Trial Outcomes & Findings for Safety, Tolerability, and Pharmacokinetics of MK-8266 in Elderly Participants With High Blood Pressure (MK-8266-003) (NCT NCT01263314)
NCT ID: NCT01263314
Last Updated: 2018-11-05
Results Overview
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
16 participants
Primary outcome timeframe
Up to 48 days
Results posted on
2018-11-05
Participant Flow
All participants will receive at least 2 doses of MK-8266. Participants completing placebo treatment in Period 1 will flow to the MK-8266 arm in the next period, with 2 participants from the MK-8266 arm receiving placebo in the next period.
Participant milestones
| Measure |
Panel A (Elderly Males, Mild/Moderate Hypertension) Sequence 1
Period 1: MK-8266 0.3 mg; Period 2: MK-8266 0.6 mg; and Period 3: placebo.
|
Panel A (Elderly Males, Mild/Moderate Hypertension) Sequence 2
Period 1: MK-8266 0.3 mg; Period 2: MK-8266 0.6 mg; and Period 3: MK-8266 0.7 mg and then 0.3 mg after 10 hours.
|
Panel A (Elderly Males, Mild/Moderate Hypertension) Sequence 3
Period 1: MK-8266 0.3 mg; Period 2: placebo; and Period 3: MK-8266 0.7 mg and then 0.3 mg after 10 hours.
|
Panel A (Elderly Males, Mild/Moderate Hypertension) Sequence 4
Period 1: placebo; Period 2: MK-8266 0.6 mg; and Period 3: MK-8266 0.7 mg and then 0.3 mg after 10 hours.
|
Panel B (Elderly Females, Mild/Moderate Hypertension) Seq. 1
Period 1: MK-8266 0.3 mg; Period 2: placebo; and Period 3: MK-8266 0.7 mg and then 0.3 mg after 10 hours.
|
Panel B (Elderly Females, Mild/Moderate Hypertension) Seq. 2
Period 1: MK-8266 0.3 mg; Period 2: MK-8266 0.6 mg; and Period 3: placebo.
|
Panel B (Elderly Females, Mild/Moderate Hypertension) Seq. 3
Period 1: MK-8266 0.3 mg; Period 2: MK-8266 0.6 mg; and Period 3: MK-8266 0.7 mg and then 0.3 mg after 10 hours.
|
Panel B (Elderly Females, Mild/Moderate Hypertension) Seq. 4
Period 1: placebo; Period 2: MK-8266 0.6 mg; and Period 3: MK-8266 0.7 mg and then 0.3 mg after 10 hours.
|
|---|---|---|---|---|---|---|---|---|
|
Period 1
STARTED
|
2
|
2
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2
|
2
|
2
|
2
|
2
|
2
|
|
Period 1
COMPLETED
|
2
|
2
|
2
|
2
|
2
|
2
|
2
|
2
|
|
Period 1
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Period 2
STARTED
|
2
|
2
|
2
|
2
|
2
|
2
|
2
|
2
|
|
Period 2
COMPLETED
|
2
|
2
|
2
|
2
|
2
|
2
|
2
|
2
|
|
Period 2
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Period 3
STARTED
|
2
|
2
|
2
|
2
|
2
|
2
|
2
|
2
|
|
Period 3
COMPLETED
|
2
|
2
|
2
|
2
|
2
|
2
|
2
|
2
|
|
Period 3
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Safety, Tolerability, and Pharmacokinetics of MK-8266 in Elderly Participants With High Blood Pressure (MK-8266-003)
Baseline characteristics by cohort
| Measure |
Panel A (Elderly Males, Mild/Moderate Hypertension)
n=8 Participants
MK-8266 (0.3 mg, 0.6 mg, or 0.7 mg and then 0.3 mg after 10 hours) or placebo
|
Panel B (Elderly Females, Mild/Moderate Hypertension)
n=8 Participants
MK-8266 (0.3 mg, 0.6 mg, or 0.7 mg and then 0.3 mg after 10 hours) or placebo
|
Total
n=16 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
68.0 Years
STANDARD_DEVIATION 2.8 • n=5 Participants
|
68.9 Years
STANDARD_DEVIATION 2.8 • n=7 Participants
|
68.4 Years
STANDARD_DEVIATION 2.7 • n=5 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Up to 48 daysPopulation: All participants who received at least one dose of the investigational drug.
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study.
Outcome measures
| Measure |
Panel A MK-8266 0.3 mg (Elderly Males With Mild/Moderate HTN)
n=6 Participants
MK-8266 single dose 0.3 mg
Hypertension (HTN)
|
Panel A MK-8266 0.6 mg (Elderly Males With Mild/Moderate HTN)
n=6 Participants
MK-8266 single dose 0.6 mg
|
Panel A MK-8266 0.7 /0.3 mg (Elderly Males, Mild/Moderate HTN)
n=6 Participants
MK-8266 0.7 mg and then 0.3 mg after 10 hours
|
Panel A Placebo to MK-8266 (Elderly Males, Mild/Moderate HTN)
n=6 Participants
Placebo to MK-8266 single dose
|
Panel B MK-8266 0.3 mg (Elderly Females, Mild/Moderate HTN)
n=6 Participants
MK-8266 single dose 0.3 mg
|
Panel B MK-8266 0.6 mg (Elderly Females, Mild/Moderate HTN)
n=6 Participants
MK-8266 single dose 0.6 mg
|
Panel B MK-8266 0.7/0.3 mg (Elderly Fem., Mild/Moderate HTN)
n=6 Participants
MK-8266 0.7 mg and then 0.3 mg after 10 hours
|
Panel B Placebo to MK-8266 (Elderly Fem., Mild/Moderate HTN)
n=6 Participants
Placebo to MK-8266 single dose
|
|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Adverse Events (AEs)
|
4 Participants
|
4 Participants
|
3 Participants
|
1 Participants
|
5 Participants
|
4 Participants
|
4 Participants
|
4 Participants
|
PRIMARY outcome
Timeframe: Up to 48 daysPopulation: All participants who received at least one dose of the investigational drug.
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. Abnormal laboratory hematology value was any AE reported under the System Organ Class of Investigations that was related to an abnormal laboratory hematology value.
