completed Part 2 MK-8723 10 mg/kg were re-enrolled in Part 2 MK-8723 100 mg/kg \& dosed per protocol procedure.
|
0.00%
0/4 • Up to 84 days
The APaT population consisting of all participants who received at least one dose of study drug was used for the safety analysis. AEs are presented according to the actual treatment administered (i.e., as treated). 2 participants that completed Part 2 MK-8723 10 mg/kg were re-enrolled in Part 2 MK-8723 100 mg/kg \& dosed per protocol procedure.
|
|
Skin and subcutaneous tissue disorders
Blood blister
|
0.00%
0/6 • Up to 84 days
The APaT population consisting of all participants who received at least one dose of study drug was used for the safety analysis. AEs are presented according to the actual treatment administered (i.e., as treated). 2 participants that completed Part 2 MK-8723 10 mg/kg were re-enrolled in Part 2 MK-8723 100 mg/kg \& dosed per protocol procedure.
|
0.00%
0/6 • Up to 84 days
The APaT population consisting of all participants who received at least one dose of study drug was used for the safety analysis. AEs are presented according to the actual treatment administered (i.e., as treated). 2 participants that completed Part 2 MK-8723 10 mg/kg were re-enrolled in Part 2 MK-8723 100 mg/kg \& dosed per protocol procedure.
|
0.00%
0/6 • Up to 84 days
The APaT population consisting of all participants who received at least one dose of study drug was used for the safety analysis. AEs are presented according to the actual treatment administered (i.e., as treated). 2 participants that completed Part 2 MK-8723 10 mg/kg were re-enrolled in Part 2 MK-8723 100 mg/kg \& dosed per protocol procedure.
|
0.00%
0/6 • Up to 84 days
The APaT population consisting of all participants who received at least one dose of study drug was used for the safety analysis. AEs are presented according to the actual treatment administered (i.e., as treated). 2 participants that completed Part 2 MK-8723 10 mg/kg were re-enrolled in Part 2 MK-8723 100 mg/kg \& dosed per protocol procedure.
|
16.7%
1/6 • Number of events 1 • Up to 84 days
The APaT population consisting of all participants who received at least one dose of study drug was used for the safety analysis. AEs are presented according to the actual treatment administered (i.e., as treated). 2 participants that completed Part 2 MK-8723 10 mg/kg were re-enrolled in Part 2 MK-8723 100 mg/kg \& dosed per protocol procedure.
|
0.00%
0/10 • Up to 84 days
The APaT population consisting of all participants who received at least one dose of study drug was used for the safety analysis. AEs are presented according to the actual treatment administered (i.e., as treated). 2 participants that completed Part 2 MK-8723 10 mg/kg were re-enrolled in Part 2 MK-8723 100 mg/kg \& dosed per protocol procedure.
|
0.00%
0/3 • Up to 84 days
The APaT population consisting of all participants who received at least one dose of study drug was used for the safety analysis. AEs are presented according to the actual treatment administered (i.e., as treated). 2 participants that completed Part 2 MK-8723 10 mg/kg were re-enrolled in Part 2 MK-8723 100 mg/kg \& dosed per protocol procedure.
|
0.00%
0/2 • Up to 84 days
The APaT population consisting of all participants who received at least one dose of study drug was used for the safety analysis. AEs are presented according to the actual treatment administered (i.e., as treated). 2 participants that completed Part 2 MK-8723 10 mg/kg were re-enrolled in Part 2 MK-8723 100 mg/kg \& dosed per protocol procedure.
|
0.00%
0/3 • Up to 84 days
The APaT population consisting of all participants who received at least one dose of study drug was used for the safety analysis. AEs are presented according to the actual treatment administered (i.e., as treated). 2 participants that completed Part 2 MK-8723 10 mg/kg were re-enrolled in Part 2 MK-8723 100 mg/kg \& dosed per protocol procedure.
