Trial Outcomes & Findings for A Single Dose Study of the Safety, Pharmacokinetics and Pharmacodynamics of MK-1064 (MK-1064-001) (NCT NCT02549014)

NCT ID: NCT02549014

Last Updated: 2018-10-23

Results Overview

An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of study drug, whether or not considered related to the use of study drug. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a pre-existing condition which is temporally associated with the use of study drug, is also an AE.

• Recruitment status: COMPLETED
• Study phase: PHASE1
• Target enrollment: 16 participants
• Primary outcome timeframe: Up to 14 days after the last dose of study drug (Up to approximately 60 days)
• Results posted on: 2018-10-23

Participant Flow

Healthy male participants aged 18-45 years (inclusive) were recruited for this study.

Participant milestones

Measure	Panel A: MK-1064 Panel A: Eight (8) participants were included in this panel. Within each of up to 5 treatment periods, 6 participants were randomly assigned to receive single oral doses of MK-1064 and 2 participants were randomly assigned to receive single oral doses of matching placebo. MK-1064 was administered in rising single doses of 5, 25, 100 and 200 mg over Periods 1-4, in the morning with participants in a fasted condition. In Period 5, a single MK-1064 dose of 25 mg or placebo was administered to participants in the morning following a standard high-fat breakfast. Dosing periods alternated with Panel B. There was to be a minimum 7-day washout between treatment periods for any given participant.	Panel B: MK-1064 Panel B: Eight (8) participants were included in this panel. Within each of up to 5 treatment periods, 6 participants were randomly assigned to receive single oral doses of MK-1064 and 2 participants were randomly assigned to receive single oral doses of matching placebo. MK-1064 was administered in rising single doses of 10, 50, 150 and 250 mg over Periods 1-4, in the morning with participants in fasted condition. In Period 5, a single MK-1064 dose of 50 mg or placebo was administered to participants in the evening after a 4-hour fast. Dosing periods alternated with Panel A. There was to be a minimum 7 day wash-out between treatment periods for any given participant.
Overall Study STARTED	8	8
Overall Study COMPLETED	8	8
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

A Single Dose Study of the Safety, Pharmacokinetics and Pharmacodynamics of MK-1064 (MK-1064-001)

Baseline characteristics by cohort

Measure	Panel A: MK-1064 n=8 Participants Panel A: Eight (8) participants were included in this panel. Within each of up to 5 treatment periods, 6 participants were randomly assigned to receive single oral doses of MK-1064 and 2 participants were randomly assigned to receive single oral doses of matching placebo. MK-1064 was administered in rising single doses of 5, 25, 100 and 200 mg over Periods 1-4, in the morning with participants in a fasted condition. In Period 5, a single MK-1064 dose of 25 mg or placebo was administered to participants in the morning following a standard high-fat breakfast. Dosing periods alternated with Panel B. There was to be a minimum 7-day washout between treatment periods for any given participant.	Panel B: MK-1064 n=8 Participants Panel B: Eight (8) participants were included in this panel. Within each of up to 5 treatment periods, 6 participants were randomly assigned to receive single oral doses of MK-1064 and 2 participants were randomly assigned to receive single oral doses of matching placebo. MK-1064 was administered in rising single doses of 10, 50, 150 and 250 mg over Periods 1-4, in the morning with participants in fasted condition. In Period 5, a single MK-1064 dose of 50 mg or placebo was administered to participants in the evening after a 4-hour fast. Dosing periods alternated with Panel A. There was to be a minimum 7 day wash-out between treatment periods for any given participant.	Total n=16 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Age, Categorical Between 18 and 65 years	8 Participants n=93 Participants	8 Participants n=4 Participants	16 Participants n=27 Participants
Age, Categorical >=65 years	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Sex: Female, Male Female	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Sex: Female, Male Male	8 Participants n=93 Participants	8 Participants n=4 Participants	16 Participants n=27 Participants

PRIMARY outcome

Timeframe: Up to 14 days after the last dose of study drug (Up to approximately 60 days)

Population: All participants who received ≥1 dose of study drug.

An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of study drug, whether or not considered related to the use of study drug. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a pre-existing condition which is temporally associated with the use of study drug, is also an AE.

Outcome measures

Measure	Panel A: MK-1064 5 mg n=6 Participants Within each of up to 4 treatment periods, 6 participants were randomly assigned to receive single oral doses of MK-1064 5 mg in a fasted state. There was to be a minimum 7-day washout between treatment periods for any given participant.	Panel B: MK-1064 10 mg n=6 Participants Within each of up to 4 treatment periods, 6 participants were randomly assigned to receive single oral doses of MK-1064 10 mg in a fasted state. There was to be a minimum 7-day washout between treatment periods for any given participant.	Panel A: MK-1064 25 mg n=6 Participants Within each of up to 4 treatment periods, 6 participants were randomly assigned to receive single oral doses of MK-1064 25 mg in a fasted state. There was to be a minimum 7-day washout between treatment periods for any given participant.	Panel B: MK-1064 50 mg n=6 Participants Within each of up to 4 treatment periods, 6 participants were randomly assigned to receive single oral doses of MK-1064 50 mg in a fasted state. There was to be a minimum 7-day washout between treatment periods for any given participant.	Panel A: MK-1064 100 mg n=6 Participants Within each of up to 4 treatment periods, 6 participants were randomly assigned to receive single oral doses of MK-1064 100 mg in a fasted state. There was to be a minimum 7-day washout between treatment periods for any given participant.	Panel B: MK-1064 150 mg n=6 Participants Within each of up to 4 treatment periods, 6 participants were randomly assigned to receive single oral doses of MK-1064 150 mg in a fasted state. There was to be a minimum 7-day washout between treatment periods for any given participant.	Panel A: MK-1064 200 mg n=6 Participants Within each of up to 4 treatment periods, 6 participants were randomly assigned to receive single oral doses of MK-1064 200 mg in a fasted state. There was to be a minimum 7-day washout between treatment periods for any given participant.	Panel B: MK-1064 250 mg n=6 Participants Within each of up to 4 treatment periods, 6 participants were randomly assigned to receive single oral doses of MK-1064 250 mg in a fasted state. There was to be a minimum 7-day washout between treatment periods for any given participant.	Panel A: MK-1064 25 mg (Fed) n=6 Participants In Period 5, 6 participants received a single MK-1064 dose of 25 mg administered in the evening following a standard high-fat breakfast.	Panel B: MK-1064 50 mg (Night) n=6 Participants In Period 5, 6 participants received a single MK-1064 dose of 50 mg administered in the evening after a 4-hour fast.	Panels A & B: Placebo n=16 Participants Within each of up to 5 treatment periods, 2 participants were randomly assigned to receive single oral doses of matching placebo in a fasted stated. There was to be a minimum 7-day washout between treatment periods for any given participant.
Number of Participants Who Experienced One or More Adverse Events (AEs)	4 Participants	5 Participants	5 Participants	5 Participants	5 Participants	5 Participants	6 Participants	6 Participants	3 Participants	3 Participants	5 Participants

PRIMARY outcome

Timeframe: Up to 14 days after the last dose of study drug (Up to approximately 60 days)

Population: All participants who received ≥1 dose of study drug.

An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of study drug, whether or not considered related to the use of study drug. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a pre-existing condition which is temporally associated with the use of study drug, is also an AE.

Outcome measures

Measure	Panel A: MK-1064 5 mg n=6 Participants Within each of up to 4 treatment periods, 6 participants were randomly assigned to receive single oral doses of MK-1064 5 mg in a fasted state. There was to be a minimum 7-day washout between treatment periods for any given participant.	Panel B: MK-1064 10 mg n=6 Participants Within each of up to 4 treatment periods, 6 participants were randomly assigned to receive single oral doses of MK-1064 10 mg in a fasted state. There was to be a minimum 7-day washout between treatment periods for any given participant.	Panel A: MK-1064 25 mg n=6 Participants Within each of up to 4 treatment periods, 6 participants were randomly assigned to receive single oral doses of MK-1064 25 mg in a fasted state. There was to be a minimum 7-day washout between treatment periods for any given participant.	Panel B: MK-1064 50 mg n=6 Participants Within each of up to 4 treatment periods, 6 participants were randomly assigned to receive single oral doses of MK-1064 50 mg in a fasted state. There was to be a minimum 7-day washout between treatment periods for any given participant.	Panel A: MK-1064 100 mg n=6 Participants Within each of up to 4 treatment periods, 6 participants were randomly assigned to receive single oral doses of MK-1064 100 mg in a fasted state. There was to be a minimum 7-day washout between treatment periods for any given participant.	Panel B: MK-1064 150 mg n=6 Participants Within each of up to 4 treatment periods, 6 participants were randomly assigned to receive single oral doses of MK-1064 150 mg in a fasted state. There was to be a minimum 7-day washout between treatment periods for any given participant.	Panel A: MK-1064 200 mg n=6 Participants Within each of up to 4 treatment periods, 6 participants were randomly assigned to receive single oral doses of MK-1064 200 mg in a fasted state. There was to be a minimum 7-day washout between treatment periods for any given participant.	Panel B: MK-1064 250 mg n=6 Participants Within each of up to 4 treatment periods, 6 participants were randomly assigned to receive single oral doses of MK-1064 250 mg in a fasted state. There was to be a minimum 7-day washout between treatment periods for any given participant.	Panel A: MK-1064 25 mg (Fed) n=6 Participants In Period 5, 6 participants received a single MK-1064 dose of 25 mg administered in the evening following a standard high-fat breakfast.	Panel B: MK-1064 50 mg (Night) n=6 Participants In Period 5, 6 participants received a single MK-1064 dose of 50 mg administered in the evening after a 4-hour fast.	Panels A & B: Placebo n=16 Participants Within each of up to 5 treatment periods, 2 participants were randomly assigned to receive single oral doses of matching placebo in a fasted stated. There was to be a minimum 7-day washout between treatment periods for any given participant.
Number of Participants Who Discontinued Study Due to an AE	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants

PRIMARY outcome

Timeframe: Pre-dose and 0.5, 1, 2, 3 and 4 hours post-dose

Population: All participants who received ≥1 dose of MK-1064.

AUC0-4hr is the area under the plasma concentration-time curve from time 0 to 4 hours post-dose. This is a measure of the average amount of study drug (MK-1064) in the blood plasma over a period of 4 hours after the dose.

Outcome measures

Measure	Panel A: MK-1064 5 mg n=6 Participants Within each of up to 4 treatment periods, 6 participants were randomly assigned to receive single oral doses of MK-1064 5 mg in a fasted state. There was to be a minimum 7-day washout between treatment periods for any given participant.	Panel B: MK-1064 10 mg n=6 Participants Within each of up to 4 treatment periods, 6 participants were randomly assigned to receive single oral doses of MK-1064 10 mg in a fasted state. There was to be a minimum 7-day washout between treatment periods for any given participant.	Panel A: MK-1064 25 mg n=6 Participants Within each of up to 4 treatment periods, 6 participants were randomly assigned to receive single oral doses of MK-1064 25 mg in a fasted state. There was to be a minimum 7-day washout between treatment periods for any given participant.	Panel B: MK-1064 50 mg n=6 Participants Within each of up to 4 treatment periods, 6 participants were randomly assigned to receive single oral doses of MK-1064 50 mg in a fasted state. There was to be a minimum 7-day washout between treatment periods for any given participant.	Panel A: MK-1064 100 mg n=6 Participants Within each of up to 4 treatment periods, 6 participants were randomly assigned to receive single oral doses of MK-1064 100 mg in a fasted state. There was to be a minimum 7-day washout between treatment periods for any given participant.	Panel B: MK-1064 150 mg n=6 Participants Within each of up to 4 treatment periods, 6 participants were randomly assigned to receive single oral doses of MK-1064 150 mg in a fasted state. There was to be a minimum 7-day washout between treatment periods for any given participant.	Panel A: MK-1064 200 mg n=6 Participants Within each of up to 4 treatment periods, 6 participants were randomly assigned to receive single oral doses of MK-1064 200 mg in a fasted state. There was to be a minimum 7-day washout between treatment periods for any given participant.	Panel B: MK-1064 250 mg n=6 Participants Within each of up to 4 treatment periods, 6 participants were randomly assigned to receive single oral doses of MK-1064 250 mg in a fasted state. There was to be a minimum 7-day washout between treatment periods for any given participant.	Panel A: MK-1064 25 mg (Fed) n=6 Participants In Period 5, 6 participants received a single MK-1064 dose of 25 mg administered in the evening following a standard high-fat breakfast.	Panel B: MK-1064 50 mg (Night) n=6 Participants In Period 5, 6 participants received a single MK-1064 dose of 50 mg administered in the evening after a 4-hour fast.	Panels A & B: Placebo Within each of up to 5 treatment periods, 2 participants were randomly assigned to receive single oral doses of matching placebo in a fasted stated. There was to be a minimum 7-day washout between treatment periods for any given participant.
Average Plasma Concentration From Time Zero to 4 Hours (Area Under the Plasma Drug Concentration-time Curve From Time Zero to 4 Hours [AUC0-4hr]) Following Single Doses of MK-1064	0.77 µmol*hr/L Standard Deviation 0.13	1.01 µmol*hr/L Standard Deviation 0.42	2.99 µmol*hr/L Standard Deviation 0.41	5.51 µmol*hr/L Standard Deviation 2.29	9.75 µmol*hr/L Standard Deviation 1.31	10.28 µmol*hr/L Standard Deviation 3.42	20.12 µmol*hr/L Standard Deviation 9.03	22.70 µmol*hr/L Standard Deviation 7.98	1.61 µmol*hr/L Standard Deviation 0.25	5.16 µmol*hr/L Standard Deviation 2.60	—

SECONDARY outcome

Timeframe: Pre-dose and 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 16, 24 and 48 hours post dose (all Periods); 72 hours post-dose (Periods 3 and 4 only)

Population: All participants who received ≥1 dose of MK-1064.

