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An Exploratory Study Investigating Safety, Tolerability and Pharmacokinetics of Ascending Doses of Lu AE04621 in Parkinson Disease Patients

NCT02649608 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 15

Last updated 2021-02-24

Study results available
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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.

Conditions

  • Parkinson Disease

Interventions

DRUG

0.04 mg Lu AE04621

0.04 mg dose group

DRUG

0.08 mg Lu AE04621

0.08mg dose group

DRUG

0.2 mg Lu AE04621

0.2 mg dose group

DRUG

0.4 mg Lu AE04621

0.4 mg dose group

DRUG

0.6 mg Lu AE04621

0.6 mg dose group

DRUG

0.8 mg Lu AE04621

0.8 mg dose group

DRUG

1.0 mg Lu AE04621

1.0 mg dose group

DRUG

1.2 mg Lu AE04621

1.2 mg dose group

Sponsors & Collaborators

  • H. Lundbeck A/S

    lead INDUSTRY

Principal Investigators

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
45 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-01-31
Primary Completion
2016-12-31
Completion
2016-12-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02649608 on ClinicalTrials.gov