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

Janssen (J&J Innovative Medicine)

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: JNJ-42847922 10 mg; Drug: JNJ-42847922 20 mg; Drug: JNJ-42847922 5 mg; Drug: JNJ-42847922 40 mg; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT02230878

CR104154

42847922EDI1003 (Other Identifier)

2014-000600-95 (EudraCT Number)

Details and patient eligibility

About

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.

Full description

This is a Phase 1, double blind (a medical research study in which neither the researchers nor the participants know what treatment the participants is receiving), randomized (study drug assigned by chance), placebo controlled, multiple ascending dose study. The study will consist of 3 parts: a Screening period (Days -21 to -2), a Double-blind treatment period (Day -1 to Day 11), and a Follow-up period (within 7 to 14 days after last dose administration). In double blind treatment period, participants will be randomly assigned to 5, 10, 20, and 40 milligram (mg) or placebo. Number of participants with any clinically relevant changes (adverse events [AEs], laboratory results,electrocardiogram [ECG], Vital signs, Physical and neurological, sedation & concentration) and columbia suicide severity rating (CSSR) scale will be evaluated as primary outcome measure. Participants' safety will be monitored throughout the study.

Enrollment: 40 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• 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)
• Participants must be healthy / medically stable on the basis of clinical laboratory tests performed at screening. If the results of the serum chemistry panel, hematology, or urinalysis are outside the normal reference ranges, retesting of an abnormal lab value(s) that may lead to exclusion will be allowed once during the screening phase
• 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

Exclusion criteria

• 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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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40 participants in 4 patient groups

JNJ-42847922, 5 milligram (mg) and Placebo

Experimental group

Description:

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.

Treatment:

Drug: Placebo

Drug: JNJ-42847922 5 mg

JNJ-42847922, 10 mg and Placebo

Experimental group

Description:

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.

Treatment:

Drug: Placebo

Drug: JNJ-42847922 10 mg

JNJ-42847922, 20 mg and Placebo

Experimental group

Description:

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.

Treatment:

Drug: JNJ-42847922 20 mg

Drug: Placebo

JNJ-42847922, 40 mg and Placebo

Experimental group

Description:

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.

Treatment:

Drug: Placebo

Drug: JNJ-42847922 40 mg