COPDPhase 1NCT02196714

PK Study of PT003 and PT001 in Japanese Healthy Subjects

A Phase 1 study testing Glycopyrronium and Formoterol Fumarate (GFF) Dose 1, Glycopyrronium and Formoterol Fumarate (GFF) Dose 2 and Glycopyrronium (GP) Dose 1 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

A Randomized, Double-Blind, Single-Dose, Four-Period, Four-Treatment, Cross-Over, Single-Center, Phase I, Crossover Study in Healthy Japanese Adult Subjects to Evaluate the Safety and Pharmacokinetics of Two Doses of PT003 and Two Doses of PT001. Read more about this study

Who is it for?: Ages 18 to 45 yearsHealthy volunteers can take part
Conditions the study is for: COPD
What is being tested?: Glycopyrronium and Formoterol Fumarate (GFF) Dose 1, Glycopyrronium and Formoterol Fumarate (GFF) Dose 2 and Glycopyrronium (GP) Dose 1
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 24 participants
Where: 1 siteUnited States
Study dates: Jul 2014to Sep 2014
Phase: Phase 1
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 45 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 first generation Japanese subjects 18 to 45 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
Baltimore, Maryland, 21201

Other trials in United States

About this study

Official title: A Phase I, Randomized, Double-Blind, Single-Dose, Four-Period, Four-Treatment, Cross-Over Study Evaluating the Safety and Pharmacokinetics of Two Doses of PT003 and Two Doses of PT001 in Japanese Healthy Subjects

Conditions: COPD
Being tested: Glycopyrronium and Formoterol Fumarate (GFF) Dose 1, Glycopyrronium and Formoterol Fumarate (GFF) Dose 2, Glycopyrronium (GP) Dose 1, Glycopyrronium (GP) Dose 2
Keywords: Japanese 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.

Glycopyrronium and Formoterol Fumarate (GFF) Dose 1Drug
Glycopyrronium and Formoterol Fumarate metered-dose inhaler MDI (GFF MDI), Dose 1; PT003 administered as 2 inhalations twice-daily (BID)
Glycopyrronium and Formoterol Fumarate (GFF) Dose 2Drug
Glycopyrronium and Formoterol Fumarate metered-dose inhaler MDI (GFF MDI), Dose 2; PT003 administered as 2 inhalations twice-daily (BID)
Glycopyrronium (GP) Dose 1Drug
Glycopyrronium metered-dose inhaler MDI (GP MDI), Dose 1; PT001 administered as 2 inhalations twice-daily (BID)
Glycopyrronium (GP) Dose 2Drug
Glycopyrronium metered-dose inhaler MDI (GP MDI), Dose 2; PT001 administered as 2 inhalations twice-daily (BID)

Study groups in NCT02196714
Study group	Role	What they receive
Glycopyrronium and Formoterol Fumarate (GFF) Dose 1	Experimental	Glycopyrronium and Formoterol Fumarate metered-dose inhaler MDI (GFF MDI), Dose 1; PT003 administered as 2 inhalations twice-daily (BID) Receives: Drug: Glycopyrronium and Formoterol Fumarate (GFF) Dose 1
Glycopyrronium and Formoterol Fumarate (GFF) Dose 2	Experimental	Glycopyrronium and Formoterol Fumarate metered-dose inhaler MDI (GFF MDI), Dose 2; PT003 administered as 2 inhalations twice-daily (BID) Receives: Drug: Glycopyrronium and Formoterol Fumarate (GFF) Dose 2
Glycopyrronium (GP) Dose 1	Experimental	Glycopyrronium metered-dose inhaler MDI (GP MDI), Dose 1; PT001 administered as 2 inhalations twice-daily (BID) Receives: Drug: Glycopyrronium (GP) Dose 1
Glycopyrronium (GP) Dose 2	Experimental	Glycopyrronium metered-dose inhaler MDI (GP MDI), Dose 2; PT001 administered as 2 inhalations twice-daily (BID) Receives: Drug: Glycopyrronium (GP) Dose 2

What is being measured

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

Cmax
Descriptive Statistics for Pharmacokinetic Parameters of Glycopyrronium by Treatment (Cmax)
Measured: Day 1
Cmax
Descriptive Statistics for Pharmacokinetic Parameters of Formoterol by Treatment (Cmax)
Measured: Day 1
AUC 0-12
Descriptive Statistics for Pharmacokinetic Parameters of Glycopyrronium by Treatment (AUC 0-12)
Measured: Day 1
AUC 0-12
Descriptive Statistics for Pharmacokinetic Parameters of Formoterol by Treatment (AUC 0-12)
Measured: Day 1
AUC 0-t
Descriptive Statistics for Pharmacokinetic Parameters of Glycopyrronium by Treatment (AUC 0-t)
Measured: Day 1
AUC 0-t
Descriptive Statistics for Pharmacokinetic Parameters of Formoterol by Treatment (AUC 0-t)
Measured: Day 1
AUC 0-∞
Descriptive Statistics for Pharmacokinetic Parameters of Glycopyrronium by Treatment (AUC 0-∞)
Measured: Day 1
AUC 0-∞
Descriptive Statistics for Pharmacokinetic Parameters of Formoterol by Treatment (AUC 0-∞)
Measured: Day 1
Tmax
Descriptive Statistics for Pharmacokinetic Parameters of Glycopyrronium by Treatment (tmax)
Measured: Day 1
Tmax
Descriptive Statistics for Pharmacokinetic Parameters of Formoterol by Treatment (tmax)
Measured: Day 1
T 1/2
Descriptive Statistics for Pharmacokinetic Parameters of Glycopyrronium by Treatment (T 1/2)
Measured: Day 1
T 1/2
Descriptive Statistics for Pharmacokinetic Parameters of Formoterol by Treatment (T 1/2)
Measured: Day 1
CL/F
Descriptive Statistics for Pharmacokinetic Parameters of Glycopyrronium by Treatment
Measured: Day 1
CL/F
Descriptive Statistics for Pharmacokinetic Parameters of Formoterol by Treatment
Measured: Day 1
Vd/F
Descriptive Statistics for Pharmacokinetic Parameters of Glycopyrroniuml by Treatment
Measured: Day 1
Vd/F
Descriptive Statistics for Pharmacokinetic Parameters of Formoterol by Treatment
Measured: Day 1
Lambda z
Descriptive Statistics for Pharmacokinetic Parameters of Glycopyrronium by Treatment
Measured: Day 1
Lambda z
Descriptive Statistics for Pharmacokinetic Parameters of Formoterol by Treatment
Measured: Day 1

Secondary outcomes (15)

Change in Mean Hematology Parameters (±SD) From Pre-dose to 12 Hours Post-dose
Change in Mean Hematology Parameters (±SD) from Pre-dose to 12 Hours Post-dose
Measured: 12 Hours
Change in Mean Hematology Parameters (±SD) From Pre-dose to 12 Hours Post-dose
Change in Mean Hematology Parameters (±SD) from Pre-dose to 12 Hours Post-dose (Ery. mean corpuscuar volume)
Measured: 12 Hours
Change in Mean Hematology Parameters (±SD) From Pre-dose to 12 Hours Post-dose
Change in Mean Hematology Parameters (±SD) from Pre-dose to 12 Hours Post-dose (Ery. mean corpuscuar hemoglobin)
Measured: 12 Hours
Change in Mean Hematology Parameters (±SD) From Pre-dose to 12 Hours Post-dose
Change in Mean Hematology Parameters (±SD) from Pre-dose to 12 Hours Post-dose (Erythrocytes)
Measured: 12 Hours
Change in Mean Chemistry Parameters (±SD) From Pre-dose to 12 Hours Post-dose
Change in Mean Chemistry Parameters (±SD) from Pre-dose to 12 Hours Post-dose
Measured: 12 hours
Change in Mean Chemistry Parameters (±SD) From Pre-dose to 12 Hours Post-dose
Change in Mean Chemistry Parameters (±SD) from Pre-dose to 12 Hours Post-dose (eGFR)
Measured: 12 hours
Change in Mean Chemistry Parameters (±SD) From Pre-dose to 12 Hours Post-dose
Change in Mean Chemistry Parameters (±SD) from Pre-dose to 12 Hours Post-dose (Ferritin)
Measured: 12 hours
Change in Mean Glucose and Potassium Results (±SD) From Pre-dose to 12 Hours Post-dose
Change in Mean Glucose and Potassium Results (±SD) from Pre-dose to 12 Hours Post-dose
Measured: 12 hours
Change in Heart Rate From Pre-dose to 12 Hours Post Dose
Change in Heart Rate from Pre-dose to 12 hours Post dose
Measured: 12 hours
Change in PR Interval From Pre-dose to 12 Hours Post Dose
Change in PR Interval from Pre-dose to 12 hours Post dose
Measured: 12 hours
Change in QRS Axis From Pre-dose to 12 Hours Post Dose
Change in QRS axis from Pre-dose to 12 hours Post dose
Measured: 12 hours
Change in QRS Duration From Pre-dose to 12 Hours Post Dose
Change in QRS duration from Pre-dose to 12 hours Post dose
Measured: 12 hours
Change in QT Interval From Pre-dose to 12 Hours Post Dose
Change in QT Interval from Pre-dose to 12 hours Post dose
Measured: 12 hours
Change in QTc Bazett Interval From Pre-dose to 12 Hours Post Dose
Change in QTc Bazett Interval from Pre-dose to 12 hours Post dose
Measured: 12 hours
Change in QTc Fridericia's Interval From Pre-dose to 12 Hours Post Dose
Change in QTc Fridericia's Interval from Pre-dose to 12 hours Post dose
Measured: 12 hours

Timeline

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

Jul 2014Sep 2014

First posted22 Jul 2014 (estimated)
Study startJul 2014
Primary completionSep 2014

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)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: Triple blind
Who is masked: Participant, Care provider, Investigator
Enrolment: 24 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02196714
Sponsor's protocol ID: PT003010-00
Status last verified: Mar 2017
First submitted: 18 Jul 2014
Last updated: 26 Apr 2017
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

Reisner C, Miller J, DePetrillo P, Maes A, Siddiqui S, Martin UJ. Pharmacokinetics and safety of a single dose of the novel LAMA/LABA fixed-dose combination of glycopyrronium/formoterol fumarate dihydrate metered dose inhaler, formulated using co-suspension delivery technology, in Japanese healthy subjects. Pulm Pharmacol Ther. 2018 Dec;53:33-38. doi: 10.1016/j.pupt.2018.09.005. Epub 2018 Sep 13.
PubMed 30218695

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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All COPD trials

Study at a glance

From the registry record, last updated by the sponsor on 26 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase I, Randomized, Double-Blind, Single-Dose, Four-Period, Four-Treatment, Cross-Over Study Evaluating the Safety and Pharmacokinetics of Two Doses of PT003 and Two Doses of PT001 in Japanese Healthy Subjects
ClinicalTrials.gov ID: NCT02196714
Acronym / sponsor ID: PT003010-00
Conditions: COPD
Keywords: Japanese Healthy Volunteers
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 24 participants (actual)
Lead sponsor: Pearl Therapeutics, Inc.Industry (pharma, biotech, devices)
Study start: Jul 2014
Primary completion: Sep 2014 (actual)
First posted: 22 Jul 2014 (estimated)
Results: Posted 26 Apr 2017

Clinical summary

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

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: Triple blind (participant, care provider, investigator)
Number of arms: 4

Arm	Type	Receives
Glycopyrronium and Formoterol Fumarate (GFF) Dose 1	Experimental	Drug: Glycopyrronium and Formoterol Fumarate (GFF) Dose 1Glycopyrronium and Formoterol Fumarate metered-dose inhaler MDI (GFF MDI), Dose 1; PT003 administered as 2 inhalations twice-daily (BID)
Glycopyrronium and Formoterol Fumarate (GFF) Dose 2	Experimental	Drug: Glycopyrronium and Formoterol Fumarate (GFF) Dose 2Glycopyrronium and Formoterol Fumarate metered-dose inhaler MDI (GFF MDI), Dose 2; PT003 administered as 2 inhalations twice-daily (BID)
Glycopyrronium (GP) Dose 1	Experimental	Drug: Glycopyrronium (GP) Dose 1Glycopyrronium metered-dose inhaler MDI (GP MDI), Dose 1; PT001 administered as 2 inhalations twice-daily (BID)
Glycopyrronium (GP) Dose 2	Experimental	Drug: Glycopyrronium (GP) Dose 2Glycopyrronium metered-dose inhaler MDI (GP MDI), Dose 2; PT001 administered as 2 inhalations twice-daily (BID)

