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A Study to Evaluate Safety, Tolerability, Pharmacodynamics, and Pharmacokinetics of JNJ-404118413 in Healthy Male Patients

NCT ID: NCT01951053

Last Updated: 2013-09-26

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

18 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-01-31

Study Completion Date

2010-05-31

Brief Summary

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The purpose of the study is to evaluate the effect of JNJ-40411813 on rapid eye movement sleep and deep sleep; safety, tolerability and pharmacokinetics (what the body does to the study medication) of JNJ-40411813.

Detailed Description

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This is a double-blind (neither physician nor participants knows the treatment that the participant receives), placebo-controlled (effect of the study medication will be compared with the effect of placebo \[inactive substance\]), comparator-controlled (effect of the study medication will be compared with the effect of FDA approved and marketed active substance \[citalopram\]), and 3-way crossover (method used to switch participants from one treatment arm to another treatment arm) study. This study will be double-blinded for treatment with placebo and JNJ-40411813; however, it will be open label (all people know the identity of the intervention) for treatment with citalopram. This study will consist of screening phase (within 28 days prior to the start of study medication), treatment phase, and follow-up phase (approximately 14 days after the last administration of study medication). Participants will be randomly assigned to 1 of 6 sequences (Sequences 1, 2, 3, 4, 5, and 6) to receive JNJ-40411813, citalopram, and placebo. Each sequence consists of 3 treatment periods (Period 1, Period 2, and Period 3) and each subsequent treatment period will be separated by a wash out period (no treatment) of at least 7 days. Approximately, 18 participants will be enrolled in this study (3 participants in each sequence). Safety will be evaluated by the assessment of adverse events, clinical laboratory tests, electrocardiogram, vital signs, and physical examination which will be evaluated throughout the study duration. The total duration of study participation for a participant will be approximately 10 Weeks.

Conditions

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Healthy

Keywords

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Healthy Safety Tolerability Pharmacokinetics Pharmacodynamics JNJ-40411813 Positive allosteric modulator

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Sequence 1

Participants will receive the study medications in the sequence of placebo, citalopram, and JNJ-40411813, in 3 treatment periods. Each treatment period has 3 days and subsequent treatment period will be separated by 7 days.

Group Type EXPERIMENTAL

JNJ-40411813

Intervention Type DRUG

Participants will receive nanosuspension of JNJ-40411813 500 mg orally once daily on Day 3 in appropriate treatment periods.

Placebo

Intervention Type DRUG

Participants will receive placebo orally once daily on Days 1 to 2 or Days 1 to 3 in appropriate treatment periods.

Citalopram

Intervention Type DRUG

Participants will receive citalopram 20 mg tablet orally once daily on Day 3 in appropriate treatment periods.

Sequence 2

Participants will receive the study medications in the sequence of placebo, JNJ-40411813, and citalopram, in 3 treatment periods. Each treatment period has 3 days and subsequent treatment period will be separated by 7 days.

Group Type EXPERIMENTAL

JNJ-40411813

Intervention Type DRUG

Participants will receive nanosuspension of JNJ-40411813 500 mg orally once daily on Day 3 in appropriate treatment periods.

Placebo

Intervention Type DRUG

Participants will receive placebo orally once daily on Days 1 to 2 or Days 1 to 3 in appropriate treatment periods.

Citalopram

Intervention Type DRUG

Participants will receive citalopram 20 mg tablet orally once daily on Day 3 in appropriate treatment periods.

Sequence 3

Participants will receive the study medications in the sequence of citalopram, placebo, and JNJ-40411813, in 3 treatment periods. Each treatment period has 3 days and subsequent treatment period will be separated by 7 days.

Group Type EXPERIMENTAL

JNJ-40411813

Intervention Type DRUG

Participants will receive nanosuspension of JNJ-40411813 500 mg orally once daily on Day 3 in appropriate treatment periods.

Placebo

Intervention Type DRUG

Participants will receive placebo orally once daily on Days 1 to 2 or Days 1 to 3 in appropriate treatment periods.