AUC0-last is the area under the plasma concentration-time curve from time zero to time of last measurable concentration. It is is a measure of the amount of study drug (MK-1064) in the blood plasma from pre-dose until the last measurable concentration of study drug could be determined.

Outcome measures

Measure	Panel A: MK-1064 5 mg n=6 Participants Within each of up to 4 treatment periods, 6 participants were randomly assigned to receive single oral doses of MK-1064 5 mg in a fasted state. There was to be a minimum 7-day washout between treatment periods for any given participant.	Panel B: MK-1064 10 mg n=6 Participants Within each of up to 4 treatment periods, 6 participants were randomly assigned to receive single oral doses of MK-1064 10 mg in a fasted state. There was to be a minimum 7-day washout between treatment periods for any given participant.	Panel A: MK-1064 25 mg n=6 Participants Within each of up to 4 treatment periods, 6 participants were randomly assigned to receive single oral doses of MK-1064 25 mg in a fasted state. There was to be a minimum 7-day washout between treatment periods for any given participant.	Panel B: MK-1064 50 mg n=6 Participants Within each of up to 4 treatment periods, 6 participants were randomly assigned to receive single oral doses of MK-1064 50 mg in a fasted state. There was to be a minimum 7-day washout between treatment periods for any given participant.	Panel A: MK-1064 100 mg n=6 Participants Within each of up to 4 treatment periods, 6 participants were randomly assigned to receive single oral doses of MK-1064 100 mg in a fasted state. There was to be a minimum 7-day washout between treatment periods for any given participant.	Panel B: MK-1064 150 mg n=6 Participants Within each of up to 4 treatment periods, 6 participants were randomly assigned to receive single oral doses of MK-1064 150 mg in a fasted state. There was to be a minimum 7-day washout between treatment periods for any given participant.	Panel A: MK-1064 200 mg n=6 Participants Within each of up to 4 treatment periods, 6 participants were randomly assigned to receive single oral doses of MK-1064 200 mg in a fasted state. There was to be a minimum 7-day washout between treatment periods for any given participant.	Panel B: MK-1064 250 mg n=6 Participants Within each of up to 4 treatment periods, 6 participants were randomly assigned to receive single oral doses of MK-1064 250 mg in a fasted state. There was to be a minimum 7-day washout between treatment periods for any given participant.	Panel A: MK-1064 25 mg (Fed) n=6 Participants In Period 5, 6 participants received a single MK-1064 dose of 25 mg administered in the evening following a standard high-fat breakfast.	Panel B: MK-1064 50 mg (Night) n=6 Participants In Period 5, 6 participants received a single MK-1064 dose of 50 mg administered in the evening after a 4-hour fast.	Panels A & B: Placebo Within each of up to 5 treatment periods, 2 participants were randomly assigned to receive single oral doses of matching placebo in a fasted stated. There was to be a minimum 7-day washout between treatment periods for any given participant.
Area Under the Plasma Drug Concentration-time Curve From Time Zero to Last Measurable Concentration (AUC0-last) Following Single Doses of MK-1064	0.94 µmol*hr/L Standard Deviation 0.25	1.67 µmol*hr/L Standard Deviation 0.52	5.32 µmol*hr/L Standard Deviation 0.71	9.89 µmol*hr/L Standard Deviation 3.80	23.12 µmol*hr/L Standard Deviation 6.23	25.92 µmol*hr/L Standard Deviation 6.03	53.37 µmol*hr/L Standard Deviation 13.78	57.10 µmol*hr/L Standard Deviation 21.98	5.27 µmol*hr/L Standard Deviation 1.13	9.91 µmol*hr/L Standard Deviation 4.32	—

SECONDARY outcome

Timeframe: Pre-dose and 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 16, 24 and 48 hours post dose (all Periods); 72 hours post dose (Periods 3 and 4 only)

Population: All participants who received ≥1 dose of MK-1064.

Cmax is the maximum (peak) concentration of study drug (MK-1064) observed in blood plasma.

Outcome measures

Measure	Panel A: MK-1064 5 mg n=6 Participants Within each of up to 4 treatment periods, 6 participants were randomly assigned to receive single oral doses of MK-1064 5 mg in a fasted state. There was to be a minimum 7-day washout between treatment periods for any given participant.	Panel B: MK-1064 10 mg n=6 Participants Within each of up to 4 treatment periods, 6 participants were randomly assigned to receive single oral doses of MK-1064 10 mg in a fasted state. There was to be a minimum 7-day washout between treatment periods for any given participant.	Panel A: MK-1064 25 mg n=6 Participants Within each of up to 4 treatment periods, 6 participants were randomly assigned to receive single oral doses of MK-1064 25 mg in a fasted state. There was to be a minimum 7-day washout between treatment periods for any given participant.	Panel B: MK-1064 50 mg n=6 Participants Within each of up to 4 treatment periods, 6 participants were randomly assigned to receive single oral doses of MK-1064 50 mg in a fasted state. There was to be a minimum 7-day washout between treatment periods for any given participant.	Panel A: MK-1064 100 mg n=6 Participants Within each of up to 4 treatment periods, 6 participants were randomly assigned to receive single oral doses of MK-1064 100 mg in a fasted state. There was to be a minimum 7-day washout between treatment periods for any given participant.	Panel B: MK-1064 150 mg n=6 Participants Within each of up to 4 treatment periods, 6 participants were randomly assigned to receive single oral doses of MK-1064 150 mg in a fasted state. There was to be a minimum 7-day washout between treatment periods for any given participant.	Panel A: MK-1064 200 mg n=6 Participants Within each of up to 4 treatment periods, 6 participants were randomly assigned to receive single oral doses of MK-1064 200 mg in a fasted state. There was to be a minimum 7-day washout between treatment periods for any given participant.	Panel B: MK-1064 250 mg n=6 Participants Within each of up to 4 treatment periods, 6 participants were randomly assigned to receive single oral doses of MK-1064 250 mg in a fasted state. There was to be a minimum 7-day washout between treatment periods for any given participant.	Panel A: MK-1064 25 mg (Fed) n=6 Participants In Period 5, 6 participants received a single MK-1064 dose of 25 mg administered in the evening following a standard high-fat breakfast.	Panel B: MK-1064 50 mg (Night) n=6 Participants In Period 5, 6 participants received a single MK-1064 dose of 50 mg administered in the evening after a 4-hour fast.	Panels A & B: Placebo Within each of up to 5 treatment periods, 2 participants were randomly assigned to receive single oral doses of matching placebo in a fasted stated. There was to be a minimum 7-day washout between treatment periods for any given participant.
Maximum Observed Plasma Concentration (Cmax) Following Single Doses of MK-1064	0.37 µmol/L Standard Deviation 0.07	0.42 µmol/L Standard Deviation 0.16	1.06 µmol/L Standard Deviation 0.22	2.09 µmol/L Standard Deviation 0.77	3.60 µmol/L Standard Deviation 0.85	3.83 µmol/L Standard Deviation 1.46	6.78 µmol/L Standard Deviation 3.52	8.28 µmol/L Standard Deviation 2.87	0.80 µmol/L Standard Deviation 0.13	1.99 µmol/L Standard Deviation 0.64	—

SECONDARY outcome

Timeframe: Pre-dose and 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 16, 24 and 48 hours post dose (all Periods); 72 hours post dose (Periods 3 and 4 only)

Population: All participants who received ≥1 dose of MK-1064.

Tmax is the amount of time to reach maximum (peak) plasma drug concentration following drug administration.

Outcome measures

Measure	Panel A: MK-1064 5 mg n=6 Participants Within each of up to 4 treatment periods, 6 participants were randomly assigned to receive single oral doses of MK-1064 5 mg in a fasted state. There was to be a minimum 7-day washout between treatment periods for any given participant.	Panel B: MK-1064 10 mg n=6 Participants Within each of up to 4 treatment periods, 6 participants were randomly assigned to receive single oral doses of MK-1064 10 mg in a fasted state. There was to be a minimum 7-day washout between treatment periods for any given participant.	Panel A: MK-1064 25 mg n=6 Participants Within each of up to 4 treatment periods, 6 participants were randomly assigned to receive single oral doses of MK-1064 25 mg in a fasted state. There was to be a minimum 7-day washout between treatment periods for any given participant.	Panel B: MK-1064 50 mg n=6 Participants Within each of up to 4 treatment periods, 6 participants were randomly assigned to receive single oral doses of MK-1064 50 mg in a fasted state. There was to be a minimum 7-day washout between treatment periods for any given participant.	Panel A: MK-1064 100 mg n=6 Participants Within each of up to 4 treatment periods, 6 participants were randomly assigned to receive single oral doses of MK-1064 100 mg in a fasted state. There was to be a minimum 7-day washout between treatment periods for any given participant.	Panel B: MK-1064 150 mg n=6 Participants Within each of up to 4 treatment periods, 6 participants were randomly assigned to receive single oral doses of MK-1064 150 mg in a fasted state. There was to be a minimum 7-day washout between treatment periods for any given participant.	Panel A: MK-1064 200 mg n=6 Participants Within each of up to 4 treatment periods, 6 participants were randomly assigned to receive single oral doses of MK-1064 200 mg in a fasted state. There was to be a minimum 7-day washout between treatment periods for any given participant.	Panel B: MK-1064 250 mg n=6 Participants Within each of up to 4 treatment periods, 6 participants were randomly assigned to receive single oral doses of MK-1064 250 mg in a fasted state. There was to be a minimum 7-day washout between treatment periods for any given participant.	Panel A: MK-1064 25 mg (Fed) n=6 Participants In Period 5, 6 participants received a single MK-1064 dose of 25 mg administered in the evening following a standard high-fat breakfast.	Panel B: MK-1064 50 mg (Night) n=6 Participants In Period 5, 6 participants received a single MK-1064 dose of 50 mg administered in the evening after a 4-hour fast.	Panels A & B: Placebo Within each of up to 5 treatment periods, 2 participants were randomly assigned to receive single oral doses of matching placebo in a fasted stated. There was to be a minimum 7-day washout between treatment periods for any given participant.
Time to Cmax (Tmax) Following Single Doses of MK-1064	1.0 hr Full Range 0.07 • Interval 0.5 to 2.0	1.5 hr Full Range 0.16 • Interval 0.5 to 2.0	1.5 hr Full Range 0.22 • Interval 0.5 to 2.0	2.0 hr Full Range 0.77 • Interval 1.0 to 2.0	2.0 hr Full Range 0.85 • Interval 1.0 to 5.0	1.0 hr Full Range 1.46 • Interval 0.5 to 5.0	2.0 hr Full Range 3.52 • Interval 1.0 to 3.0	2.0 hr Full Range 2.87 • Interval 0.5 to 2.0	5.0 hr Full Range 0.13 • Interval 2.0 to 5.0	2.0 hr Full Range 0.64 • Interval 1.0 to 5.0	—

SECONDARY outcome

Timeframe: Pre-dose and 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 16, 24 and 48 hours post dose (all Periods); 72 hours post dose (Periods 3 and 4 only)

Population: All participants who received ≥1 dose of MK-1064.

t1/2 is the elimination half-life of study drug. t1/2 is the time it takes for half of the study drug (MK-1064) in the blood plama to dissipate.

Outcome measures

Measure	Panel A: MK-1064 5 mg n=6 Participants Within each of up to 4 treatment periods, 6 participants were randomly assigned to receive single oral doses of MK-1064 5 mg in a fasted state. There was to be a minimum 7-day washout between treatment periods for any given participant.	Panel B: MK-1064 10 mg n=6 Participants Within each of up to 4 treatment periods, 6 participants were randomly assigned to receive single oral doses of MK-1064 10 mg in a fasted state. There was to be a minimum 7-day washout between treatment periods for any given participant.	Panel A: MK-1064 25 mg n=6 Participants Within each of up to 4 treatment periods, 6 participants were randomly assigned to receive single oral doses of MK-1064 25 mg in a fasted state. There was to be a minimum 7-day washout between treatment periods for any given participant.	Panel B: MK-1064 50 mg n=6 Participants Within each of up to 4 treatment periods, 6 participants were randomly assigned to receive single oral doses of MK-1064 50 mg in a fasted state. There was to be a minimum 7-day washout between treatment periods for any given participant.	Panel A: MK-1064 100 mg n=6 Participants Within each of up to 4 treatment periods, 6 participants were randomly assigned to receive single oral doses of MK-1064 100 mg in a fasted state. There was to be a minimum 7-day washout between treatment periods for any given participant.	Panel B: MK-1064 150 mg n=6 Participants Within each of up to 4 treatment periods, 6 participants were randomly assigned to receive single oral doses of MK-1064 150 mg in a fasted state. There was to be a minimum 7-day washout between treatment periods for any given participant.	Panel A: MK-1064 200 mg n=6 Participants Within each of up to 4 treatment periods, 6 participants were randomly assigned to receive single oral doses of MK-1064 200 mg in a fasted state. There was to be a minimum 7-day washout between treatment periods for any given participant.	Panel B: MK-1064 250 mg n=5 Participants Within each of up to 4 treatment periods, 6 participants were randomly assigned to receive single oral doses of MK-1064 250 mg in a fasted state. There was to be a minimum 7-day washout between treatment periods for any given participant.	Panel A: MK-1064 25 mg (Fed) n=6 Participants In Period 5, 6 participants received a single MK-1064 dose of 25 mg administered in the evening following a standard high-fat breakfast.	Panel B: MK-1064 50 mg (Night) n=6 Participants In Period 5, 6 participants received a single MK-1064 dose of 50 mg administered in the evening after a 4-hour fast.	Panels A & B: Placebo Within each of up to 5 treatment periods, 2 participants were randomly assigned to receive single oral doses of matching placebo in a fasted stated. There was to be a minimum 7-day washout between treatment periods for any given participant.
Apparent Terminal Half-life (t1/2) Following Single Doses of MK-1064	NA hr Standard Deviation NA • Interval 0.5 to 2.0 t1/2 estimates not available due to lack of data at terminal phase.	NA hr Standard Deviation NA • Interval 0.5 to 2.0 t1/2 estimates not available due to lack of data at terminal phase.	NA hr Standard Deviation NA • Interval 0.5 to 2.0 t1/2 estimates not available due to lack of data at terminal phase.	NA hr Standard Deviation NA • Interval 1.0 to 2.0 t1/2 estimates not available due to lack of data at terminal phase.	11.1 hr Standard Deviation 5.0 • Interval 1.0 to 5.0	6.8 hr Standard Deviation 3.2 • Interval 0.5 to 5.0	7.5 hr Standard Deviation 1.6 • Interval 1.0 to 3.0	8.6 hr Standard Deviation 2.7 • Interval 0.5 to 2.0	NA hr Standard Deviation NA • Interval 2.0 to 5.0 t1/2 estimates not available due to lack of data at terminal phase.	NA hr Standard Deviation NA • Interval 1.0 to 5.0 t1/2 estimates not available due to lack of data at terminal phase.	—

