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NCT02649608 · ClinicalTrials.gov registry record · Phase 1
An Exploratory Study Investigating Safety, Tolerability and Pharmacokinetics of Ascending Doses of Lu AE04621 in Parkinson Disease Patients
A Phase 1 study, sponsored by H. Lundbeck A/S.
- Completed
- Registry status
- Phase 1
- Development phase
- 15
- Enrollment target
NCT02649608: Completed Phase 1 study, sponsored by H. Lundbeck A/S.
NCT02649608 is a Phase 1 study that has completed, run by H. Lundbeck A/S. The registered enrollment target is 15 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (75% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02649608, a Phase 1 study, has completed, sponsored by H. Lundbeck A/S.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 15 participants
- Enrollment target
Study Summary
To evaluate the safety, tolerability, pharmacokinetics, and efficacy of the Lu AE04621 and metabolite after ascending oral doses of Lu AE04621 in patients with Parkinson's Disease.
Primary Outcome
Number of patients with an adverse event
Interventions
- DRUG 0.04 mg Lu AE04621
- DRUG 0.08 mg Lu AE04621
- DRUG 0.2 mg Lu AE04621
- DRUG 0.4 mg Lu AE04621
- DRUG 0.6 mg Lu AE04621
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 15 participants |
| Start Date | 2016-01 |
| Est. Completion | 2016-12 |
| Phase | Phase 1 |
What the finished NCT02649608 record still lists
NCT02649608 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 15 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (75% lower).
The record links to 0 conditions, and to 5 interventions - of which 0.04 mg Lu AE04621 is the first listed.
NCT02649608 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02649608 about?
NCT02649608 is a clinical study titled "An Exploratory Study Investigating Safety, Tolerability and Pharmacokinetics of Ascending Doses of Lu AE04621 in Parkinson Disease Patients". To evaluate the safety, tolerability, pharmacokinetics, and efficacy of the Lu AE04621 and metabolite after ascending oral doses of Lu AE04621 in patients with Parkinson's Disease.
What is the current status of trial NCT02649608?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 15 participants. The study started on 2016-01. Estimated completion is 2016-12.
What interventions are being tested in trial NCT02649608?
The interventions under investigation include: 0.04 mg Lu AE04621 (DRUG), 0.08 mg Lu AE04621 (DRUG), 0.2 mg Lu AE04621 (DRUG), 0.4 mg Lu AE04621 (DRUG), 0.6 mg Lu AE04621 (DRUG).
Who is sponsoring clinical trial NCT02649608?
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 NCT02649608's enrollment target sits among peer trials
15 1798th of 2000 higher than 157 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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