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Lu AF28996 in Participants With Parkinson's Disease (PD)

Primary Purpose

Parkinson Disease

Status

Recruiting

Phase

Phase 1

Locations

International

Study Type

Interventional

Intervention

Lu AF28996

About this trial

This is an interventional treatment trial for Parkinson Disease

Eligibility Criteria

45 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Men or women diagnosed with idiopathic PD (consistent with the UK PD Society Brain Bank Criteria for the Diagnosis of PD), Modified Hoehn and Yahr Score ≤4 in the 'OFF' state and ≤3 in 'ON' state and a Mini Mental State Examination Score >25.
Participants must currently have a good response to levodopa, and have been receiving a stable dose of levodopa (≥3 doses per day of levodopa/dopa decarboxylase inhibitor therapy or ≥3 doses per day of levodopa Extended-Release Capsules) ≥4 weeks prior to screening.
Participants must experience recognizable and predictable motor fluctuations (with at least 1.5 hours of OFF-periods in the awake time, including predictable morning OFF episodes) causing clinically significant disability during the 7-week screening period. This will be documented using a participant ON/OFF state registration over 3 consecutive days prior to enrolment.

Exclusion Criteria:

The participant has or had one or more of the following conditions that are considered clinically relevant in the context of the study; other neurological disorder, psychiatric disorder, seizure disorder or encephalopathy, respiratory disease, hepatic impairment or renal insufficiency, metabolic disorder, endocrinological disorder, haematological disorder, infectious disorder, any clinically significant immunological condition, or a history of narrow-angle glaucoma.

Other inclusion and exclusion criteria may apply.

Sites / Locations

VelocityRecruiting
Atlanta Center for Medical ResearchRecruiting
QUEST Research InstituteRecruiting
QPS Netherlands BV

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Lu AF28996

Arm Description

Participants will receive ascending oral doses of Lu AF28996 OD for 14 days (Day 1 to Day 14) in all OD Cohorts 1-4 (5). On Day 15, the participant will initiate down-titration of Lu AF28996 as per Investigator's judgement. For the BID Cohort A1, participants will receive Lu AF28996 BID for 24 days (Day 1 to Day 24), followed by down-titration as per Investigator's judgement. For the BID Cohort A2, participants will receive Lu AF28996 BID for 39 days (Day 1 to Day 39), followed by down-titration as per Investigator's judgement.

Outcomes

Primary Outcome Measures

Number of Participants with Treatment-emergent Adverse Events

Safety and tolerability based on the safety assessments (clinical safety laboratory tests, vital signs, weight, ECG parameters and physical examination)

AUC(last) of Lu AF28996

Area under the plasma concentration time curve from zero to last quantifiable plasma concentration

AUC(0-24h) of Lu AF28996

Area under the plasma concentration time curve from zero to 24 hours post dose

Cmax of Lu AF28996

Maximum observed plasma concentration of Lu AF28996

CL/F of Lu AF28996

Oral clearance for Lu AF28996 in plasma

Amount of Lu AF28996, Lu AF28995, Lu AF29308, and Lu AF29309 Excreted in Urine

Secondary Outcome Measures

Full Information

NCT ID

NCT04291859

First Posted

February 28, 2020

Last Updated

August 7, 2023

Sponsor

H. Lundbeck A/S

1. Study Identification

Unique Protocol Identification Number

NCT04291859

Brief Title

Lu AF28996 in Participants With Parkinson's Disease (PD)

Official Title

Interventional, Open-label, Exploratory Study, Investigating the Safety, Tolerability, Pharmacokinetics, and Efficacy of Lu AF28996 in Patients With Parkinson's Disease

Study Type

Interventional

2. Study Status

Record Verification Date

August 2023

Overall Recruitment Status

Recruiting

Study Start Date

February 26, 2020 (Actual)

Primary Completion Date

October 8, 2023 (Anticipated)

Study Completion Date

October 18, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

H. Lundbeck A/S

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

5. Study Description

Brief Summary

The purpose of this study is to investigate the safety of Lu AF28996, how well it is tolerated and what the body does to the drug in participants with Parkinson's disease.