Adverse Events

Panel A: MK-1064 5 mg

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

Panel B: MK-1064 10 mg

Serious events: 0 serious events

Other events: 5 other events

Deaths: 0 deaths

Panel A: MK-1064 25 mg

Serious events: 0 serious events

Other events: 5 other events

Deaths: 0 deaths

Panel B: MK-1064 50 mg

Serious events: 0 serious events

Other events: 5 other events

Deaths: 0 deaths

Panel A: MK-1064 100 mg

Serious events: 0 serious events

Other events: 5 other events

Deaths: 0 deaths

Panel B: MK-1064 150 mg

Serious events: 0 serious events

Other events: 5 other events

Deaths: 0 deaths

Panel A: MK-1064 200 mg

Serious events: 0 serious events

Other events: 6 other events

Deaths: 0 deaths

Panel B: MK-1064 250 mg

Serious events: 0 serious events

Other events: 6 other events

Deaths: 0 deaths

Panel A: MK-1064 25 mg (Fed)

Serious events: 1 serious events

Other events: 3 other events

Deaths: 0 deaths

Panel B: MK-1064 50 mg (Night)

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Panels A & B: Placebo

Serious events: 0 serious events

Other events: 5 other events

Deaths: 0 deaths

Serious adverse events

Measure	Panel A: MK-1064 5 mg n=6 participants at risk Within each of up to 4 treatment periods, 6 participants were randomly assigned to receive single oral doses of MK-1064 5 mg in a fasted state. There was to be a minimum 7-day washout between treatment periods for any given participant.	Panel B: MK-1064 10 mg n=6 participants at risk Within each of up to 4 treatment periods, 6 participants were randomly assigned to receive single oral doses of MK-1064 10 mg in a fasted state. There was to be a minimum 7-day washout between treatment periods for any given participant.	Panel A: MK-1064 25 mg n=6 participants at risk Within each of up to 4 treatment periods, 6 participants were randomly assigned to receive single oral doses of MK-1064 25 mg in a fasted state. There was to be a minimum 7-day washout between treatment periods for any given participant.	Panel B: MK-1064 50 mg n=6 participants at risk Within each of up to 4 treatment periods, 6 participants were randomly assigned to receive single oral doses of MK-1064 50 mg in a fasted state. There was to be a minimum 7-day washout between treatment periods for any given participant.	Panel A: MK-1064 100 mg n=6 participants at risk Within each of up to 4 treatment periods, 6 participants were randomly assigned to receive single oral doses of MK-1064 100 mg in a fasted state. There was to be a minimum 7-day washout between treatment periods for any given participant.	Panel B: MK-1064 150 mg n=6 participants at risk Within each of up to 4 treatment periods, 6 participants were randomly assigned to receive single oral doses of MK-1064 150 mg in a fasted state. There was to be a minimum 7-day washout between treatment periods for any given participant.	Panel A: MK-1064 200 mg n=6 participants at risk Within each of up to 4 treatment periods, 6 participants were randomly assigned to receive single oral doses of MK-1064 200 mg in a fasted state. There was to be a minimum 7-day washout between treatment periods for any given participant.	Panel B: MK-1064 250 mg n=6 participants at risk Within each of up to 4 treatment periods, 6 participants were randomly assigned to receive single oral doses of MK-1064 250 mg in a fasted state. There was to be a minimum 7-day washout between treatment periods for any given participant.	Panel A: MK-1064 25 mg (Fed) n=6 participants at risk In Period 5, 6 participants received a single MK-1064 dose of 25 mg administered in the evening following a standard high-fat breakfast.	Panel B: MK-1064 50 mg (Night) n=6 participants at risk In Period 5, 6 participants received a single MK-1064 dose of 50 mg administered in the evening after a 4-hour fast.	Panels A & B: Placebo n=16 participants at risk Within each of up to 5 treatment periods, 2 participants were randomly assigned to receive single oral doses of matching placebo in a fasted stated. There was to be a minimum 7-day washout between treatment periods for any given participant.
Injury, poisoning and procedural complications Head injury	0.00% 0/6 • Up to 14 days after the last dose of study drug (Up to approximately 60 days) All participants who recieved ≥1 dose of study drug. Adverse events are reported based on the study drug a participant was taking at the time of the event.	0.00% 0/6 • Up to 14 days after the last dose of study drug (Up to approximately 60 days) All participants who recieved ≥1 dose of study drug. Adverse events are reported based on the study drug a participant was taking at the time of the event.	0.00% 0/6 • Up to 14 days after the last dose of study drug (Up to approximately 60 days) All participants who recieved ≥1 dose of study drug. Adverse events are reported based on the study drug a participant was taking at the time of the event.	0.00% 0/6 • Up to 14 days after the last dose of study drug (Up to approximately 60 days) All participants who recieved ≥1 dose of study drug. Adverse events are reported based on the study drug a participant was taking at the time of the event.	0.00% 0/6 • Up to 14 days after the last dose of study drug (Up to approximately 60 days) All participants who recieved ≥1 dose of study drug. Adverse events are reported based on the study drug a participant was taking at the time of the event.	0.00% 0/6 • Up to 14 days after the last dose of study drug (Up to approximately 60 days) All participants who recieved ≥1 dose of study drug. Adverse events are reported based on the study drug a participant was taking at the time of the event.	0.00% 0/6 • Up to 14 days after the last dose of study drug (Up to approximately 60 days) All participants who recieved ≥1 dose of study drug. Adverse events are reported based on the study drug a participant was taking at the time of the event.	0.00% 0/6 • Up to 14 days after the last dose of study drug (Up to approximately 60 days) All participants who recieved ≥1 dose of study drug. Adverse events are reported based on the study drug a participant was taking at the time of the event.	16.7% 1/6 • Number of events 1 • Up to 14 days after the last dose of study drug (Up to approximately 60 days) All participants who recieved ≥1 dose of study drug. Adverse events are reported based on the study drug a participant was taking at the time of the event.	0.00% 0/6 • Up to 14 days after the last dose of study drug (Up to approximately 60 days) All participants who recieved ≥1 dose of study drug. Adverse events are reported based on the study drug a participant was taking at the time of the event.	0.00% 0/16 • Up to 14 days after the last dose of study drug (Up to approximately 60 days) All participants who recieved ≥1 dose of study drug. Adverse events are reported based on the study drug a participant was taking at the time of the event.

