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

NCT02230878 | Completed Phase 1

• 3 other identifiers: CR10415442847922EDI10032014-000600-95
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to investigate the safety, tolerability, pharmacokinetic (the study of the way a drug enters and leaves the blood and tissues over time), dose-proportionality, accumulation, urinary excretion, pharmacodynamics (the study of how drugs act on the body) and sedative effects of JNJ-42847922 in healthy male and female participants.

Conditions

Healthy

Keywords

JNJ-42847922; Phase 1; Healthy; Placebo

Outcome Measures

Primary Outcomes (8)

• Supine and Standing Systolic and Diastolic Blood Pressure (BP)

  BP is the pressure of the blood within the arteries. It is produced primarily by the contraction of the heart muscle. BP measurement is recorded by 2 numbers: systolic BP (SBP, BP when heart is contracting; it is the maximum arterial pressure during contraction of left ventricle) and diastolic BP (DBP, BP when heart is relaxing; it is the minimum arterial pressure during relaxation and dilation of ventricles).

  Baseline up to End of study (7-14 days after last dose) or Early withdrawal

• Supine and Standing Heart Rate

  Baseline up to End of study (7-14 days after last dose) or Early withdrawal

• Tympanic Temperature

  Baseline up to End of study (7-14 days after last dose) or Early withdrawal

• 12 Lead Electrocardiogram (ECG): RR, QRS, PR, QT, QTcB, QTcF Interval

  Baseline up to End of study (7-14 days after last dose) or Early withdrawal

• Columbia Suicide Severity Rating Scale (C-SSRS)

  Baseline up to End of study (7-14 days after last dose) or Early withdrawal

• Number of Participants with Adverse Events

  Baseline up to End of study (7-14 days after last dose) or Early withdrawal

• Number of Participants With Change From Baseline in Laboratory Tests Results

  Laboratory values included Hematology, clinical chemistry and urinalysis.

  Baseline up to End of study (7-14 days after last dose) or Early withdrawal

• Physical and Neurological Examination

  Physical and neurological examination will be performed.

  Baseline up to End of study (7-14 days after last dose) or Early withdrawal

Secondary Outcomes (17)

• Maximum Plasma Concentration (C[max])

  Baseline up to End of study (7-14 days after last dose) or Early withdrawal

• Time to Reach the Maximum Plasma Concentration (T[max])

  Baseline up to End of study (7-14 days after last dose) or Early withdrawal

• Time to Reach Last Quantifiable Plasma Concentration (T[last])

  Baseline up to End of study (7-14 days after last dose) or Early withdrawal

• Area Under the Plasma Concentration-Time Curve From Time Zero to hour 24 Time (AUC [0-24])

  Baseline up to End of study (7-14 days after last dose) or Early withdrawal

• Area Under the Plasma Concentration-Time Curve From Time Zero to Infinite Time (AUC [0-last])

  Baseline up to End of study (7-14 days after last dose) or Early withdrawal

Other Outcomes (3)

• Assessment of Sedation

  Baseline up to End of study (7-14 days after last dose) or Early withdrawal

• Bond and Lader Visual Analogue Scale (B and L VAS)

  Baseline up to End of study (7-14 days after last dose) or Early withdrawal

• Addiction Research Center Inventory Questionnaire (ARCI-49)

  Baseline up to End of study (7-14 days after last dose) or Early withdrawal

Study Arms (4)

JNJ-42847922, 5 milligram (mg) and Placebo

EXPERIMENTAL

Participants will be receive either 5 mg of JNJ-42847922 from Day 1 up to Day 10 or matching placebo from Day 1 up to Day 10.

Drug: JNJ-42847922 5 mg; Drug: Placebo

JNJ-42847922, 10 mg and Placebo

EXPERIMENTAL

Participants will be receive either 10 mg of JNJ-42847922 from Day 1 up to Day 10 or matching placebo from Day 1 up to Day 10.

Drug: JNJ-42847922 10 mg; Drug: Placebo

JNJ-42847922, 20 mg and Placebo

EXPERIMENTAL

Participants will be receive either 20 mg of JNJ-42847922 from Day 1 up to Day 10 or matching placebo from Day 1 up to Day 10.

Drug: JNJ-42847922 20 mg; Drug: Placebo

JNJ-42847922, 40 mg and Placebo

EXPERIMENTAL

Participants will be receive either 40mg of JNJ-42847922 from Day 1 up to Day 10 or matching placebo from Day 1 up to Day 10.

Drug: JNJ-42847922 40 mg; Drug: Placebo

Interventions

JNJ-42847922 5 mg DRUG

Participants will receive 5 mg of JNJ-42847922, from Day 1 up to Day 10.

JNJ-42847922, 5 milligram (mg) and Placebo

JNJ-42847922 10 mg DRUG

Participants will receive 10 mg of JNJ-42847922, from Day 1 up to Day 10.

JNJ-42847922, 10 mg and Placebo

JNJ-42847922 20 mg DRUG

Participants will receive 20 mg of JNJ-42847922, from Day 1 up to Day 10.

JNJ-42847922, 20 mg and Placebo

JNJ-42847922 40 mg DRUG

Participants will receive 40 mg of JNJ-42847922, from Day 1 up to Day 10 .

JNJ-42847922, 40 mg and Placebo

Placebo DRUG

Participants will receive matching placebo from Day 1 up to Day 10.

JNJ-42847922, 10 mg and Placebo; JNJ-42847922, 20 mg and Placebo; JNJ-42847922, 40 mg and Placebo; JNJ-42847922, 5 milligram (mg) and Placebo

Eligibility Criteria

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

You may qualify if:

• Women should not be of child bearing potential due to either tubal ligation or hysterectomy or who are postmenopausal (no spontaneous menses for at least 2 years
• Body Mass Index (BMI) between 18 and 30 kilogram per meter square (kg/m\^2) inclusive (BMI=weight/height\^2)
• Non-smokers (not smoked for 6 months prior to screening)
• Participant must be willing and able to adhere to the prohibitions and restrictions specified in this protocol

You may not qualify if:

• Clinically significant abnormal values for hematology, serum chemistry or urinalysis at screening or admission
• Clinically significant abnormal physical or neurological examination, vital signs or 12-lead electrocardiogram (ECG) at screening or admission
• History of or current significant medical illness including (but not limited to) cardiac arrhythmias or other cardiac disease, hematological disease, lipid abnormalities, bronchospastic respiratory disease, diabetes mellitus, renal or hepatic insufficiency, thyroid disease, Parkinson's disease, infection, or any other illness that the Investigator considers should exclude the participant
• Serology positive for hepatitis B surface antigen (HBsAg), hepatitis C virus (HCV) antibodies or human immunodeficiency virus (HIV) antibodies
• Subjects with a relevant history of a suicide attempt or suicidal behavior. Any recent suicidal ideation within the last 6 months (a level of 4 or 5), or who are at significant risk to commit suicide, as judged by the investigator using the columbia suicide severity rating score (C-SSRS)

Sponsors & Collaborators

• Janssen-Cilag International NV: lead

Study Sites (1)

Unknown Facility

Berlin, Germany

Location

MeSH Terms

Interventions

seltorexant

Study Officials

• Janssen-Cilag International NV Clinical Trial

  Janssen-Cilag International NV

  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: August 14, 2014
• First Posted: September 3, 2014
• Study Start: May 1, 2014
• Primary Completion: November 1, 2014
• Study Completion: November 1, 2014
• Last Updated: January 24, 2017

Record last verified: 2017-01

Locations

DE (1)