Staccato Apomorphine Multi-dose PK and PD in Patients With Parkinson's Disease

Alexza Pharmaceuticals

Status and phase: Completed; Phase 1

Conditions: Parkinson's Disease

Treatments: Drug: 009-A1; Drug: 009-B2 (placebo --> active) crossover; Drug: 009-B1 (active --> placebo) crossover; Drug: 009-A3; Drug: 009-A0; Drug: 009-A2

Study type: Interventional

Funder types: Industry

Identifiers

NCT04157933

AMDC-009-102

Details and patient eligibility

About

This study will be conducted in subjects with established Parkinson's disease in 2 parts. Part A will examine the tolerability, safety, and pharmacokinetics of AZ-009 dose escalation ; and Part B will assess the tolerability, safety, pharmacokinetics, and pharmacodynamics of AZ-009 compared with placebo in a crossover design

Full description

This study will be conducted in subjects with established Parkinson's disease in 2 parts.

Part A will examine the tolerability, safety, and pharmacokinetics of daily doses of AZ-009 for 5 days followed by 3 doses on each of days 6 and 7 in dose escalation through 3 cohorts

Part B will assess the tolerability, safety, pharmacokinetics, and pharmacodynamics of AZ-009 compared with placebo in subjects with established Parkinson's disease experiencing regular OFF episodes

Enrollment: 35 patients

Sex: All

Ages: 30 to 85 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Healthy adult males and females between 30 and 85 years of age, inclusive at the time of signing the informed consent document with a clinical diagnosis of Parkinson's Disease
• Body weight ≥ 50 kg and BMI within the range of 18 to 32 kg/m2.
• Willing and able to be confined at the clinical research center for the study period and adhere to overall study visit schedule, procedures and other protocol requirements.
• Understand and voluntarily sign an informed consent document prior to any study related assessments/procedures being conducted.

Exclusion criteria

• Any significant medical condition, psychiatric illness or history of depression that could, in the investigator's opinion, compromise the subject's safety or interfere with the completion of this protocol.
• History of clinically significant central nervous system, cardiac, pulmonary, metabolic, renal, hepatic, or gastrointestinal conditions including gastric bypass or other weight loss

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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35 participants in 6 patient groups, including a placebo group

A-1a

Experimental group

Description:

Part A, Arm 1 (active), Dose 1 (009-A1)

Treatment:

Drug: 009-A1

A-2a

Experimental group

Description:

Part A, Arm 2 (active), Dose 2 (009-A2)

Treatment:

Drug: 009-A2

A-3a

Experimental group

Description:

Part A, Arm 3 (active), Dose 3 (009-A3)

Treatment:

Drug: 009-A3

A-0p

Placebo Comparator group

Description:

Part A, placebo comparator in all 3 arms, placebo dose (009-A0)

Treatment:

Drug: 009-A0

B-1 (009-B3 -> 009-B0)

Experimental group

Description:

Crossover (active to placebo)

Treatment:

Drug: 009-B1 (active --> placebo) crossover

B-1 (009-B0 -> 009-B3)

Experimental group

Description:

Crossover (placebo to active)

Treatment:

Drug: 009-B2 (placebo --> active) crossover