Who may qualify

Ages: 18 to 45 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 first generation Japanese subjects 18 to 45 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
Glycopyrronium and Formoterol Fumarate (GFF) Dose 1Glycopyrronium and Formoterol Fumarate metered-dose inhaler MDI (GFF MDI), Dose 1; PT003 administered as 2 inhalations twice-daily (BID)	Drug	Glycopyrronium and Formoterol Fumarate (GFF) Dose 1
Glycopyrronium and Formoterol Fumarate (GFF) Dose 2Glycopyrronium and Formoterol Fumarate metered-dose inhaler MDI (GFF MDI), Dose 2; PT003 administered as 2 inhalations twice-daily (BID)	Drug	Glycopyrronium and Formoterol Fumarate (GFF) Dose 2
Glycopyrronium (GP) Dose 1Glycopyrronium metered-dose inhaler MDI (GP MDI), Dose 1; PT001 administered as 2 inhalations twice-daily (BID)	Drug	Glycopyrronium (GP) Dose 1
Glycopyrronium (GP) Dose 2Glycopyrronium metered-dose inhaler MDI (GP MDI), Dose 2; PT001 administered as 2 inhalations twice-daily (BID)	Drug	Glycopyrronium (GP) Dose 2

Primary outcome

Cmax
Time frame: Day 1
Descriptive Statistics for Pharmacokinetic Parameters of Glycopyrronium by Treatment (Cmax)
Cmax
Time frame: Day 1
Descriptive Statistics for Pharmacokinetic Parameters of Formoterol by Treatment (Cmax)
AUC 0-12
Time frame: Day 1
Descriptive Statistics for Pharmacokinetic Parameters of Glycopyrronium by Treatment (AUC 0-12)
AUC 0-12
Time frame: Day 1
Descriptive Statistics for Pharmacokinetic Parameters of Formoterol by Treatment (AUC 0-12)
AUC 0-t
Time frame: Day 1
Descriptive Statistics for Pharmacokinetic Parameters of Glycopyrronium by Treatment (AUC 0-t)
AUC 0-t
Time frame: Day 1
Descriptive Statistics for Pharmacokinetic Parameters of Formoterol by Treatment (AUC 0-t)
AUC 0-∞
Time frame: Day 1
Descriptive Statistics for Pharmacokinetic Parameters of Glycopyrronium by Treatment (AUC 0-∞)
AUC 0-∞
Time frame: Day 1
Descriptive Statistics for Pharmacokinetic Parameters of Formoterol by Treatment (AUC 0-∞)
Tmax
Time frame: Day 1
Descriptive Statistics for Pharmacokinetic Parameters of Glycopyrronium by Treatment (tmax)
Tmax
Time frame: Day 1
Descriptive Statistics for Pharmacokinetic Parameters of Formoterol by Treatment (tmax)
T 1/2
Time frame: Day 1
Descriptive Statistics for Pharmacokinetic Parameters of Glycopyrronium by Treatment (T 1/2)
T 1/2
Time frame: Day 1
Descriptive Statistics for Pharmacokinetic Parameters of Formoterol by Treatment (T 1/2)
CL/F
Time frame: Day 1
Descriptive Statistics for Pharmacokinetic Parameters of Glycopyrronium by Treatment
CL/F
Time frame: Day 1
Descriptive Statistics for Pharmacokinetic Parameters of Formoterol by Treatment
Vd/F
Time frame: Day 1
Descriptive Statistics for Pharmacokinetic Parameters of Glycopyrroniuml by Treatment
Vd/F
Time frame: Day 1
Descriptive Statistics for Pharmacokinetic Parameters of Formoterol by Treatment
Lambda z
Time frame: Day 1
Descriptive Statistics for Pharmacokinetic Parameters of Glycopyrronium by Treatment
Lambda z
Time frame: Day 1
Descriptive Statistics for Pharmacokinetic Parameters of Formoterol by Treatment

15 secondary outcomes

Change in Mean Hematology Parameters (±SD) From Pre-dose to 12 Hours Post-dose
Time frame: 12 Hours
Change in Mean Hematology Parameters (±SD) From Pre-dose to 12 Hours Post-dose
Time frame: 12 Hours
Change in Mean Hematology Parameters (±SD) From Pre-dose to 12 Hours Post-dose
Time frame: 12 Hours
Change in Mean Hematology Parameters (±SD) From Pre-dose to 12 Hours Post-dose
Time frame: 12 Hours
Change in Mean Chemistry Parameters (±SD) From Pre-dose to 12 Hours Post-dose
Time frame: 12 hours
Change in Mean Chemistry Parameters (±SD) From Pre-dose to 12 Hours Post-dose
Time frame: 12 hours
Change in Mean Chemistry Parameters (±SD) From Pre-dose to 12 Hours Post-dose
Time frame: 12 hours
Change in Mean Glucose and Potassium Results (±SD) From Pre-dose to 12 Hours Post-dose
Time frame: 12 hours
Change in Heart Rate From Pre-dose to 12 Hours Post Dose
Time frame: 12 hours
Change in PR Interval From Pre-dose to 12 Hours Post Dose
Time frame: 12 hours
Change in QRS Axis From Pre-dose to 12 Hours Post Dose
Time frame: 12 hours
Change in QRS Duration From Pre-dose to 12 Hours Post Dose
Time frame: 12 hours
Change in QT Interval From Pre-dose to 12 Hours Post Dose
Time frame: 12 hours
Change in QTc Bazett Interval From Pre-dose to 12 Hours Post Dose
Time frame: 12 hours
Change in QTc Fridericia's Interval From Pre-dose to 12 Hours Post Dose
Time frame: 12 hours

