Pharmacokinetics and Safety Study of PT010 in Healthy Subjects

June 11, 2018 updated by: Pearl Therapeutics, Inc.

A Phase I, Randomized, Double-Blind, Single-Dose, Three-Period, Three-Treatment, Cross-Over Study Evaluating the Pharmacokinetics and Safety of a Single Dose of PT010, a Single Dose of PT009, and a Single Dose of Open-Label Symbicort® Turbohaler® in Healthy Subjects

This is a single-center, Phase I, healthy adult subject study with a randomized, double blind, three period, three-treatment, cross-over design.

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.
59

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

  • United States
    • Maryland
      • Baltimore, Maryland, United States, 21201
        • SNBL Clinical Pharmacology Center

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:

  • Informed Consent Form (ICF) prior to any study related procedures
  • Male and female subjects 18 to 55 years, inclusive
  • Good general health
  • Medically acceptable contraception for women of child-bearing potential and males with female partners of childbearing potential
  • Clinical labs within normal ranges or determined to be not clinically significant by the Investigator

Exclusion Criteria:

  • Pregnancy, nursing female subjects, or subjects trying to conceive
  • Clinically significant neurologic, cardiovascular, hepatic, renal, endocrinologic, pulmonary, hematological, psychiatric, or other medical illness that would interfere with participation in this study
  • History of ECG abnormalities
  • Cancer not in complete remission for at least 5 years
  • Clinically significant, symptomatic prostatic hypertrophy
  • Male subjects with a trans-urethral resection of the prostate or full resection of the prostate within 6 months prior to Screening
  • Clinically significant bladder neck obstruction or urinary retention
  • Inadequately treated glaucoma
  • History of an allergic reaction or hypersensitivity to any drug or to any component of the formulations used in this study
  • Subjects with pre-existing anemia and/or iron deficiency

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: PT010
PT010; Budesonide, Glycopyrrolate, and Formoterol Fumarate Inhalation Aerosol. Administered as 2 inhalations
Drug: PT009
PT009 administered as 2 inhalations
Other Names:
  • PT009; Budesonide and Formoterol Fumarate Inhalation Aerosol. Administered as 2 inhalations
Drug: Symbicort Turbohaler
Symbicort Turbohaler taken as 2 inhalations
Other Names:
  • Symbicort Turbohaler; Budesonide and Formoterol Fumarate Inhalation Powder
Experimental: PT009
PT009; Budesonide and Formoterol Fumarate Inhalation Aerosol. Administered as 2 inhalations
Drug: Symbicort Turbohaler
Symbicort Turbohaler taken as 2 inhalations
Other Names:
  • Symbicort Turbohaler; Budesonide and Formoterol Fumarate Inhalation Powder
Drug: PT010
PT010; Budesonide, Glycopyrrolate, and Formoterol Fumarate Inhalation Aerosol. Administered as 2 inhalations
Other Names:
  • PT010; Budesonide, Glycopyrrolate, and Formoterol Fumarate Inhalation Aerosol
Active Comparator: Symbicort Turbohaler
Symbicort Turbohaler; Budesonide and Formoterol Fumarate Inhalation Powder taken as 2 inhalations
Drug: PT009
PT009 administered as 2 inhalations
Other Names:
  • PT009; Budesonide and Formoterol Fumarate Inhalation Aerosol. Administered as 2 inhalations
Drug: PT010
PT010; Budesonide, Glycopyrrolate, and Formoterol Fumarate Inhalation Aerosol. Administered as 2 inhalations
Other Names:
  • PT010; Budesonide, Glycopyrrolate, and Formoterol Fumarate Inhalation Aerosol

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
Overall Safety of PT010, PT009 and Symbicort Turbohaler
Time Frame: 12 hours post dose
The safety of PT010 and PT009 and Symbicort Turbohaler will be assessed based on physical examination, adverse events, vital signs, clinical laboratory values, and electrocardiogram
12 hours post dose

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
Time Frame
◦Maximum plasma concentration (Cmax) of PT010, PT009 and Symbicort Turbohaler
Time Frame: 12 Hour post dose
12 Hour post dose
◦Area under the curve from 0 to 12 hours (AUC0 12) of PT010, PT009 and Symbicort Turbohaler
Time Frame: 12 Hour post dose
12 Hour post dose
◦Area under the curve from 0 to the time of the last measureable plasma concentration (AUC0 t) of PT010, PT009 and Symbicort Turbohaler
Time Frame: 12 Hour post dose
12 Hour post dose
◦Area under the curve from 0 extrapolated to infinity (AUC0-∞) of PT010, PT009, and Symbicort Turbohaler
Time Frame: 12 Hour post dose
12 Hour post dose
◦Time to maximum plasma concentration (tmax) of PT010, PT009, and Symbicort Turbohaler
Time Frame: 12 Hour post dose
12 Hour post dose
◦Apparent terminal elimination half life (t½) of PT010, PT009, and Symbicort Turbohaler
Time Frame: 12 Hour post dose
12 Hour post dose
◦Apparent total body clearance (CL/F) of PT010, PT009, and Symbicort Turbohaler
Time Frame: 12 Hour post dose
12 Hour post dose
◦Apparent volume of distribution (Vd/F) of PT010, PT009, and Symbicort Turbohaler
Time Frame: 12 Hour post dose
12 Hour post dose
◦Termination elimination rate constant (λz) of PT010, PT009, and Symbicort Turbohaler
Time Frame: 12 Hour post dose
12 Hour 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 Chair: Chadwick Orevillo, Pearl Therapeutics

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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 (Actual)

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.
June 1, 2014

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.
September 1, 2014

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.
September 1, 2014

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).
July 9, 2014

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.
July 10, 2014

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.
July 14, 2014

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.
June 13, 2018

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.
June 11, 2018

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.
June 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

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.
  • PT010002-00

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

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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