Chronic Obstructive Pulmonary DiseasePhase 1NCT03075267
Pharmacokinetics and Safety Study of PT010 and PT003 in Healthy Chinese Adult Subjects
A Phase 1 study testing PT010 (BGF MDI) 320/14.4/9.6 µg, PT010 (BGF MDI) 160/14.4/9.6 µg and PT003 (GFF MDI) 14.4/9.6 µg in people with Chronic Obstructive Pulmonary Disease, run by Pearl Therapeutics, Inc. at 1 site in China.
Trial summary
A study to assess the pharmacokinetics and safety of two doses of PT010 and a single dose of PT003 in healthy Chinese adult subjects Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease
- What is being tested?
- PT010 (BGF MDI) 320/14.4/9.6 µg, PT010 (BGF MDI) 160/14.4/9.6 µg and PT003 (GFF MDI) 14.4/9.6 µg
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 96 participants
- Where
- 1 siteChina
- Study dates
- 17 Apr 2017to 5 Sep 2017
- 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
- Male and female Chinese subjects 18-45 years of age
- Females of childbearing potential must agree to be abstinent or else use one of the medically acceptable forms of contraception A female whose male partner has had a vasectomy must agree to use one additional form of medically acceptable contraception.
- A male subject with female partner of child bearing potential must agree to use one additional form of medically acceptable contraception
- -Be in good general health as assessed at Screening and have no clinically significant abnormal labs at Screening.
Who cannot join
- Pregnant or nursing female subjects or subjects who are trying to conceive
- Subjects with clinically significant neurologic, cardiovascular, hepatic, renal, endocrinologic, pulmonary, hematological, psychiatric, or other medical illness that would interfere with participation in this study
- Subjects with a history of ECG abnormalities
- Subjects who have cancer that has not been in complete remission for at least 5 years
- Male subjects with symptomatic prostatic hypertrophy that is clinically significant in the opinion of the Investigator
- Male subjects with a trans-urethral resection of the prostate or full resection of the prostate within 6 months prior to Screening
Show all 16Show fewer
- Males with bladder neck obstruction or urinary retention that is clinically significant in the opinion of the Investigator
- Subjects with a diagnosis of glaucoma that in the opinion of the Investigator has not been adequately treated
- History of substance-related disorders within 1 year of Screening
- History of smoking or the use of nicotine containing products or electronic cigarettes within 3 months of Screening by self-reporting
- A positive alcohol breathalyzer or urine drug screen for drugs of abuse at the Screening Visit or at the beginning of each inpatient period
- Treatment with any prescription or non-prescription drugs (including vitamins, herbal, and dietary supplements) within 30 days
- Positivity for human immunodeficiency virus (HIV) or Hepatitis B surface antigen (HbsAg) or positive hepatitis C antibody at Screening
- Positive for Syphilis Antibody
- Subjects with any flu-like syndrome or other respiratory infections
- Recently vaccinated with an attenuated live virus
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase I, Randomized, Double-Blind, Parallel-Group, Study to Assess the Pharmacokinetics and Safety of Two Doses of PT010 and a Single Dose of PT003 in Healthy Chinese Adult Subjects Following A Single Administrations and After Chronic Administration for 7 Days
A study to assess the pharmacokinetics and safety of two doses of PT010 and a single dose of PT003 in healthy Chinese adult subjects
Read the detailed description
A Phase I, Randomized, Double-Blind, Parallel Group, Study to Assess the Pharmacokinetics and Safety of Two Doses of PT010 and a Single Dose of PT003 in Healthy Chinese Adult Subjects Following a Single Administration and After Chronic Administration for 7 Days
- Conditions
- Chronic Obstructive Pulmonary Disease
- Being tested
- PT010 (BGF MDI) 320/14.4/9.6 µg, PT010 (BGF MDI) 160/14.4/9.6 µg, PT003 (GFF MDI) 14.4/9.6 µg
- 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.
PT010 (BGF MDI) 320/14.4/9.6 µgDrug
Also called Budesonide, Glycopyrronium, Formoterol Metered Dose Inhaler
A single dose of study drug will be administered on Day 1 and BID doses will be administered Day 2 through Day 7 of the Treatment Period, with a final single administration of study drug occurring on the morning of Day 8.
PT010 (BGF MDI) 160/14.4/9.6 µgDrug
Also called Budesonide, Glycopyrronium, Formoterol Metered Dose Inhaler
A single dose of study drug will be administered on Day 1 and BID doses will be administered Day 2 through Day 7 of the Treatment Period, with a final single administration of study drug occurring on the morning of Day 8.