Outcome measures
| Measure |
Panel A MK-8266 0.3 mg (Elderly Males With Mild/Moderate HTN)
n=6 Participants
MK-8266 single dose 0.3 mg
Hypertension (HTN)
|
Panel A MK-8266 0.6 mg (Elderly Males With Mild/Moderate HTN)
n=6 Participants
MK-8266 single dose 0.6 mg
|
Panel A MK-8266 0.7 /0.3 mg (Elderly Males, Mild/Moderate HTN)
n=6 Participants
MK-8266 0.7 mg and then 0.3 mg after 10 hours
|
Panel A Placebo to MK-8266 (Elderly Males, Mild/Moderate HTN)
n=6 Participants
Placebo to MK-8266 single dose
|
Panel B MK-8266 0.3 mg (Elderly Females, Mild/Moderate HTN)
n=6 Participants
MK-8266 single dose 0.3 mg
|
Panel B MK-8266 0.6 mg (Elderly Females, Mild/Moderate HTN)
n=6 Participants
MK-8266 single dose 0.6 mg
|
Panel B MK-8266 0.7/0.3 mg (Elderly Fem., Mild/Moderate HTN)
n=6 Participants
MK-8266 0.7 mg and then 0.3 mg after 10 hours
|
Panel B Placebo to MK-8266 (Elderly Fem., Mild/Moderate HTN)
n=6 Participants
Placebo to MK-8266 single dose
|
|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Abnormal Laboratory Hematology Values Reported as an AE
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Up to 48 daysPopulation: All participants who received at least one dose of the investigational drug.
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. Abnormal laboratory chemistry value was any AE reported under the System Organ Class of Investigations that was related to an abnormal laboratory chemistry value.
Outcome measures
| Measure |
Panel A MK-8266 0.3 mg (Elderly Males With Mild/Moderate HTN)
n=6 Participants
MK-8266 single dose 0.3 mg
Hypertension (HTN)
|
Panel A MK-8266 0.6 mg (Elderly Males With Mild/Moderate HTN)
n=6 Participants
MK-8266 single dose 0.6 mg
|
Panel A MK-8266 0.7 /0.3 mg (Elderly Males, Mild/Moderate HTN)
n=6 Participants
MK-8266 0.7 mg and then 0.3 mg after 10 hours
|
Panel A Placebo to MK-8266 (Elderly Males, Mild/Moderate HTN)
n=6 Participants
Placebo to MK-8266 single dose
|
Panel B MK-8266 0.3 mg (Elderly Females, Mild/Moderate HTN)
n=6 Participants
MK-8266 single dose 0.3 mg
|
Panel B MK-8266 0.6 mg (Elderly Females, Mild/Moderate HTN)
n=6 Participants
MK-8266 single dose 0.6 mg
|
Panel B MK-8266 0.7/0.3 mg (Elderly Fem., Mild/Moderate HTN)
n=6 Participants
MK-8266 0.7 mg and then 0.3 mg after 10 hours
|
Panel B Placebo to MK-8266 (Elderly Fem., Mild/Moderate HTN)
n=6 Participants
Placebo to MK-8266 single dose
|
|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Abnormal Laboratory Chemistry Values Reported as an AE
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Up to 37 daysPopulation: All participants who received at least one dose of the investigational drug.
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. Abnormal laboratory urinalysis value was any AE reported under the System Organ Class of Investigations that was related to an abnormal laboratory urinalysis value.
Outcome measures
| Measure |
Panel A MK-8266 0.3 mg (Elderly Males With Mild/Moderate HTN)
n=6 Participants
MK-8266 single dose 0.3 mg
Hypertension (HTN)
|
Panel A MK-8266 0.6 mg (Elderly Males With Mild/Moderate HTN)
n=6 Participants
MK-8266 single dose 0.6 mg
|
Panel A MK-8266 0.7 /0.3 mg (Elderly Males, Mild/Moderate HTN)
n=6 Participants
MK-8266 0.7 mg and then 0.3 mg after 10 hours
|
Panel A Placebo to MK-8266 (Elderly Males, Mild/Moderate HTN)
n=6 Participants
Placebo to MK-8266 single dose
|
Panel B MK-8266 0.3 mg (Elderly Females, Mild/Moderate HTN)
n=6 Participants
MK-8266 single dose 0.3 mg
|
Panel B MK-8266 0.6 mg (Elderly Females, Mild/Moderate HTN)
n=6 Participants
MK-8266 single dose 0.6 mg
|
Panel B MK-8266 0.7/0.3 mg (Elderly Fem., Mild/Moderate HTN)
n=6 Participants
MK-8266 0.7 mg and then 0.3 mg after 10 hours
|
Panel B Placebo to MK-8266 (Elderly Fem., Mild/Moderate HTN)
n=6 Participants
Placebo to MK-8266 single dose
|
|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Abnormal Laboratory Urinalysis Values Reported as an AE
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Baseline and 0 to 8 hours postdosePopulation: All participants who received at least one dose of the investigational drug.
Participants rested for at least 10 minutes prior to having vital sign measurements obtained.
Outcome measures
| Measure |
Panel A MK-8266 0.3 mg (Elderly Males With Mild/Moderate HTN)
n=6 Participants
MK-8266 single dose 0.3 mg
Hypertension (HTN)
|
Panel A MK-8266 0.6 mg (Elderly Males With Mild/Moderate HTN)
n=6 Participants
MK-8266 single dose 0.6 mg
|
Panel A MK-8266 0.7 /0.3 mg (Elderly Males, Mild/Moderate HTN)
n=6 Participants
MK-8266 0.7 mg and then 0.3 mg after 10 hours
|
Panel A Placebo to MK-8266 (Elderly Males, Mild/Moderate HTN)
n=6 Participants
Placebo to MK-8266 single dose
|
Panel B MK-8266 0.3 mg (Elderly Females, Mild/Moderate HTN)
n=6 Participants
MK-8266 single dose 0.3 mg
|
Panel B MK-8266 0.6 mg (Elderly Females, Mild/Moderate HTN)
n=6 Participants
MK-8266 single dose 0.6 mg
|
Panel B MK-8266 0.7/0.3 mg (Elderly Fem., Mild/Moderate HTN)
n=6 Participants
MK-8266 0.7 mg and then 0.3 mg after 10 hours
|
Panel B Placebo to MK-8266 (Elderly Fem., Mild/Moderate HTN)
n=6 Participants
Placebo to MK-8266 single dose
|
|---|---|---|---|---|---|---|---|---|
|
Change From Baseline in Systolic Blood Pressure (SBP)
Baseline
|
148.3 Millimeters of mercury
Standard Deviation 8.87
|
137.2 Millimeters of mercury
Standard Deviation 19.09
|
134.0 Millimeters of mercury
Standard Deviation 12.96
|
132.7 Millimeters of mercury
Standard Deviation 10.93
|
141.7 Millimeters of mercury
Standard Deviation 13.38
|
139.5 Millimeters of mercury
Standard Deviation 11.10
|
137.7 Millimeters of mercury
Standard Deviation 7.76
|
142.0 Millimeters of mercury
Standard Deviation 18.10
|
|
Change From Baseline in Systolic Blood Pressure (SBP)
Change from Baseline
|
-0.71 Millimeters of mercury
Standard Deviation 3.85
|
-0.79 Millimeters of mercury
Standard Deviation 7.44
|
-1.13 Millimeters of mercury
Standard Deviation 4.13
|
0.54 Millimeters of mercury
Standard Deviation 4.83
|
-0.33 Millimeters of mercury
Standard Deviation 10.01
|
-4.16 Millimeters of mercury
Standard Deviation 10.25
|
-2.28 Millimeters of mercury
Standard Deviation 5.87
|
5.91 Millimeters of mercury
Standard Deviation 9.00
|
PRIMARY outcome
Timeframe: Baseline and 0 to 8 hours postdosePopulation: All participants who received at least one dose of the investigational drug.
