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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-08-13

Study Completion Date

2018-05-02

Brief Summary

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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.

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Detailed Description

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Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Part 1 Single Dose

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.

Group Type EXPERIMENTAL

JNJ-48816274

Intervention Type DRUG

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

Placebo

Intervention Type DRUG

Oral dose; appearance matched to JNJ-48816274

Part 2 Crossover Sleep Study

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).

Group Type EXPERIMENTAL

JNJ-48816274

Intervention Type DRUG

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

Placebo

Intervention Type DRUG

Oral dose; appearance matched to JNJ-48816274

Part 3 Repeated Dose (Optional)

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).

Group Type EXPERIMENTAL

JNJ-48816274

Intervention Type DRUG

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

Placebo

Intervention Type DRUG

Oral dose; appearance matched to JNJ-48816274

Interventions

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JNJ-48816274

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

Intervention Type DRUG

Placebo

Oral dose; appearance matched to JNJ-48816274

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* 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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes