Study to Evaluate Single Inhaled Doses of PT001, PT003, PT005 and PT001 Plus PT005 in Healthy Subjects

March 16, 2017 updated by: Pearl Therapeutics, Inc.

A Randomized, Double-blind, Single Dose, Four-period, Four-treatment, Cross-over Study Evaluating the Safety of PT001, PT003, PT005 Administered Individually and PT001 + PT005 Delivered Together in Separate Inhalers in Healthy Subjects

The purpose of this study is to evaluate the safety of a single dose of PT003 compared with single doses of PT001 and PT005, and compared with PT001 plus PT005 delivered together as two separate single doses in healthy subjects.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
16

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
    • Queensland
      • Herston, Queensland, Australia, 4006
        • Dr Joanne Marjason

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 55 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Provide signed written informed consent
  • 18-55 years of age
  • Healthy subjects confirmed by medical history, physical examination, vital signs, pulmonary function tests, electrocardiogram and clinical laboratory tests
  • Female subjects of child-bearing potential who are sexually active must be willing to undergo a pregnancy test and agree to use two forms of contraception
  • Body mass index (BMI) between 18.5 and 30, inclusive
  • Non-smokers for at least 6 months prior to screening
  • Pulmonary function tests within normal limits
  • Willing to remain at the study center for at least 12-24 hours on each test day
  • Venous access in both arms to allow collection of numerous blood samples

Exclusion Criteria:

  • Women who are pregnant or lactating
  • Clinically significant medical conditions
  • Viral illness within the last 30 days
  • Symptomatic prostatic hypertrophy or bladder neck obstruction
  • Known narrow-angle glaucoma
  • History of bowel obstruction
  • Clinically significant abnormal electrocardiogram
  • Positive Hepatitis B surface antigen or positive Hepatitis C antibody
  • Positive screening test for HIV antibodies
  • History of hypersensitivity to any beta2-agonists, anticholinergics, or any component of the MDI
  • Known or suspected history of alcohol or drug abuse within the last 2-years
  • Greater than normal alcohol consumption
  • Ingestion of any poppy seeds within the 48 hours prior to the screening
  • Ingestion of any poppy seeds within the 48 hours prior to, or any alcohol, xanthines or grapefruit-containing foods or beverages within the 24 hours prior to, or during, each confinement
  • Positive breath alcohol result
  • Positive urine drug screen
  • Use of any beta2-agonists,or anticholinergics prior to the recruitment interview
  • Lower respiratory tract infections requiring antibiotics in the previous 6 weeks
  • Use of any other prescription medication
  • Use of any over the counter product, herbal product, diet aid, hormone supplement
  • Donation > 450 ml of blood within 8 weeks of first treatment dose
  • Clinically significant vital sign abnormality
  • Clinically significant biochemical, hematological or urinalysis abnormality
  • Affiliations with investigator site
  • Treatment with investigational study drug or participation in another clinical trial or study within the last 30 days or 5 half lives prior to screening, whichever is longer

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: 1
Inhaled PT001 18 μg
Drug: PT001
Inhaled PT001, single dose
Experimental: 2
Inhaled PT005 2.4 μg
Drug: PT005
Inhaled PT005, single dose
Experimental: 3
Inhaled PT003 (PT001 18 μg / 2.4 μg PT005)
Drug: PT003
Inhaled PT003, single dose
Experimental: 4
PT001 18 μg + PT005 2.4 μg
Drug: PT001 + PT005
Inhaled PT001 + PT005, single dose

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Symptoms of Dry Mouth
Time Frame: 12 hours
Number of participants reporting dry mouth at 12 hours post-dose
12 hours
Symptoms of Tremor
Time Frame: 12 hours
Number of participants reporting tremor at 12 hours post-dose
12 hours
Blood Chemistry Change From Baseline
Time Frame: 24 hours post dose for sentinel subjects, 12 hours post dose for subsequent subjects
Series of 11 blood chemistries assessed throughout the study
24 hours post dose for sentinel subjects, 12 hours post dose for subsequent subjects
Hematology Change From Baseline
Time Frame: 24 hours post dose for sentinel subjects, 12 hours post dose for subsequent subjects
Hematology assessments taken throughout the study Hematocrit
24 hours post dose for sentinel subjects, 12 hours post dose for subsequent subjects
Hematology Change From Baseline
Time Frame: 24 hours post dose for sentinel subjects, 12 hours post dose for subsequent subjects
Hematology assessments taken throughout the study
24 hours post dose for sentinel subjects, 12 hours post dose for subsequent subjects
Hematology Change From Baseline
Time Frame: 24 hours post dose for sentinel subjects, 12 hours post dose for subsequent subjects
Hematology assessments taken throughout the study Hemoglobin
24 hours post dose for sentinel subjects, 12 hours post dose for subsequent subjects
Heart Rate Change From Baseline
Time Frame: 12 hours
Change from baseline for heart rate 12-hours post-dose Heart rate (bpm)
12 hours
Vital Sign Change Baseline; Blood Pressure
Time Frame: 12 hours
Vital sign change baseline; blood pressure
12 hours
Vital Sign Change From Baseline, SpO2
Time Frame: 12 hours
Vital Sign Change from baseline 12-hours post-dose SpO2 (%)
12 hours
ECG Change From Baseline
Time Frame: 12 hours
Change from baseline for ECG parameters 12-hours post-dose Ventricular rate (bpm)
12 hours
ECG Change From Baseline
Time Frame: 12 hours
Change from baseline for ECG parameters 12-hours post-dose
12 hours
Spirometry Change From Baseline
Time Frame: 12 hours
Change from baseline for spirometery measures 12-hours post-dose
12 hours
Spirometry Change From Baseline
Time Frame: 12 hours
Change from baseline for spirometery measures 12-hours post-dose (FEV1 % predicted)
12 hours
Spirometry Change From Baseline
Time Frame: 12 hours
Change from baseline for spirometery measures 12-hours post-dose FEV/FVC (%)
12 hours
Spirometry Change From Baseline
Time Frame: 12 hours
Change from baseline for spirometery measures 12-hours post-dose PEFR (L/min)
12 hours
Serum Potassium Change From Baseline
Time Frame: 12 hours
12 hours