Participants rested for at least 10 minutes prior to having vital sign measurements obtained. Heart rate measurements were obtained in the semirecumbent position and 3 sets of measurements were obtained approximately 1 minute apart.
Outcome measures
| Measure |
Panel A MK-8266 0.3 mg (Elderly Males With Mild/Moderate HTN)
n=6 Participants
MK-8266 single dose 0.3 mg
Hypertension (HTN)
|
Panel A MK-8266 0.6 mg (Elderly Males With Mild/Moderate HTN)
n=6 Participants
MK-8266 single dose 0.6 mg
|
Panel A MK-8266 0.7 /0.3 mg (Elderly Males, Mild/Moderate HTN)
n=6 Participants
MK-8266 0.7 mg and then 0.3 mg after 10 hours
|
Panel A Placebo to MK-8266 (Elderly Males, Mild/Moderate HTN)
n=6 Participants
Placebo to MK-8266 single dose
|
Panel B MK-8266 0.3 mg (Elderly Females, Mild/Moderate HTN)
n=6 Participants
MK-8266 single dose 0.3 mg
|
Panel B MK-8266 0.6 mg (Elderly Females, Mild/Moderate HTN)
n=6 Participants
MK-8266 single dose 0.6 mg
|
Panel B MK-8266 0.7/0.3 mg (Elderly Fem., Mild/Moderate HTN)
n=6 Participants
MK-8266 0.7 mg and then 0.3 mg after 10 hours
|
Panel B Placebo to MK-8266 (Elderly Fem., Mild/Moderate HTN)
n=6 Participants
Placebo to MK-8266 single dose
|
|---|---|---|---|---|---|---|---|---|
|
Change From Baseline in Heart Rate
Baseline
|
68.83 Beats per minute
Standard Deviation 9.24
|
67.83 Beats per minute
Standard Deviation 10.53
|
58.33 Beats per minute
Standard Deviation 5.50
|
69.00 Beats per minute
Standard Deviation 8.37
|
65.33 Beats per minute
Standard Deviation 5.32
|
65.00 Beats per minute
Standard Deviation 5.97
|
61.33 Beats per minute
Standard Deviation 4.23
|
63.83 Beats per minute
Standard Deviation 5.64
|
|
Change From Baseline in Heart Rate
Change from Baseline
|
0.58 Beats per minute
Standard Deviation 6.12
|
4.23 Beats per minute
Standard Deviation 4.78
|
7.90 Beats per minute
Standard Deviation 4.89
|
0.11 Beats per minute
Standard Deviation 7.85
|
2.40 Beats per minute
Standard Deviation 2.37
|
5.51 Beats per minute
Standard Deviation 3.27
|
6.65 Beats per minute
Standard Deviation 3.33
|
1.25 Beats per minute
Standard Deviation 3.57
|
PRIMARY outcome
Timeframe: Up to 48 daysPopulation: All participants who received at least one dose of the investigational drug.
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. An abnormal ECG value was any AE reported under the System Organ Classes of Investigations or Cardiac that was related to an abnormal ECG value.
Outcome measures
| Measure |
Panel A MK-8266 0.3 mg (Elderly Males With Mild/Moderate HTN)
n=6 Participants
MK-8266 single dose 0.3 mg
Hypertension (HTN)
|
Panel A MK-8266 0.6 mg (Elderly Males With Mild/Moderate HTN)
n=6 Participants
MK-8266 single dose 0.6 mg
|
Panel A MK-8266 0.7 /0.3 mg (Elderly Males, Mild/Moderate HTN)
n=6 Participants
MK-8266 0.7 mg and then 0.3 mg after 10 hours
|
Panel A Placebo to MK-8266 (Elderly Males, Mild/Moderate HTN)
n=6 Participants
Placebo to MK-8266 single dose
|
Panel B MK-8266 0.3 mg (Elderly Females, Mild/Moderate HTN)
n=6 Participants
MK-8266 single dose 0.3 mg
|
Panel B MK-8266 0.6 mg (Elderly Females, Mild/Moderate HTN)
n=6 Participants
MK-8266 single dose 0.6 mg
|
Panel B MK-8266 0.7/0.3 mg (Elderly Fem., Mild/Moderate HTN)
n=6 Participants
MK-8266 0.7 mg and then 0.3 mg after 10 hours
|
Panel B Placebo to MK-8266 (Elderly Fem., Mild/Moderate HTN)
n=6 Participants
Placebo to MK-8266 single dose
|
|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Abnormal Electrocardiograms (ECG) Reported as an AE
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Period 1, 2 and 3: Predose, 1.5, 2, 3, 4, 6, 8, 12, 24, 36 and 48 hours postdose.Population: The subset of participants who comply with the protocol sufficiently to ensure that these data will be likely to exhibit the effects of treatment, according to the underlying scientific model. AUC\[0-inf\] was not estimated for participants receiving placebo and for MK-8266 doses below 0.6 mg due to the lack of measureable concentrations.
PK is the process by which a drug is absorbed, distributed, metabolized, and eliminated by the body. (AUC\[0-inf\]) is a measure of the mean concentration levels of drug in the plasma after the dose.
