A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of JNJ-48816274

NCT02852395 | Completed Phase 1

• 3 other identifiers: CR10809048816274EDI10012015-004186-89
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 2

Brief Summary

This is a 3-part study to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of JNJ-48816274 in healthy participants after administration of single and repeated doses, and to evaluate its potential effectiveness for treating insomnia.

Conditions

Healthy

Outcome Measures

Primary Outcomes (6)

• Number of Participants with Treatment Emergent Adverse Events as a Measure of Safety and Tolerability

  Up to 14 days after last dose in Part 1 (approximately 5.5 weeks)

• Area Under the Plasma Concentration-Time Curve From Time Zero to Time 't' (AUC[0-t])

  Days 1-2 in Part 1

• Maximum Observed Plasma Concentration (Cmax)

  Day 1 in Part 1

• Time to Reach the Maximum Plasma Concentration (Tmax)

  Day 1 in Part 1

• Elimination Half Life (t1/2)

  Days 1-2 in Part 1

• Mean Karolinska Sleepiness Scale score

  A 1-item questionnaire completed by participants to rate their degree of sleepiness on a scale of 1 to 9, ranging from 'extremely alert' (1) to 'very sleepy, great effort to keep awake, fighting sleep' (9).

  Day 1 in Part 1

Secondary Outcomes (8)

• Mean Total Sleep Time by 8-hour overnight Polysomnography

  Part 2: Days 1-2 of each of 3 or 4 crossover periods

• Mean Latency to Persistent Sleep by 8-hour overnight Polysomnography

  Part 2: Days 1-2 of each of 3 or 4 crossover periods

• Mean Leeds Sleep Evaluation Questionnaire (LSEQ) Score

  Part 2: Day 2 of each of 3 or 4 crossover periods

• Mean Subjective Quality of Sleep Questionnaire (SQSQ) Item Scores

  Part 2: Day 2 of each of 3 or 4 crossover periods

• Mean Karolinska Sleepiness Scale score

  Part 2: Days 1-2 of each of 3 or 4 crossover periods; Part 3: Days 1-7

Study Arms (3)

Part 1 Single Dose

EXPERIMENTAL

Part 1 single daytime oral dose of JNJ-48816274 or placebo. Doses of JNJ-48816274 will start at 5 milligram (mg) and increase sequentially to a maximum dose of 250 mg.

Drug: JNJ-48816274; Drug: Placebo

Part 2 Crossover Sleep Study

EXPERIMENTAL

Part 2 single nighttime oral dose of JNJ-48816274 or placebo administered during each of 3 or 4 crossover periods separated by 7-9 days. The doses of JNJ-48816274 will be selected based on data from Part 1 (not to exceed 250 mg).

Drug: JNJ-48816274; Drug: Placebo

Part 3 Repeated Dose (Optional)

EXPERIMENTAL

Part 3 daytime oral dose of JNJ-48816274 or placebo administered once daily for 7 consecutive days. Doses will be determined based on data from Part 1, and may increase sequentially (not to exceed 250 mg/day).

Drug: JNJ-48816274; Drug: Placebo

Interventions

JNJ-48816274 DRUG

Oral dose; dose range of 5 mg up to 250 mg

Part 1 Single Dose; Part 2 Crossover Sleep Study; Part 3 Repeated Dose (Optional)

Placebo DRUG

Oral dose; appearance matched to JNJ-48816274

Part 1 Single Dose; Part 2 Crossover Sleep Study; Part 3 Repeated Dose (Optional)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Must be healthy as assessed by medical history and safety evaluations performed at screening
• Has a body mass index between 18 and 30 kilogram per square meter (kg/m2) and body weight not less than 50 kg
• Must be willing and able to abide by the prohibitions and restrictions of the study, including requirements for contraception
• Women must not be of childbearing potential by either being postmenapausal or permanently sterilized
• Part 2 Only: Maintains a regular sleep-wake cycle as measured by sleep diaries and a watch that measures activity
• Has a habitual (majority of days) bedtime and duration of sleep that meet the study requirements

You may not qualify if:

• Current or history of clinically significant medical or psychiatric illness, or recent major surgery or blood loss/donation
• Any current sleep-wake disorder, recent night shift work, or history of insomnia within the last 5 years
• Man who has a pregnant female partner
• Woman who is breastfeeding
• Is participating or has participated within the last 3 months in a study with an investigational drug or medical device
• Tests positive or has a history of human immunodeficiency virus (HIV), hepatitis B, hepatitis C, or other active liver disease
• Drug or alcohol abuse within the last 5 years, nicotine use within the last 3 months, or tests positive for alcohol, drugs of abuse, or nicotine
• Routinely consumes an excessive amount of caffeine

Sponsors & Collaborators

• Janssen-Cilag International NV: lead

Study Sites (2)

Unknown Facility

Guildford, United Kingdom

Location

Unknown Facility

United Kingdom, United Kingdom

Location

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, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 11, 2016
• First Posted: August 2, 2016
• Study Start: August 13, 2016
• Primary Completion: May 2, 2018
• Study Completion: May 2, 2018
• Last Updated: April 27, 2025

Record last verified: 2025-04

Locations

GB (2)