Other adverse events

Measure	Panel A: MK-1064 5 mg n=6 participants at risk Within each of up to 4 treatment periods, 6 participants were randomly assigned to receive single oral doses of MK-1064 5 mg in a fasted state. There was to be a minimum 7-day washout between treatment periods for any given participant.	Panel B: MK-1064 10 mg n=6 participants at risk Within each of up to 4 treatment periods, 6 participants were randomly assigned to receive single oral doses of MK-1064 10 mg in a fasted state. There was to be a minimum 7-day washout between treatment periods for any given participant.	Panel A: MK-1064 25 mg n=6 participants at risk Within each of up to 4 treatment periods, 6 participants were randomly assigned to receive single oral doses of MK-1064 25 mg in a fasted state. There was to be a minimum 7-day washout between treatment periods for any given participant.	Panel B: MK-1064 50 mg n=6 participants at risk Within each of up to 4 treatment periods, 6 participants were randomly assigned to receive single oral doses of MK-1064 50 mg in a fasted state. There was to be a minimum 7-day washout between treatment periods for any given participant.	Panel A: MK-1064 100 mg n=6 participants at risk Within each of up to 4 treatment periods, 6 participants were randomly assigned to receive single oral doses of MK-1064 100 mg in a fasted state. There was to be a minimum 7-day washout between treatment periods for any given participant.	Panel B: MK-1064 150 mg n=6 participants at risk Within each of up to 4 treatment periods, 6 participants were randomly assigned to receive single oral doses of MK-1064 150 mg in a fasted state. There was to be a minimum 7-day washout between treatment periods for any given participant.	Panel A: MK-1064 200 mg n=6 participants at risk Within each of up to 4 treatment periods, 6 participants were randomly assigned to receive single oral doses of MK-1064 200 mg in a fasted state. There was to be a minimum 7-day washout between treatment periods for any given participant.	Panel B: MK-1064 250 mg n=6 participants at risk Within each of up to 4 treatment periods, 6 participants were randomly assigned to receive single oral doses of MK-1064 250 mg in a fasted state. There was to be a minimum 7-day washout between treatment periods for any given participant.	Panel A: MK-1064 25 mg (Fed) n=6 participants at risk In Period 5, 6 participants received a single MK-1064 dose of 25 mg administered in the evening following a standard high-fat breakfast.	Panel B: MK-1064 50 mg (Night) n=6 participants at risk In Period 5, 6 participants received a single MK-1064 dose of 50 mg administered in the evening after a 4-hour fast.	Panels A & B: Placebo n=16 participants at risk Within each of up to 5 treatment periods, 2 participants were randomly assigned to receive single oral doses of matching placebo in a fasted stated. There was to be a minimum 7-day washout between treatment periods for any given participant.
Ear and labyrinth disorders Sensation of block in ear	0.00% 0/6 • Up to 14 days after the last dose of study drug (Up to approximately 60 days) All participants who recieved ≥1 dose of study drug. Adverse events are reported based on the study drug a participant was taking at the time of the event.	0.00% 0/6 • Up to 14 days after the last dose of study drug (Up to approximately 60 days) All participants who recieved ≥1 dose of study drug. Adverse events are reported based on the study drug a participant was taking at the time of the event.	0.00% 0/6 • Up to 14 days after the last dose of study drug (Up to approximately 60 days) All participants who recieved ≥1 dose of study drug. Adverse events are reported based on the study drug a participant was taking at the time of the event.	0.00% 0/6 • Up to 14 days after the last dose of study drug (Up to approximately 60 days) All participants who recieved ≥1 dose of study drug. Adverse events are reported based on the study drug a participant was taking at the time of the event.	0.00% 0/6 • Up to 14 days after the last dose of study drug (Up to approximately 60 days) All participants who recieved ≥1 dose of study drug. Adverse events are reported based on the study drug a participant was taking at the time of the event.	0.00% 0/6 • Up to 14 days after the last dose of study drug (Up to approximately 60 days) All participants who recieved ≥1 dose of study drug. Adverse events are reported based on the study drug a participant was taking at the time of the event.	0.00% 0/6 • Up to 14 days after the last dose of study drug (Up to approximately 60 days) All participants who recieved ≥1 dose of study drug. Adverse events are reported based on the study drug a participant was taking at the time of the event.	0.00% 0/6 • Up to 14 days after the last dose of study drug (Up to approximately 60 days) All participants who recieved ≥1 dose of study drug. Adverse events are reported based on the study drug a participant was taking at the time of the event.	16.7% 1/6 • Number of events 1 • Up to 14 days after the last dose of study drug (Up to approximately 60 days) All participants who recieved ≥1 dose of study drug. Adverse events are reported based on the study drug a participant was taking at the time of the event.	0.00% 0/6 • Up to 14 days after the last dose of study drug (Up to approximately 60 days) All participants who recieved ≥1 dose of study drug. Adverse events are reported based on the study drug a participant was taking at the time of the event.	0.00% 0/16 • Up to 14 days after the last dose of study drug (Up to approximately 60 days) All participants who recieved ≥1 dose of study drug. Adverse events are reported based on the study drug a participant was taking at the time of the event.
Eye disorders Vision blurred	0.00% 0/6 • Up to 14 days after the last dose of study drug (Up to approximately 60 days) All participants who recieved ≥1 dose of study drug. Adverse events are reported based on the study drug a participant was taking at the time of the event.	0.00% 0/6 • Up to 14 days after the last dose of study drug (Up to approximately 60 days) All participants who recieved ≥1 dose of study drug. Adverse events are reported based on the study drug a participant was taking at the time of the event.	0.00% 0/6 • Up to 14 days after the last dose of study drug (Up to approximately 60 days) All participants who recieved ≥1 dose of study drug. Adverse events are reported based on the study drug a participant was taking at the time of the event.	0.00% 0/6 • Up to 14 days after the last dose of study drug (Up to approximately 60 days) All participants who recieved ≥1 dose of study drug. Adverse events are reported based on the study drug a participant was taking at the time of the event.	16.7% 1/6 • Number of events 1 • Up to 14 days after the last dose of study drug (Up to approximately 60 days) All participants who recieved ≥1 dose of study drug. Adverse events are reported based on the study drug a participant was taking at the time of the event.	0.00% 0/6 • Up to 14 days after the last dose of study drug (Up to approximately 60 days) All participants who recieved ≥1 dose of study drug. Adverse events are reported based on the study drug a participant was taking at the time of the event.	0.00% 0/6 • Up to 14 days after the last dose of study drug (Up to approximately 60 days) All participants who recieved ≥1 dose of study drug. Adverse events are reported based on the study drug a participant was taking at the time of the event.	0.00% 0/6 • Up to 14 days after the last dose of study drug (Up to approximately 60 days) All participants who recieved ≥1 dose of study drug. Adverse events are reported based on the study drug a participant was taking at the time of the event.	0.00% 0/6 • Up to 14 days after the last dose of study drug (Up to approximately 60 days) All participants who recieved ≥1 dose of study drug. Adverse events are reported based on the study drug a participant was taking at the time of the event.	0.00% 0/6 • Up to 14 days after the last dose of study drug (Up to approximately 60 days) All participants who recieved ≥1 dose of study drug. Adverse events are reported based on the study drug a participant was taking at the time of the event.	0.00% 0/16 • Up to 14 days after the last dose of study drug (Up to approximately 60 days) All participants who recieved ≥1 dose of study drug. Adverse events are reported based on the study drug a participant was taking at the time of the event.
Gastrointestinal disorders Bloated feeling	16.7% 1/6 • Number of events 1 • Up to 14 days after the last dose of study drug (Up to approximately 60 days) All participants who recieved ≥1 dose of study drug. Adverse events are reported based on the study drug a participant was taking at the time of the event.	0.00% 0/6 • Up to 14 days after the last dose of study drug (Up to approximately 60 days) All participants who recieved ≥1 dose of study drug. Adverse events are reported based on the study drug a participant was taking at the time of the event.	0.00% 0/6 • Up to 14 days after the last dose of study drug (Up to approximately 60 days) All participants who recieved ≥1 dose of study drug. Adverse events are reported based on the study drug a participant was taking at the time of the event.	0.00% 0/6 • Up to 14 days after the last dose of study drug (Up to approximately 60 days) All participants who recieved ≥1 dose of study drug. Adverse events are reported based on the study drug a participant was taking at the time of the event.	0.00% 0/6 • Up to 14 days after the last dose of study drug (Up to approximately 60 days) All participants who recieved ≥1 dose of study drug. Adverse events are reported based on the study drug a participant was taking at the time of the event.	0.00% 0/6 • Up to 14 days after the last dose of study drug (Up to approximately 60 days) All participants who recieved ≥1 dose of study drug. Adverse events are reported based on the study drug a participant was taking at the time of the event.	0.00% 0/6 • Up to 14 days after the last dose of study drug (Up to approximately 60 days) All participants who recieved ≥1 dose of study drug. Adverse events are reported based on the study drug a participant was taking at the time of the event.	0.00% 0/6 • Up to 14 days after the last dose of study drug (Up to approximately 60 days) All participants who recieved ≥1 dose of study drug. Adverse events are reported based on the study drug a participant was taking at the time of the event.	0.00% 0/6 • Up to 14 days after the last dose of study drug (Up to approximately 60 days) All participants who recieved ≥1 dose of study drug. Adverse events are reported based on the study drug a participant was taking at the time of the event.	0.00% 0/6 • Up to 14 days after the last dose of study drug (Up to approximately 60 days) All participants who recieved ≥1 dose of study drug. Adverse events are reported based on the study drug a participant was taking at the time of the event.	0.00% 0/16 • Up to 14 days after the last dose of study drug (Up to approximately 60 days) All participants who recieved ≥1 dose of study drug. Adverse events are reported based on the study drug a participant was taking at the time of the event.
Gastrointestinal disorders Flatulence	0.00% 0/6 • Up to 14 days after the last dose of study drug (Up to approximately 60 days) All participants who recieved ≥1 dose of study drug. Adverse events are reported based on the study drug a participant was taking at the time of the event.	0.00% 0/6 • Up to 14 days after the last dose of study drug (Up to approximately 60 days) All participants who recieved ≥1 dose of study drug. Adverse events are reported based on the study drug a participant was taking at the time of the event.	0.00% 0/6 • Up to 14 days after the last dose of study drug (Up to approximately 60 days) All participants who recieved ≥1 dose of study drug. Adverse events are reported based on the study drug a participant was taking at the time of the event.	0.00% 0/6 • Up to 14 days after the last dose of study drug (Up to approximately 60 days) All participants who recieved ≥1 dose of study drug. Adverse events are reported based on the study drug a participant was taking at the time of the event.	0.00% 0/6 • Up to 14 days after the last dose of study drug (Up to approximately 60 days) All participants who recieved ≥1 dose of study drug. Adverse events are reported based on the study drug a participant was taking at the time of the event.	16.7% 1/6 • Number of events 1 • Up to 14 days after the last dose of study drug (Up to approximately 60 days) All participants who recieved ≥1 dose of study drug. Adverse events are reported based on the study drug a participant was taking at the time of the event.	0.00% 0/6 • Up to 14 days after the last dose of study drug (Up to approximately 60 days) All participants who recieved ≥1 dose of study drug. Adverse events are reported based on the study drug a participant was taking at the time of the event.	0.00% 0/6 • Up to 14 days after the last dose of study drug (Up to approximately 60 days) All participants who recieved ≥1 dose of study drug. Adverse events are reported based on the study drug a participant was taking at the time of the event.	0.00% 0/6 • Up to 14 days after the last dose of study drug (Up to approximately 60 days) All participants who recieved ≥1 dose of study drug. Adverse events are reported based on the study drug a participant was taking at the time of the event.	0.00% 0/6 • Up to 14 days after the last dose of study drug (Up to approximately 60 days) All participants who recieved ≥1 dose of study drug. Adverse events are reported based on the study drug a participant was taking at the time of the event.	0.00% 0/16 • Up to 14 days after the last dose of study drug (Up to approximately 60 days) All participants who recieved ≥1 dose of study drug. Adverse events are reported based on the study drug a participant was taking at the time of the event.
Gastrointestinal disorders Loose stools	0.00% 0/6 • Up to 14 days after the last dose of study drug (Up to approximately 60 days) All participants who recieved ≥1 dose of study drug. Adverse events are reported based on the study drug a participant was taking at the time of the event.	16.7% 1/6 • Number of events 1 • Up to 14 days after the last dose of study drug (Up to approximately 60 days) All participants who recieved ≥1 dose of study drug. Adverse events are reported based on the study drug a participant was taking at the time of the event.	0.00% 0/6 • Up to 14 days after the last dose of study drug (Up to approximately 60 days) All participants who recieved ≥1 dose of study drug. Adverse events are reported based on the study drug a participant was taking at the time of the event.	0.00% 0/6 • Up to 14 days after the last dose of study drug (Up to approximately 60 days) All participants who recieved ≥1 dose of study drug. Adverse events are reported based on the study drug a participant was taking at the time of the event.	0.00% 0/6 • Up to 14 days after the last dose of study drug (Up to approximately 60 days) All participants who recieved ≥1 dose of study drug. Adverse events are reported based on the study drug a participant was taking at the time of the event.	0.00% 0/6 • Up to 14 days after the last dose of study drug (Up to approximately 60 days) All participants who recieved ≥1 dose of study drug. Adverse events are reported based on the study drug a participant was taking at the time of the event.	0.00% 0/6 • Up to 14 days after the last dose of study drug (Up to approximately 60 days) All participants who recieved ≥1 dose of study drug. Adverse events are reported based on the study drug a participant was taking at the time of the event.	0.00% 0/6 • Up to 14 days after the last dose of study drug (Up to approximately 60 days) All participants who recieved ≥1 dose of study drug. Adverse events are reported based on the study drug a participant was taking at the time of the event.	0.00% 0/6 • Up to 14 days after the last dose of study drug (Up to approximately 60 days) All participants who recieved ≥1 dose of study drug. Adverse events are reported based on the study drug a participant was taking at the time of the event.	0.00% 0/6 • Up to 14 days after the last dose of study drug (Up to approximately 60 days) All participants who recieved ≥1 dose of study drug. Adverse events are reported based on the study drug a participant was taking at the time of the event.	6.2% 1/16 • Number of events 1 • Up to 14 days after the last dose of study drug (Up to approximately 60 days) All participants who recieved ≥1 dose of study drug. Adverse events are reported based on the study drug a participant was taking at the time of the event.