Outcome measures
| Measure |
Panel A MK-8266 0.3 mg (Elderly Males With Mild/Moderate HTN)
MK-8266 single dose 0.3 mg
Hypertension (HTN)
|
Panel A MK-8266 0.6 mg (Elderly Males With Mild/Moderate HTN)
n=6 Participants
MK-8266 single dose 0.6 mg
|
Panel A MK-8266 0.7 /0.3 mg (Elderly Males, Mild/Moderate HTN)
n=6 Participants
MK-8266 0.7 mg and then 0.3 mg after 10 hours
|
Panel A Placebo to MK-8266 (Elderly Males, Mild/Moderate HTN)
Placebo to MK-8266 single dose
|
Panel B MK-8266 0.3 mg (Elderly Females, Mild/Moderate HTN)
MK-8266 single dose 0.3 mg
|
Panel B MK-8266 0.6 mg (Elderly Females, Mild/Moderate HTN)
n=6 Participants
MK-8266 single dose 0.6 mg
|
Panel B MK-8266 0.7/0.3 mg (Elderly Fem., Mild/Moderate HTN)
n=6 Participants
MK-8266 0.7 mg and then 0.3 mg after 10 hours
|
Panel B Placebo to MK-8266 (Elderly Fem., Mild/Moderate HTN)
Placebo to MK-8266 single dose
|
|---|---|---|---|---|---|---|---|---|
|
MK-8266 Pharmacokinetic (PK) Parameter Area Under the Plasma Concentration Versus Time Curve From Time 0 Extrapolated to Infinity (AUC[0-inf])
|
—
|
208 nM•hr
Standard Deviation 81.5
|
314 nM•hr
Standard Deviation 108
|
—
|
—
|
247 nM•hr
Standard Deviation 66.8
|
449 nM•hr
Standard Deviation 130
|
—
|
SECONDARY outcome
Timeframe: Period 1, 2 and 3: Predose, 1.5, 2, 3, 4, 6, 8, 12, 24, 36 and 48 hours postdose.Population: The subset of participants who comply with the protocol sufficiently to ensure that these data will be likely to exhibit the effects of treatment, according to the underlying scientific model. Cmax was not estimated for participants receiving placebo.
PK is the process by which a drug is absorbed, distributed, metabolized, and eliminated by the body. Cmax is a measure of the maximum amount of drug in the plasma after the dose is given.
Outcome measures
| Measure |
Panel A MK-8266 0.3 mg (Elderly Males With Mild/Moderate HTN)
n=6 Participants
MK-8266 single dose 0.3 mg
Hypertension (HTN)
|
Panel A MK-8266 0.6 mg (Elderly Males With Mild/Moderate HTN)
n=6 Participants
MK-8266 single dose 0.6 mg
|
Panel A MK-8266 0.7 /0.3 mg (Elderly Males, Mild/Moderate HTN)
n=6 Participants
MK-8266 0.7 mg and then 0.3 mg after 10 hours
|
Panel A Placebo to MK-8266 (Elderly Males, Mild/Moderate HTN)
Placebo to MK-8266 single dose
|
Panel B MK-8266 0.3 mg (Elderly Females, Mild/Moderate HTN)
n=6 Participants
MK-8266 single dose 0.3 mg
|
Panel B MK-8266 0.6 mg (Elderly Females, Mild/Moderate HTN)
n=6 Participants
MK-8266 single dose 0.6 mg
|
Panel B MK-8266 0.7/0.3 mg (Elderly Fem., Mild/Moderate HTN)
n=6 Participants
MK-8266 0.7 mg and then 0.3 mg after 10 hours
|
Panel B Placebo to MK-8266 (Elderly Fem., Mild/Moderate HTN)
Placebo to MK-8266 single dose
|
|---|---|---|---|---|---|---|---|---|
|
MK-8266 PK Parameter Observed Maximum (Peak) Plasma Concentration (Cmax)
|
7.76 ng/mL
Standard Deviation 2.25
|
14.1 ng/mL
Standard Deviation 3.45
|
16.2 ng/mL
Standard Deviation 4.13
|
—
|
7.84 ng/mL
Standard Deviation 1.80
|
17.8 ng/mL
Standard Deviation 2.52
|
19.5 ng/mL
Standard Deviation 2.61
|
—
|
SECONDARY outcome
Timeframe: Period 1, 2 and 3: Predose, 1.5, 2, 3, 4, 6, 8, 12, 24, 36 and 48 hours postdose.Population: The subset of participants who comply with the protocol sufficiently to ensure that these data will be likely to exhibit the effects of treatment, according to the underlying scientific model. Tmax was not estimated for participants receiving placebo.
PK is the process by which a drug is absorbed, distributed, metabolized, and eliminated by the body. Tmax is a measure of the time to reach the maximum concentration in the plasma after the drug dose. Nominal instead of actual times are presented.
Outcome measures
| Measure |
Panel A MK-8266 0.3 mg (Elderly Males With Mild/Moderate HTN)
n=6 Participants
MK-8266 single dose 0.3 mg
Hypertension (HTN)
|
Panel A MK-8266 0.6 mg (Elderly Males With Mild/Moderate HTN)
n=6 Participants
MK-8266 single dose 0.6 mg
|
Panel A MK-8266 0.7 /0.3 mg (Elderly Males, Mild/Moderate HTN)
n=6 Participants
MK-8266 0.7 mg and then 0.3 mg after 10 hours
|
Panel A Placebo to MK-8266 (Elderly Males, Mild/Moderate HTN)
Placebo to MK-8266 single dose
|
Panel B MK-8266 0.3 mg (Elderly Females, Mild/Moderate HTN)
n=6 Participants
MK-8266 single dose 0.3 mg
|
Panel B MK-8266 0.6 mg (Elderly Females, Mild/Moderate HTN)
n=6 Participants
MK-8266 single dose 0.6 mg
|
Panel B MK-8266 0.7/0.3 mg (Elderly Fem., Mild/Moderate HTN)
n=6 Participants
MK-8266 0.7 mg and then 0.3 mg after 10 hours
|
Panel B Placebo to MK-8266 (Elderly Fem., Mild/Moderate HTN)
Placebo to MK-8266 single dose
|
|---|---|---|---|---|---|---|---|---|
|
MK-8266 PK Parameter Observed Time to Reach Cmax (Tmax)
|
2.0 Hours
Interval 1.5 to 4.0
|
2.0 Hours
Interval 1.5 to 3.0
|
2.0 Hours
Interval 2.0 to 3.0
|
—
|
4.0 Hours
Interval 2.0 to 6.0
|
3.5 Hours
Interval 2.0 to 4.0
|
4.0 Hours
Interval 3.0 to 12.0
|
—
|
SECONDARY outcome
Timeframe: Period 1, 2 and 3: Predose, 1.5, 2, 3, 4, 6, 8, 12, 24, 36 and 48 hours postdose.Population: The subset of participants who comply with the protocol sufficiently to ensure that these data will be likely to exhibit the effects of treatment, according to the underlying scientific model. t1/2 was not estimated for participants receiving placebo and for MK-8266 doses below 0.6 mg due to the lack of measureable concentrations.
PK is the process by which a drug is absorbed, distributed, metabolized, and eliminated by the body. t1/2 is the time required for a given drug concentration in the plasma to decrease by 50%. Results are presented for the Harmonic Mean ± Pseudo standard deviation.