|
0.00%
0/4 • Up to 84 days
The APaT population consisting of all participants who received at least one dose of study drug was used for the safety analysis. AEs are presented according to the actual treatment administered (i.e., as treated). 2 participants that completed Part 2 MK-8723 10 mg/kg were re-enrolled in Part 2 MK-8723 100 mg/kg \& dosed per protocol procedure.
|
|
Skin and subcutaneous tissue disorders
Dermatitis contact
|
0.00%
0/6 • Up to 84 days
The APaT population consisting of all participants who received at least one dose of study drug was used for the safety analysis. AEs are presented according to the actual treatment administered (i.e., as treated). 2 participants that completed Part 2 MK-8723 10 mg/kg were re-enrolled in Part 2 MK-8723 100 mg/kg \& dosed per protocol procedure.
|
0.00%
0/6 • Up to 84 days
The APaT population consisting of all participants who received at least one dose of study drug was used for the safety analysis. AEs are presented according to the actual treatment administered (i.e., as treated). 2 participants that completed Part 2 MK-8723 10 mg/kg were re-enrolled in Part 2 MK-8723 100 mg/kg \& dosed per protocol procedure.
|
16.7%
1/6 • Number of events 1 • Up to 84 days
The APaT population consisting of all participants who received at least one dose of study drug was used for the safety analysis. AEs are presented according to the actual treatment administered (i.e., as treated). 2 participants that completed Part 2 MK-8723 10 mg/kg were re-enrolled in Part 2 MK-8723 100 mg/kg \& dosed per protocol procedure.
|
0.00%
0/6 • Up to 84 days
The APaT population consisting of all participants who received at least one dose of study drug was used for the safety analysis. AEs are presented according to the actual treatment administered (i.e., as treated). 2 participants that completed Part 2 MK-8723 10 mg/kg were re-enrolled in Part 2 MK-8723 100 mg/kg \& dosed per protocol procedure.
|
0.00%
0/6 • Up to 84 days
The APaT population consisting of all participants who received at least one dose of study drug was used for the safety analysis. AEs are presented according to the actual treatment administered (i.e., as treated). 2 participants that completed Part 2 MK-8723 10 mg/kg were re-enrolled in Part 2 MK-8723 100 mg/kg \& dosed per protocol procedure.
|
0.00%
0/10 • Up to 84 days
The APaT population consisting of all participants who received at least one dose of study drug was used for the safety analysis. AEs are presented according to the actual treatment administered (i.e., as treated). 2 participants that completed Part 2 MK-8723 10 mg/kg were re-enrolled in Part 2 MK-8723 100 mg/kg \& dosed per protocol procedure.
|
0.00%
0/3 • Up to 84 days
The APaT population consisting of all participants who received at least one dose of study drug was used for the safety analysis. AEs are presented according to the actual treatment administered (i.e., as treated). 2 participants that completed Part 2 MK-8723 10 mg/kg were re-enrolled in Part 2 MK-8723 100 mg/kg \& dosed per protocol procedure.
|
0.00%
0/2 • Up to 84 days
The APaT population consisting of all participants who received at least one dose of study drug was used for the safety analysis. AEs are presented according to the actual treatment administered (i.e., as treated). 2 participants that completed Part 2 MK-8723 10 mg/kg were re-enrolled in Part 2 MK-8723 100 mg/kg \& dosed per protocol procedure.
|
0.00%
0/3 • Up to 84 days
The APaT population consisting of all participants who received at least one dose of study drug was used for the safety analysis. AEs are presented according to the actual treatment administered (i.e., as treated). 2 participants that completed Part 2 MK-8723 10 mg/kg were re-enrolled in Part 2 MK-8723 100 mg/kg \& dosed per protocol procedure.
|
0.00%
0/4 • Up to 84 days
The APaT population consisting of all participants who received at least one dose of study drug was used for the safety analysis. AEs are presented according to the actual treatment administered (i.e., as treated). 2 participants that completed Part 2 MK-8723 10 mg/kg were re-enrolled in Part 2 MK-8723 100 mg/kg \& dosed per protocol procedure.