Gastrointestinal disorders Toothache	16.7% 1/6 • Number of events 1 • Up to 14 days after the last dose of study drug (Up to approximately 60 days) All participants who recieved ≥1 dose of study drug. Adverse events are reported based on the study drug a participant was taking at the time of the event.	0.00% 0/6 • Up to 14 days after the last dose of study drug (Up to approximately 60 days) All participants who recieved ≥1 dose of study drug. Adverse events are reported based on the study drug a participant was taking at the time of the event.	0.00% 0/6 • Up to 14 days after the last dose of study drug (Up to approximately 60 days) All participants who recieved ≥1 dose of study drug. Adverse events are reported based on the study drug a participant was taking at the time of the event.	0.00% 0/6 • Up to 14 days after the last dose of study drug (Up to approximately 60 days) All participants who recieved ≥1 dose of study drug. Adverse events are reported based on the study drug a participant was taking at the time of the event.	0.00% 0/6 • Up to 14 days after the last dose of study drug (Up to approximately 60 days) All participants who recieved ≥1 dose of study drug. Adverse events are reported based on the study drug a participant was taking at the time of the event.	0.00% 0/6 • Up to 14 days after the last dose of study drug (Up to approximately 60 days) All participants who recieved ≥1 dose of study drug. Adverse events are reported based on the study drug a participant was taking at the time of the event.	0.00% 0/6 • Up to 14 days after the last dose of study drug (Up to approximately 60 days) All participants who recieved ≥1 dose of study drug. Adverse events are reported based on the study drug a participant was taking at the time of the event.	0.00% 0/6 • Up to 14 days after the last dose of study drug (Up to approximately 60 days) All participants who recieved ≥1 dose of study drug. Adverse events are reported based on the study drug a participant was taking at the time of the event.	0.00% 0/6 • Up to 14 days after the last dose of study drug (Up to approximately 60 days) All participants who recieved ≥1 dose of study drug. Adverse events are reported based on the study drug a participant was taking at the time of the event.	0.00% 0/6 • Up to 14 days after the last dose of study drug (Up to approximately 60 days) All participants who recieved ≥1 dose of study drug. Adverse events are reported based on the study drug a participant was taking at the time of the event.	0.00% 0/16 • Up to 14 days after the last dose of study drug (Up to approximately 60 days) All participants who recieved ≥1 dose of study drug. Adverse events are reported based on the study drug a participant was taking at the time of the event.
Gastrointestinal disorders Vomiting	0.00% 0/6 • Up to 14 days after the last dose of study drug (Up to approximately 60 days) All participants who recieved ≥1 dose of study drug. Adverse events are reported based on the study drug a participant was taking at the time of the event.	0.00% 0/6 • Up to 14 days after the last dose of study drug (Up to approximately 60 days) All participants who recieved ≥1 dose of study drug. Adverse events are reported based on the study drug a participant was taking at the time of the event.	0.00% 0/6 • Up to 14 days after the last dose of study drug (Up to approximately 60 days) All participants who recieved ≥1 dose of study drug. Adverse events are reported based on the study drug a participant was taking at the time of the event.	0.00% 0/6 • Up to 14 days after the last dose of study drug (Up to approximately 60 days) All participants who recieved ≥1 dose of study drug. Adverse events are reported based on the study drug a participant was taking at the time of the event.	0.00% 0/6 • Up to 14 days after the last dose of study drug (Up to approximately 60 days) All participants who recieved ≥1 dose of study drug. Adverse events are reported based on the study drug a participant was taking at the time of the event.	0.00% 0/6 • Up to 14 days after the last dose of study drug (Up to approximately 60 days) All participants who recieved ≥1 dose of study drug. Adverse events are reported based on the study drug a participant was taking at the time of the event.	0.00% 0/6 • Up to 14 days after the last dose of study drug (Up to approximately 60 days) All participants who recieved ≥1 dose of study drug. Adverse events are reported based on the study drug a participant was taking at the time of the event.	0.00% 0/6 • Up to 14 days after the last dose of study drug (Up to approximately 60 days) All participants who recieved ≥1 dose of study drug. Adverse events are reported based on the study drug a participant was taking at the time of the event.	0.00% 0/6 • Up to 14 days after the last dose of study drug (Up to approximately 60 days) All participants who recieved ≥1 dose of study drug. Adverse events are reported based on the study drug a participant was taking at the time of the event.	0.00% 0/6 • Up to 14 days after the last dose of study drug (Up to approximately 60 days) All participants who recieved ≥1 dose of study drug. Adverse events are reported based on the study drug a participant was taking at the time of the event.	6.2% 1/16 • Number of events 1 • Up to 14 days after the last dose of study drug (Up to approximately 60 days) All participants who recieved ≥1 dose of study drug. Adverse events are reported based on the study drug a participant was taking at the time of the event.
General disorders Flu-like symptoms	0.00% 0/6 • Up to 14 days after the last dose of study drug (Up to approximately 60 days) All participants who recieved ≥1 dose of study drug. Adverse events are reported based on the study drug a participant was taking at the time of the event.	0.00% 0/6 • Up to 14 days after the last dose of study drug (Up to approximately 60 days) All participants who recieved ≥1 dose of study drug. Adverse events are reported based on the study drug a participant was taking at the time of the event.	0.00% 0/6 • Up to 14 days after the last dose of study drug (Up to approximately 60 days) All participants who recieved ≥1 dose of study drug. Adverse events are reported based on the study drug a participant was taking at the time of the event.	16.7% 1/6 • Number of events 1 • Up to 14 days after the last dose of study drug (Up to approximately 60 days) All participants who recieved ≥1 dose of study drug. Adverse events are reported based on the study drug a participant was taking at the time of the event.	0.00% 0/6 • Up to 14 days after the last dose of study drug (Up to approximately 60 days) All participants who recieved ≥1 dose of study drug. Adverse events are reported based on the study drug a participant was taking at the time of the event.	0.00% 0/6 • Up to 14 days after the last dose of study drug (Up to approximately 60 days) All participants who recieved ≥1 dose of study drug. Adverse events are reported based on the study drug a participant was taking at the time of the event.	0.00% 0/6 • Up to 14 days after the last dose of study drug (Up to approximately 60 days) All participants who recieved ≥1 dose of study drug. Adverse events are reported based on the study drug a participant was taking at the time of the event.	0.00% 0/6 • Up to 14 days after the last dose of study drug (Up to approximately 60 days) All participants who recieved ≥1 dose of study drug. Adverse events are reported based on the study drug a participant was taking at the time of the event.	0.00% 0/6 • Up to 14 days after the last dose of study drug (Up to approximately 60 days) All participants who recieved ≥1 dose of study drug. Adverse events are reported based on the study drug a participant was taking at the time of the event.	0.00% 0/6 • Up to 14 days after the last dose of study drug (Up to approximately 60 days) All participants who recieved ≥1 dose of study drug. Adverse events are reported based on the study drug a participant was taking at the time of the event.	0.00% 0/16 • Up to 14 days after the last dose of study drug (Up to approximately 60 days) All participants who recieved ≥1 dose of study drug. Adverse events are reported based on the study drug a participant was taking at the time of the event.
General disorders Tiredness	0.00% 0/6 • Up to 14 days after the last dose of study drug (Up to approximately 60 days) All participants who recieved ≥1 dose of study drug. Adverse events are reported based on the study drug a participant was taking at the time of the event.	0.00% 0/6 • Up to 14 days after the last dose of study drug (Up to approximately 60 days) All participants who recieved ≥1 dose of study drug. Adverse events are reported based on the study drug a participant was taking at the time of the event.	0.00% 0/6 • Up to 14 days after the last dose of study drug (Up to approximately 60 days) All participants who recieved ≥1 dose of study drug. Adverse events are reported based on the study drug a participant was taking at the time of the event.	0.00% 0/6 • Up to 14 days after the last dose of study drug (Up to approximately 60 days) All participants who recieved ≥1 dose of study drug. Adverse events are reported based on the study drug a participant was taking at the time of the event.	0.00% 0/6 • Up to 14 days after the last dose of study drug (Up to approximately 60 days) All participants who recieved ≥1 dose of study drug. Adverse events are reported based on the study drug a participant was taking at the time of the event.	16.7% 1/6 • Number of events 1 • Up to 14 days after the last dose of study drug (Up to approximately 60 days) All participants who recieved ≥1 dose of study drug. Adverse events are reported based on the study drug a participant was taking at the time of the event.	0.00% 0/6 • Up to 14 days after the last dose of study drug (Up to approximately 60 days) All participants who recieved ≥1 dose of study drug. Adverse events are reported based on the study drug a participant was taking at the time of the event.	0.00% 0/6 • Up to 14 days after the last dose of study drug (Up to approximately 60 days) All participants who recieved ≥1 dose of study drug. Adverse events are reported based on the study drug a participant was taking at the time of the event.	0.00% 0/6 • Up to 14 days after the last dose of study drug (Up to approximately 60 days) All participants who recieved ≥1 dose of study drug. Adverse events are reported based on the study drug a participant was taking at the time of the event.	0.00% 0/6 • Up to 14 days after the last dose of study drug (Up to approximately 60 days) All participants who recieved ≥1 dose of study drug. Adverse events are reported based on the study drug a participant was taking at the time of the event.	0.00% 0/16 • Up to 14 days after the last dose of study drug (Up to approximately 60 days) All participants who recieved ≥1 dose of study drug. Adverse events are reported based on the study drug a participant was taking at the time of the event.
Infections and infestations Common cold	0.00% 0/6 • Up to 14 days after the last dose of study drug (Up to approximately 60 days) All participants who recieved ≥1 dose of study drug. Adverse events are reported based on the study drug a participant was taking at the time of the event.	0.00% 0/6 • Up to 14 days after the last dose of study drug (Up to approximately 60 days) All participants who recieved ≥1 dose of study drug. Adverse events are reported based on the study drug a participant was taking at the time of the event.	0.00% 0/6 • Up to 14 days after the last dose of study drug (Up to approximately 60 days) All participants who recieved ≥1 dose of study drug. Adverse events are reported based on the study drug a participant was taking at the time of the event.	33.3% 2/6 • Number of events 2 • Up to 14 days after the last dose of study drug (Up to approximately 60 days) All participants who recieved ≥1 dose of study drug. Adverse events are reported based on the study drug a participant was taking at the time of the event.	0.00% 0/6 • Up to 14 days after the last dose of study drug (Up to approximately 60 days) All participants who recieved ≥1 dose of study drug. Adverse events are reported based on the study drug a participant was taking at the time of the event.	0.00% 0/6 • Up to 14 days after the last dose of study drug (Up to approximately 60 days) All participants who recieved ≥1 dose of study drug. Adverse events are reported based on the study drug a participant was taking at the time of the event.	33.3% 2/6 • Number of events 2 • Up to 14 days after the last dose of study drug (Up to approximately 60 days) All participants who recieved ≥1 dose of study drug. Adverse events are reported based on the study drug a participant was taking at the time of the event.	0.00% 0/6 • Up to 14 days after the last dose of study drug (Up to approximately 60 days) All participants who recieved ≥1 dose of study drug. Adverse events are reported based on the study drug a participant was taking at the time of the event.	0.00% 0/6 • Up to 14 days after the last dose of study drug (Up to approximately 60 days) All participants who recieved ≥1 dose of study drug. Adverse events are reported based on the study drug a participant was taking at the time of the event.	0.00% 0/6 • Up to 14 days after the last dose of study drug (Up to approximately 60 days) All participants who recieved ≥1 dose of study drug. Adverse events are reported based on the study drug a participant was taking at the time of the event.	6.2% 1/16 • Number of events 1 • Up to 14 days after the last dose of study drug (Up to approximately 60 days) All participants who recieved ≥1 dose of study drug. Adverse events are reported based on the study drug a participant was taking at the time of the event.
Injury, poisoning and procedural complications Fractured thumb	0.00% 0/6 • Up to 14 days after the last dose of study drug (Up to approximately 60 days) All participants who recieved ≥1 dose of study drug. Adverse events are reported based on the study drug a participant was taking at the time of the event.	0.00% 0/6 • Up to 14 days after the last dose of study drug (Up to approximately 60 days) All participants who recieved ≥1 dose of study drug. Adverse events are reported based on the study drug a participant was taking at the time of the event.	0.00% 0/6 • Up to 14 days after the last dose of study drug (Up to approximately 60 days) All participants who recieved ≥1 dose of study drug. Adverse events are reported based on the study drug a participant was taking at the time of the event.	0.00% 0/6 • Up to 14 days after the last dose of study drug (Up to approximately 60 days) All participants who recieved ≥1 dose of study drug. Adverse events are reported based on the study drug a participant was taking at the time of the event.	0.00% 0/6 • Up to 14 days after the last dose of study drug (Up to approximately 60 days) All participants who recieved ≥1 dose of study drug. Adverse events are reported based on the study drug a participant was taking at the time of the event.	0.00% 0/6 • Up to 14 days after the last dose of study drug (Up to approximately 60 days) All participants who recieved ≥1 dose of study drug. Adverse events are reported based on the study drug a participant was taking at the time of the event.	0.00% 0/6 • Up to 14 days after the last dose of study drug (Up to approximately 60 days) All participants who recieved ≥1 dose of study drug. Adverse events are reported based on the study drug a participant was taking at the time of the event.	0.00% 0/6 • Up to 14 days after the last dose of study drug (Up to approximately 60 days) All participants who recieved ≥1 dose of study drug. Adverse events are reported based on the study drug a participant was taking at the time of the event.	16.7% 1/6 • Number of events 1 • Up to 14 days after the last dose of study drug (Up to approximately 60 days) All participants who recieved ≥1 dose of study drug. Adverse events are reported based on the study drug a participant was taking at the time of the event.	0.00% 0/6 • Up to 14 days after the last dose of study drug (Up to approximately 60 days) All participants who recieved ≥1 dose of study drug. Adverse events are reported based on the study drug a participant was taking at the time of the event.	0.00% 0/16 • Up to 14 days after the last dose of study drug (Up to approximately 60 days) All participants who recieved ≥1 dose of study drug. Adverse events are reported based on the study drug a participant was taking at the time of the event.