Outcome measures
| Measure |
Panel A MK-8266 0.3 mg (Elderly Males With Mild/Moderate HTN)
MK-8266 single dose 0.3 mg
Hypertension (HTN)
|
Panel A MK-8266 0.6 mg (Elderly Males With Mild/Moderate HTN)
n=6 Participants
MK-8266 single dose 0.6 mg
|
Panel A MK-8266 0.7 /0.3 mg (Elderly Males, Mild/Moderate HTN)
n=6 Participants
MK-8266 0.7 mg and then 0.3 mg after 10 hours
|
Panel A Placebo to MK-8266 (Elderly Males, Mild/Moderate HTN)
Placebo to MK-8266 single dose
|
Panel B MK-8266 0.3 mg (Elderly Females, Mild/Moderate HTN)
MK-8266 single dose 0.3 mg
|
Panel B MK-8266 0.6 mg (Elderly Females, Mild/Moderate HTN)
n=6 Participants
MK-8266 single dose 0.6 mg
|
Panel B MK-8266 0.7/0.3 mg (Elderly Fem., Mild/Moderate HTN)
n=6 Participants
MK-8266 0.7 mg and then 0.3 mg after 10 hours
|
Panel B Placebo to MK-8266 (Elderly Fem., Mild/Moderate HTN)
Placebo to MK-8266 single dose
|
|---|---|---|---|---|---|---|---|---|
|
MK-8266 PK Parameter Apparent Half-Life (t1/2)
|
—
|
12.7 Hours
Standard Deviation 4.8
|
14.3 Hours
Standard Deviation 3.8
|
—
|
—
|
13.6 Hours
Standard Deviation 4.5
|
15.4 Hours
Standard Deviation 3.4
|
—
|
SECONDARY outcome
Timeframe: Up to 8 hours post dose in each dosing period (Up to 8 hours)Population: The analysis population was all participants who received at least 1 dose of the investigational drug.
Participants rested for at least 10 minutes prior to having vital sign measurements obtained. Single dose effects on central SBP were estimated as a time-weighted average over the 8-hour post single dose observation period.
Outcome measures
| Measure |
Panel A MK-8266 0.3 mg (Elderly Males With Mild/Moderate HTN)
n=6 Participants
MK-8266 single dose 0.3 mg
Hypertension (HTN)
|
Panel A MK-8266 0.6 mg (Elderly Males With Mild/Moderate HTN)
n=6 Participants
MK-8266 single dose 0.6 mg
|
Panel A MK-8266 0.7 /0.3 mg (Elderly Males, Mild/Moderate HTN)
n=6 Participants
MK-8266 0.7 mg and then 0.3 mg after 10 hours
|
Panel A Placebo to MK-8266 (Elderly Males, Mild/Moderate HTN)
n=6 Participants
Placebo to MK-8266 single dose
|
Panel B MK-8266 0.3 mg (Elderly Females, Mild/Moderate HTN)
n=6 Participants
MK-8266 single dose 0.3 mg
|
Panel B MK-8266 0.6 mg (Elderly Females, Mild/Moderate HTN)
n=6 Participants
MK-8266 single dose 0.6 mg
|
Panel B MK-8266 0.7/0.3 mg (Elderly Fem., Mild/Moderate HTN)
n=6 Participants
MK-8266 0.7 mg and then 0.3 mg after 10 hours
|
Panel B Placebo to MK-8266 (Elderly Fem., Mild/Moderate HTN)
n=6 Participants
Placebo to MK-8266 single dose
|
|---|---|---|---|---|---|---|---|---|
|
The Time Weighted Average Systolic Blood Pressure (SBP) Evaluated Over 8 Hours Post Dose (TWA[0-8hrs]) Following a Single Oral Dose of MK-8266.
|
146.4 millimeters of mercury
Standard Deviation 11.73
|
134.2 millimeters of mercury
Standard Deviation 12.96
|
132.7 millimeters of mercury
Standard Deviation 12.34
|
136.8 millimeters of mercury
Standard Deviation 8.61
|
142.4 millimeters of mercury
Standard Deviation 13.19
|
135.0 millimeters of mercury
Standard Deviation 8.22
|
136.0 millimeters of mercury
Standard Deviation 6.82
|
146.6 millimeters of mercury
Standard Deviation 12.54
|
Adverse Events
Panel A MK-8266 0.3 mg (Elderly Males With Mild/Moderate HTN)
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Panel A MK-8266 0.6 mg (Elderly Males With Mild/Moderate HTN)
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Panel A MK-8266 0.7 /0.3 mg (Elderly Males, Mild/Moderate HTN)
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Panel A Placebo to MK-8266 (Elderly Males, Mild/Moderate HTN)
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Panel B MK-8266 0.3 mg (Elderly Females, Mild/Moderate HTN)
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Panel B MK-8266 0.6 mg (Elderly Females, Mild/Moderate HTN)
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Panel B MK-8266 0.7/0.3 mg (Elderly Fem., Mild/Moderate HTN)
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Panel B Placebo to MK-8266 (Elderly Fem., Mild/Moderate HTN)
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Panel A MK-8266 0.3 mg (Elderly Males With Mild/Moderate HTN)
n=6 participants at risk
MK-8266 single dose 0.3 mg
|
Panel A MK-8266 0.6 mg (Elderly Males With Mild/Moderate HTN)
n=6 participants at risk
MK-8266 single dose 0.6 mg
|
Panel A MK-8266 0.7 /0.3 mg (Elderly Males, Mild/Moderate HTN)
n=6 participants at risk
MK-8266 0.7 mg and then 0.3 mg after 10 hours
|
Panel A Placebo to MK-8266 (Elderly Males, Mild/Moderate HTN)
n=6 participants at risk
Placebo to MK-8266 single dose
|
Panel B MK-8266 0.3 mg (Elderly Females, Mild/Moderate HTN)
n=6 participants at risk
MK-8266 single dose 0.3 mg
|
Panel B MK-8266 0.6 mg (Elderly Females, Mild/Moderate HTN)
n=6 participants at risk
MK-8266 single dose 0.6 mg
|
Panel B MK-8266 0.7/0.3 mg (Elderly Fem., Mild/Moderate HTN)
n=6 participants at risk
MK-8266 0.7 mg and then 0.3 mg after 10 hours
|
Panel B Placebo to MK-8266 (Elderly Fem., Mild/Moderate HTN)
n=6 participants at risk
Placebo to MK-8266 single dose
|
|---|---|---|---|---|---|---|---|---|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.00%
0/6 • Up to 48 days
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The analysis population included all participants who received at least one dose of the investigational drug.
|
0.00%
0/6 • Up to 48 days
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The analysis population included all participants who received at least one dose of the investigational drug.
|
0.00%
0/6 • Up to 48 days
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The analysis population included all participants who received at least one dose of the investigational drug.
|
0.00%
0/6 • Up to 48 days
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The analysis population included all participants who received at least one dose of the investigational drug.
|
0.00%
0/6 • Up to 48 days
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The analysis population included all participants who received at least one dose of the investigational drug.
|
16.7%
1/6 • Number of events 1 • Up to 48 days
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The analysis population included all participants who received at least one dose of the investigational drug.