Detailed Description

The study will consist of once daily (OD) cohorts (OD Cohort 1 to 4[5]) as well as twice daily (BID) cohorts (BID Cohorts A1 and A2). The study has been re-designed following the inclusion of 2 participants. The study will consist of 4 cohorts (men or women). OD Cohort 1 and OD Cohort 2 are complete and included 2 participants in OD Cohort 1 and 3 participants in OD Cohort 2. New participants will start with Cohort 3. OD Cohorts 3 and 4 will each consist of 4 participants with the possibility of adding 1 more cohort including 4 participants (OD Cohort 5). In BID Cohort A1, 8 participants are planned for enrolment, and in BID Cohort A2, 12 participants are planned for enrolment.

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

Sequential Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

29 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Lu AF28996

Arm Type

Experimental

Arm Description

Intervention Type

Drug

Intervention Name(s)

Lu AF28996

Intervention Description

capsule, orally, doses and dose escalation scheme will be decided upon at dosing conferences

Primary Outcome Measure Information:

Title

Number of Participants with Treatment-emergent Adverse Events

Description

Safety and tolerability based on the safety assessments (clinical safety laboratory tests, vital signs, weight, ECG parameters and physical examination)

Time Frame

From Baseline to Day 62

Title

AUC(last) of Lu AF28996

Description

Area under the plasma concentration time curve from zero to last quantifiable plasma concentration

Time Frame

0 (predose) to 24 hours postdose on Day 1 to Day 39

Title

AUC(0-24h) of Lu AF28996

Description

Area under the plasma concentration time curve from zero to 24 hours post dose

Time Frame

0 (predose) to 24 hours postdose on Day 1 to Day 39

Title

Cmax of Lu AF28996

Description

Maximum observed plasma concentration of Lu AF28996

Time Frame

0 (predose) to 24 hours postdose on Day 1 to Day 39

Title

CL/F of Lu AF28996

Description

Oral clearance for Lu AF28996 in plasma

Time Frame

0 (predose) to 24 hours postdose on Day 1 to Day 39

Title

Amount of Lu AF28996, Lu AF28995, Lu AF29308, and Lu AF29309 Excreted in Urine

Time Frame

0 (predose) to 24 hours postdose on Day 1 to Day 62

10. Eligibility

Sex

All

Minimum Age & Unit of Time

45 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Men or women diagnosed with idiopathic PD (consistent with the UK PD Society Brain Bank Criteria for the Diagnosis of PD), Modified Hoehn and Yahr Score ≤4 in the 'OFF' state and ≤3 in 'ON' state and a Mini Mental State Examination Score >25. Participants must currently have a good response to levodopa, and have been receiving a stable dose of levodopa (≥3 doses per day of levodopa/dopa decarboxylase inhibitor therapy or ≥3 doses per day of levodopa Extended-Release Capsules) ≥4 weeks prior to screening. Participants must experience recognizable and predictable motor fluctuations (with at least 1.5 hours of OFF-periods in the awake time, including predictable morning OFF episodes) causing clinically significant disability during the 7-week screening period. This will be documented using a participant ON/OFF state registration over 3 consecutive days prior to enrolment. Exclusion Criteria: The participant has or had one or more of the following conditions that are considered clinically relevant in the context of the study; other neurological disorder, psychiatric disorder, seizure disorder or encephalopathy, respiratory disease, hepatic impairment or renal insufficiency, metabolic disorder, endocrinological disorder, haematological disorder, infectious disorder, any clinically significant immunological condition, or a history of narrow-angle glaucoma. Other inclusion and exclusion criteria may apply.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Email contact via H. Lundbeck A/S

Phone

+45 36301311

LundbeckClinicalTrials@Lundbeck.com

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

Velocity

City

Hallandale Beach

State/Province

Florida

ZIP/Postal Code

33009

Country

United States

Individual Site Status

Recruiting

Facility Name

Atlanta Center for Medical Research

City

Atlanta

State/Province

Georgia

ZIP/Postal Code

30331

Country

United States

Individual Site Status

Recruiting

Facility Name

QUEST Research Institute

City

Farmington Hills

State/Province

Michigan

ZIP/Postal Code

48334

Country

United States

Individual Site Status

Recruiting

Facility Name

QPS Netherlands BV

City

Leeuwarden

ZIP/Postal Code

8934 AD

Country

Netherlands

Individual Site Status

Completed

12. IPD Sharing Statement

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Lu AF28996 in Participants With Parkinson's Disease (PD)

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