Citalopram

Intervention Type DRUG

Participants will receive citalopram 20 mg tablet orally once daily on Day 3 in appropriate treatment periods.

Sequence 4

Participants will receive the study medications in the sequence of citalopram, JNJ-40411813, and placebo, in 3 treatment periods. Each treatment period has 3 days and subsequent treatment period will be separated by 7 days.

Group Type EXPERIMENTAL

JNJ-40411813

Intervention Type DRUG

Participants will receive nanosuspension of JNJ-40411813 500 mg orally once daily on Day 3 in appropriate treatment periods.

Placebo

Intervention Type DRUG

Participants will receive placebo orally once daily on Days 1 to 2 or Days 1 to 3 in appropriate treatment periods.

Citalopram

Intervention Type DRUG

Participants will receive citalopram 20 mg tablet orally once daily on Day 3 in appropriate treatment periods.

Sequence 5

Participants will receive the study medications in the sequence of JNJ-40411813, placebo, and citalopram, in 3 treatment periods. Each treatment period has 3 days and subsequent treatment period will be separated by 7 days.

Group Type EXPERIMENTAL

JNJ-40411813

Intervention Type DRUG

Participants will receive nanosuspension of JNJ-40411813 500 mg orally once daily on Day 3 in appropriate treatment periods.

Placebo

Intervention Type DRUG

Participants will receive placebo orally once daily on Days 1 to 2 or Days 1 to 3 in appropriate treatment periods.

Citalopram

Intervention Type DRUG

Participants will receive citalopram 20 mg tablet orally once daily on Day 3 in appropriate treatment periods.

Sequence 6

Participants will receive the study medications in the sequence of JNJ-40411813, citalopram, and placebo, in 3 treatment periods. Each treatment period has 3 days and subsequent treatment period will be separated by 7 days.

Group Type EXPERIMENTAL

JNJ-40411813

Intervention Type DRUG

Participants will receive nanosuspension of JNJ-40411813 500 mg orally once daily on Day 3 in appropriate treatment periods.

Placebo

Intervention Type DRUG

Participants will receive placebo orally once daily on Days 1 to 2 or Days 1 to 3 in appropriate treatment periods.

Citalopram

Intervention Type DRUG

Participants will receive citalopram 20 mg tablet orally once daily on Day 3 in appropriate treatment periods.

Interventions

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JNJ-40411813

Participants will receive nanosuspension of JNJ-40411813 500 mg orally once daily on Day 3 in appropriate treatment periods.

Intervention Type DRUG

Placebo

Participants will receive placebo orally once daily on Days 1 to 2 or Days 1 to 3 in appropriate treatment periods.

Intervention Type DRUG

Citalopram

Participants will receive citalopram 20 mg tablet orally once daily on Day 3 in appropriate treatment periods.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

\- Body mass index (BMI) between 18 and 29.9 kg/m2 (BMI is calculated as weight \[kilogram\] divided by square of height \[meter\])

Exclusion Criteria

* Significant history of or current significant medical illness including (but not limited to) liver or renal insufficiency; significant cardiac, vascular, pulmonary, gastrointestinal, endocrine, neurologic, hematologic, rheumatologic, psychiatric, or metabolic disturbances or any other illness that the investigator considers clinically significant
* History of a relevant sleep disorder and / or receiving treatment for sleep disorders
* Regular or periodic use of benzodiazepines
* Serology positive for hepatitis B surface antigen, hepatitis C antibodies or HIV antibodies at screening
* Positive urine screen for drugs of abuse and positive alcohol breath test at screening or administration of the study medication
* Use of any prescription medication or over-the-counter medication (not including paracetamol), or herbal medication within 2 weeks of start of study medication
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Johnson & Johnson Pharmaceutical Research & Development Clinical Trial

Role: STUDY_DIRECTOR

Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

Locations

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Berlin, , Germany

Site Status

Countries

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Germany

Other Identifiers

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40411813EDI1003

Identifier Type: OTHER

Identifier Source: secondary_id

2009-016637-95

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

CR100064

Identifier Type: -

Identifier Source: org_study_id