A Single Ascending Dose Study to Investigate the Safety, Tolerability, and Pharmacokinetics of JNJ-42165279 in Healthy Male Participants

NCT01650597 | Completed Phase 1

• 3 other identifiers: CR10070742165279EDI10012011-002861-39
• Study Type: interventional
• Target: 29
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to investigate the safety, tolerability and pharmacokinetics of single ascending doses as well as repeated doses of JNJ-42165279 in healthy male participants.

Conditions

Healthy Volunteers; Pharmacokinetics

Keywords

Healthy volunteers; Pharmacokinetics; Free fatty amides

Outcome Measures

Primary Outcomes (6)

• Incidents of adverse events amongst participants (Part 1)

  As a measure of safety.

  Day -21 to Day 114 (~19 wks)

• Incidents of adverse events amongst participants (Part 2)

  Day -21 to Day 23 (~6 wks)

• Pharmacokinetics of JNJ-42165279 as measured by Cmax (Part 1)

  Cmax is defined as maximum plasma concentration of JNJ-42165279.

  Day 1 to Day 4

• Pharmacokinetics of JNJ-42165279 as measured by Cmax (Part 2)

  Day 1 to Day 7

• Pharmacokinetics of JNJ-42165279 as measured by AUC (Part 1)

  AUC is defined area under the plasma concentration time curve from 0 to t hours post dosing of JNJ-42165279.

  Day 1 to Day 4

• Pharmacokinetics of JNJ-42165279 as measured by AUC (Part 2)

  Day 1 to Day 7

Secondary Outcomes (8)

• Fatty acid amide hydrolase (FAAH) inhibition in white blood cells (WBCs) (Part 1)

  Day 1 to Day 4

• FAAH inhibition in WBC (Part 2)

  Day 1 to Day 7 and Day 9

• Effects on mood (Part 1)

  Day 1 and Day 2

• Effects on mood (Part 2)

  Day 1 to Day 9

• Effects on cognition (Part 1)

  Day -1 and Day 1

Study Arms (3)

Part 1 - Panel 1

EXPERIMENTAL

The participants will receive 3 or 4 ascending doses (2.5, 10, 30, 100, 250, 500 mg) of JNJ-42165279 and placebo during the study.

Drug: JNJ-42165279 2.5 - 500 mg oral; Drug: Placebo

Part 1 - Panel 2

EXPERIMENTAL

The participants will receive 3 or 4 ascending doses (2.5, 10, 30, 100, 250, 500 mg) of JNJ-42165279 and placebo during the study.

Drug: JNJ-42165279 2.5 - 500 mg oral; Drug: Placebo

Part 2 (parallel)- additional cohort

EXPERIMENTAL

The participants will receive repeated daily dosing of 100 mg JNJ-42165279 or placebo for 6 consecutive days.

Drug: Placebo; Drug: JNJ-42165279 100 mg oral

Interventions

JNJ-42165279 2.5 - 500 mg oral DRUG

Type=exact number, unit=mg, numbers=2.5, 10, 30, 100, 250 and 500, form=suspension, route=oral use. One single dose administered orally.

Part 1 - Panel 1; Part 1 - Panel 2

Placebo DRUG

Type=exact number, unit=mg, form=solution, route=oral use. One single dose administered orally.

Part 1 - Panel 1; Part 1 - Panel 2; Part 2 (parallel)- additional cohort

JNJ-42165279 100 mg oral DRUG

Type=exact number, unit=mg, form=solution, route=oral use. One single dose administered orally.

Part 2 (parallel)- additional cohort

Eligibility Criteria

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

You may qualify if:

• Has a body mass index between 18 and 30 kg/m2 and body weight not less than 50 kg.
• Must adhere to required contraception (subject and partner, if applicable) during the study and for 3 months after study
• Must agree to not donate sperm during the study and for 3 months after receiving the last dose of study drug

You may not qualify if:

• Has history of or current clinically significant medical illness including cardiac arrhythmias or other cardiac disease, hematologic disease, coagulation disorders (including any abnormal bleeding or blood dyscrasias), lipid abnormalities, significant pulmonary disease, including bronchospastic respiratory disease, diabetes mellitus, renal or hepatic insufficiency, thyroid disease, neurologic or psychiatric disease, infection, recent surgery or trauma.
• Has history of malignancy within 5 years before screening (exceptions are squamous and basal cell carcinomas of the skin, or malignancy that in the opinion of the investigator, with concurrence with the sponsor's medical monitor, is considered cured with minimal risk of recurrence)
• Has clinically significant abnormal values for hematology, clinical chemistry, coagulation, or urinalysis at screening or at first admission to the study center.
• Has clinically significant abnormal physical examination, neurological examination, vital signs, or 12-lead electrocardiogram (ECG) at screening or at first admission to the study center. Subjects with a QTcF interval \>450 msec or QRS interval ≥110 msec will be excluded.
• Has use of any prescription or nonprescription medications or herbal supplements, except for paracetamol, within 14 days before the first dose of study drug. Paracetamol is not allowed within 1 day (Day -1) before the first dose of study drug.
• Has known allergy, hypersensitivity, or intolerance to hypromellose (the excipient of JNJ-42165279)
• Has Known allergy to heparin or history of heparin induced thrombocytopenia
• Has positive test for human immunodeficiency virus (HIV) 1 and 2 antibodies, hepatitis B core antibody (HBcAB), hepatitis B surface antigen (HBsAg), or hepatitis C antibodies (HCV)
• Has history of significant drug or alcohol abuse within past 5 years, or has a positive drug screen
• Smoking or use of nicotine-containing substances within past 2 months
• Blood donation or blood loss within past 3 months
• Recent use of an investigational drug or device

Sponsors & Collaborators

• Janssen-Cilag International NV: lead

Study Sites (1)

Unknown Facility

Merksem, Belgium

Location

MeSH Terms

Interventions

JNJ-42165279

Study Officials

• Janssen-Cilag International NV Clinical Trial

  Janssen-Cilag International NV

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 24, 2012
• First Posted: July 26, 2012
• Study Start: August 1, 2011
• Primary Completion: May 1, 2012
• Study Completion: May 1, 2012
• Last Updated: July 6, 2017

Record last verified: 2014-05

Locations

BE (1)