|
0.00%
0/6 • Up to 48 days
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The analysis population included all participants who received at least one dose of the investigational drug.
|
0.00%
0/6 • Up to 48 days
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The analysis population included all participants who received at least one dose of the investigational drug.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/6 • Up to 48 days
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The analysis population included all participants who received at least one dose of the investigational drug.
|
0.00%
0/6 • Up to 48 days
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The analysis population included all participants who received at least one dose of the investigational drug.
|
0.00%
0/6 • Up to 48 days
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The analysis population included all participants who received at least one dose of the investigational drug.
|
0.00%
0/6 • Up to 48 days
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The analysis population included all participants who received at least one dose of the investigational drug.
|
0.00%
0/6 • Up to 48 days
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The analysis population included all participants who received at least one dose of the investigational drug.
|
0.00%
0/6 • Up to 48 days
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The analysis population included all participants who received at least one dose of the investigational drug.
|
16.7%
1/6 • Number of events 1 • Up to 48 days
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The analysis population included all participants who received at least one dose of the investigational drug.
|
0.00%
0/6 • Up to 48 days
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The analysis population included all participants who received at least one dose of the investigational drug.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/6 • Up to 48 days
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The analysis population included all participants who received at least one dose of the investigational drug.
|
0.00%
0/6 • Up to 48 days
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The analysis population included all participants who received at least one dose of the investigational drug.
|
16.7%
1/6 • Number of events 1 • Up to 48 days
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The analysis population included all participants who received at least one dose of the investigational drug.
|
0.00%
0/6 • Up to 48 days
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The analysis population included all participants who received at least one dose of the investigational drug.
|
16.7%
1/6 • Number of events 1 • Up to 48 days
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The analysis population included all participants who received at least one dose of the investigational drug.
|
16.7%
1/6 • Number of events 1 • Up to 48 days
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The analysis population included all participants who received at least one dose of the investigational drug.
|
16.7%
1/6 • Number of events 1 • Up to 48 days
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The analysis population included all participants who received at least one dose of the investigational drug.
|
0.00%
0/6 • Up to 48 days
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The analysis population included all participants who received at least one dose of the investigational drug.
|
|
Gastrointestinal disorders
Faeces hard
|
16.7%
1/6 • Number of events 1 • Up to 48 days
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The analysis population included all participants who received at least one dose of the investigational drug.
|
0.00%
0/6 • Up to 48 days
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The analysis population included all participants who received at least one dose of the investigational drug.
|
0.00%
0/6 • Up to 48 days
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The analysis population included all participants who received at least one dose of the investigational drug.
|
0.00%
0/6 • Up to 48 days
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The analysis population included all participants who received at least one dose of the investigational drug.
|
0.00%
0/6 • Up to 48 days
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The analysis population included all participants who received at least one dose of the investigational drug.
|
0.00%
0/6 • Up to 48 days
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The analysis population included all participants who received at least one dose of the investigational drug.
|
0.00%
0/6 • Up to 48 days
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The analysis population included all participants who received at least one dose of the investigational drug.
|
0.00%
0/6 • Up to 48 days
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The analysis population included all participants who received at least one dose of the investigational drug.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/6 • Up to 48 days
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The analysis population included all participants who received at least one dose of the investigational drug.
|
0.00%
0/6 • Up to 48 days
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The analysis population included all participants who received at least one dose of the investigational drug.
|
0.00%
0/6 • Up to 48 days
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The analysis population included all participants who received at least one dose of the investigational drug.
|
0.00%
0/6 • Up to 48 days
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The analysis population included all participants who received at least one dose of the investigational drug.
|
0.00%
0/6 • Up to 48 days
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The analysis population included all participants who received at least one dose of the investigational drug.
|
16.7%
1/6 • Number of events 1 • Up to 48 days
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The analysis population included all participants who received at least one dose of the investigational drug.
|
0.00%
0/6 • Up to 48 days
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The analysis population included all participants who received at least one dose of the investigational drug.
|
0.00%
0/6 • Up to 48 days
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The analysis population included all participants who received at least one dose of the investigational drug.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/6 • Up to 48 days
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The analysis population included all participants who received at least one dose of the investigational drug.
|
0.00%
0/6 • Up to 48 days
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The analysis population included all participants who received at least one dose of the investigational drug.
|
0.00%
0/6 • Up to 48 days
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The analysis population included all participants who received at least one dose of the investigational drug.
|
0.00%
0/6 • Up to 48 days
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The analysis population included all participants who received at least one dose of the investigational drug.
|
0.00%
0/6 • Up to 48 days
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The analysis population included all participants who received at least one dose of the investigational drug.
|
16.7%
1/6 • Number of events 1 • Up to 48 days
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The analysis population included all participants who received at least one dose of the investigational drug.
|
0.00%
0/6 • Up to 48 days
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The analysis population included all participants who received at least one dose of the investigational drug.
|
16.7%
1/6 • Number of events 2 • Up to 48 days
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The analysis population included all participants who received at least one dose of the investigational drug.
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/6 • Up to 48 days
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The analysis population included all participants who received at least one dose of the investigational drug.
|
0.00%
0/6 • Up to 48 days
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The analysis population included all participants who received at least one dose of the investigational drug.
|
0.00%
0/6 • Up to 48 days
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The analysis population included all participants who received at least one dose of the investigational drug.
|
0.00%
0/6 • Up to 48 days
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The analysis population included all participants who received at least one dose of the investigational drug.
|
0.00%
0/6 • Up to 48 days
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The analysis population included all participants who received at least one dose of the investigational drug.
|
0.00%
0/6 • Up to 48 days
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The analysis population included all participants who received at least one dose of the investigational drug.
|
33.3%
2/6 • Number of events 2 • Up to 48 days
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The analysis population included all participants who received at least one dose of the investigational drug.
|
0.00%
0/6 • Up to 48 days
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The analysis population included all participants who received at least one dose of the investigational drug.
|
|
Infections and infestations
Oral herpes
|
0.00%
0/6 • Up to 48 days
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The analysis population included all participants who received at least one dose of the investigational drug.
|
16.7%
1/6 • Number of events 1 • Up to 48 days
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The analysis population included all participants who received at least one dose of the investigational drug.
|
0.00%
0/6 • Up to 48 days
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The analysis population included all participants who received at least one dose of the investigational drug.
|
0.00%
0/6 • Up to 48 days
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The analysis population included all participants who received at least one dose of the investigational drug.
|
0.00%
0/6 • Up to 48 days
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The analysis population included all participants who received at least one dose of the investigational drug.
|
0.00%
0/6 • Up to 48 days
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The analysis population included all participants who received at least one dose of the investigational drug.
|
0.00%
0/6 • Up to 48 days
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The analysis population included all participants who received at least one dose of the investigational drug.
