A Study to Investigate the Safety, Tolerability and Pharmacokinetics of JNJ-42847922 in Healthy Japanese Male Participants

• Register: ClinicalTrials.gov
• Last refreshed on: 16 December 2017
• Main ID: NCT02555124
• Date of registration: 18/09/2015
• Prospective Registration: No
• Primary sponsor: Janssen Pharmaceutical K.K.
• Public title: A Study to Investigate the Safety, Tolerability and Pharmacokinetics of JNJ-42847922 in Healthy Japanese Male Participants
• Scientific title: A Double-Blind, Placebo-Controlled, Randomized, Single-Ascending Dose Study to Investigate the Safety, Tolerability and Pharmacokinetics of JNJ-42847922 in Healthy Japanese Male Subjects
• Date of first enrolment: September 12, 2015
• Target sample size: 24
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02555124
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Double (Participant, Care Provider).
• Phase: Phase 1

Countries of recruitment

Japan

Contacts

• Name: Janssen Pharmaceutical K.K., Japan Clinical Trial
• Affiliation: Janssen Pharmaceutical K.K.

Key inclusion & exclusion criteria

Inclusion Criteria:

- Participant must be willing and able to adhere to the prohibitions and restrictions
specified inprotocol, Prohibitions and Restrictions

- A man who is sexually active with a woman of childbearing potential and has not had
avasectomy must agree to use an adequate contraception method as deemed appropriate by
the investigator (eg, vasectomy, double-barrier, partner using effective
contraception), and all men must also agree not to donate sperm during the study and
for 3 months afterreceiving the last dose of study drug

- Participant must have a body mass index (BMI) between 18.0 and 29.9 kilogram per
square meter (kg/m^2), and body weight not less than 50 kg

- Participant must have a 12-lead electrocardiogram (ECG) consistent with normal cardiac
conduction and function, Including: Synus rhythm; Heart rate between 45 and 99 beats
per minute (bpm); QT corrected according to Fridericia's formula (QTcF) interval less
than or equal to (<=)450 milliseconds (ms); QRS interval of <=120 ms; PR interval
<=220 ms; Morphology consistent with healthy cardiac conduction and function

- Nonsmoker (not smoked for 3 months prior to screening)

Exclusion Criteria:

- Participant has a history of or current clinically significant medical illness
including (but notlimited to) cardiac arrhythmias or other cardiac disease,
hematologic disease, coagulationdisorders (including any abnormal bleeding or blood
dyscrasias), lipid abnormalities,significant pulmonary disease, including
bronchospastic respiratory disease, diabetesmellitus, hepatic or renal insufficiency,
thyroid disease, neurologic or psychiatric disease,infection, or any other illness
that the investigator considers should exclude the participant orthat could interfere
with the interpretation of the study results

- Participant has a clinically significant abnormal value for hematology,
coagulation,biochemistry, or urinalysis at screening as deemed appropriate by the
investigator

- Participant has a clinically significant abnormal physical examination, neurologic
examination,or vital signs as deemed appropriate by the investigator

- Use of any prescription or nonprescription medication (including vitamins and
herbalsupplements), except for acetaminophen within 14 days before study drug
administration onDay 1

- Participant has known allergies, hypersensitivity, or intolerance to JNJ-42847922 or
its excipients



Age minimum: 20 Years
Age maximum: 55 Years
Gender: Male

Health Condition(s) or Problem(s) studied

Healthy

Intervention(s)

Drug: Placebo

Drug: JNJ-42847922, 20 mg

Drug: JNJ-42847922, 5 mg

Drug: JNJ-42847922, 40 mg

Primary Outcome(s)

Number of Participants With Adverse Events (AEs) [Time Frame: up to Day 8]

Number of Participants With Serious Adverse Events (SAEs) [Time Frame: up to Day 8]

Secondary Outcome(s)

Maximum Plasma Concentration (Cmax) [Time Frame: Day 1 (pre-dose), 0.16, 0.33, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12,16 hour (hr) post-dose on Day 1; 24, 36 hr post-dose on Day 2; 48, 60 hr post-dose on Day 3; 72 hr post-dose on Day 4]

Apparent Elimination Half-life (t1/2) [Time Frame: Day 1 (pre-dose), 0.16, 0.33, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12,16 hour (hr) post-dose on Day 1; 24, 36 hr post-dose on Day 2; 48, 60 hr post-dose on Day 3; 72 hr post-dose on Day 4]

Apparent Volume of Distribution (Vd/F) [Time Frame: Day 1 (pre-dose), 0.16, 0.33, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12,16 hour (hr) post-dose on Day 1; 24, 36 hr post-dose on Day 2; 48, 60 hr post-dose on Day 3; 72 hr post-dose on Day 4]

Total Apparent Clearance (CL/F) [Time Frame: Day 1 (pre-dose), 0.16, 0.33, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12,16 hour (hr) post-dose on Day 1; 24, 36 hr post-dose on Day 2; 48, 60 hr post-dose on Day 3; 72 hr post-dose on Day 4]

Apparent Terminal Elimination Rate Constant (Lambda[z]) [Time Frame: Day 1 (pre-dose), 0.16, 0.33, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12,16 hour (hr) post-dose on Day 1; 24, 36 hr post-dose on Day 2; 48, 60 hr post-dose on Day 3; 72 hr post-dose on Day 4]

Area Under the Plasma Concentration-Time Curve From Time Zero to Infinite Time (AUC [0-infinity]) [Time Frame: Day 1 (pre-dose), 0.16, 0.33, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12,16 hour (hr) post-dose on Day 1; 24, 36 hr post-dose on Day 2; 48, 60 hr post-dose on Day 3; 72 hr post-dose on Day 4]

AUC From Time 0 to the Time of the Last Measurable (nonBQL) Plasma Concentration (AUClast) [Time Frame: Day 1 (pre-dose), 0.16, 0.33, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12,16 hour (hr) post-dose on Day 1; 24, 36 hr post-dose on Day 2; 48, 60 hr post-dose on Day 3; 72 hr post-dose on Day 4]

Time to Last Time of the Last Measurable (nonbelow quantification limit [nonBQL]) Plasma Concentration (Tlast) [Time Frame: Day 1 (pre-dose), 0.16, 0.33, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12,16 hour (hr) post-dose on Day 1; 24, 36 hr post-dose on Day 2; 48, 60 hr post-dose on Day 3; 72 hr post-dose on Day 4]

Change From Baseline in Stanford Sleepiness Scale Score at Day 1 [Time Frame: Baseline and Day 1]

Percentage of Area Under the Plasma Concentrationtime Curve Obtained by Extrapolation (%AUC [infinity,ex]) [Time Frame: Day 1 (pre-dose), 0.16, 0.33, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12,16 hour (hr) post-dose on Day 1; 24, 36 hr post-dose on Day 2; 48, 60 hr post-dose on Day 3; 72 hr post-dose on Day 4]

Time to Reach the Maximum Observed Plasma Concentration (Tmax) [Time Frame: Day 1 (pre-dose), 0.16, 0.33, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12,16 hour (hr) post-dose on Day 1; 24, 36 hr post-dose on Day 2; 48, 60 hr post-dose on Day 3; 72 hr post-dose on Day 4]

Secondary ID(s)

42847922ISM1002

CR107878

Source(s) of Monetary Support

Please refer to primary and secondary sponsors