Back to resultsAn Exploratory Study Investigating Safety, Tolerability and Pharmacokinetics of Ascending Doses of Lu AE04621 in Parkinson Disease Patients
Primary Purpose
Parkinson Disease
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
0.04 mg Lu AE04621
0.08 mg Lu AE04621
0.2 mg Lu AE04621
0.4 mg Lu AE04621
0.6 mg Lu AE04621
0.8 mg Lu AE04621
1.0 mg Lu AE04621
1.2 mg Lu AE04621
Sponsored by
About this trial
This is an interventional treatment trial for Parkinson Disease
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
Sites / Locations
- US1251
- US1126
- US1352
- US1084
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm 6
Arm 7
Arm 8
Arm Type
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
Arm Label
0.04 mg Lu AE04621
0.08 mg Lu AE04621
0.2 mg Lu AE04621
0.4 mg Lu AE04621
0.6 mg Lu AE04621
0.8 mg Lu AE04621
1.0 mg Lu AE04621
1.2 mg Lu AE04621
Arm Description
Patients having received a dose of 0.04 mg, independent of which Cohort they belong to.
Patients having received a dose of 0.08 mg, independent of which Cohort they belong to.
Patients having received a dose of 0.2 mg, independent of which Cohort they belong to.
Patients having received a dose of 1.2 mg, independent of which Cohort they belong to.
Patients having received a dose of 0.6 mg, independent of which Cohort they belong to.
Patients having received a dose of 0.8 mg, independent of which Cohort they belong to.
Patients having received a dose of 1.0 mg, independent of which Cohort they belong to.
Patients having received a dose of 1.2 mg, independent of which Cohort they belong to.
Outcomes
Primary Outcome Measures
Safety and Tolerability Based on the Safety Variables (Adverse Events, Clinical Safety Laboratory Tests, Vital Signs, Weight, and ECG)
Number of patients with an adverse event
Area Under the Plasma Concentration-time Curve (AUC(0-24 Hours)) for Lu AE04621
Maximum Observed Concentration (Cmax) for Lu AE04621
Apparent Elimination Half-life of Lu AE04621 in Plasma (t½)
Time to Onset of "ON" Time After Lu AE04621 Administration
"ON" state is defined as a period of good control of parkinsonian features with relatively good overall function and mobility. Motor fluctuation assessments are patient-reported outcomes, and guidance will be given to the patients on how to complete them. Date and time will be registered when the patient turns to "ON" and "OFF" state. "OFF" state is defined as a period of poor control of parkinsonian features with relatively poor overall function, such as worsening tremor, rigidity, balance or bradykinesia.
Data are no presented for the dose groups 0.04, 0.08, and 1.0 mg Lu AE04621 since no patients turned 'ON'.
Duration of "ON" Time
"ON" state is defined as a period of good control of parkinsonian features with relatively good overall function and mobility. Motor fluctuation assessments are patient-reported outcomes, and guidance will be given to the patients on how to complete them. Date and time will be registered when the patient turns to "ON" and "OFF" state. "OFF" state is defined as a period of poor control of parkinsonian features with relatively poor overall function, such as worsening tremor, rigidity, balance or bradykinesia. Outcome measured in minutes.
Data are no presented for the dose groups 0.04, 0.08, and 1.0 mg Lu AE04621 since no patients turned 'ON' following administration of Lu AE04621.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02649608
Brief Title
An Exploratory Study Investigating Safety, Tolerability and Pharmacokinetics of Ascending Doses of Lu AE04621 in Parkinson Disease Patients
Official 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
Study Type
Interventional
2. Study Status
Record Verification Date
November 2019
Overall Recruitment Status
Completed
Study Start Date
January 2016 (undefined)
Primary Completion Date
December 2016 (Actual)
Study Completion Date
December 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
H. Lundbeck A/S
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson Disease
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Model Description
The study comprised 5 cohorts (Cohorts 1 to 5), with each cohort consisting of 3 patients (men and/or women). The dosing regimen planned for Cohort 1 was a dose of 0.2 mg Lu AE04621 on Day 1 followed by a dose of 0.4 mg Lu AE04621 on Day 2, and a dose of 0.6 mg Lu AE04621 on Day 3. • The dosing regimen planned for Cohort 2 was 0.4 mg Lu AE04621 on Day 1 followed by a dose of 0.6 mg Lu AE04621 on Day 2, and a dose of 0.8 mg Lu AE04621 on Day 3. The dosing regimen planned for Cohort 3 was 0.2 mg Lu AE04621 on Day 1 followed by a dose of 0.4 mg Lu AE04621 on Day 2, a dose of 0.6 mg Lu AE04621 on Day 3, and a dose of 1.0 mg Lu AE04621 on Day 4. The dosing regimen planned for Cohorts 4 and 5 was 0.2 mg Lu AE04621 on Day 1 followed by a dose of 0.4 mg Lu AE04621 on Day 2, a dose of 0.6 mg Lu AE04621 on Day 3, and a dose of 1.2 mg Lu AE04621 on Day 4. The results are presented by dose groups and are based on the actual doses administered.
