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

Lundbeck

Status and phase: Completed; Phase 1

Conditions: Parkinson Disease

Treatments: Drug: 1.2 mg Lu AE04621; Drug: 0.8 mg Lu AE04621; Drug: 0.4 mg Lu AE04621; Drug: 0.2 mg Lu AE04621; Drug: 0.6 mg Lu AE04621; Drug: 0.08 mg Lu AE04621; Drug: 0.04 mg Lu AE04621; Drug: 1.0 mg Lu AE04621

Study type: Interventional

Funder types: Industry

Identifiers

NCT02649608

16779A

Details and patient eligibility

About

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.

Full 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.

Enrollment: 15 patients

Sex: All

Ages: 45 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• The patient is diagnosed with idiopathic Parkinson Disease (consistent with the UK Parkinson's Disease Society Brain Bank Criteria for the Diagnosis of PD).
• The patient's Hoehn and Yahr Staging score is ≤ 3 in the "ON" state.
• The patient experiences motor fluctuations with at least 2.5 hours of "OFF" periods in the awake time and has predictable morning "OFF" episodes, which have been consistent within the past 4 weeks.
• The patient currently has a good response to L-DOPA and has been receiving a stable dose of L-DOPA (≥3 doses per day of standard L-DOPA or ≥3 doses per day of Carbidopa and L-DOPA, Extended-Release Capsules) during at least four weeks prior to screening.

Exclusion criteria

• The patient has cognitive impairment, defined as a Mini Mental State Examination(MMSE) score ≤ 26 at the Screening Visit.
• The patient has severe disabling dyskinesia
• The patient takes or has taken disallowed recent or concomitant medication (CYP2D6 inhibitors, CYP 3A4 substrate, Dopamine agonists, 5 HT3 antagonists, Anti-viral (Amantadine))

Other protocol defined inclusion and exclusion criteria may apply

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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15 participants in 8 patient groups

0.04 mg Lu AE04621

Experimental group

Description:

Patients having received a dose of 0.04 mg, independent of which Cohort they belong to.

Treatment:

Drug: 0.04 mg Lu AE04621

0.08 mg Lu AE04621

Experimental group

Description:

Patients having received a dose of 0.08 mg, independent of which Cohort they belong to.

Treatment:

Drug: 0.08 mg Lu AE04621

0.2 mg Lu AE04621

Experimental group

Description:

Patients having received a dose of 0.2 mg, independent of which Cohort they belong to.

Treatment:

Drug: 0.2 mg Lu AE04621

0.4 mg Lu AE04621

Experimental group

Description:

Patients having received a dose of 1.2 mg, independent of which Cohort they belong to.

Treatment:

Drug: 0.4 mg Lu AE04621

0.6 mg Lu AE04621

Experimental group

Description:

Patients having received a dose of 0.6 mg, independent of which Cohort they belong to.

Treatment:

Drug: 0.6 mg Lu AE04621

0.8 mg Lu AE04621

Experimental group

Description:

Patients having received a dose of 0.8 mg, independent of which Cohort they belong to.

Treatment:

Drug: 0.8 mg Lu AE04621

1.0 mg Lu AE04621

Experimental group

Description:

Patients having received a dose of 1.0 mg, independent of which Cohort they belong to.

Treatment:

Drug: 1.0 mg Lu AE04621

1.2 mg Lu AE04621

Experimental group

Description:

Patients having received a dose of 1.2 mg, independent of which Cohort they belong to.

Treatment:

Drug: 1.2 mg Lu AE04621