COPDPhase 1NCT02189304

Pharmacokinetics and Safety Study of PT010 in Healthy Subjects

A Phase 1 study testing PT010, PT009 and Symbicort Turbohaler in people with COPD, run by Pearl Therapeutics, Inc. at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

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

Who is it for?: Ages 18 to 55 yearsHealthy volunteers can take part
Conditions the study is for: COPD
What is being tested?: PT010, PT009 and Symbicort Turbohaler
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 59 participants
Where: 1 siteUnited States
Study dates: 1 Jun 2014to 1 Sep 2014
Phase: Phase 1
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 55 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

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

Who cannot join

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

Show all 10Show fewer

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

Trial locations and contacts

1 site in 1 country.

United States1 site

SNBL Clinical Pharmacology Center
Baltimore, Maryland, 21201

Other trials in United States

About this study

Official title: 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.

Conditions: COPD
Being tested: PT010, PT009, Symbicort Turbohaler
Keywords: Healthy volunteers
Medical subject headings: Pulmonary Disease, Chronic Obstructive

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

PT010Drug
Also called PT010; Budesonide, Glycopyrrolate, and Formoterol Fumarate Inhalation Aerosol
PT010; Budesonide, Glycopyrrolate, and Formoterol Fumarate Inhalation Aerosol. Administered as 2 inhalations
PT009Drug
Also called PT009; Budesonide and Formoterol Fumarate Inhalation Aerosol. Administered as 2 inhalations
PT009 administered as 2 inhalations
Symbicort TurbohalerDrug
Also called Symbicort Turbohaler; Budesonide and Formoterol Fumarate Inhalation Powder
Symbicort Turbohaler taken as 2 inhalations

Study groups in NCT02189304
Study group	Role	What they receive
PT010	Experimental	PT010; Budesonide, Glycopyrrolate, and Formoterol Fumarate Inhalation Aerosol. Administered as 2 inhalations Receives: Drug: PT009; Drug: Symbicort Turbohaler
PT009	Experimental	PT009; Budesonide and Formoterol Fumarate Inhalation Aerosol. Administered as 2 inhalations Receives: Drug: PT010; Drug: Symbicort Turbohaler
Symbicort Turbohaler	Active comparator	Symbicort Turbohaler; Budesonide and Formoterol Fumarate Inhalation Powder taken as 2 inhalations Receives: Drug: PT010; Drug: PT009

What is being measured

The primary outcome is the main question the study is designed to answer.

Overall Safety of PT010, PT009 and Symbicort Turbohaler
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
Measured: 12 hours post dose

Secondary outcomes (9)

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Jun 20141 Sep 2014

First posted14 Jul 2014 (estimated)
Study start1 Jun 2014
Primary completion1 Sep 2014
Study completion1 Sep 2014

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (2)Papers the sponsor has linked to this study.
Other trials for COPDStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 59 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02189304
Sponsor's protocol ID: PT010002-00
Status last verified: Jun 2018
First submitted: 9 Jul 2014
Last updated: 13 Jun 2018
Results posted: No
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No

Publications

Huang Y, Assam PN, Feng C, Su R, Dorinsky P, Gillen M. Ethnic pharmacokinetic comparison of budesonide/glycopyrrolate/formoterol fumarate metered dose inhaler (BGF MDI) between Asian and Western healthy subjects. Pulm Pharmacol Ther. 2020 Oct;64:101976. doi: 10.1016/j.pupt.2020.101976. Epub 2020 Nov 2.
PubMed 33152467
Maes A, DePetrillo P, Siddiqui S, Reisner C, Dorinsky P. Pharmacokinetics of Co-Suspension Delivery Technology Budesonide/Glycopyrronium/Formoterol Fumarate Dihydrate (BGF MDI) and Budesonide/Formoterol Fumarate Dihydrate (BFF MDI) Fixed-Dose Combinations Compared With an Active Control: A Phase 1, Randomized, Single-Dose, Crossover Study in Healthy Adults. Clin Pharmacol Drug Dev. 2019 Feb;8(2):223-233. doi: 10.1002/cpdd.585. Epub 2018 Jun 14.
PubMed 29901860