|
0.00%
0/6 • Up to 48 days
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The analysis population included all participants who received at least one dose of the investigational drug.
|
|
Investigations
Blood pressure systolic increased
|
33.3%
2/6 • Number of events 3 • Up to 48 days
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The analysis population included all participants who received at least one dose of the investigational drug.
|
0.00%
0/6 • Up to 48 days
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The analysis population included all participants who received at least one dose of the investigational drug.
|
0.00%
0/6 • Up to 48 days
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The analysis population included all participants who received at least one dose of the investigational drug.
|
0.00%
0/6 • Up to 48 days
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The analysis population included all participants who received at least one dose of the investigational drug.
|
16.7%
1/6 • Number of events 1 • Up to 48 days
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The analysis population included all participants who received at least one dose of the investigational drug.
|
0.00%
0/6 • Up to 48 days
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The analysis population included all participants who received at least one dose of the investigational drug.
|
16.7%
1/6 • Number of events 4 • Up to 48 days
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The analysis population included all participants who received at least one dose of the investigational drug.
|
16.7%
1/6 • Number of events 1 • Up to 48 days
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The analysis population included all participants who received at least one dose of the investigational drug.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/6 • Up to 48 days
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The analysis population included all participants who received at least one dose of the investigational drug.
|
0.00%
0/6 • Up to 48 days
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The analysis population included all participants who received at least one dose of the investigational drug.
|
0.00%
0/6 • Up to 48 days
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The analysis population included all participants who received at least one dose of the investigational drug.
|
0.00%
0/6 • Up to 48 days
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The analysis population included all participants who received at least one dose of the investigational drug.
|
16.7%
1/6 • Number of events 1 • Up to 48 days
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The analysis population included all participants who received at least one dose of the investigational drug.
|
0.00%
0/6 • Up to 48 days
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The analysis population included all participants who received at least one dose of the investigational drug.
|
0.00%
0/6 • Up to 48 days
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The analysis population included all participants who received at least one dose of the investigational drug.
|
0.00%
0/6 • Up to 48 days
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The analysis population included all participants who received at least one dose of the investigational drug.
|
|
Musculoskeletal and connective tissue disorders
Joint swelling
|
16.7%
1/6 • Number of events 1 • Up to 48 days
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The analysis population included all participants who received at least one dose of the investigational drug.
|
0.00%
0/6 • Up to 48 days
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The analysis population included all participants who received at least one dose of the investigational drug.
|
0.00%
0/6 • Up to 48 days
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The analysis population included all participants who received at least one dose of the investigational drug.
|
0.00%
0/6 • Up to 48 days
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The analysis population included all participants who received at least one dose of the investigational drug.
|
0.00%
0/6 • Up to 48 days
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The analysis population included all participants who received at least one dose of the investigational drug.
|
0.00%
0/6 • Up to 48 days
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The analysis population included all participants who received at least one dose of the investigational drug.
|
0.00%
0/6 • Up to 48 days
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The analysis population included all participants who received at least one dose of the investigational drug.
|
0.00%
0/6 • Up to 48 days
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The analysis population included all participants who received at least one dose of the investigational drug.
|
|
Nervous system disorders
Dizziness
|
16.7%
1/6 • Number of events 1 • Up to 48 days
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The analysis population included all participants who received at least one dose of the investigational drug.
|
0.00%
0/6 • Up to 48 days
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The analysis population included all participants who received at least one dose of the investigational drug.
|
0.00%
0/6 • Up to 48 days
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The analysis population included all participants who received at least one dose of the investigational drug.
|
0.00%
0/6 • Up to 48 days
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The analysis population included all participants who received at least one dose of the investigational drug.
|
0.00%
0/6 • Up to 48 days
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The analysis population included all participants who received at least one dose of the investigational drug.
|
0.00%
0/6 • Up to 48 days
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The analysis population included all participants who received at least one dose of the investigational drug.
|
0.00%
0/6 • Up to 48 days
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The analysis population included all participants who received at least one dose of the investigational drug.
|
0.00%
0/6 • Up to 48 days
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The analysis population included all participants who received at least one dose of the investigational drug.
|
|
Nervous system disorders
Headache
|
33.3%
2/6 • Number of events 2 • Up to 48 days
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The analysis population included all participants who received at least one dose of the investigational drug.
|
33.3%
2/6 • Number of events 3 • Up to 48 days
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The analysis population included all participants who received at least one dose of the investigational drug.
|
16.7%
1/6 • Number of events 1 • Up to 48 days
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The analysis population included all participants who received at least one dose of the investigational drug.
|
0.00%
0/6 • Up to 48 days
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The analysis population included all participants who received at least one dose of the investigational drug.
|
16.7%
1/6 • Number of events 1 • Up to 48 days
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The analysis population included all participants who received at least one dose of the investigational drug.
|
50.0%
3/6 • Number of events 4 • Up to 48 days
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The analysis population included all participants who received at least one dose of the investigational drug.
|
16.7%
1/6 • Number of events 1 • Up to 48 days
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The analysis population included all participants who received at least one dose of the investigational drug.
|
33.3%
2/6 • Number of events 5 • Up to 48 days
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The analysis population included all participants who received at least one dose of the investigational drug.
|
|
Nervous system disorders
Presyncope
|
0.00%
0/6 • Up to 48 days
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The analysis population included all participants who received at least one dose of the investigational drug.
|
0.00%
0/6 • Up to 48 days
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The analysis population included all participants who received at least one dose of the investigational drug.
|
0.00%
0/6 • Up to 48 days
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The analysis population included all participants who received at least one dose of the investigational drug.
|
16.7%
1/6 • Number of events 1 • Up to 48 days
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The analysis population included all participants who received at least one dose of the investigational drug.
|
0.00%
0/6 • Up to 48 days
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The analysis population included all participants who received at least one dose of the investigational drug.
|
0.00%
0/6 • Up to 48 days
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The analysis population included all participants who received at least one dose of the investigational drug.
|
0.00%
0/6 • Up to 48 days
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The analysis population included all participants who received at least one dose of the investigational drug.
|
0.00%
0/6 • Up to 48 days
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The analysis population included all participants who received at least one dose of the investigational drug.
|
|
Psychiatric disorders
Nervousness
|
0.00%
0/6 • Up to 48 days
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The analysis population included all participants who received at least one dose of the investigational drug.
|
0.00%
0/6 • Up to 48 days
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The analysis population included all participants who received at least one dose of the investigational drug.
|
0.00%
0/6 • Up to 48 days
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The analysis population included all participants who received at least one dose of the investigational drug.
|
0.00%
0/6 • Up to 48 days
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The analysis population included all participants who received at least one dose of the investigational drug.