PT003 (GFF MDI) 14.4/9.6 µgDrug
Also called Glycopyrronium and Formoterol Fumurate Metered Dose Inhaler
A single dose of study drug will be administered on Day 1 and BID doses will be administered Day 2 through Day 7 of the Treatment Period, with a final single administration of study drug occurring on the morning of Day 8.
| Study group | Role | What they receive |
|---|---|---|
| PT010 (BGF MDI) 320/14.4/9.6 µg | Experimental | PT010 Budesonide, Glycopyrronium and Formoterol Fumurate Metered Dose Inhaler (BGF MDI) 320/14.4/9.6 µg Receives: Drug: PT010 (BGF MDI) 320/14.4/9.6 µg |
| PT010 (BGF MDI) 160/14.4/9.6 µg | Experimental | PT010 (BGF MDI) 160/14.4/9.6 µg Receives: Drug: PT010 (BGF MDI) 160/14.4/9.6 µg |
| PT003 (GFF MDI) 14.4/9.6 µg | Experimental | PT003 (GFF MDI) 14.4/9.6 µg Receives: Drug: PT003 (GFF MDI) 14.4/9.6 µg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum Plasma Concentration (Cmax) - Budesonide
Maximum plasma concentration (Cmax) of Budesonide Day 1
Measured: Day 1 Pre-dose and 2, 6, 20, 40 min, 1, 2, 4, 8, 10, 12 and 24 h post-dose
Maximum Plasma Concentration (Cmax) - Budesonide
Maximum plasma concentration (Cmax) of Budesonide Day 8
Measured: Day 8 Pre-dose -60, and 2, 6, 20, 40 min, 1, 2, 4, 8, 10, 12 and 24 h post-dose
Maximum Plasma Concentration (Cmax) - Glycopyrronium
Maximum plasma concentration (Cmax) of Glycopyrronium Day 1
Measured: Day 1 Pre-dose and 2, 6, 20, 40 min, 1, 2, 4, 8, 10, 12 and 24 h post-dose
Maximum Plasma Concentration (Cmax) - Glycopyrronium
Maximum plasma concentration (Cmax) of Glycopyrronium Day 8
Measured: Day 8 Pre-dose -60, and 2, 6, 20, 40 min, 1, 2, 4, 8, 10, 12 and 24 h post-dose
Maximum Plasma Concentration (Cmax) - Formoterol
Maximum plasma concentration (Cmax) of Formoterol Day 1
Measured: Day 1 Pre-dose and 2, 6, 20, 40 min, 1, 2, 4, 8, 10, 12 and 24 h post-dose
Maximum Plasma Concentration (Cmax) - Formoterol
Maximum plasma concentration (Cmax) of Formoterol Day 8
Measured: Day 8 Pre-dose -60, and 2, 6, 20, 40 min, 1, 2, 4, 8, 10, 12 and 24 h post-dose
Area Under the Plasma Concentration-time Curve From 0-12 Hours (AUC 0-12) - Budesonide
Area under the plasma concentration-time curve from 0-12 hours (AUC 0-12) - Budesonide Day 1
Measured: Day 1 Pre-dose and 2, 6, 20, 40 min, 1, 2, 4, 8, 10, 12 and 24 h post-dose
Area Under the Plasma Concentration-time Curve From 0-12 Hours (AUC 0-12) - Budesonide
Area under the plasma concentration-time curve from 0-12 hours (AUC 0-12) - Budesonide Day 8
Measured: Day 8
Area Under the Plasma Concentration-time Curve From 0-12 Hours (AUC 0-12) - Glycopyrronium
Area under the plasma concentration-time curve from 0-12 hours (AUC 0-12) - Glycopyrronium Day 1
Measured: Day 1
Area Under the Plasma Concentration-time Curve From 0-12 Hours (AUC 0-12) - Glycopyrronium
Area under the plasma concentration-time curve from 0-12 hours (AUC 0-12) - Glycopyrronium Day 8
Measured: Day 8
Area Under the Plasma Concentration-time Curve From 0-12 Hours (AUC 0-12) - Formoterol
Area under the plasma concentration-time curve from 0-12 hours (AUC 0-12) - Formoterol Day 1
Measured: Day 1
Area Under the Plasma Concentration-time Curve From 0-12 Hours (AUC 0-12) - Formoterol
Area under the plasma concentration-time curve from 0-12 hours (AUC 0-12) - Formoterol Day 8
Measured: Day 8
Time to Maximum Plasma Concentration (Tmax) - Budesonide
Time to maximum plasma concentration (tmax) - Budesonide Day 1
Measured: Day 1 Pre-dose and 2, 6, 20, 40 min, 1, 2, 4, 8, 10, 12 and 24 h post-dose