|
|
Skin and subcutaneous tissue disorders
Swelling face
|
0.00%
0/6 • Up to 84 days
The APaT population consisting of all participants who received at least one dose of study drug was used for the safety analysis. AEs are presented according to the actual treatment administered (i.e., as treated). 2 participants that completed Part 2 MK-8723 10 mg/kg were re-enrolled in Part 2 MK-8723 100 mg/kg \& dosed per protocol procedure.
|
0.00%
0/6 • Up to 84 days
The APaT population consisting of all participants who received at least one dose of study drug was used for the safety analysis. AEs are presented according to the actual treatment administered (i.e., as treated). 2 participants that completed Part 2 MK-8723 10 mg/kg were re-enrolled in Part 2 MK-8723 100 mg/kg \& dosed per protocol procedure.
|
0.00%
0/6 • Up to 84 days
The APaT population consisting of all participants who received at least one dose of study drug was used for the safety analysis. AEs are presented according to the actual treatment administered (i.e., as treated). 2 participants that completed Part 2 MK-8723 10 mg/kg were re-enrolled in Part 2 MK-8723 100 mg/kg \& dosed per protocol procedure.
|
16.7%
1/6 • Number of events 1 • Up to 84 days
The APaT population consisting of all participants who received at least one dose of study drug was used for the safety analysis. AEs are presented according to the actual treatment administered (i.e., as treated). 2 participants that completed Part 2 MK-8723 10 mg/kg were re-enrolled in Part 2 MK-8723 100 mg/kg \& dosed per protocol procedure.
|
0.00%
0/6 • Up to 84 days
The APaT population consisting of all participants who received at least one dose of study drug was used for the safety analysis. AEs are presented according to the actual treatment administered (i.e., as treated). 2 participants that completed Part 2 MK-8723 10 mg/kg were re-enrolled in Part 2 MK-8723 100 mg/kg \& dosed per protocol procedure.
|
0.00%
0/10 • Up to 84 days
The APaT population consisting of all participants who received at least one dose of study drug was used for the safety analysis. AEs are presented according to the actual treatment administered (i.e., as treated). 2 participants that completed Part 2 MK-8723 10 mg/kg were re-enrolled in Part 2 MK-8723 100 mg/kg \& dosed per protocol procedure.
|
0.00%
0/3 • Up to 84 days
The APaT population consisting of all participants who received at least one dose of study drug was used for the safety analysis. AEs are presented according to the actual treatment administered (i.e., as treated). 2 participants that completed Part 2 MK-8723 10 mg/kg were re-enrolled in Part 2 MK-8723 100 mg/kg \& dosed per protocol procedure.
|
0.00%
0/2 • Up to 84 days
The APaT population consisting of all participants who received at least one dose of study drug was used for the safety analysis. AEs are presented according to the actual treatment administered (i.e., as treated). 2 participants that completed Part 2 MK-8723 10 mg/kg were re-enrolled in Part 2 MK-8723 100 mg/kg \& dosed per protocol procedure.
|
0.00%
0/3 • Up to 84 days
The APaT population consisting of all participants who received at least one dose of study drug was used for the safety analysis. AEs are presented according to the actual treatment administered (i.e., as treated). 2 participants that completed Part 2 MK-8723 10 mg/kg were re-enrolled in Part 2 MK-8723 100 mg/kg \& dosed per protocol procedure.
|
0.00%
0/4 • Up to 84 days
The APaT population consisting of all participants who received at least one dose of study drug was used for the safety analysis. AEs are presented according to the actual treatment administered (i.e., as treated). 2 participants that completed Part 2 MK-8723 10 mg/kg were re-enrolled in Part 2 MK-8723 100 mg/kg \& dosed per protocol procedure.
|
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