Injury, poisoning and procedural complications Scalp laceration	0.00% 0/6 • Up to 14 days after the last dose of study drug (Up to approximately 60 days) All participants who recieved ≥1 dose of study drug. Adverse events are reported based on the study drug a participant was taking at the time of the event.	0.00% 0/6 • Up to 14 days after the last dose of study drug (Up to approximately 60 days) All participants who recieved ≥1 dose of study drug. Adverse events are reported based on the study drug a participant was taking at the time of the event.	0.00% 0/6 • Up to 14 days after the last dose of study drug (Up to approximately 60 days) All participants who recieved ≥1 dose of study drug. Adverse events are reported based on the study drug a participant was taking at the time of the event.	0.00% 0/6 • Up to 14 days after the last dose of study drug (Up to approximately 60 days) All participants who recieved ≥1 dose of study drug. Adverse events are reported based on the study drug a participant was taking at the time of the event.	0.00% 0/6 • Up to 14 days after the last dose of study drug (Up to approximately 60 days) All participants who recieved ≥1 dose of study drug. Adverse events are reported based on the study drug a participant was taking at the time of the event.	0.00% 0/6 • Up to 14 days after the last dose of study drug (Up to approximately 60 days) All participants who recieved ≥1 dose of study drug. Adverse events are reported based on the study drug a participant was taking at the time of the event.	0.00% 0/6 • Up to 14 days after the last dose of study drug (Up to approximately 60 days) All participants who recieved ≥1 dose of study drug. Adverse events are reported based on the study drug a participant was taking at the time of the event.	0.00% 0/6 • Up to 14 days after the last dose of study drug (Up to approximately 60 days) All participants who recieved ≥1 dose of study drug. Adverse events are reported based on the study drug a participant was taking at the time of the event.	16.7% 1/6 • Number of events 1 • Up to 14 days after the last dose of study drug (Up to approximately 60 days) All participants who recieved ≥1 dose of study drug. Adverse events are reported based on the study drug a participant was taking at the time of the event.	0.00% 0/6 • Up to 14 days after the last dose of study drug (Up to approximately 60 days) All participants who recieved ≥1 dose of study drug. Adverse events are reported based on the study drug a participant was taking at the time of the event.	0.00% 0/16 • Up to 14 days after the last dose of study drug (Up to approximately 60 days) All participants who recieved ≥1 dose of study drug. Adverse events are reported based on the study drug a participant was taking at the time of the event.
Injury, poisoning and procedural complications Thumb sprain	0.00% 0/6 • Up to 14 days after the last dose of study drug (Up to approximately 60 days) All participants who recieved ≥1 dose of study drug. Adverse events are reported based on the study drug a participant was taking at the time of the event.	0.00% 0/6 • Up to 14 days after the last dose of study drug (Up to approximately 60 days) All participants who recieved ≥1 dose of study drug. Adverse events are reported based on the study drug a participant was taking at the time of the event.	0.00% 0/6 • Up to 14 days after the last dose of study drug (Up to approximately 60 days) All participants who recieved ≥1 dose of study drug. Adverse events are reported based on the study drug a participant was taking at the time of the event.	0.00% 0/6 • Up to 14 days after the last dose of study drug (Up to approximately 60 days) All participants who recieved ≥1 dose of study drug. Adverse events are reported based on the study drug a participant was taking at the time of the event.	0.00% 0/6 • Up to 14 days after the last dose of study drug (Up to approximately 60 days) All participants who recieved ≥1 dose of study drug. Adverse events are reported based on the study drug a participant was taking at the time of the event.	0.00% 0/6 • Up to 14 days after the last dose of study drug (Up to approximately 60 days) All participants who recieved ≥1 dose of study drug. Adverse events are reported based on the study drug a participant was taking at the time of the event.	0.00% 0/6 • Up to 14 days after the last dose of study drug (Up to approximately 60 days) All participants who recieved ≥1 dose of study drug. Adverse events are reported based on the study drug a participant was taking at the time of the event.	0.00% 0/6 • Up to 14 days after the last dose of study drug (Up to approximately 60 days) All participants who recieved ≥1 dose of study drug. Adverse events are reported based on the study drug a participant was taking at the time of the event.	16.7% 1/6 • Number of events 1 • Up to 14 days after the last dose of study drug (Up to approximately 60 days) All participants who recieved ≥1 dose of study drug. Adverse events are reported based on the study drug a participant was taking at the time of the event.	0.00% 0/6 • Up to 14 days after the last dose of study drug (Up to approximately 60 days) All participants who recieved ≥1 dose of study drug. Adverse events are reported based on the study drug a participant was taking at the time of the event.	0.00% 0/16 • Up to 14 days after the last dose of study drug (Up to approximately 60 days) All participants who recieved ≥1 dose of study drug. Adverse events are reported based on the study drug a participant was taking at the time of the event.
Metabolism and nutrition disorders Appetite lost	16.7% 1/6 • Number of events 1 • Up to 14 days after the last dose of study drug (Up to approximately 60 days) All participants who recieved ≥1 dose of study drug. Adverse events are reported based on the study drug a participant was taking at the time of the event.	0.00% 0/6 • Up to 14 days after the last dose of study drug (Up to approximately 60 days) All participants who recieved ≥1 dose of study drug. Adverse events are reported based on the study drug a participant was taking at the time of the event.	0.00% 0/6 • Up to 14 days after the last dose of study drug (Up to approximately 60 days) All participants who recieved ≥1 dose of study drug. Adverse events are reported based on the study drug a participant was taking at the time of the event.	0.00% 0/6 • Up to 14 days after the last dose of study drug (Up to approximately 60 days) All participants who recieved ≥1 dose of study drug. Adverse events are reported based on the study drug a participant was taking at the time of the event.	0.00% 0/6 • Up to 14 days after the last dose of study drug (Up to approximately 60 days) All participants who recieved ≥1 dose of study drug. Adverse events are reported based on the study drug a participant was taking at the time of the event.	0.00% 0/6 • Up to 14 days after the last dose of study drug (Up to approximately 60 days) All participants who recieved ≥1 dose of study drug. Adverse events are reported based on the study drug a participant was taking at the time of the event.	0.00% 0/6 • Up to 14 days after the last dose of study drug (Up to approximately 60 days) All participants who recieved ≥1 dose of study drug. Adverse events are reported based on the study drug a participant was taking at the time of the event.	0.00% 0/6 • Up to 14 days after the last dose of study drug (Up to approximately 60 days) All participants who recieved ≥1 dose of study drug. Adverse events are reported based on the study drug a participant was taking at the time of the event.	0.00% 0/6 • Up to 14 days after the last dose of study drug (Up to approximately 60 days) All participants who recieved ≥1 dose of study drug. Adverse events are reported based on the study drug a participant was taking at the time of the event.	0.00% 0/6 • Up to 14 days after the last dose of study drug (Up to approximately 60 days) All participants who recieved ≥1 dose of study drug. Adverse events are reported based on the study drug a participant was taking at the time of the event.	0.00% 0/16 • Up to 14 days after the last dose of study drug (Up to approximately 60 days) All participants who recieved ≥1 dose of study drug. Adverse events are reported based on the study drug a participant was taking at the time of the event.
Musculoskeletal and connective tissue disorders Back pain	0.00% 0/6 • Up to 14 days after the last dose of study drug (Up to approximately 60 days) All participants who recieved ≥1 dose of study drug. Adverse events are reported based on the study drug a participant was taking at the time of the event.	0.00% 0/6 • Up to 14 days after the last dose of study drug (Up to approximately 60 days) All participants who recieved ≥1 dose of study drug. Adverse events are reported based on the study drug a participant was taking at the time of the event.	0.00% 0/6 • Up to 14 days after the last dose of study drug (Up to approximately 60 days) All participants who recieved ≥1 dose of study drug. Adverse events are reported based on the study drug a participant was taking at the time of the event.	0.00% 0/6 • Up to 14 days after the last dose of study drug (Up to approximately 60 days) All participants who recieved ≥1 dose of study drug. Adverse events are reported based on the study drug a participant was taking at the time of the event.	0.00% 0/6 • Up to 14 days after the last dose of study drug (Up to approximately 60 days) All participants who recieved ≥1 dose of study drug. Adverse events are reported based on the study drug a participant was taking at the time of the event.	0.00% 0/6 • Up to 14 days after the last dose of study drug (Up to approximately 60 days) All participants who recieved ≥1 dose of study drug. Adverse events are reported based on the study drug a participant was taking at the time of the event.	0.00% 0/6 • Up to 14 days after the last dose of study drug (Up to approximately 60 days) All participants who recieved ≥1 dose of study drug. Adverse events are reported based on the study drug a participant was taking at the time of the event.	0.00% 0/6 • Up to 14 days after the last dose of study drug (Up to approximately 60 days) All participants who recieved ≥1 dose of study drug. Adverse events are reported based on the study drug a participant was taking at the time of the event.	16.7% 1/6 • Number of events 1 • Up to 14 days after the last dose of study drug (Up to approximately 60 days) All participants who recieved ≥1 dose of study drug. Adverse events are reported based on the study drug a participant was taking at the time of the event.	0.00% 0/6 • Up to 14 days after the last dose of study drug (Up to approximately 60 days) All participants who recieved ≥1 dose of study drug. Adverse events are reported based on the study drug a participant was taking at the time of the event.	0.00% 0/16 • Up to 14 days after the last dose of study drug (Up to approximately 60 days) All participants who recieved ≥1 dose of study drug. Adverse events are reported based on the study drug a participant was taking at the time of the event.
Musculoskeletal and connective tissue disorders Neck pain	0.00% 0/6 • Up to 14 days after the last dose of study drug (Up to approximately 60 days) All participants who recieved ≥1 dose of study drug. Adverse events are reported based on the study drug a participant was taking at the time of the event.	0.00% 0/6 • Up to 14 days after the last dose of study drug (Up to approximately 60 days) All participants who recieved ≥1 dose of study drug. Adverse events are reported based on the study drug a participant was taking at the time of the event.	0.00% 0/6 • Up to 14 days after the last dose of study drug (Up to approximately 60 days) All participants who recieved ≥1 dose of study drug. Adverse events are reported based on the study drug a participant was taking at the time of the event.	0.00% 0/6 • Up to 14 days after the last dose of study drug (Up to approximately 60 days) All participants who recieved ≥1 dose of study drug. Adverse events are reported based on the study drug a participant was taking at the time of the event.	0.00% 0/6 • Up to 14 days after the last dose of study drug (Up to approximately 60 days) All participants who recieved ≥1 dose of study drug. Adverse events are reported based on the study drug a participant was taking at the time of the event.	0.00% 0/6 • Up to 14 days after the last dose of study drug (Up to approximately 60 days) All participants who recieved ≥1 dose of study drug. Adverse events are reported based on the study drug a participant was taking at the time of the event.	0.00% 0/6 • Up to 14 days after the last dose of study drug (Up to approximately 60 days) All participants who recieved ≥1 dose of study drug. Adverse events are reported based on the study drug a participant was taking at the time of the event.	0.00% 0/6 • Up to 14 days after the last dose of study drug (Up to approximately 60 days) All participants who recieved ≥1 dose of study drug. Adverse events are reported based on the study drug a participant was taking at the time of the event.	16.7% 1/6 • Number of events 1 • Up to 14 days after the last dose of study drug (Up to approximately 60 days) All participants who recieved ≥1 dose of study drug. Adverse events are reported based on the study drug a participant was taking at the time of the event.	0.00% 0/6 • Up to 14 days after the last dose of study drug (Up to approximately 60 days) All participants who recieved ≥1 dose of study drug. Adverse events are reported based on the study drug a participant was taking at the time of the event.	0.00% 0/16 • Up to 14 days after the last dose of study drug (Up to approximately 60 days) All participants who recieved ≥1 dose of study drug. Adverse events are reported based on the study drug a participant was taking at the time of the event.
Musculoskeletal and connective tissue disorders Pain in arm	0.00% 0/6 • Up to 14 days after the last dose of study drug (Up to approximately 60 days) All participants who recieved ≥1 dose of study drug. Adverse events are reported based on the study drug a participant was taking at the time of the event.	0.00% 0/6 • Up to 14 days after the last dose of study drug (Up to approximately 60 days) All participants who recieved ≥1 dose of study drug. Adverse events are reported based on the study drug a participant was taking at the time of the event.	0.00% 0/6 • Up to 14 days after the last dose of study drug (Up to approximately 60 days) All participants who recieved ≥1 dose of study drug. Adverse events are reported based on the study drug a participant was taking at the time of the event.	0.00% 0/6 • Up to 14 days after the last dose of study drug (Up to approximately 60 days) All participants who recieved ≥1 dose of study drug. Adverse events are reported based on the study drug a participant was taking at the time of the event.	33.3% 2/6 • Number of events 2 • Up to 14 days after the last dose of study drug (Up to approximately 60 days) All participants who recieved ≥1 dose of study drug. Adverse events are reported based on the study drug a participant was taking at the time of the event.	0.00% 0/6 • Up to 14 days after the last dose of study drug (Up to approximately 60 days) All participants who recieved ≥1 dose of study drug. Adverse events are reported based on the study drug a participant was taking at the time of the event.	0.00% 0/6 • Up to 14 days after the last dose of study drug (Up to approximately 60 days) All participants who recieved ≥1 dose of study drug. Adverse events are reported based on the study drug a participant was taking at the time of the event.	0.00% 0/6 • Up to 14 days after the last dose of study drug (Up to approximately 60 days) All participants who recieved ≥1 dose of study drug. Adverse events are reported based on the study drug a participant was taking at the time of the event.	0.00% 0/6 • Up to 14 days after the last dose of study drug (Up to approximately 60 days) All participants who recieved ≥1 dose of study drug. Adverse events are reported based on the study drug a participant was taking at the time of the event.	0.00% 0/6 • Up to 14 days after the last dose of study drug (Up to approximately 60 days) All participants who recieved ≥1 dose of study drug. Adverse events are reported based on the study drug a participant was taking at the time of the event.	0.00% 0/16 • Up to 14 days after the last dose of study drug (Up to approximately 60 days) All participants who recieved ≥1 dose of study drug. Adverse events are reported based on the study drug a participant was taking at the time of the event.
Musculoskeletal and connective tissue disorders Painful L arm	0.00% 0/6 • Up to 14 days after the last dose of study drug (Up to approximately 60 days) All participants who recieved ≥1 dose of study drug. Adverse events are reported based on the study drug a participant was taking at the time of the event.	0.00% 0/6 • Up to 14 days after the last dose of study drug (Up to approximately 60 days) All participants who recieved ≥1 dose of study drug. Adverse events are reported based on the study drug a participant was taking at the time of the event.	0.00% 0/6 • Up to 14 days after the last dose of study drug (Up to approximately 60 days) All participants who recieved ≥1 dose of study drug. Adverse events are reported based on the study drug a participant was taking at the time of the event.	0.00% 0/6 • Up to 14 days after the last dose of study drug (Up to approximately 60 days) All participants who recieved ≥1 dose of study drug. Adverse events are reported based on the study drug a participant was taking at the time of the event.	0.00% 0/6 • Up to 14 days after the last dose of study drug (Up to approximately 60 days) All participants who recieved ≥1 dose of study drug. Adverse events are reported based on the study drug a participant was taking at the time of the event.	0.00% 0/6 • Up to 14 days after the last dose of study drug (Up to approximately 60 days) All participants who recieved ≥1 dose of study drug. Adverse events are reported based on the study drug a participant was taking at the time of the event.	0.00% 0/6 • Up to 14 days after the last dose of study drug (Up to approximately 60 days) All participants who recieved ≥1 dose of study drug. Adverse events are reported based on the study drug a participant was taking at the time of the event.	0.00% 0/6 • Up to 14 days after the last dose of study drug (Up to approximately 60 days) All participants who recieved ≥1 dose of study drug. Adverse events are reported based on the study drug a participant was taking at the time of the event.	16.7% 1/6 • Number of events 1 • Up to 14 days after the last dose of study drug (Up to approximately 60 days) All participants who recieved ≥1 dose of study drug. Adverse events are reported based on the study drug a participant was taking at the time of the event.	0.00% 0/6 • Up to 14 days after the last dose of study drug (Up to approximately 60 days) All participants who recieved ≥1 dose of study drug. Adverse events are reported based on the study drug a participant was taking at the time of the event.	0.00% 0/16 • Up to 14 days after the last dose of study drug (Up to approximately 60 days) All participants who recieved ≥1 dose of study drug. Adverse events are reported based on the study drug a participant was taking at the time of the event.