Time to Maximum Plasma Concentration (Tmax) - Budesonide
Time to maximum plasma concentration (tmax) - Budesonide Day 8
Measured: Day 8 Pre-dose -60, and 2, 6, 20, 40 min, 1, 2, 4, 8, 10, 12 and 24 h post-dose
Time to Maximum Plasma Concentration (Tmax) - Glycopyrronium
Time to maximum plasma concentration (tmax) - Glycopyrronium Day 1
Measured: Day 1 Pre-dose and 2, 6, 20, 40 min, 1, 2, 4, 8, 10, 12 and 24 h post-dose
Time to Maximum Plasma Concentration (Tmax) - Glycopyrronium
Time to maximum plasma concentration (tmax) - Glycopyrronium Day 8
Measured: Day 8 Pre-dose -60, and 2, 6, 20, 40 min, 1, 2, 4, 8, 10, 12 and 24 h post-dose
Time to Maximum Plasma Concentration (Tmax) - Formoterol
Time to maximum plasma concentration (tmax) - Formoterol Day 1
Measured: Day 1 Pre-dose and 2, 6, 20, 40 min, 1, 2, 4, 8, 10, 12 and 24 h post-dose
Time to Maximum Plasma Concentration (Tmax) - Formoterol
Time to maximum plasma concentration (tmax) - Formoterol Day 8
Measured: Day 8 Pre-dose -60, and 2, 6, 20, 40 min, 1, 2, 4, 8, 10, 12 and 24 h post-dose
Area Under the Plasma Concentration-time Curve From 0 to the Time of the Last Measurable Plasma Concentration (AUC 0-t) - Budesonide
Area under the plasma concentration-time curve from 0 to the time of the last measurable plasma concentration (AUC 0-t) - Budesonide Day 1
Measured: Day 1
Area Under the Plasma Concentration-time Curve From 0 to the Time of the Last Measurable Plasma Concentration (AUC 0-t) - Glycopyrronium
Area under the plasma concentration-time curve from 0 to the time of the last measurable plasma concentration (AUC 0-t) - Glycopyrronium Day 1
Measured: Day 1
Area Under the Plasma Concentration-time Curve From 0 to the Time of the Last Measurable Plasma Concentration (AUC 0-t) - Formoterol
Area under the plasma concentration-time curve from 0 to the time of the last measurable plasma concentration (AUC 0-t) - Formoterol Day 1
Measured: Day 1
Area Under the Plasma Concentration-time Curve From 0 Extrapolated to Infinity (AUC 0-∞) - Budesonide
Area under the plasma concentration-time curve from 0 extrapolated to infinity (AUC 0-∞) - Budesonide Day 1
Measured: Day 1
Area Under the Plasma Concentration-time Curve From 0 Extrapolated to Infinity (AUC 0-∞) - Glycopyrronium
Area under the plasma concentration-time curve from 0 extrapolated to infinity (AUC 0-∞) - Glycopyrronium Day 1
Measured: Day 1
Area Under the Plasma Concentration-time Curve From 0 Extrapolated to Infinity (AUC 0-∞) - Formoterol
Area under the plasma concentration-time curve from 0 extrapolated to infinity (AUC 0-∞) - Formoterol Day 1
Measured: Day 1
Elimination Half-life (t½) - Budesonide
Elimination half-life (t½) - Budesonide Day 1
Measured: Day 1 Pre-dose and 2, 6, 20, 40 min, 1, 2, 4, 8, 10, 12 and 24 h post-dose
Elimination Half-life (t½) - Glycopyrronium
Elimination half-life (t½) - Glycopyrronium Day 1
Measured: Day 1 Pre-dose and 2, 6, 20, 40 min, 1, 2, 4, 8, 10, 12 and 24 h post-dose
Elimination Half-life (t½) - Formoterol
Elimination half-life (t½) - Formoterol Day 1
Measured: Day 1 Pre-dose and 2, 6, 20, 40 min, 1, 2, 4, 8, 10, 12 and 24 h post-dose
Apparent Total Body Clearance (CL/F) - Budesonide
Apparent total body clearance (CL/F) - Budesonide Day 1
Measured: Day 1 Pre-dose and 2, 6, 20, 40 min, 1, 2, 4, 8, 10, 12 and 24 h post-dose
Apparent Total Body Clearance (CL/F) - Glycopyrronium
Apparent total body clearance (CL/F) - Glycopyrronium Day 1
Measured: Day 1 Pre-dose and 2, 6, 20, 40 min, 1, 2, 4, 8, 10, 12 and 24 h post-dose
