---
title: A Dose-Ranging Study of JNJ-40411813 in Healthy Male Volunteers
nct_id: NCT01358006
overall_status: COMPLETED
phase: PHASE1
sponsor: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
study_type: INTERVENTIONAL
primary_condition: Healthy
countries: Netherlands
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT01358006.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT01358006"
ct_last_update_post_date: 2013-07-09
last_seen_at: "2026-05-12T07:28:29.385Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# A Dose-Ranging Study of JNJ-40411813 in Healthy Male Volunteers

**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

**NCT ID:** [NCT01358006](https://clinicaltrials.gov/study/NCT01358006)

## Key Facts

- **Status:** COMPLETED
- **Phase:** PHASE1
- **Study Type:** INTERVENTIONAL
- **Target Enrollment:** 13
- **Lead Sponsor:** Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
- **Conditions:** Healthy
- **Start Date:** 2010-11
- **Completion Date:** 2011-03
- **CT.gov Last Update:** 2013-07-09

## 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.

## Detailed 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.

## Eligibility

- **Minimum age:** 18 Years
- **Maximum age:** 45 Years
- **Sex:** MALE
- **Healthy Volunteers:** Yes

```
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
```

## Arms

- **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.

## 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.
- **JNJ-40411813** (DRUG) — 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.

## Primary Outcomes

- **5-HT2A binding determined by Positron Emission Tomography (PET) scans** _(time frame: Up to 24 hours after study drug administration)_

## Secondary Outcomes

- **Plasma concentration of JNJ-40411813** _(time frame: Up to 2 days)_
- **Adverse Events Reported** _(time frame: Up to 10 days after study drug administration)_

## Locations (1)

- Groningen, Netherlands

## Recent Field Changes (last 30 days)

- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.phases` — added _(2026-05-12)_
- `status.overallStatus` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.minAge` — added _(2026-05-12)_
- `eligibility.maxAge` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `outcomes.secondary` — added _(2026-05-12)_
- `armsInterventions.arms` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_
- `locations.|groningen||netherlands` — added _(2026-05-12)_

---

*Canonical: https://parkinsonspathways.com/agent/trials/NCT01358006.md*  
*Source data (authoritative): https://clinicaltrials.gov/study/NCT01358006*  
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