A Dose-Ranging Study of JNJ-40411813 in Healthy Male Volunteers

NCT01358006 | Completed Phase 1

• 3 other identifiers: CR01748540411813EDI10082010-022176-32
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to characterize the 5-HT2A binding over the maximum feasible dose range of JNJ-40411813, to estimate the plasma concentration associated with 50% 5-HT2A binding, and to investigate the safety and tolerability of JNJ-40411813 in healthy male volunteers.

Conditions

Healthy

Keywords

JNJ-40411813; Positron Emission Tomography (PET); Serotonin-2A (5-HT2A) receptor antagonist; Male Volunteers

Outcome Measures

Primary Outcomes (1)

• 5-HT2A binding determined by Positron Emission Tomography (PET) scans

  Up to 24 hours after study drug administration

Secondary Outcomes (2)

• Plasma concentration of JNJ-40411813

  Up to 2 days

• Adverse Events Reported

  Up to 10 days after study drug administration

Study Arms (1)

001

EXPERIMENTAL

JNJ-40411813 Cohort 1: Type=2 to 3 unit=mg number=200 to 300 form=capsule route=oral use.Capsule(s) taken in the fed state Capsule(s) taken in the fed state.,JNJ-40411813 Cohort 2: Type=up to 7 unit=mg number=up to 700 mg form=capsule route=oral use. Capsule(s) taken in the fed state.

Drug: JNJ-40411813

Interventions

JNJ-40411813 DRUG

Cohort 1: Type=2 to 3, unit=mg, number=200 to 300, form=capsule, route=oral use.Capsule(s) taken in the fed state Capsule(s) taken in the fed state.

001

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Have a body mass index (BMI) between 18 and 30 kg/m2, inclusive
• Willing to adhere to the prohibitions and restrictions specified in this protocol
• Volunteers must sign an informed consent to document that they understand the purpose of and procedures required for the study and are willing to participate in the study

You may not qualify if:

• Have abnormal values for clinical laboratory tests, clinically significant abnormal physical examination findings, vital signs, or 12-lead Electrocardiograms (ECGs) performed at screening considered to be of clinical significance to the Investigator
• Have Significant history of or current significant medical illness that the Investigator considers should exclude the volunteer
• Have known allergies, hypersensitivity, or intolerance to JNJ-40411813, its excipients, or to the PET ligand used in the study
• Have significant history of psychiatric or neurological illness in first-degree relatives
• Been exposed to ionizing radiation as a volunteer (including diagnostic procedures)

Sponsors & Collaborators

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

Study Sites (1)

Unknown Facility

Groningen, Netherlands

Location

MeSH Terms

Interventions

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

Study Officials

• Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial

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

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 19, 2011
• First Posted: May 23, 2011
• Study Start: November 1, 2010
• Primary Completion: March 1, 2011
• Study Completion: March 1, 2011
• Last Updated: July 9, 2013

Record last verified: 2013-07

Locations

NL (1)