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

NCT02555124 | Completed Phase 1

• 2 other identifiers: CR10787842847922ISM1002
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to evaluate the safety of JNJ-42847922 following single oral administration.

Conditions

Healthy

Keywords

Healthy; JNJ-42847922

Outcome Measures

Primary Outcomes (2)

• Number of Participants With Adverse Events (AEs)

  An AE is any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.

  up to Day 8

• Number of Participants With Serious Adverse Events (SAEs)

  An AE is any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.

  up to Day 8

Secondary Outcomes (11)

• Maximum Plasma Concentration (Cmax)

  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)

  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)

  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)

  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])

  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

Study Arms (3)

Cohort A

EXPERIMENTAL

Participants will receive single oral dose of 5 milligram (mg) of JNJ-42847922 or Placebo on Day 1, fasted condition.

Drug: JNJ-42847922, 5 mg; Drug: Placebo

Cohort B

EXPERIMENTAL

Participants will receive single oral dose of 20 mg of JNJ-42847922 or Placebo on Day 1, fasted condition.

Drug: JNJ-42847922, 20 mg; Drug: Placebo

Cohort C

EXPERIMENTAL

Participants will receive single oral dose of 40 mg of JNJ-42847922 or Placebo on Day 1, fasted condition.

Drug: JNJ-42847922, 40 mg; Drug: Placebo

Interventions

JNJ-42847922, 5 mg DRUG

Participants will receive single oral dose of 5 milligram (mg) of JNJ-42847922 on Day 1, fasted condition.

Cohort A

JNJ-42847922, 20 mg DRUG

Participants will receive single oral dose of 20 mg of JNJ-42847922 on Day 1, fasted condition.

Cohort B

JNJ-42847922, 40 mg DRUG

Participants will receive single oral dose of 40 mg of JNJ-42847922 on Day 1, fasted condition.

Cohort C

Placebo DRUG

Participants will receive placebo on Day 1, fasted condition in Cohort A, Cohort B and Cohort C.

Cohort A; Cohort B; Cohort C

Eligibility Criteria

• Age: 20 Years - 55 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Janssen Pharmaceutical K.K.: lead

Study Sites (1)

Unknown Facility

Osaka, Japan

Location

MeSH Terms

Interventions

seltorexant

Study Officials

• Janssen Pharmaceutical K.K., Japan Clinical Trial

  Janssen Pharmaceutical K.K.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 18, 2015
• First Posted: September 21, 2015
• Study Start: September 12, 2015
• Primary Completion: October 31, 2015
• Study Completion: October 31, 2015
• Last Updated: March 10, 2017

Record last verified: 2017-03

Locations

JP (1)