A Dose-Ranging Study of JNJ-40411813 in Healthy Male Volunteers
|ClinicalTrials.gov Identifier: NCT01358006|
Recruitment Status : Completed
First Posted : May 23, 2011
Last Update Posted : July 9, 2013
|Condition or disease||Intervention/treatment||Phase|
|Healthy||Drug: JNJ-40411813||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||13 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
|Study Start Date :||November 2010|
|Actual Primary Completion Date :||March 2011|
|Actual Study Completion Date :||March 2011|
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.
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.
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.
- 5-HT2A binding determined by Positron Emission Tomography (PET) scans [ Time Frame: Up to 24 hours after study drug administration ]
- Plasma concentration of JNJ-40411813 [ Time Frame: Up to 2 days ]
- Adverse Events Reported [ Time Frame: Up to 10 days after study drug administration ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01358006
|Study Director:||Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial||Johnson & Johnson Pharmaceutical Research & Development, L.L.C.|