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 13 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: 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
ClinicalTrials.gov ID: NCT02189304
Acronym / sponsor ID: PT010002-00
Conditions: COPD
Keywords: Healthy volunteers
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 59 participants (actual)
Lead sponsor: Pearl Therapeutics, Inc.Industry (pharma, biotech, devices)
Study start: 1 Jun 2014 (actual)
Primary completion: 1 Sep 2014 (actual)
Study completion: 1 Sep 2014 (actual)
First posted: 14 Jul 2014 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 3

Arm	Type	Receives
PT010	Experimental	Drug: PT009, Drug: Symbicort TurbohalerPT010; Budesonide, Glycopyrrolate, and Formoterol Fumarate Inhalation Aerosol. Administered as 2 inhalations
PT009	Experimental	Drug: PT010, Drug: Symbicort TurbohalerPT009; Budesonide and Formoterol Fumarate Inhalation Aerosol. Administered as 2 inhalations
Symbicort Turbohaler	Active comparator	Drug: PT010, Drug: PT009Symbicort Turbohaler; Budesonide and Formoterol Fumarate Inhalation Powder taken as 2 inhalations

Who may qualify

Ages: 18 to 55 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (5 listed)

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

Key exclusion criteria (10 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
PT010Also: PT010; Budesonide, Glycopyrrolate, and Formoterol Fumarate Inhalation AerosolPT010; Budesonide, Glycopyrrolate, and Formoterol Fumarate Inhalation Aerosol. Administered as 2 inhalations	Drug	PT009, Symbicort Turbohaler
PT009Also: PT009; Budesonide and Formoterol Fumarate Inhalation Aerosol. Administered as 2 inhalationsPT009 administered as 2 inhalations	Drug	PT010, Symbicort Turbohaler
Symbicort TurbohalerAlso: Symbicort Turbohaler; Budesonide and Formoterol Fumarate Inhalation PowderSymbicort Turbohaler taken as 2 inhalations	Drug	PT009, PT010

Primary outcome

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

9 secondary outcomes

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

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 13 Jun 2018.
Derived from this study: PubMed 33152467Huang Y, Assam PN, Feng C, Su R, Dorinsky P, Gillen M. Ethnic pharmacokinetic comparison of budesonide/glycopyrrolate/formoterol fumarate metered dose inhaler (BGF MDI) between Asian and Western healthy subjects. Pulm Pharmacol Ther. 2020 Oct;64:101976. doi: 10.1016/j.pupt.2020.101976. Epub 2020 Nov 2.
Derived from this study: PubMed 29901860Maes A, DePetrillo P, Siddiqui S, Reisner C, Dorinsky P. Pharmacokinetics of Co-Suspension Delivery Technology Budesonide/Glycopyrronium/Formoterol Fumarate Dihydrate (BGF MDI) and Budesonide/Formoterol Fumarate Dihydrate (BFF MDI) Fixed-Dose Combinations Compared With an Active Control: A Phase 1, Randomized, Single-Dose, Crossover Study in Healthy Adults. Clin Pharmacol Drug Dev. 2019 Feb;8(2):223-233. doi: 10.1002/cpdd.585. Epub 2018 Jun 14.

Related trials for COPD

Active, not recruiting
Symptoms and Functions in Patients With COPD and Chronic Bronchitis Switching From CIG to THS
COPD, Smoking
Not yet recruitingPhase 2/3
An Open-Label Extension Study to Evaluate Inhaled Treprostinil SMI in Participants With Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease (PH-COPD)
Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease
Not yet recruiting
The Aim of the Study is to Decipher the Alterations in Signalling Pathways of Skeletal Muscle Stem Cells (Satellite Cells (SCs)) in Individuals With COPD, as Well as to Examine the Effect of Exercise Training on SCs.
COPD (Chronic Obstructive Pulmonary Disease), Sarcopenia in Elderly
Not yet recruitingPhase 2
Study of Treprostinil Administered Via Soft Mist Inhaler (SMI) in Participants With Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease (PH-COPD)
Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease
Active, not recruitingPhase 1
A Study for GSK3862995B in Healthy Participants and Participants With Chronic Obstructive Pulmonary Disease
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Chadwick Orevillo study chair

Pearl Therapeutics

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing PT010, PT009 and Symbicort Turbohaler in people with COPD, run by Pearl Therapeutics, Inc. at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 13 Jun 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Overall Safety of PT010, PT009 and Symbicort Turbohaler (time frame: 12 hours post dose). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02189304, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jun 2018.