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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.

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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

FieldValue
Enrollment Target 15 participants
Start Date 2016-01
Est. Completion 2016-12
Phase Phase 1
H. Lundbeck A/S

72 total trials

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.

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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Source: ClinicalTrials.gov NCT02649608, the US trial registry maintained by the National Library of Medicine. NCT02649608 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.