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
15 (Actual)
8. Arms, Groups, and Interventions
Arm Title
0.04 mg Lu AE04621
Arm Type
Experimental
Arm Description
Patients having received a dose of 0.04 mg, independent of which Cohort they belong to.
Arm Title
0.08 mg Lu AE04621
Arm Type
Experimental
Arm Description
Patients having received a dose of 0.08 mg, independent of which Cohort they belong to.
Arm Title
0.2 mg Lu AE04621
Arm Type
Experimental
Arm Description
Patients having received a dose of 0.2 mg, independent of which Cohort they belong to.
Arm Title
0.4 mg Lu AE04621
Arm Type
Experimental
Arm Description
Patients having received a dose of 1.2 mg, independent of which Cohort they belong to.
Arm Title
0.6 mg Lu AE04621
Arm Type
Experimental
Arm Description
Patients having received a dose of 0.6 mg, independent of which Cohort they belong to.
Arm Title
0.8 mg Lu AE04621
Arm Type
Experimental
Arm Description
Patients having received a dose of 0.8 mg, independent of which Cohort they belong to.
Arm Title
1.0 mg Lu AE04621
Arm Type
Experimental
Arm Description
Patients having received a dose of 1.0 mg, independent of which Cohort they belong to.
Arm Title
1.2 mg Lu AE04621
Arm Type
Experimental
Arm Description
Patients having received a dose of 1.2 mg, independent of which Cohort they belong to.
Intervention Type
Drug
Intervention Name(s)
0.04 mg Lu AE04621
Intervention Description
0.04 mg dose group
Intervention Type
Drug
Intervention Name(s)
0.08 mg Lu AE04621
Intervention Description
0.08mg dose group
Intervention Type
Drug
Intervention Name(s)
0.2 mg Lu AE04621
Intervention Description
0.2 mg dose group
Intervention Type
Drug
Intervention Name(s)
0.4 mg Lu AE04621
Intervention Description
0.4 mg dose group
Intervention Type
Drug
Intervention Name(s)
0.6 mg Lu AE04621
Intervention Description
0.6 mg dose group
Intervention Type
Drug
Intervention Name(s)
0.8 mg Lu AE04621
Intervention Description
0.8 mg dose group
Intervention Type
Drug
Intervention Name(s)
1.0 mg Lu AE04621
Intervention Description
1.0 mg dose group
Intervention Type
Drug
Intervention Name(s)
1.2 mg Lu AE04621
Intervention Description
1.2 mg dose group
Primary Outcome Measure Information:
Title
Safety and Tolerability Based on the Safety Variables (Adverse Events, Clinical Safety Laboratory Tests, Vital Signs, Weight, and ECG)
Description
Number of patients with an adverse event
Time Frame
Baseline to day 11
Title
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
Title
Maximum Observed Concentration (Cmax) for Lu AE04621
Time Frame
From dosing to up to 24 hours after dosing
Title
Apparent Elimination Half-life of Lu AE04621 in Plasma (t½)
Time Frame
From dosing to up to 24 hours after dosing
Title
Time to Onset of "ON" Time After Lu AE04621 Administration
Description
"ON" state is defined as a period of good control of parkinsonian features with relatively good overall function and mobility. Motor fluctuation assessments are patient-reported outcomes, and guidance will be given to the patients on how to complete them. Date and time will be registered when the patient turns to "ON" and "OFF" state. "OFF" state is defined as a period of poor control of parkinsonian features with relatively poor overall function, such as worsening tremor, rigidity, balance or bradykinesia.
Data are no presented for the dose groups 0.04, 0.08, and 1.0 mg Lu AE04621 since no patients turned 'ON'.
Time Frame
From dosing to 90 minutes after dosing
Title
Duration of "ON" Time
Description
"ON" state is defined as a period of good control of parkinsonian features with relatively good overall function and mobility. Motor fluctuation assessments are patient-reported outcomes, and guidance will be given to the patients on how to complete them. Date and time will be registered when the patient turns to "ON" and "OFF" state. "OFF" state is defined as a period of poor control of parkinsonian features with relatively poor overall function, such as worsening tremor, rigidity, balance or bradykinesia. Outcome measured in minutes.
Data are no presented for the dose groups 0.04, 0.08, and 1.0 mg Lu AE04621 since no patients turned 'ON' following administration of Lu AE04621.
Time Frame
From dosing up to 24h post-dose
10. Eligibility
Sex
All
Minimum Age & Unit of Time
45 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Email contact via H. Lundbeck A/S
Organizational Affiliation
LundbeckClinicalTrials@Lundbeck.com
Official's Role
Study Director
Facility Information:
Facility Name
US1251
City
Hallandale Beach
State/Province
Florida
Country
United States
Facility Name
US1126
City
Orlando
State/Province
Florida
Country
United States
Facility Name
US1352
City
Chicago
State/Province
Illinois
Country
United States
Facility Name
US1084
City
Detroit
State/Province
Michigan
Country
United States
12. IPD Sharing Statement
Learn more about this trial
An Exploratory Study Investigating Safety, Tolerability and Pharmacokinetics of Ascending Doses of Lu AE04621 in Parkinson Disease Patients
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