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

NCT01951053 | Completed Phase 1

• 3 other identifiers: CR10006440411813EDI10032009-016637-95
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Healthy

Keywords

Healthy; Safety; Tolerability; Pharmacokinetics; Pharmacodynamics; JNJ-40411813; Positive allosteric modulator

Outcome Measures

Primary Outcomes (4)

• Rapid Eye Movement (REM) sleep latency

  REM sleep is a normal stage of sleep characterized by the rapid and random movement of the eyes. REM sleep latency is the time from sleep onset until first period of REM sleep. Polysomnographic recordings will be used to determine the time spent in different sleep stages (S1: light sleep, S2: light sleep, S3: deep sleep, and S4: REM sleep).

  Day 3 and Day 4

• Total duration of Rapid Eye Movement (REM) sleep

  Polysomnographic recordings will be used to determine the time spent in different sleep stages (S1: light sleep, S2: light sleep, S3: deep sleep, and S4: REM sleep). It will be calculated as number of epochs scored as REM sleep divided by 2.

  Day 3 and Day 4

• Total time spent in deep sleep

  Polysomnographic recordings will be used to determine the time spent in different sleep stages (S1: light sleep, S2: light sleep, S3: deep sleep, and S4: REM sleep). It will be calculated as number of stages score as 3 or stage 4 divided by 2.

  Day 3 and Day 4

• Number of participants with adverse events as a measure of safety

  Up to Week 10

Secondary Outcomes (17)

• Peak plasma concentration of JNJ-40411813

  Day 3 (predose; 1, 3, 6, 14 and 16 hours post dose)

• Time to reach the peak plasma concentration of JNJ-40411813

  Day 3 (predose; 1, 3, 6, 14 and 16 hours post dose)

• Area under the plasma concentration of JNJ-40411813-time curve from 0 to t hours post dosing

  Day 3 (predose; 1, 3, 6, 14 and 16 hours post dose)

• Area under the plasma concentration of JNJ-40411813-time curve from 0 to infinity post dosing

  Day 3 (predose; 1, 3, 6, 14 and 16 hours post dose)

• Elimination rate constant of JNJ-40411813

  Day 3 (predose; 1, 3, 6, 14 and 16 hours post dose)

Study Arms (6)

Sequence 1

EXPERIMENTAL

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.

Drug: JNJ-40411813; Drug: Placebo; Drug: Citalopram

Sequence 2

EXPERIMENTAL

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.

Drug: JNJ-40411813; Drug: Placebo; Drug: Citalopram

Sequence 3

EXPERIMENTAL

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.

Drug: JNJ-40411813; Drug: Placebo; Drug: Citalopram

Sequence 4

EXPERIMENTAL

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.

Drug: JNJ-40411813; Drug: Placebo; Drug: Citalopram

Sequence 5

EXPERIMENTAL

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.

Drug: JNJ-40411813; Drug: Placebo; Drug: Citalopram

Sequence 6

EXPERIMENTAL

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.

Drug: JNJ-40411813; Drug: Placebo; Drug: Citalopram

Interventions

JNJ-40411813 DRUG

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

Sequence 1; Sequence 2; Sequence 3; Sequence 4; Sequence 5; Sequence 6

Placebo DRUG

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

Sequence 1; Sequence 2; Sequence 3; Sequence 4; Sequence 5; Sequence 6

Citalopram DRUG

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

Sequence 1; Sequence 2; Sequence 3; Sequence 4; Sequence 5; Sequence 6

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Johnson & Johnson Pharmaceutical Research & Development, L.L.C.: lead

Study Sites (1)

Unknown Facility

Berlin, Germany

Location

MeSH Terms

Interventions

1-butyl-3-chloro-4-(4-phenyl-1-piperidinyl)-(1H)-pyridone; Citalopram

Intervention Hierarchy (Ancestors)

Propylamines; Amines; Organic Chemicals; Nitriles; Benzofurans; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Johnson & Johnson Pharmaceutical Research & Development Clinical Trial

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

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 27, 2013
• First Posted: September 26, 2013
• Study Start: January 1, 2010
• Primary Completion: May 1, 2010
• Study Completion: May 1, 2010
• Last Updated: September 26, 2013

Record last verified: 2013-09

Locations

DE (1)