Results and safety

Results posted to the registry on 26 Apr 2017, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Received GFF MDI 28.8/9.6 μg	24	24
Received GFF MDI 14.4/9.6 μg	23	23
Received GP MDI 28.8 μg	24	23
Received GP MDI 14.4 μg	24	24

Primary outcome: Cmax

Time frame: Day 1. Mean (Full Range). Unit: pg/mL

Measure	GFF MDI 28.8/9.6 ug n = 24	GFF MDI 14.4/9.6 ug n = 22	GP MDI 28.8 ug n = 24	GP MDI 14.4 µg n = 23
Value	15.23 (7.69)	9.09 (6.5)	16.85 (4.26)	7.26 (2.51 to 16.10)

Population analysed: Pharmacokinetic Population (includes subjects with an evaluable profile for this analyte)

Primary outcome: Cmax

Time frame: Day 1. Mean (Full Range). Unit: pg/mL

Measure	GFF MDI 28.8/9.6 ug n = 24	GFF MDI 14.4/9.6 ug n = 23
Value	10.74 (3.46)	11.99 (7.07)

Population analysed: Pharmacokinetic Population (includes subjects with an evaluable profile for this analyte)

Primary outcome: AUC 0-12

Time frame: Day 1. Mean (Full Range). Unit: h*pg/mL

Measure	GFF MDI 28.8/9.6 ug n = 24	GFF MDI 14.4/9.6 ug n = 22	GP MDI 28.8 ug n = 24	GP MDI 14.4 ug n = 23
Value	45.43 (19.43)	21.75 (9.00)	50.59 (10.75)	24.72 (7.63 to 51.06)

Population analysed: Pharmacokinetic Population (includes subjects with an evaluable profile for this analyte)

Primary outcome: AUC 0-12

Time frame: Day 1. Mean (Full Range). Unit: h*pg/mL

Measure	GFF MDI 28.8/9.6 ug n = 24	GFF MDI 14.4/9.6 ug n = 23
Value	44.15 (15.3)	42.54 (12.04)

Population analysed: Pharmacokinetic Population (includes subjects with an evaluable profile for this analyte)

20 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse Events were collected from Day 0 (Randomization visit and first dose) through Final Follow-up Visit, which is 7-14 days post final dose.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
GFF MDI 28.8/9.6 ug	0 of 24 (0%)	2 of 24 (8.3%)	Not reported
GFF MDI 14.4/9.6 ug	0 of 23 (0%)	8 of 23 (34.8%)	Not reported
GP MDI 28.8 ug	0 of 24 (0%)	4 of 24 (16.7%)	Not reported
GP MDI 14.4 µg	0 of 24 (0%)	4 of 24 (16.7%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 26 Apr 2017.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 30218695Reisner C, Miller J, DePetrillo P, Maes A, Siddiqui S, Martin UJ. Pharmacokinetics and safety of a single dose of the novel LAMA/LABA fixed-dose combination of glycopyrronium/formoterol fumarate dihydrate metered dose inhaler, formulated using co-suspension delivery technology, in Japanese healthy subjects. Pulm Pharmacol Ther. 2018 Dec;53:33-38. doi: 10.1016/j.pupt.2018.09.005. Epub 2018 Sep 13.

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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, Inc.

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

Questions about this trial

What is this clinical trial studying?

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 26 Apr 2017. 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?

Yes. Results are posted in the registry (first posted 26 Apr 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Cmax (time frame: Day 1). The study lists 18 primary outcomes in all. 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 NCT02196714, which also lists 1 linked publication.

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 26 Apr 2017.