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Plasma Glycopyrrolate PK Parameters
Time Frame: Concentrations were measured at pre-dose and 2,5,15, and 30 minutes post dose as well as 1,2,4,6,8, and 12 hours post dose
Various pharmacokinetic parameters for plasma glycopyrrolate
Concentrations were measured at pre-dose and 2,5,15, and 30 minutes post dose as well as 1,2,4,6,8, and 12 hours post dose
Plasma Glycopyrrolate PK Parameters AUC0-inf (h*pg/mL)
Time Frame: Concentrations were measured at pre-dose and 2,5,15, and 30 minutes post dose as well as 1,2,4,6,8, and 12 hours post dose
Various pharmacokinetic parameters for plasma glycopyrrolate
Concentrations were measured at pre-dose and 2,5,15, and 30 minutes post dose as well as 1,2,4,6,8, and 12 hours post dose
Plasma Glycopyrrolate PK Parameters (Tmax)
Time Frame: Concentrations were measured at pre-dose and 2,5,15, and 30 minutes post dose as well as 1,2,4,6,8, and 12 hours post dose
Various pharmacokinetic parameters for plasma glycopyrrolate
Concentrations were measured at pre-dose and 2,5,15, and 30 minutes post dose as well as 1,2,4,6,8, and 12 hours post dose
Plasma Glycopyrrolate PK Parameters (t1/2)
Time Frame: Concentrations were measured at pre-dose and 2,5,15, and 30 minutes post dose as well as 1,2,4,6,8, and 12 hours post dose
Various pharmacokinetic parameters for plasma glycopyrrolate
Concentrations were measured at pre-dose and 2,5,15, and 30 minutes post dose as well as 1,2,4,6,8, and 12 hours post dose
Plasma Glycopyrrolate PK Parameters Cmax (pg/mL)
Time Frame: Concentrations were measured at pre-dose and 2,5,15, and 30 minutes post dose as well as 1,2,4,6,8, and 12 hours post dose
Various pharmacokinetic parameters for plasma glycopyrrolate
Concentrations were measured at pre-dose and 2,5,15, and 30 minutes post dose as well as 1,2,4,6,8, and 12 hours post dose
Plasma Glycopyrrolate PK Parameters (ke)
Time Frame: Concentrations were measured at pre-dose and 2,5,15, and 30 minutes post dose as well as 1,2,4,6,8, and 12 hours post dose
Various pharmacokinetic parameters for plasma glycopyrrolate
Concentrations were measured at pre-dose and 2,5,15, and 30 minutes post dose as well as 1,2,4,6,8, and 12 hours post dose
Plasma Formoterol PK Parameters
Time Frame: Concentrations were measured at pre-dose and 2,5,15, and 30 minutes post dose as well as 1,2,4,6,8, and 12 hours post dose
Various pharmacokinetic parameters for plasma formoterol
Concentrations were measured at pre-dose and 2,5,15, and 30 minutes post dose as well as 1,2,4,6,8, and 12 hours post dose
Plasma Formoterol PK Parameters AUC0-inf (h*pg/mL)
Time Frame: Concentrations were measured at pre-dose and 2,5,15, and 30 minutes post dose as well as 1,2,4,6,8, and 12 hours post dose
Various pharmacokinetic parameters for plasma formoterol
Concentrations were measured at pre-dose and 2,5,15, and 30 minutes post dose as well as 1,2,4,6,8, and 12 hours post dose
Plasma Formoterol PK Parameters (Tmax)
Time Frame: Concentrations were measured at pre-dose and 2,5,15, and 30 minutes post dose as well as 1,2,4,6,8, and 12 hours post dose
Various pharmacokinetic parameters for plasma formoterol
Concentrations were measured at pre-dose and 2,5,15, and 30 minutes post dose as well as 1,2,4,6,8, and 12 hours post dose
Plasma Formoterol PK Parameters (t1/2)
Time Frame: Concentrations were measured at pre-dose and 2,5,15, and 30 minutes post dose as well as 1,2,4,6,8, and 12 hours post dose
Various pharmacokinetic parameters for plasma formoterol
Concentrations were measured at pre-dose and 2,5,15, and 30 minutes post dose as well as 1,2,4,6,8, and 12 hours post dose
Plasma Formoterol PK Parameters (Cmax)
Time Frame: Concentrations were measured at pre-dose and 2,5,15, and 30 minutes post dose as well as 1,2,4,6,8, and 12 hours post dose
Pharmacokinetic parameters for plasma formoterol Cmax
Concentrations were measured at pre-dose and 2,5,15, and 30 minutes post dose as well as 1,2,4,6,8, and 12 hours post dose
Plasma Formoterol PK Parameters (ke)
Time Frame: Concentrations were measured at pre-dose and 2,5,15, and 30 minutes post dose as well as 1,2,4,6,8, and 12 hours post dose
Pharmacokinetic parameters for plasma formoterol ke
Concentrations were measured at pre-dose and 2,5,15, and 30 minutes post dose as well as 1,2,4,6,8, and 12 hours post dose

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Pearl Therapeutics, Inc.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Colin Reisner, M.D., Pearl Therapeutics

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 1, 2009

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 1, 2009

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 1, 2009

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 5, 2009

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 5, 2009

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 6, 2009

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 26, 2017

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 16, 2017

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2017

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • PT0030901

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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