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NCT02333487 · ClinicalTrials.gov registry record · Phase 1
Positron Emission Tomography (PET) Study Investigating Dopamine and Serotonin Receptor Occupancy After Multiple Oral Dosing of Lu AF35700
A Phase 1 study, sponsored by H. Lundbeck A/S.
- Completed
- Registry status
- Phase 1
- Development phase
- 22
- Enrollment target
NCT02333487: Completed Phase 1 study, sponsored by H. Lundbeck A/S.
NCT02333487 is a Phase 1 study that has completed, run by H. Lundbeck A/S. The registered enrollment target is 22 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (63% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02333487, a Phase 1 study, has completed, sponsored by H. Lundbeck A/S.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 22 participants
- Enrollment target
Study Summary
The purpose of this PET study is to verify the binding of Lu AF35700 after multiple oral dosing at the dopamine and the serotonin receptors in male patients with schizophrenia.
Primary Outcome
Maximal target occupancy (Emax) on the D1 dopamine receptor using PET with \[11C\]-NNC 112 tracer compound. The relationship between systemic exposure of Lu AF35700 and D1 dopamine occupancy was investigated using an Emax model containing the regression parameters maximal target occupancy (Emax) and plasma concentration which gives 50% of Emax (EC50). Both Emax and EC50 were estimated using one model for all post-baseline scans combined. No statistical testing was performed.
Interventions
- DRUG Lu AF35700
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 22 participants |
| Start Date | 2014-12-30 |
| Est. Completion | 2016-02-11 |
| Phase | Phase 1 |
What the finished NCT02333487 record still lists
NCT02333487 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 22 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (63% lower).
The record links to 0 conditions, and to 1 intervention - of which Lu AF35700 is the first listed.
NCT02333487 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02333487 about?
NCT02333487 is a clinical study titled "Positron Emission Tomography (PET) Study Investigating Dopamine and Serotonin Receptor Occupancy After Multiple Oral Dosing of Lu AF35700". The purpose of this PET study is to verify the binding of Lu AF35700 after multiple oral dosing at the dopamine and the serotonin receptors in male patients with schizophrenia.
What is the current status of trial NCT02333487?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 22 participants. The study started on 2014-12-30. Estimated completion is 2016-02-11.
What interventions are being tested in trial NCT02333487?
The interventions under investigation include: Lu AF35700 (DRUG).
Who is sponsoring clinical trial NCT02333487?
This trial is sponsored by H. Lundbeck A/S, which has 72 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02333487's enrollment target sits among peer trials
22 1601st of 2000 higher than 386 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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