Apparent Total Body Clearance (CL/F) - Formoterol
Apparent total body clearance (CL/F) - Formoterol Day 1
Measured: Day 1 Pre-dose and 2, 6, 20, 40 min, 1, 2, 4, 8, 10, 12 and 24 h post-dose
Apparent Volume of Distribution (Vd/F) - Budesonide
Apparent volume of distribution (Vd/F) - Budesonide - Day 1
Measured: Day 1 Pre-dose and 2, 6, 20, 40 min, 1, 2, 4, 8, 10, 12 and 24 h post-dose
Apparent Volume of Distribution (Vd/F) - Glycopyrronium
Apparent volume of distribution (Vd/F) - Glycopyrronium - Day 1
Measured: Day 1 Pre-dose and 2, 6, 20, 40 min, 1, 2, 4, 8, 10, 12 and 24 h post-dose
Apparent Volume of Distribution (Vd/F) - Formoterol
Apparent volume of distribution (Vd/F) - Formoterol - Day 1
Measured: Day 1 Pre-dose and 2, 6, 20, 40 min, 1, 2, 4, 8, 10, 12 and 24 h post-dose
Terminal Elimination Rate Constant (λz) - Budesonide
Terminal elimination rate constant (λz) - Budesonide - Day 1
Measured: Day 1 Pre-dose and 2, 6, 20, 40 min, 1, 2, 4, 8, 10, 12 and 24 h post-dose
Terminal Elimination Rate Constant (λz) - Glycopyrronium
Terminal elimination rate constant (λz) - Glycopyrronium - Day 1
Measured: Day 1 Pre-dose and 2, 6, 20, 40 min, 1, 2, 4, 8, 10, 12 and 24 h post-dose
Terminal Elimination Rate Constant (λz) - Formoterol
Terminal elimination rate constant (λz) - Formoterol - Day 1
Measured: Day 1 Pre-dose and 2, 6, 20, 40 min, 1, 2, 4, 8, 10, 12 and 24 h post-dose
Accumulation Ratio for Cmax (RAC [Cmax]) - Budesonide
Accumulation ratio for Cmax (RAC [Cmax]) - Budesonide
Measured: Day 1 Pre-dose and 2, 6, 20, 40 min, 1, 2, 4, 8, 10, 12 and 24 h post-dose and Day 8 Pre-dose -60, and 2, 6, 20, 40 min, 1, 2, 4, 8, 10, 12 and 24 h post-dose
Accumulation Ratio for Cmax (RAC [Cmax]) - Glycopyrronium
Accumulation ratio for Cmax (RAC [Cmax]) - Glycopyrronium
Measured: Day 1 Pre-dose and 2, 6, 20, 40 min, 1, 2, 4, 8, 10, 12 and 24 h post-dose and Day 8 Pre-dose -60, and 2, 6, 20, 40 min, 1, 2, 4, 8, 10, 12 and 24 h post-dose
Accumulation Ratio for Cmax (RAC [Cmax]) - Formoterol
Accumulation ratio for Cmax (RAC [Cmax]) - Formoterol
Measured: Day 1 and Day 8
Accumulation Ratio for AUC 0-12 (RAC [AUC 0-12]) - Budesonide
Accumulation ratio for AUC 0-12 (RAC [AUC 0-12]) - Budesonide
Measured: Day 1 and Day 8
Accumulation Ratio for AUC 0-12 (RAC [AUC 0-12]) - Glycopyrronium
Accumulation ratio for AUC 0-12 (RAC [AUC 0-12]) - Glycopyrronium
Measured: Day 1 and Day 8
Accumulation Ratio for AUC 0-12 (RAC [AUC 0-12]) - Formoterol
Accumulation ratio for AUC 0-12 (RAC [AUC 0-12]) - Formoterol
Measured: Day 1 and Day 8
Secondary outcomes (5)
Physical Exam Findings
Number of subjects with clinically significant changes in post baseline physical exam findings
Measured: Visit 4, Day 8
Laboratory Tests
Number of subjects with clinically significant changes in post baseline laboratory tests
Measured: Visit 4, Day 8
Electrocardiogram
Number of subjects with clinically significant changes in post baseline electrocardiogram
Measured: Visit 4, Day 8
Serious Adverse Events/Adverse Events
Number of subjects with clinically significant changes in post baseline serious TEAEs (treatment-emergent adverse events) or TEAEs leading to withdrawal
Measured: Visit 4, Day 8
Vital Signs
Number of subjects with clinically significant changes in post baseline vital signs
Measured: Visit 4, Day 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2017
- Study start17 Apr 2017
- Primary completion5 Sep 2017
- Study completion5 Sep 2017
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 (2)Papers the sponsor has linked to this study.