Nervous system disorders Dizziness postural	16.7% 1/6 • Number of events 1 • Up to 14 days after the last dose of study drug (Up to approximately 60 days) All participants who recieved ≥1 dose of study drug. Adverse events are reported based on the study drug a participant was taking at the time of the event.	0.00% 0/6 • Up to 14 days after the last dose of study drug (Up to approximately 60 days) All participants who recieved ≥1 dose of study drug. Adverse events are reported based on the study drug a participant was taking at the time of the event.	0.00% 0/6 • Up to 14 days after the last dose of study drug (Up to approximately 60 days) All participants who recieved ≥1 dose of study drug. Adverse events are reported based on the study drug a participant was taking at the time of the event.	0.00% 0/6 • Up to 14 days after the last dose of study drug (Up to approximately 60 days) All participants who recieved ≥1 dose of study drug. Adverse events are reported based on the study drug a participant was taking at the time of the event.	16.7% 1/6 • Number of events 1 • Up to 14 days after the last dose of study drug (Up to approximately 60 days) All participants who recieved ≥1 dose of study drug. Adverse events are reported based on the study drug a participant was taking at the time of the event.	0.00% 0/6 • Up to 14 days after the last dose of study drug (Up to approximately 60 days) All participants who recieved ≥1 dose of study drug. Adverse events are reported based on the study drug a participant was taking at the time of the event.	0.00% 0/6 • Up to 14 days after the last dose of study drug (Up to approximately 60 days) All participants who recieved ≥1 dose of study drug. Adverse events are reported based on the study drug a participant was taking at the time of the event.	16.7% 1/6 • Number of events 1 • Up to 14 days after the last dose of study drug (Up to approximately 60 days) All participants who recieved ≥1 dose of study drug. Adverse events are reported based on the study drug a participant was taking at the time of the event.	0.00% 0/6 • Up to 14 days after the last dose of study drug (Up to approximately 60 days) All participants who recieved ≥1 dose of study drug. Adverse events are reported based on the study drug a participant was taking at the time of the event.	0.00% 0/6 • Up to 14 days after the last dose of study drug (Up to approximately 60 days) All participants who recieved ≥1 dose of study drug. Adverse events are reported based on the study drug a participant was taking at the time of the event.	0.00% 0/16 • Up to 14 days after the last dose of study drug (Up to approximately 60 days) All participants who recieved ≥1 dose of study drug. Adverse events are reported based on the study drug a participant was taking at the time of the event.
Nervous system disorders Drowsiness	0.00% 0/6 • Up to 14 days after the last dose of study drug (Up to approximately 60 days) All participants who recieved ≥1 dose of study drug. Adverse events are reported based on the study drug a participant was taking at the time of the event.	33.3% 2/6 • Number of events 2 • Up to 14 days after the last dose of study drug (Up to approximately 60 days) All participants who recieved ≥1 dose of study drug. Adverse events are reported based on the study drug a participant was taking at the time of the event.	0.00% 0/6 • Up to 14 days after the last dose of study drug (Up to approximately 60 days) All participants who recieved ≥1 dose of study drug. Adverse events are reported based on the study drug a participant was taking at the time of the event.	0.00% 0/6 • Up to 14 days after the last dose of study drug (Up to approximately 60 days) All participants who recieved ≥1 dose of study drug. Adverse events are reported based on the study drug a participant was taking at the time of the event.	0.00% 0/6 • Up to 14 days after the last dose of study drug (Up to approximately 60 days) All participants who recieved ≥1 dose of study drug. Adverse events are reported based on the study drug a participant was taking at the time of the event.	16.7% 1/6 • Number of events 1 • Up to 14 days after the last dose of study drug (Up to approximately 60 days) All participants who recieved ≥1 dose of study drug. Adverse events are reported based on the study drug a participant was taking at the time of the event.	0.00% 0/6 • Up to 14 days after the last dose of study drug (Up to approximately 60 days) All participants who recieved ≥1 dose of study drug. Adverse events are reported based on the study drug a participant was taking at the time of the event.	0.00% 0/6 • Up to 14 days after the last dose of study drug (Up to approximately 60 days) All participants who recieved ≥1 dose of study drug. Adverse events are reported based on the study drug a participant was taking at the time of the event.	0.00% 0/6 • Up to 14 days after the last dose of study drug (Up to approximately 60 days) All participants who recieved ≥1 dose of study drug. Adverse events are reported based on the study drug a participant was taking at the time of the event.	0.00% 0/6 • Up to 14 days after the last dose of study drug (Up to approximately 60 days) All participants who recieved ≥1 dose of study drug. Adverse events are reported based on the study drug a participant was taking at the time of the event.	0.00% 0/16 • Up to 14 days after the last dose of study drug (Up to approximately 60 days) All participants who recieved ≥1 dose of study drug. Adverse events are reported based on the study drug a participant was taking at the time of the event.
Nervous system disorders Headache	0.00% 0/6 • Up to 14 days after the last dose of study drug (Up to approximately 60 days) All participants who recieved ≥1 dose of study drug. Adverse events are reported based on the study drug a participant was taking at the time of the event.	66.7% 4/6 • Number of events 4 • Up to 14 days after the last dose of study drug (Up to approximately 60 days) All participants who recieved ≥1 dose of study drug. Adverse events are reported based on the study drug a participant was taking at the time of the event.	0.00% 0/6 • Up to 14 days after the last dose of study drug (Up to approximately 60 days) All participants who recieved ≥1 dose of study drug. Adverse events are reported based on the study drug a participant was taking at the time of the event.	16.7% 1/6 • Number of events 1 • Up to 14 days after the last dose of study drug (Up to approximately 60 days) All participants who recieved ≥1 dose of study drug. Adverse events are reported based on the study drug a participant was taking at the time of the event.	16.7% 1/6 • Number of events 1 • Up to 14 days after the last dose of study drug (Up to approximately 60 days) All participants who recieved ≥1 dose of study drug. Adverse events are reported based on the study drug a participant was taking at the time of the event.	0.00% 0/6 • Up to 14 days after the last dose of study drug (Up to approximately 60 days) All participants who recieved ≥1 dose of study drug. Adverse events are reported based on the study drug a participant was taking at the time of the event.	50.0% 3/6 • Number of events 3 • Up to 14 days after the last dose of study drug (Up to approximately 60 days) All participants who recieved ≥1 dose of study drug. Adverse events are reported based on the study drug a participant was taking at the time of the event.	16.7% 1/6 • Number of events 1 • Up to 14 days after the last dose of study drug (Up to approximately 60 days) All participants who recieved ≥1 dose of study drug. Adverse events are reported based on the study drug a participant was taking at the time of the event.	0.00% 0/6 • Up to 14 days after the last dose of study drug (Up to approximately 60 days) All participants who recieved ≥1 dose of study drug. Adverse events are reported based on the study drug a participant was taking at the time of the event.	16.7% 1/6 • Number of events 1 • Up to 14 days after the last dose of study drug (Up to approximately 60 days) All participants who recieved ≥1 dose of study drug. Adverse events are reported based on the study drug a participant was taking at the time of the event.	12.5% 2/16 • Number of events 2 • Up to 14 days after the last dose of study drug (Up to approximately 60 days) All participants who recieved ≥1 dose of study drug. Adverse events are reported based on the study drug a participant was taking at the time of the event.
Nervous system disorders Lightheadedness	0.00% 0/6 • Up to 14 days after the last dose of study drug (Up to approximately 60 days) All participants who recieved ≥1 dose of study drug. Adverse events are reported based on the study drug a participant was taking at the time of the event.	0.00% 0/6 • Up to 14 days after the last dose of study drug (Up to approximately 60 days) All participants who recieved ≥1 dose of study drug. Adverse events are reported based on the study drug a participant was taking at the time of the event.	0.00% 0/6 • Up to 14 days after the last dose of study drug (Up to approximately 60 days) All participants who recieved ≥1 dose of study drug. Adverse events are reported based on the study drug a participant was taking at the time of the event.	0.00% 0/6 • Up to 14 days after the last dose of study drug (Up to approximately 60 days) All participants who recieved ≥1 dose of study drug. Adverse events are reported based on the study drug a participant was taking at the time of the event.	0.00% 0/6 • Up to 14 days after the last dose of study drug (Up to approximately 60 days) All participants who recieved ≥1 dose of study drug. Adverse events are reported based on the study drug a participant was taking at the time of the event.	0.00% 0/6 • Up to 14 days after the last dose of study drug (Up to approximately 60 days) All participants who recieved ≥1 dose of study drug. Adverse events are reported based on the study drug a participant was taking at the time of the event.	16.7% 1/6 • Number of events 1 • Up to 14 days after the last dose of study drug (Up to approximately 60 days) All participants who recieved ≥1 dose of study drug. Adverse events are reported based on the study drug a participant was taking at the time of the event.	0.00% 0/6 • Up to 14 days after the last dose of study drug (Up to approximately 60 days) All participants who recieved ≥1 dose of study drug. Adverse events are reported based on the study drug a participant was taking at the time of the event.	0.00% 0/6 • Up to 14 days after the last dose of study drug (Up to approximately 60 days) All participants who recieved ≥1 dose of study drug. Adverse events are reported based on the study drug a participant was taking at the time of the event.	0.00% 0/6 • Up to 14 days after the last dose of study drug (Up to approximately 60 days) All participants who recieved ≥1 dose of study drug. Adverse events are reported based on the study drug a participant was taking at the time of the event.	0.00% 0/16 • Up to 14 days after the last dose of study drug (Up to approximately 60 days) All participants who recieved ≥1 dose of study drug. Adverse events are reported based on the study drug a participant was taking at the time of the event.
Nervous system disorders Loss of consciousness	0.00% 0/6 • Up to 14 days after the last dose of study drug (Up to approximately 60 days) All participants who recieved ≥1 dose of study drug. Adverse events are reported based on the study drug a participant was taking at the time of the event.	0.00% 0/6 • Up to 14 days after the last dose of study drug (Up to approximately 60 days) All participants who recieved ≥1 dose of study drug. Adverse events are reported based on the study drug a participant was taking at the time of the event.	0.00% 0/6 • Up to 14 days after the last dose of study drug (Up to approximately 60 days) All participants who recieved ≥1 dose of study drug. Adverse events are reported based on the study drug a participant was taking at the time of the event.	0.00% 0/6 • Up to 14 days after the last dose of study drug (Up to approximately 60 days) All participants who recieved ≥1 dose of study drug. Adverse events are reported based on the study drug a participant was taking at the time of the event.	0.00% 0/6 • Up to 14 days after the last dose of study drug (Up to approximately 60 days) All participants who recieved ≥1 dose of study drug. Adverse events are reported based on the study drug a participant was taking at the time of the event.	0.00% 0/6 • Up to 14 days after the last dose of study drug (Up to approximately 60 days) All participants who recieved ≥1 dose of study drug. Adverse events are reported based on the study drug a participant was taking at the time of the event.	0.00% 0/6 • Up to 14 days after the last dose of study drug (Up to approximately 60 days) All participants who recieved ≥1 dose of study drug. Adverse events are reported based on the study drug a participant was taking at the time of the event.	0.00% 0/6 • Up to 14 days after the last dose of study drug (Up to approximately 60 days) All participants who recieved ≥1 dose of study drug. Adverse events are reported based on the study drug a participant was taking at the time of the event.	16.7% 1/6 • Number of events 1 • Up to 14 days after the last dose of study drug (Up to approximately 60 days) All participants who recieved ≥1 dose of study drug. Adverse events are reported based on the study drug a participant was taking at the time of the event.	0.00% 0/6 • Up to 14 days after the last dose of study drug (Up to approximately 60 days) All participants who recieved ≥1 dose of study drug. Adverse events are reported based on the study drug a participant was taking at the time of the event.	0.00% 0/16 • Up to 14 days after the last dose of study drug (Up to approximately 60 days) All participants who recieved ≥1 dose of study drug. Adverse events are reported based on the study drug a participant was taking at the time of the event.
Nervous system disorders Mental concentration difficulty	0.00% 0/6 • Up to 14 days after the last dose of study drug (Up to approximately 60 days) All participants who recieved ≥1 dose of study drug. Adverse events are reported based on the study drug a participant was taking at the time of the event.	16.7% 1/6 • Number of events 1 • Up to 14 days after the last dose of study drug (Up to approximately 60 days) All participants who recieved ≥1 dose of study drug. Adverse events are reported based on the study drug a participant was taking at the time of the event.	0.00% 0/6 • Up to 14 days after the last dose of study drug (Up to approximately 60 days) All participants who recieved ≥1 dose of study drug. Adverse events are reported based on the study drug a participant was taking at the time of the event.	0.00% 0/6 • Up to 14 days after the last dose of study drug (Up to approximately 60 days) All participants who recieved ≥1 dose of study drug. Adverse events are reported based on the study drug a participant was taking at the time of the event.	0.00% 0/6 • Up to 14 days after the last dose of study drug (Up to approximately 60 days) All participants who recieved ≥1 dose of study drug. Adverse events are reported based on the study drug a participant was taking at the time of the event.	16.7% 1/6 • Number of events 1 • Up to 14 days after the last dose of study drug (Up to approximately 60 days) All participants who recieved ≥1 dose of study drug. Adverse events are reported based on the study drug a participant was taking at the time of the event.	0.00% 0/6 • Up to 14 days after the last dose of study drug (Up to approximately 60 days) All participants who recieved ≥1 dose of study drug. Adverse events are reported based on the study drug a participant was taking at the time of the event.	0.00% 0/6 • Up to 14 days after the last dose of study drug (Up to approximately 60 days) All participants who recieved ≥1 dose of study drug. Adverse events are reported based on the study drug a participant was taking at the time of the event.	0.00% 0/6 • Up to 14 days after the last dose of study drug (Up to approximately 60 days) All participants who recieved ≥1 dose of study drug. Adverse events are reported based on the study drug a participant was taking at the time of the event.	0.00% 0/6 • Up to 14 days after the last dose of study drug (Up to approximately 60 days) All participants who recieved ≥1 dose of study drug. Adverse events are reported based on the study drug a participant was taking at the time of the event.	0.00% 0/16 • Up to 14 days after the last dose of study drug (Up to approximately 60 days) All participants who recieved ≥1 dose of study drug. Adverse events are reported based on the study drug a participant was taking at the time of the event.
