A Study to Investigate Safety and Tolerability, Pharmacokinetics and Pharmacodynamics of JNJ-55375515 in Healthy Male Participants

NCT03405441 | Completed Phase 1

• 3 other identifiers: CR10840955375515EDI10022017-002457-11
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to assess safety and tolerability of day-time and night-time dosing of JNJ-55375515 in healthy male participants.

Conditions

Healthy

Outcome Measures

Primary Outcomes (2)

• Part 1 (Day-Time Dosing): Number of Participants with Adverse Events (AEs) as a Measure of Safety and Tolerability

  An adverse event (AE) is any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship.

  Up to Week 8

• Part 2 (Night-Time Dosing): Number of Participants with AEs as a Measure of Safety and Tolerability

  An adverse event (AE) is any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship.

  Up to Week 9

Secondary Outcomes (25)

• Slow Wave Activity Recorded by the Electroencephalogram (EEG)

  Pre-dose, 1 hour (h), 2h, and 4h post dose on Day 1

• Part 1: PD of JNJ-55375515 as Assessed by Heart Rate Variability (HRV)

  Pre-dose (Day 1) up to 24 hours post dose

• Part 1: Saccadic Reaction Time (RT) as Measured by Saccadic Eye Movements

  Pre-dose, 1 h, 2h, and 4h post dose on Day 1

• Part 1: Saccadic Peak Velocity (SPV) as Measured by Saccadic Eye Movements

  Pre-dose, 1h, 2h, and 4h post dose on Day 1

• Part 1: Change from Baseline in Body Sway

  Baseline, 1h, 2h, and 4h post dose on Day 1

Study Arms (3)

Part 1 (Panel 1): JNJ-55375515 and placebo

EXPERIMENTAL

Participants will receive dose level (DL) 1 of JNJ-55375515 (starting dose) or placebo on Day 1 of period 1 based on their randomization sequence 1, 2 or 3. Dose of the study medication will be escalated to DL 3 (period 2) and a maximum of DL 5 (period 3) based on the safety and tolerability profile and pharmacodynamic (PD) profile assessed at the preceding dose level. A wash-out period of at least 10 days will be maintained between study drug administrations.

Drug: JNJ-55375515 Dose Level 1; Drug: JNJ-55375515 Dose Level 3; Drug: JNJ-55375515 Dose Level 5; Drug: Placebo

Part 1 (Panel 2): JNJ-55375515 and placebo

EXPERIMENTAL

Participants will receive DL 2 of JNJ-55375515 (starting dose) or placebo on Day 1 of period 1 based on their randomization sequence 1, 2 or 3. Dose of the study medication will be escalated to DL 4 (period 2) and a maximum of DL 6 (period 3) based on the safety and tolerability profile and PD profile assessed at the preceding dose level. A wash-out period of at least 10 days will be maintained between study drug administrations.

Drug: JNJ-55375515 Dose Level 2; Drug: JNJ-55375515 Dose Level 4; Drug: JNJ-55375515 Dose Level 6; Drug: Placebo

Part 2: JNJ-55375515 and placebo

EXPERIMENTAL

Participants will randomly be assigned to one of four treatment sequences 1, 2, 3 or 4. In the first 3 sequences, participants will receive 2 doses of JNJ-55375515 and placebo. Participants assigned to sequence 4 will receive placebo only in all periods. 3 dose levels will be tested in Part 2 based on Part 1 and will not exceed those evaluated in Part 1. A wash-out period of at least 10 days will be maintained between study drug administrations in period 1, 2, 3 and 4. In period 4 (open-label pharmacokinetic (PK) assessment period) participants will be randomly assigned to one of two dose levels tested in periods 1 to 3.

Drug: Placebo; Drug: JNJ-55375515

Interventions

JNJ-55375515 Dose Level 1 DRUG

Participants will receive JNJ-55375515 orally at a Dose level 1 in Part 1 of study.

Part 1 (Panel 1): JNJ-55375515 and placebo

JNJ-55375515 Dose Level 2 DRUG

Participants will receive JNJ-55375515 orally at a Dose level 2 in Part 1 of study.