- Other trials for Chronic Obstructive Pulmonary DiseaseStudies 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
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 96 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pearl Therapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Paul M. Dorinsky, MD, Study director, Pearl Therapeutics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03075267
- Sponsor's protocol ID
- PT010010
- Status last verified
- Dec 2020
- First submitted
- 6 Mar 2017
- Last updated
- 19 Jan 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes
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 33152467Chen Q, Hu C, Yu H, Shen K, Assam PN, Gillen M, Liu Y, Dorinsky P. Pharmacokinetics and Tolerability of Budesonide/Glycopyrronium/Formoterol Fumarate Dihydrate and Glycopyrronium/Formoterol Fumarate Dihydrate Metered Dose Inhalers in Healthy Chinese Adults: A Randomized, Double-blind, Parallel-group Study. Clin Ther. 2019 May;41(5):897-909.e1. doi: 10.1016/j.clinthera.2019.03.007. Epub 2019 Apr 11.
PubMed 30982547
Study at a glance
From the registry record, last updated by the sponsor on 19 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I, Randomized, Double-Blind, Parallel-Group, Study to Assess the Pharmacokinetics and Safety of Two Doses of PT010 and a Single Dose of PT003 in Healthy Chinese Adult Subjects Following A Single Administrations and After Chronic Administration for 7 Days
- ClinicalTrials.gov ID
- NCT03075267
- Acronym / sponsor ID
- PT010010
- Conditions
- Chronic Obstructive Pulmonary Disease
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 96 participants (actual)
- Lead sponsor
- Pearl Therapeutics, Inc.Industry (pharma, biotech, devices)
- Study start
- 17 Apr 2017 (actual)
- Primary completion
- 5 Sep 2017 (actual)
- Study completion
- 5 Sep 2017 (actual)
- First posted
- 9 Mar 2017 (actual)
- Results
- Posted 19 Jan 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A study to assess the pharmacokinetics and safety of two doses of PT010 and a single dose of PT003 in healthy Chinese adult subjects
Detailed description
A Phase I, Randomized, Double-Blind, Parallel Group, Study to Assess the Pharmacokinetics and Safety of Two Doses of PT010 and a Single Dose of PT003 in Healthy Chinese Adult Subjects Following a Single Administration and After Chronic Administration for 7 Days
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| PT010 (BGF MDI) 320/14.4/9.6 µg | Experimental | Drug: PT010 (BGF MDI) 320/14.4/9.6 µgPT010 Budesonide, Glycopyrronium and Formoterol Fumurate Metered Dose Inhaler (BGF MDI) 320/14.4/9.6 µg |
| PT010 (BGF MDI) 160/14.4/9.6 µg | Experimental | Drug: PT010 (BGF MDI) 160/14.4/9.6 µgPT010 (BGF MDI) 160/14.4/9.6 µg |
| PT003 (GFF MDI) 14.4/9.6 µg | Experimental | Drug: PT003 (GFF MDI) 14.4/9.6 µgPT003 (GFF MDI) 14.4/9.6 µg |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Male and female Chinese subjects 18-45 years of age
- Females of childbearing potential must agree to be abstinent or else use one of the medically acceptable forms of contraception A female whose male partner has had a vasectomy must agree to use one additional form of medically acceptable contraception.
- A male subject with female partner of child bearing potential must agree to use one additional form of medically acceptable contraception
- -Be in good general health as assessed at Screening and have no clinically significant abnormal labs at Screening.
Key exclusion criteria (16 listed)
- Pregnant or nursing female subjects or subjects who are trying to conceive
- Subjects with clinically significant neurologic, cardiovascular, hepatic, renal, endocrinologic, pulmonary, hematological, psychiatric, or other medical illness that would interfere with participation in this study
- Subjects with a history of ECG abnormalities
- Subjects who have cancer that has not been in complete remission for at least 5 years
