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

• Register: ClinicalTrials.gov
• Last refreshed on: 8 March 2021
• Main ID: NCT02649608
• Date of registration: 06/01/2016
• Prospective Registration: No
• Primary sponsor: H. Lundbeck A/S
• Public title: An Exploratory Study Investigating Safety, Tolerability and Pharmacokinetics of Ascending Doses of Lu AE04621 in Parkinson Disease Patients
• Scientific title: 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
• Date of first enrolment: January 2016
• Target sample size: 15
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02649608
• Study type: Interventional
• Study design: Allocation: Non-Randomized. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 1

Countries of recruitment

United States

Contacts

• Name: Email contact via H. Lundbeck A/S
• Affiliation: [e-mail]

Key inclusion & exclusion criteria

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



Age minimum: 45 Years
Age maximum: 75 Years
Gender: All

Health Condition(s) or Problem(s) studied

Parkinson Disease

Intervention(s)

Drug: 0.2 mg Lu AE04621

Drug: 0.4 mg Lu AE04621

Drug: 0.6 mg Lu AE04621

Drug: 0.08 mg Lu AE04621

Drug: 0.04 mg Lu AE04621

Drug: 1.2 mg Lu AE04621

Drug: 0.8 mg Lu AE04621

Drug: 1.0 mg Lu AE04621

Primary Outcome(s)

Area Under the Plasma Concentration-time Curve (AUC(0-24 Hours)) for Lu AE04621 [Time Frame: From dosing to up to 24 hours after dosing]

Time to Onset of "ON" Time After Lu AE04621 Administration [Time Frame: From dosing to 90 minutes after dosing]

Duration of "ON" Time [Time Frame: From dosing up to 24h post-dose]

Apparent Elimination Half-life of Lu AE04621 in Plasma (t½) [Time Frame: From dosing to up to 24 hours after dosing]

Maximum Observed Concentration (Cmax) for Lu AE04621 [Time Frame: From dosing to up to 24 hours after dosing]

Safety and Tolerability Based on the Safety Variables (Adverse Events, Clinical Safety Laboratory Tests, Vital Signs, Weight, and ECG) [Time Frame: Baseline to day 11]

Secondary ID(s)

16779A

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 02/12/2019
• URL: https://clinicaltrials.gov/ct2/show/results/NCT02649608