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

Healthy Clinical Trial

Official title:

An Open Label Dose-Ranging Study in Healthy Male Subjects to Investigate the Binding Potential of JNJ-40411813 to Serotonin 2A Receptors in the Central Nervous System

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01358006
• Other study ID #: CR017485
• Secondary ID: 40411813EDI10082
• Status: Completed
• Phase: Phase 1
• First received: May 19, 2011
• Last updated: July 8, 2013
• Start date: November 2010
• Est. completion date: March 2011

Study information

• Verified date: July 2013
• Source: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Description:

This will be an open-label (volunteers and study staff will know the identity of assigned treatment), dose-ranging study to determine 5-HT2A receptor engagement by JNJ-40411813 as a function of dose and time in healthy male volunteers. The study will consist of an eligibility screening examination, an open-label treatment period and a follow-up examination (approximately 10 days after dose administration, a follow-up examination will be performed). Initially, 4 volunteers (Cohort 1) will be included to determine 5-HT2A receptor occupancy following single dose administration of JNJ-40411813. Dependent on the results, doses for the remaining 8 volunteers (Cohort 2 and 3) will be selected to further characterize 5-HT2A receptor occupancy within the feasible dose range up to maximally 700 mg JNJ-40411813.The maximal study duration for a volunteer will be 6 weeks. In this study, [11C]-MDL 100,907 will be used as positron emission tomography (PET) ligand to investigate the concentration-related binding of 40411813 to the 5-HT2A receptor in the brain. JNJ-40411813 (200 mg to 700 mg) will be taken orally (by mouth). If multiple capsules have to be taken, the actual intake may be spread over a 15-minute period. Study drug will be administered to each volunteer just after completion of a meal and within 30 minutes after the start of the meal.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 13
• Est. completion date: March 2011
• Est. primary completion date: March 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 45 Years

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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)

• Presence of other exclusion criteria as specified in the protocol

Study Design

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Healthy

Intervention

Drug:
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	5-HT2A binding determined by Positron Emission Tomography (PET) scans		Up to 24 hours after study drug administration	No
Secondary	Plasma concentration of JNJ-40411813		Up to 2 days	No
Secondary	Adverse Events Reported		Up to 10 days after study drug administration	No