- Male subjects with symptomatic prostatic hypertrophy that is clinically significant in the opinion of the Investigator
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 |
|---|---|---|
| PT010 (BGF MDI) 320/14.4/9.6 µgAlso: Budesonide, Glycopyrronium, Formoterol Metered Dose InhalerA single dose of study drug will be administered on Day 1 and BID doses will be administered Day 2 through Day 7 of the Treatment Period, with a final single administration of study drug occurring on the morning of Day 8. | Drug | PT010 (BGF MDI) 320/14.4/9.6 µg |
| PT010 (BGF MDI) 160/14.4/9.6 µgAlso: Budesonide, Glycopyrronium, Formoterol Metered Dose InhalerA single dose of study drug will be administered on Day 1 and BID doses will be administered Day 2 through Day 7 of the Treatment Period, with a final single administration of study drug occurring on the morning of Day 8. | Drug | PT010 (BGF MDI) 160/14.4/9.6 µg |
| PT003 (GFF MDI) 14.4/9.6 µgAlso: Glycopyrronium and Formoterol Fumurate Metered Dose InhalerA single dose of study drug will be administered on Day 1 and BID doses will be administered Day 2 through Day 7 of the Treatment Period, with a final single administration of study drug occurring on the morning of Day 8. | Drug | PT003 (GFF MDI) 14.4/9.6 µg |
Primary outcome
Maximum Plasma Concentration (Cmax) - Budesonide
Time frame: Day 1 Pre-dose and 2, 6, 20, 40 min, 1, 2, 4, 8, 10, 12 and 24 h post-dose
Maximum plasma concentration (Cmax) of Budesonide Day 1
Maximum Plasma Concentration (Cmax) - Budesonide
Time frame: Day 8 Pre-dose -60, and 2, 6, 20, 40 min, 1, 2, 4, 8, 10, 12 and 24 h post-dose
Maximum plasma concentration (Cmax) of Budesonide Day 8
Maximum Plasma Concentration (Cmax) - Glycopyrronium
Time frame: Day 1 Pre-dose and 2, 6, 20, 40 min, 1, 2, 4, 8, 10, 12 and 24 h post-dose
Maximum plasma concentration (Cmax) of Glycopyrronium Day 1
Maximum Plasma Concentration (Cmax) - Glycopyrronium
Time frame: Day 8 Pre-dose -60, and 2, 6, 20, 40 min, 1, 2, 4, 8, 10, 12 and 24 h post-dose
Maximum plasma concentration (Cmax) of Glycopyrronium Day 8
Maximum Plasma Concentration (Cmax) - Formoterol
Time frame: Day 1 Pre-dose and 2, 6, 20, 40 min, 1, 2, 4, 8, 10, 12 and 24 h post-dose
Maximum plasma concentration (Cmax) of Formoterol Day 1
Maximum Plasma Concentration (Cmax) - Formoterol
Time frame: Day 8 Pre-dose -60, and 2, 6, 20, 40 min, 1, 2, 4, 8, 10, 12 and 24 h post-dose
Maximum plasma concentration (Cmax) of Formoterol Day 8
Area Under the Plasma Concentration-time Curve From 0-12 Hours (AUC 0-12) - Budesonide
Time frame: Day 1 Pre-dose and 2, 6, 20, 40 min, 1, 2, 4, 8, 10, 12 and 24 h post-dose
Area under the plasma concentration-time curve from 0-12 hours (AUC 0-12) - Budesonide Day 1
Area Under the Plasma Concentration-time Curve From 0-12 Hours (AUC 0-12) - Budesonide
Time frame: Day 8
Area under the plasma concentration-time curve from 0-12 hours (AUC 0-12) - Budesonide Day 8
Area Under the Plasma Concentration-time Curve From 0-12 Hours (AUC 0-12) - Glycopyrronium
Time frame: Day 1
Area under the plasma concentration-time curve from 0-12 hours (AUC 0-12) - Glycopyrronium Day 1
Area Under the Plasma Concentration-time Curve From 0-12 Hours (AUC 0-12) - Glycopyrronium
Time frame: Day 8
Area under the plasma concentration-time curve from 0-12 hours (AUC 0-12) - Glycopyrronium Day 8
Area Under the Plasma Concentration-time Curve From 0-12 Hours (AUC 0-12) - Formoterol
Time frame: Day 1
Area under the plasma concentration-time curve from 0-12 hours (AUC 0-12) - Formoterol Day 1
Area Under the Plasma Concentration-time Curve From 0-12 Hours (AUC 0-12) - Formoterol
Time frame: Day 8
Area under the plasma concentration-time curve from 0-12 hours (AUC 0-12) - Formoterol Day 8
Time to Maximum Plasma Concentration (Tmax) - Budesonide
Time frame: Day 1 Pre-dose and 2, 6, 20, 40 min, 1, 2, 4, 8, 10, 12 and 24 h post-dose
Time to maximum plasma concentration (tmax) - Budesonide Day 1
Time to Maximum Plasma Concentration (Tmax) - Budesonide