|
16.7%
1/6 • Number of events 1 • Up to 48 days
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The analysis population included all participants who received at least one dose of the investigational drug.
|
0.00%
0/6 • Up to 48 days
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The analysis population included all participants who received at least one dose of the investigational drug.
|
0.00%
0/6 • Up to 48 days
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The analysis population included all participants who received at least one dose of the investigational drug.
|
0.00%
0/6 • Up to 48 days
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The analysis population included all participants who received at least one dose of the investigational drug.
|
|
Psychiatric disorders
Sleep disorder
|
0.00%
0/6 • Up to 48 days
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The analysis population included all participants who received at least one dose of the investigational drug.
|
0.00%
0/6 • Up to 48 days
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The analysis population included all participants who received at least one dose of the investigational drug.
|
0.00%
0/6 • Up to 48 days
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The analysis population included all participants who received at least one dose of the investigational drug.
|
16.7%
1/6 • Number of events 1 • Up to 48 days
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The analysis population included all participants who received at least one dose of the investigational drug.
|
0.00%
0/6 • Up to 48 days
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The analysis population included all participants who received at least one dose of the investigational drug.
|
0.00%
0/6 • Up to 48 days
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The analysis population included all participants who received at least one dose of the investigational drug.
|
0.00%
0/6 • Up to 48 days
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The analysis population included all participants who received at least one dose of the investigational drug.
|
0.00%
0/6 • Up to 48 days
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The analysis population included all participants who received at least one dose of the investigational drug.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/6 • Up to 48 days
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The analysis population included all participants who received at least one dose of the investigational drug.
|
0.00%
0/6 • Up to 48 days
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The analysis population included all participants who received at least one dose of the investigational drug.
|
0.00%
0/6 • Up to 48 days
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The analysis population included all participants who received at least one dose of the investigational drug.
|
16.7%
1/6 • Number of events 1 • Up to 48 days
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The analysis population included all participants who received at least one dose of the investigational drug.
|
0.00%
0/6 • Up to 48 days
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The analysis population included all participants who received at least one dose of the investigational drug.
|
0.00%
0/6 • Up to 48 days
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The analysis population included all participants who received at least one dose of the investigational drug.
|
0.00%
0/6 • Up to 48 days
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The analysis population included all participants who received at least one dose of the investigational drug.
|
0.00%
0/6 • Up to 48 days
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The analysis population included all participants who received at least one dose of the investigational drug.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/6 • Up to 48 days
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The analysis population included all participants who received at least one dose of the investigational drug.
|
0.00%
0/6 • Up to 48 days
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The analysis population included all participants who received at least one dose of the investigational drug.
|
16.7%
1/6 • Number of events 1 • Up to 48 days
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The analysis population included all participants who received at least one dose of the investigational drug.
|
0.00%
0/6 • Up to 48 days
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The analysis population included all participants who received at least one dose of the investigational drug.
|
0.00%
0/6 • Up to 48 days
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The analysis population included all participants who received at least one dose of the investigational drug.
|
0.00%
0/6 • Up to 48 days
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The analysis population included all participants who received at least one dose of the investigational drug.
|
0.00%
0/6 • Up to 48 days
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The analysis population included all participants who received at least one dose of the investigational drug.
|
0.00%
0/6 • Up to 48 days
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The analysis population included all participants who received at least one dose of the investigational drug.
|
|
Respiratory, thoracic and mediastinal disorders
Throat irritation
|
0.00%
0/6 • Up to 48 days
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The analysis population included all participants who received at least one dose of the investigational drug.
|
0.00%
0/6 • Up to 48 days
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The analysis population included all participants who received at least one dose of the investigational drug.
|
0.00%
0/6 • Up to 48 days
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The analysis population included all participants who received at least one dose of the investigational drug.
|
0.00%
0/6 • Up to 48 days
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The analysis population included all participants who received at least one dose of the investigational drug.
|
0.00%
0/6 • Up to 48 days
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The analysis population included all participants who received at least one dose of the investigational drug.
|
16.7%
1/6 • Number of events 1 • Up to 48 days
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The analysis population included all participants who received at least one dose of the investigational drug.
|
0.00%
0/6 • Up to 48 days
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The analysis population included all participants who received at least one dose of the investigational drug.
|
16.7%
1/6 • Number of events 1 • Up to 48 days
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The analysis population included all participants who received at least one dose of the investigational drug.
|
|
Skin and subcutaneous tissue disorders
Skin irritation
|
0.00%
0/6 • Up to 48 days
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The analysis population included all participants who received at least one dose of the investigational drug.
|
0.00%
0/6 • Up to 48 days
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The analysis population included all participants who received at least one dose of the investigational drug.
|
0.00%
0/6 • Up to 48 days
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The analysis population included all participants who received at least one dose of the investigational drug.
|
0.00%
0/6 • Up to 48 days
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The analysis population included all participants who received at least one dose of the investigational drug.
|
33.3%
2/6 • Number of events 2 • Up to 48 days
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The analysis population included all participants who received at least one dose of the investigational drug.
|
0.00%
0/6 • Up to 48 days
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The analysis population included all participants who received at least one dose of the investigational drug.
|
0.00%
0/6 • Up to 48 days
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The analysis population included all participants who received at least one dose of the investigational drug.
|
0.00%
0/6 • Up to 48 days
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The analysis population included all participants who received at least one dose of the investigational drug.
|
|
Vascular disorders
Orthostatic hypotension
|
0.00%
0/6 • Up to 48 days
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The analysis population included all participants who received at least one dose of the investigational drug.
|
16.7%
1/6 • Number of events 1 • Up to 48 days
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The analysis population included all participants who received at least one dose of the investigational drug.
|
0.00%
0/6 • Up to 48 days
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The analysis population included all participants who received at least one dose of the investigational drug.
|
0.00%
0/6 • Up to 48 days
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The analysis population included all participants who received at least one dose of the investigational drug.
|
0.00%
0/6 • Up to 48 days
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The analysis population included all participants who received at least one dose of the investigational drug.
|
0.00%
0/6 • Up to 48 days
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The analysis population included all participants who received at least one dose of the investigational drug.
|
0.00%
0/6 • Up to 48 days
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The analysis population included all participants who received at least one dose of the investigational drug.
|
0.00%
0/6 • Up to 48 days
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The analysis population included all participants who received at least one dose of the investigational drug.
|
Additional Information
Senior Vice President, Global Clinical Development
Merck Sharp & Dohme Corp.
Phone: 1-800-672-6372
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee The sponsor must have the opportunity to review all proposed abstracts, manuscripts, or presentations regarding this study 60 days prior to submission for publication/presentation. Any information identified by the sponsor as confidential must be deleted prior to submission. Sponsor review can be expedited to meet publication timelines.
- Publication restrictions are in place
Restriction type: OTHER