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OpenTrials
Completed

NCT Number: NCT03822364

Staccato Apomorphine Single and Multi Dose PK

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.

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Key information

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Center for Human Drug Research

Leiden, 2333 CL, Netherlands

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

009-1

Drug

Inhaled apomorphine via Staccato aerosol, Dose 1

Active Comparator

Drug

commercially available apomorphine injector

009-0

Drug

Inhaled placebo via Staccato device

009-2

Drug

Inhaled apomorphine via Staccato aerosol, Dose 2

009-3

Drug

Inhaled apomorphine via Staccato aerosol, Dose 3

009-4

Drug

Inhaled apomorphine via Staccato aerosol, Dose 4

009-5

Drug

Inhaled apomorphine via Staccato aerosol, Dose 5

Primary outcomes

  1. A-Relative bioavailability of inhaled Staccato apomorphine dose compared to the subcutaneous administration

    Time frame: 24 hours

    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

  2. B-Dose Proportionality by Power Analysis of AUCinf

    Time frame: 24 hours

    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)]

Sponsors and collaborators

Lead sponsor

Alexza Pharmaceuticals, Inc.

Unknown

Registry information

Official study 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

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Jan 30, 2019
Registry last updated
Aug 30, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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