Time frame: Day 8 Pre-dose -60, and 2, 6, 20, 40 min, 1, 2, 4, 8, 10, 12 and 24 h post-dose
Time to maximum plasma concentration (tmax) - Budesonide Day 8
Time to Maximum Plasma Concentration (Tmax) - Glycopyrronium
Time frame: Day 1 Pre-dose and 2, 6, 20, 40 min, 1, 2, 4, 8, 10, 12 and 24 h post-dose
Time to maximum plasma concentration (tmax) - Glycopyrronium Day 1
Time to Maximum Plasma Concentration (Tmax) - Glycopyrronium
Time frame: Day 8 Pre-dose -60, and 2, 6, 20, 40 min, 1, 2, 4, 8, 10, 12 and 24 h post-dose
Time to maximum plasma concentration (tmax) - Glycopyrronium Day 8
Time to Maximum Plasma Concentration (Tmax) - Formoterol
Time frame: Day 1 Pre-dose and 2, 6, 20, 40 min, 1, 2, 4, 8, 10, 12 and 24 h post-dose
Time to maximum plasma concentration (tmax) - Formoterol Day 1
Time to Maximum Plasma Concentration (Tmax) - Formoterol
Time frame: Day 8 Pre-dose -60, and 2, 6, 20, 40 min, 1, 2, 4, 8, 10, 12 and 24 h post-dose
Time to maximum plasma concentration (tmax) - Formoterol Day 8
Area Under the Plasma Concentration-time Curve From 0 to the Time of the Last Measurable Plasma Concentration (AUC 0-t) - Budesonide
Time frame: Day 1
Area under the plasma concentration-time curve from 0 to the time of the last measurable plasma concentration (AUC 0-t) - Budesonide Day 1
Area Under the Plasma Concentration-time Curve From 0 to the Time of the Last Measurable Plasma Concentration (AUC 0-t) - Glycopyrronium
Time frame: Day 1
Area under the plasma concentration-time curve from 0 to the time of the last measurable plasma concentration (AUC 0-t) - Glycopyrronium Day 1
Area Under the Plasma Concentration-time Curve From 0 to the Time of the Last Measurable Plasma Concentration (AUC 0-t) - Formoterol
Time frame: Day 1
Area under the plasma concentration-time curve from 0 to the time of the last measurable plasma concentration (AUC 0-t) - Formoterol Day 1
Area Under the Plasma Concentration-time Curve From 0 Extrapolated to Infinity (AUC 0-∞) - Budesonide
Time frame: Day 1
Area under the plasma concentration-time curve from 0 extrapolated to infinity (AUC 0-∞) - Budesonide Day 1
Area Under the Plasma Concentration-time Curve From 0 Extrapolated to Infinity (AUC 0-∞) - Glycopyrronium
Time frame: Day 1
Area under the plasma concentration-time curve from 0 extrapolated to infinity (AUC 0-∞) - Glycopyrronium Day 1
Area Under the Plasma Concentration-time Curve From 0 Extrapolated to Infinity (AUC 0-∞) - Formoterol
Time frame: Day 1
Area under the plasma concentration-time curve from 0 extrapolated to infinity (AUC 0-∞) - Formoterol Day 1
Elimination Half-life (t½) - Budesonide
Time frame: Day 1 Pre-dose and 2, 6, 20, 40 min, 1, 2, 4, 8, 10, 12 and 24 h post-dose
Elimination half-life (t½) - Budesonide Day 1
Elimination Half-life (t½) - Glycopyrronium
Time frame: Day 1 Pre-dose and 2, 6, 20, 40 min, 1, 2, 4, 8, 10, 12 and 24 h post-dose
Elimination half-life (t½) - Glycopyrronium Day 1
Elimination Half-life (t½) - Formoterol
Time frame: Day 1 Pre-dose and 2, 6, 20, 40 min, 1, 2, 4, 8, 10, 12 and 24 h post-dose
Elimination half-life (t½) - Formoterol Day 1
Apparent Total Body Clearance (CL/F) - Budesonide
Time frame: Day 1 Pre-dose and 2, 6, 20, 40 min, 1, 2, 4, 8, 10, 12 and 24 h post-dose
Apparent total body clearance (CL/F) - Budesonide Day 1
Apparent Total Body Clearance (CL/F) - Glycopyrronium
Time frame: Day 1 Pre-dose and 2, 6, 20, 40 min, 1, 2, 4, 8, 10, 12 and 24 h post-dose
Apparent total body clearance (CL/F) - Glycopyrronium Day 1
Apparent Total Body Clearance (CL/F) - Formoterol
Time frame: Day 1 Pre-dose and 2, 6, 20, 40 min, 1, 2, 4, 8, 10, 12 and 24 h post-dose
Apparent total body clearance (CL/F) - Formoterol Day 1
Apparent Volume of Distribution (Vd/F) - Budesonide
Time frame: Day 1 Pre-dose and 2, 6, 20, 40 min, 1, 2, 4, 8, 10, 12 and 24 h post-dose
Apparent volume of distribution (Vd/F) - Budesonide - Day 1
Apparent Volume of Distribution (Vd/F) - Glycopyrronium
Time frame: Day 1 Pre-dose and 2, 6, 20, 40 min, 1, 2, 4, 8, 10, 12 and 24 h post-dose