Part 1 (Panel 2): JNJ-55375515 and placebo

JNJ-55375515 Dose Level 3 DRUG

Participants will receive JNJ-55375515 orally at a Dose level 3 in Part 1 of study.

Part 1 (Panel 1): JNJ-55375515 and placebo

JNJ-55375515 Dose Level 4 DRUG

Participants will receive JNJ-55375515 orally at a Dose level 4 in Part 1 of study.

Part 1 (Panel 2): JNJ-55375515 and placebo

JNJ-55375515 Dose Level 5 DRUG

Participants will receive JNJ-55375515 orally at a Dose level 5 in Part 1 of study.

Part 1 (Panel 1): JNJ-55375515 and placebo

JNJ-55375515 Dose Level 6 DRUG

Participants will receive JNJ-55375515 orally at a Dose level 6 in Part 1 of study.

Part 1 (Panel 2): JNJ-55375515 and placebo

Placebo DRUG

All participants will receive matching placebo orally in Part 1 and Part 2 of the study.

Part 1 (Panel 1): JNJ-55375515 and placebo; Part 1 (Panel 2): JNJ-55375515 and placebo; Part 2: JNJ-55375515 and placebo

JNJ-55375515 DRUG

Participants will receive JNJ-55375515 as per the assigned treatment in Part 2.

Part 2: JNJ-55375515 and placebo

Eligibility Criteria

• Age: 18 Years - 54 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Body Mass Index (BMI) between 18 and 30 kilogram / square meter (kg/m\^2) inclusive (BMI=weight/height\^2)
• Non-smoker (not smoked for 3 months prior to screening)
• During the study and for a minimum of 1 spermatogenesis cycle (defined as approximately 90 days) after receiving the last dose of study drug, in addition to the highly effective method of contraception, a man who is sexually active with a woman of childbearing potential must agree to use a barrier method of contraception (for example, condom with spermicidal foam/gel/film/cream/suppository); who is sexually active with a woman who is pregnant must use a condom; must agree not to donate sperm

You may not qualify if:

• History of or current significant medical illness including (but not limited to psychotic, bipolar, major depressive, or anxiety disorder)
• Cardiac arrhythmias or other cardiac disease, hematological disease, lipid abnormalities, 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
• Participant has a history of or current vestibular disease including (but not limited to) Meniere's disease, benign paroxysmal positional vertigo (BPPV), vestibular neuronitis, vestibular schwannoma or vestibular migraine
• Only for part 2: Has a current diagnosis or history of narcolepsy, central sleep apnea, sleep related hypoventilation, circadian rhythm sleep-wake disorders, substance/medication induced sleep disorder or parasomnias (non-rapid eye movement sleep arousal disorders, nightmare disorder, rapid eye movement sleep behavior disorder); obstructive sleep apnea/hypopnea (apnea/hypopnea index greater than (\>)10) or restless legs syndrome (periodic leg movements with arousal index \>15); night-shift worker or significantly shifted diurnal activity pattern (it is expected that eligible participant normally wake up between 6:00 am - 8:00 am and go to bed between 10:00 pm - 12:00 am); usual bedtime outside of 10:00 pm and 12:00 am and taking, on average, less than 6 hours or more than 9 hours of bed rest

Sponsors & Collaborators

• Janssen Research & Development, LLC: lead

Study Sites (1)

PRA Health Sciences Onderzoekscentrum Groningen, locatie Martini

Groningen, 9728 NZ, Netherlands

Location

Study Officials

• Janssen Research & Development, LLC Clinical Trial

  Janssen Research & Development, LLC

  STUDY DIRECTOR

Study Design

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

Study Record Dates

• First Submitted: January 8, 2018
• First Posted: January 23, 2018
• Study Start: January 2, 2018
• Primary Completion: September 4, 2018
• Study Completion: September 4, 2018
• Last Updated: April 27, 2025

Record last verified: 2025-04

Locations

NL (1)