Nervous system disorders Somnolence	0.00% 0/6 • Up to 14 days after the last dose of study drug (Up to approximately 60 days) All participants who recieved ≥1 dose of study drug. Adverse events are reported based on the study drug a participant was taking at the time of the event.	16.7% 1/6 • Number of events 1 • Up to 14 days after the last dose of study drug (Up to approximately 60 days) All participants who recieved ≥1 dose of study drug. Adverse events are reported based on the study drug a participant was taking at the time of the event.	66.7% 4/6 • Number of events 4 • Up to 14 days after the last dose of study drug (Up to approximately 60 days) All participants who recieved ≥1 dose of study drug. Adverse events are reported based on the study drug a participant was taking at the time of the event.	33.3% 2/6 • Number of events 2 • Up to 14 days after the last dose of study drug (Up to approximately 60 days) All participants who recieved ≥1 dose of study drug. Adverse events are reported based on the study drug a participant was taking at the time of the event.	83.3% 5/6 • Number of events 5 • Up to 14 days after the last dose of study drug (Up to approximately 60 days) All participants who recieved ≥1 dose of study drug. Adverse events are reported based on the study drug a participant was taking at the time of the event.	83.3% 5/6 • Number of events 5 • Up to 14 days after the last dose of study drug (Up to approximately 60 days) All participants who recieved ≥1 dose of study drug. Adverse events are reported based on the study drug a participant was taking at the time of the event.	100.0% 6/6 • Number of events 6 • Up to 14 days after the last dose of study drug (Up to approximately 60 days) All participants who recieved ≥1 dose of study drug. Adverse events are reported based on the study drug a participant was taking at the time of the event.	100.0% 6/6 • Number of events 6 • Up to 14 days after the last dose of study drug (Up to approximately 60 days) All participants who recieved ≥1 dose of study drug. Adverse events are reported based on the study drug a participant was taking at the time of the event.	50.0% 3/6 • Number of events 3 • Up to 14 days after the last dose of study drug (Up to approximately 60 days) All participants who recieved ≥1 dose of study drug. Adverse events are reported based on the study drug a participant was taking at the time of the event.	16.7% 1/6 • Number of events 1 • Up to 14 days after the last dose of study drug (Up to approximately 60 days) All participants who recieved ≥1 dose of study drug. Adverse events are reported based on the study drug a participant was taking at the time of the event.	6.2% 1/16 • Number of events 1 • Up to 14 days after the last dose of study drug (Up to approximately 60 days) All participants who recieved ≥1 dose of study drug. Adverse events are reported based on the study drug a participant was taking at the time of the event.
Psychiatric disorders Euphoric mood	0.00% 0/6 • Up to 14 days after the last dose of study drug (Up to approximately 60 days) All participants who recieved ≥1 dose of study drug. Adverse events are reported based on the study drug a participant was taking at the time of the event.	0.00% 0/6 • Up to 14 days after the last dose of study drug (Up to approximately 60 days) All participants who recieved ≥1 dose of study drug. Adverse events are reported based on the study drug a participant was taking at the time of the event.	0.00% 0/6 • Up to 14 days after the last dose of study drug (Up to approximately 60 days) All participants who recieved ≥1 dose of study drug. Adverse events are reported based on the study drug a participant was taking at the time of the event.	0.00% 0/6 • Up to 14 days after the last dose of study drug (Up to approximately 60 days) All participants who recieved ≥1 dose of study drug. Adverse events are reported based on the study drug a participant was taking at the time of the event.	0.00% 0/6 • Up to 14 days after the last dose of study drug (Up to approximately 60 days) All participants who recieved ≥1 dose of study drug. Adverse events are reported based on the study drug a participant was taking at the time of the event.	16.7% 1/6 • Number of events 1 • Up to 14 days after the last dose of study drug (Up to approximately 60 days) All participants who recieved ≥1 dose of study drug. Adverse events are reported based on the study drug a participant was taking at the time of the event.	0.00% 0/6 • Up to 14 days after the last dose of study drug (Up to approximately 60 days) All participants who recieved ≥1 dose of study drug. Adverse events are reported based on the study drug a participant was taking at the time of the event.	0.00% 0/6 • Up to 14 days after the last dose of study drug (Up to approximately 60 days) All participants who recieved ≥1 dose of study drug. Adverse events are reported based on the study drug a participant was taking at the time of the event.	0.00% 0/6 • Up to 14 days after the last dose of study drug (Up to approximately 60 days) All participants who recieved ≥1 dose of study drug. Adverse events are reported based on the study drug a participant was taking at the time of the event.	0.00% 0/6 • Up to 14 days after the last dose of study drug (Up to approximately 60 days) All participants who recieved ≥1 dose of study drug. Adverse events are reported based on the study drug a participant was taking at the time of the event.	0.00% 0/16 • Up to 14 days after the last dose of study drug (Up to approximately 60 days) All participants who recieved ≥1 dose of study drug. Adverse events are reported based on the study drug a participant was taking at the time of the event.
Reproductive system and breast disorders Spontaneous penile erection	0.00% 0/6 • Up to 14 days after the last dose of study drug (Up to approximately 60 days) All participants who recieved ≥1 dose of study drug. Adverse events are reported based on the study drug a participant was taking at the time of the event.	0.00% 0/6 • Up to 14 days after the last dose of study drug (Up to approximately 60 days) All participants who recieved ≥1 dose of study drug. Adverse events are reported based on the study drug a participant was taking at the time of the event.	0.00% 0/6 • Up to 14 days after the last dose of study drug (Up to approximately 60 days) All participants who recieved ≥1 dose of study drug. Adverse events are reported based on the study drug a participant was taking at the time of the event.	0.00% 0/6 • Up to 14 days after the last dose of study drug (Up to approximately 60 days) All participants who recieved ≥1 dose of study drug. Adverse events are reported based on the study drug a participant was taking at the time of the event.	0.00% 0/6 • Up to 14 days after the last dose of study drug (Up to approximately 60 days) All participants who recieved ≥1 dose of study drug. Adverse events are reported based on the study drug a participant was taking at the time of the event.	0.00% 0/6 • Up to 14 days after the last dose of study drug (Up to approximately 60 days) All participants who recieved ≥1 dose of study drug. Adverse events are reported based on the study drug a participant was taking at the time of the event.	0.00% 0/6 • Up to 14 days after the last dose of study drug (Up to approximately 60 days) All participants who recieved ≥1 dose of study drug. Adverse events are reported based on the study drug a participant was taking at the time of the event.	16.7% 1/6 • Number of events 1 • Up to 14 days after the last dose of study drug (Up to approximately 60 days) All participants who recieved ≥1 dose of study drug. Adverse events are reported based on the study drug a participant was taking at the time of the event.	0.00% 0/6 • Up to 14 days after the last dose of study drug (Up to approximately 60 days) All participants who recieved ≥1 dose of study drug. Adverse events are reported based on the study drug a participant was taking at the time of the event.	0.00% 0/6 • Up to 14 days after the last dose of study drug (Up to approximately 60 days) All participants who recieved ≥1 dose of study drug. Adverse events are reported based on the study drug a participant was taking at the time of the event.	0.00% 0/16 • Up to 14 days after the last dose of study drug (Up to approximately 60 days) All participants who recieved ≥1 dose of study drug. Adverse events are reported based on the study drug a participant was taking at the time of the event.
Respiratory, thoracic and mediastinal disorders Cough	0.00% 0/6 • Up to 14 days after the last dose of study drug (Up to approximately 60 days) All participants who recieved ≥1 dose of study drug. Adverse events are reported based on the study drug a participant was taking at the time of the event.	0.00% 0/6 • Up to 14 days after the last dose of study drug (Up to approximately 60 days) All participants who recieved ≥1 dose of study drug. Adverse events are reported based on the study drug a participant was taking at the time of the event.	0.00% 0/6 • Up to 14 days after the last dose of study drug (Up to approximately 60 days) All participants who recieved ≥1 dose of study drug. Adverse events are reported based on the study drug a participant was taking at the time of the event.	0.00% 0/6 • Up to 14 days after the last dose of study drug (Up to approximately 60 days) All participants who recieved ≥1 dose of study drug. Adverse events are reported based on the study drug a participant was taking at the time of the event.	16.7% 1/6 • Number of events 1 • Up to 14 days after the last dose of study drug (Up to approximately 60 days) All participants who recieved ≥1 dose of study drug. Adverse events are reported based on the study drug a participant was taking at the time of the event.	0.00% 0/6 • Up to 14 days after the last dose of study drug (Up to approximately 60 days) All participants who recieved ≥1 dose of study drug. Adverse events are reported based on the study drug a participant was taking at the time of the event.	0.00% 0/6 • Up to 14 days after the last dose of study drug (Up to approximately 60 days) All participants who recieved ≥1 dose of study drug. Adverse events are reported based on the study drug a participant was taking at the time of the event.	0.00% 0/6 • Up to 14 days after the last dose of study drug (Up to approximately 60 days) All participants who recieved ≥1 dose of study drug. Adverse events are reported based on the study drug a participant was taking at the time of the event.	0.00% 0/6 • Up to 14 days after the last dose of study drug (Up to approximately 60 days) All participants who recieved ≥1 dose of study drug. Adverse events are reported based on the study drug a participant was taking at the time of the event.	0.00% 0/6 • Up to 14 days after the last dose of study drug (Up to approximately 60 days) All participants who recieved ≥1 dose of study drug. Adverse events are reported based on the study drug a participant was taking at the time of the event.	0.00% 0/16 • Up to 14 days after the last dose of study drug (Up to approximately 60 days) All participants who recieved ≥1 dose of study drug. Adverse events are reported based on the study drug a participant was taking at the time of the event.
Respiratory, thoracic and mediastinal disorders Sore throat	16.7% 1/6 • Number of events 1 • Up to 14 days after the last dose of study drug (Up to approximately 60 days) All participants who recieved ≥1 dose of study drug. Adverse events are reported based on the study drug a participant was taking at the time of the event.	0.00% 0/6 • Up to 14 days after the last dose of study drug (Up to approximately 60 days) All participants who recieved ≥1 dose of study drug. Adverse events are reported based on the study drug a participant was taking at the time of the event.	16.7% 1/6 • Number of events 1 • Up to 14 days after the last dose of study drug (Up to approximately 60 days) All participants who recieved ≥1 dose of study drug. Adverse events are reported based on the study drug a participant was taking at the time of the event.	0.00% 0/6 • Up to 14 days after the last dose of study drug (Up to approximately 60 days) All participants who recieved ≥1 dose of study drug. Adverse events are reported based on the study drug a participant was taking at the time of the event.	0.00% 0/6 • Up to 14 days after the last dose of study drug (Up to approximately 60 days) All participants who recieved ≥1 dose of study drug. Adverse events are reported based on the study drug a participant was taking at the time of the event.	0.00% 0/6 • Up to 14 days after the last dose of study drug (Up to approximately 60 days) All participants who recieved ≥1 dose of study drug. Adverse events are reported based on the study drug a participant was taking at the time of the event.	16.7% 1/6 • Number of events 1 • Up to 14 days after the last dose of study drug (Up to approximately 60 days) All participants who recieved ≥1 dose of study drug. Adverse events are reported based on the study drug a participant was taking at the time of the event.	0.00% 0/6 • Up to 14 days after the last dose of study drug (Up to approximately 60 days) All participants who recieved ≥1 dose of study drug. Adverse events are reported based on the study drug a participant was taking at the time of the event.	0.00% 0/6 • Up to 14 days after the last dose of study drug (Up to approximately 60 days) All participants who recieved ≥1 dose of study drug. Adverse events are reported based on the study drug a participant was taking at the time of the event.	16.7% 1/6 • Number of events 1 • Up to 14 days after the last dose of study drug (Up to approximately 60 days) All participants who recieved ≥1 dose of study drug. Adverse events are reported based on the study drug a participant was taking at the time of the event.	0.00% 0/16 • Up to 14 days after the last dose of study drug (Up to approximately 60 days) All participants who recieved ≥1 dose of study drug. Adverse events are reported based on the study drug a participant was taking at the time of the event.
Vascular disorders Orthostatic hypotension	16.7% 1/6 • Number of events 1 • Up to 14 days after the last dose of study drug (Up to approximately 60 days) All participants who recieved ≥1 dose of study drug. Adverse events are reported based on the study drug a participant was taking at the time of the event.	0.00% 0/6 • Up to 14 days after the last dose of study drug (Up to approximately 60 days) All participants who recieved ≥1 dose of study drug. Adverse events are reported based on the study drug a participant was taking at the time of the event.	0.00% 0/6 • Up to 14 days after the last dose of study drug (Up to approximately 60 days) All participants who recieved ≥1 dose of study drug. Adverse events are reported based on the study drug a participant was taking at the time of the event.	0.00% 0/6 • Up to 14 days after the last dose of study drug (Up to approximately 60 days) All participants who recieved ≥1 dose of study drug. Adverse events are reported based on the study drug a participant was taking at the time of the event.	0.00% 0/6 • Up to 14 days after the last dose of study drug (Up to approximately 60 days) All participants who recieved ≥1 dose of study drug. Adverse events are reported based on the study drug a participant was taking at the time of the event.	0.00% 0/6 • Up to 14 days after the last dose of study drug (Up to approximately 60 days) All participants who recieved ≥1 dose of study drug. Adverse events are reported based on the study drug a participant was taking at the time of the event.	0.00% 0/6 • Up to 14 days after the last dose of study drug (Up to approximately 60 days) All participants who recieved ≥1 dose of study drug. Adverse events are reported based on the study drug a participant was taking at the time of the event.	0.00% 0/6 • Up to 14 days after the last dose of study drug (Up to approximately 60 days) All participants who recieved ≥1 dose of study drug. Adverse events are reported based on the study drug a participant was taking at the time of the event.	0.00% 0/6 • Up to 14 days after the last dose of study drug (Up to approximately 60 days) All participants who recieved ≥1 dose of study drug. Adverse events are reported based on the study drug a participant was taking at the time of the event.	0.00% 0/6 • Up to 14 days after the last dose of study drug (Up to approximately 60 days) All participants who recieved ≥1 dose of study drug. Adverse events are reported based on the study drug a participant was taking at the time of the event.	0.00% 0/16 • Up to 14 days after the last dose of study drug (Up to approximately 60 days) All participants who recieved ≥1 dose of study drug. Adverse events are reported based on the study drug a participant was taking at the time of the event.

Additional Information

Senior Vice President, Global Clinical Development

Merck Sharp & Dohme Corp.

Phone: 1-800-672-6372

Email: ClinicalTrialsDisclosure@merck.com

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.
• Publication restrictions are in place

Restriction type: OTHER