Apparent volume of distribution (Vd/F) - Glycopyrronium - Day 1
Apparent Volume of Distribution (Vd/F) - Formoterol
Time frame: Day 1 Pre-dose and 2, 6, 20, 40 min, 1, 2, 4, 8, 10, 12 and 24 h post-dose
Apparent volume of distribution (Vd/F) - Formoterol - Day 1
Terminal Elimination Rate Constant (λz) - Budesonide
Time frame: Day 1 Pre-dose and 2, 6, 20, 40 min, 1, 2, 4, 8, 10, 12 and 24 h post-dose
Terminal elimination rate constant (λz) - Budesonide - Day 1
Terminal Elimination Rate Constant (λz) - Glycopyrronium
Time frame: Day 1 Pre-dose and 2, 6, 20, 40 min, 1, 2, 4, 8, 10, 12 and 24 h post-dose
Terminal elimination rate constant (λz) - Glycopyrronium - Day 1
Terminal Elimination Rate Constant (λz) - Formoterol
Time frame: Day 1 Pre-dose and 2, 6, 20, 40 min, 1, 2, 4, 8, 10, 12 and 24 h post-dose
Terminal elimination rate constant (λz) - Formoterol - Day 1
Accumulation Ratio for Cmax (RAC [Cmax]) - Budesonide
Time frame: Day 1 Pre-dose and 2, 6, 20, 40 min, 1, 2, 4, 8, 10, 12 and 24 h post-dose and Day 8 Pre-dose -60, and 2, 6, 20, 40 min, 1, 2, 4, 8, 10, 12 and 24 h post-dose
Accumulation ratio for Cmax (RAC [Cmax]) - Budesonide
Accumulation Ratio for Cmax (RAC [Cmax]) - Glycopyrronium
Time frame: Day 1 Pre-dose and 2, 6, 20, 40 min, 1, 2, 4, 8, 10, 12 and 24 h post-dose and Day 8 Pre-dose -60, and 2, 6, 20, 40 min, 1, 2, 4, 8, 10, 12 and 24 h post-dose
Accumulation ratio for Cmax (RAC [Cmax]) - Glycopyrronium
Accumulation Ratio for Cmax (RAC [Cmax]) - Formoterol
Time frame: Day 1 and Day 8
Accumulation ratio for Cmax (RAC [Cmax]) - Formoterol
Accumulation Ratio for AUC 0-12 (RAC [AUC 0-12]) - Budesonide
Time frame: Day 1 and Day 8
Accumulation ratio for AUC 0-12 (RAC [AUC 0-12]) - Budesonide
Accumulation Ratio for AUC 0-12 (RAC [AUC 0-12]) - Glycopyrronium
Time frame: Day 1 and Day 8
Accumulation ratio for AUC 0-12 (RAC [AUC 0-12]) - Glycopyrronium
Accumulation Ratio for AUC 0-12 (RAC [AUC 0-12]) - Formoterol
Time frame: Day 1 and Day 8
Accumulation ratio for AUC 0-12 (RAC [AUC 0-12]) - Formoterol
5 secondary outcomes
Physical Exam Findings
Time frame: Visit 4, Day 8
Laboratory Tests
Time frame: Visit 4, Day 8
Electrocardiogram
Time frame: Visit 4, Day 8
Serious Adverse Events/Adverse Events
Time frame: Visit 4, Day 8
Vital Signs
Time frame: Visit 4, Day 8
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jan 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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 30982547Chen Q, Hu C, Yu H, Shen K, Assam PN, Gillen M, Liu Y, Dorinsky P. Pharmacokinetics and Tolerability of Budesonide/Glycopyrronium/Formoterol Fumarate Dihydrate and Glycopyrronium/Formoterol Fumarate Dihydrate Metered Dose Inhalers in Healthy Chinese Adults: A Randomized, Double-blind, Parallel-group Study. Clin Ther. 2019 May;41(5):897-909.e1. doi: 10.1016/j.clinthera.2019.03.007. Epub 2019 Apr 11.
- Related InfoLink provided by the sponsor.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: Yes
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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.
Paul M. Dorinsky, MD study director
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 (BGF MDI) 320/14.4/9.6 µg, PT010 (BGF MDI) 160/14.4/9.6 µg and PT003 (GFF MDI) 14.4/9.6 µg in people with Chronic Obstructive Pulmonary Disease, run by Pearl Therapeutics, Inc. at 1 site in China.
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 4 inclusion and 16 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 19 Jan 2021. 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 China. 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 19 Jan 2021). 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?
Maximum Plasma Concentration (Cmax) - Budesonide (time frame: Day 1 Pre-dose and 2, 6, 20, 40 min, 1, 2, 4, 8, 10, 12 and 24 h post-dose). The study lists 42 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 NCT03075267, 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 19 Jan 2021.