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

Janssen (J&J Innovative Medicine)

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: JNJ-48816274; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT02852395

48816274EDI1001 (Other Identifier)

2015-004186-89 (EudraCT Number)

CR108090

Details and patient eligibility

About

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.

Enrollment: 90 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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90 participants in 3 patient groups

Part 1 Single Dose

Experimental group

Description:

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.

Treatment:

Drug: Placebo

Drug: JNJ-48816274

Part 2 Crossover Sleep Study

Experimental group

Description:

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).

Treatment:

Drug: Placebo

Drug: JNJ-48816274

Part 3 Repeated Dose (Optional)

Experimental group

Description:

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).

Treatment:

Drug: Placebo

Drug: JNJ-48816274