Phase 1
Completed N=15
An Exploratory Study Investigating Safety, Tolerability and Pharmacokinetics of Ascending Doses of Lu AE04621 in Parkinson Disease Patients
Source: ClinicalTrials.gov NCT02649608 ↗Enrolled (actual)
15
Serious AEs
0.0%
Results posted
Dec 2019
Primary outcomePrimary: Safety and Tolerability Based on the Safety Variables (Adverse Events, Clinical Safety Laboratory Tests, Vital Signs, Weight, and ECG) — 0; 0; 2; 7 Participants
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Safety and Tolerability Based on the Safety Variables (Adverse Events, Clinical Safety Laboratory Tests, Vital Signs, Weight, and ECG) |
0; 0; 2; 7; 3; 3 | — |
| PRIMARY Area Under the Plasma Concentration-time Curve (AUC(0-24 Hours)) for Lu AE04621 |
212; 292; 309 | — |
| PRIMARY Maximum Observed Concentration (Cmax) for Lu AE04621 |
3.52; 6.31; 48.6; 60.4; 52.8; 29.8 | — |
| PRIMARY Apparent Elimination Half-life of Lu AE04621 in Plasma (t½) |
3.24; 5.00; 4.11 | — |
| PRIMARY Time to Onset of "ON" Time After Lu AE04621 Administration |
35; 41; 39; 17; 20 | — |
| PRIMARY Duration of "ON" Time |
203; 249; 270; 87; 401 | — |
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT02649608). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.