Staccato Apomorphine Single and Multi Dose PK

Parkinson Disease Clinical Trial

Official title:

A Randomized Study of the Safety, Tolerability, and Pharmacokinetics of AZ-009 (Staccato Apomorphine) in Healthy Volunteers and the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of AZ-009 in Subjects With Parkinson's Disease

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03822364
• Other study ID #: AMDC-009-101
• Status: Completed
• Phase: Phase 1
• Start date: November 26, 2018
• Est. completion date: March 26, 2019

Study information

• Verified date: December 2018
• Source: Alexza Pharmaceuticals, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study will be conducted in 3 parts. A) compare the pharmacokinetics (PK) of a single dose of AZ-009 with that of a therapeutically-relevant dose of a commercially available apomorphine injector in healthy volunteers; B) ascending doses of active drug in healthy volunteers; and C) examine the tolerability, safety, and PK of AZ-009 in subjects with established Parkinson's disease.

Description:

This study will be conducted in 3 parts. Parts A and B will be conducted in healthy volunteers and Part C will be conducted in subjects with established Parkinson's disease. The primary objectives for each part are as follows.

Part A: To compare the pharmacokinetics of a single low dose of AZ-009 with that of a therapeutically-relevant dose a commercially available apomorphine injector in healthy volunteers.

Part B: To examine the tolerability and safety of AZ-009 of single ascending doses of active drug in healthy volunteers while; and to characterize the pharmacokinetics of single ascending doses of AZ-009 in healthy volunteers

Part C: To examine the tolerability, safety, and pharmacokinetics of AZ-009 in subjects with established Parkinson's disease and to identify optimal doses to bring into multiple ascending dose safety and efficacy studies; and to assess the usability of AZ-009 in subjects with Parkinson's Disease

Recruitment information / eligibility

• Status: Completed
• Enrollment: 56
• Est. completion date: March 26, 2019
• Est. primary completion date: March 26, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

Inclusion Criteria:

• Healthy adult males and females between 18 and 60 years of age, inclusive at the time of signing the informed consent document.

• 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 surgical procedure; or history of such conditions that, in the opinion of the investigator, may place the subject at an unacceptable risk as a participant in this trial.

• Use of non-prescription medications within 5 days prior to the first dose of study drug.

• Use of medication that is inhibitor or inducer of CYP450-3A4/5 within 3 days of dosing.

• Consumption of grapefruit, grapefruit juice, star fruit, oranges, orange juice, Seville oranges, within 3 days prior to administration of study drug.

Related Conditions & MeSH terms

• Parkinson Disease

Intervention

Drug:
• 009-1
Inhaled apomorphine via Staccato aerosol, Dose 1
• active comparator
commercially available apomorphine injector
• 009-0
Inhaled placebo via Staccato device
• 009-2
Inhaled apomorphine via Staccato aerosol, Dose 2
• 009-3
Inhaled apomorphine via Staccato aerosol, Dose 3
• 009-4
Inhaled apomorphine via Staccato aerosol, Dose 4
• 009-5
Inhaled apomorphine via Staccato aerosol, Dose 5

Locations

Country	Name	City	State
Netherlands	Center for Human Drug Research	Leiden

Sponsors (1)

Lead Sponsor	Collaborator
Alexza Pharmaceuticals, Inc.

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	A-Relative bioavailability of inhaled Staccato apomorphine dose compared to the subcutaneous administration	Relative bioavailability of inhaled Staccato apomorphine compared to active comparator injection based on the Geometric Least Squares Mean Ratio of AUCinf for all subjects completing the crossover part of the trial	24 hours
Primary	B-Dose Proportionality by Power Analysis of AUCinf	Dose proportionality of inhaled Staccato apomorphine AUCinf across all doses administered in the single ascending dose portions of the study (Parts B and C) using a power model [regression of log(AUCinf) versus log(dose)]	24 hours