NCT02649608

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

Interventional, Open-label, Exploratory Study Investigating the Safety, Tolerability, Pharmacokinetics, and Efficacy of Lu AE04621 and the Active Metabolite Lu AA40326 After Ascending Oral Doses of Lu AE04621 to Patients With Parkinson's Disease

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 15 (actual)
• Sponsor: H. Lundbeck A/S · Industry
• Sex: All
• Age: 45 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Detailed description

The study comprised 5 cohorts (Cohorts 1 to 5), with each cohort consisting of 3 patients with Parkinson's disease (men and/or women). Each patient will be treated for 3 or 4 days, with increasing dose each day. Dosing regimen will be decided at a dosing conferences. Dose levels can be increased, maintained or reduced both between cohorts but also within same cohort. The results are presented by dose level and reflect the actual doses administered. A follow-up safety visit was scheduled approximately 7 days after the last dose of IMP.

Conditions

• Parkinson Disease

Interventions

Type	Name	Description
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

Timeline

• Start date: 2016-01-01
• Primary completion: 2016-12-01
• Completion: 2016-12-01
• First posted: 2016-01-07
• Last updated: 2021-02-24
• Results posted: 2019-12-02

Locations

4 sites across 1 country: United States