COPDPhase 1NCT02197975
Randomized, Crossover Safety and Pharmacokinetics Study of PT010
A Phase 1 study testing PT010 Dose 1 and PT010 Dose 2 in people with COPD, run by Pearl Therapeutics, Inc. at 1 site in United States.
Trial summary
Safety and Pharmacokinetics of Two Doses of PT010 in Healthy Adult Subjects of Japanese Descent Following a Single Dose and After Chronic Dosing for 7 Days. 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 Dose 1 and PT010 Dose 2
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2014to Oct 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 first generation Japanese subjects 18 to 55 years, inclusive
- Body weight ≥50 kg (110 lbs) at the Screening Visit and body mass index between 18.5 and 32 kg/m2, 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
About this study
Official title: A Phase I, Randomized, Double Blind, Placebo-Controlled, Two Period, Ascending Dose, Crossover Study to Assess the Safety and Pharmacokinetics of Two Doses of PT010 in Healthy Adult Subjects of Japanese Descent Following a Single Dose and After Chronic Dosing for 7 Days
Safety and Pharmacokinetics of Two Doses of PT010 in Healthy Adult Subjects of Japanese Descent Following a Single Dose and After Chronic Dosing for 7 Days.
Read the detailed description
This is a Phase I, single-center, randomized, double-blind, placebo-controlled, two period, ascending dose, cross-over study to assess safety and PK of two doses of PT010 in healthy adult subjects of Japanese descent. Safety and PK will be assessed following a single dose and during twice-daily (BID) chronic dosing for 7 days.
- Conditions
- COPD
- Being tested
- PT010 Dose 1, PT010 Dose 2, Placebo MDI
- 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.
PT010 Dose 1Drug
PT010 Dose 1; Budesonide, Glycopyrrolate, and Formoterol Fumarate (BGF) Inhalation Aerosol. Administered as 2 inhalations.
PT010 Dose 2Drug
PT010 Dose 2; Budesonide, Glycopyrrolate, and Formoterol Fumarate (BGF) Inhalation Aerosol. Administered as 2 inhalations.
Placebo MDIDrug
Placebo MDI. Administered as 2 inhalations
| Study group | Role | What they receive |
|---|---|---|
| PT010 Dose 1 | Experimental | PT010 Dose 1; Budesonide, Glycopyrrolate, and Formoterol Fumarate (BGF) Inhalation Aerosol. Administered as 2 inhalations. Receives: Drug: PT010 Dose 1 |
| PT010 Dose 2 | Experimental | PT010 Dose 2; Budesonide, Glycopyrrolate, and Formoterol Fumarate (BGF) Inhalation Aerosol. Administered as 2 inhalations. Receives: Drug: PT010 Dose 2 |
| Placebo MDI | Placebo comparator | Placebo MDI. Administered as 2 inhalations Receives: Drug: Placebo MDI |
What is being measured
The primary outcome is the main question the study is designed to answer.
The pharmacokinetic profile of PT010
The pharmacokinetic profile of PT010 will be assessed at the first day (Day 1) and last dose (Day 8) in each Treatment Period based on:
- maximum plasma concentration (Cmax)
- area under the plasma concentration-time curve from 0 to 12 hours (AUC0 12)
- area under the plasma concentration-time curve from 0 to the time of the last measureable plasma concentration (AUC0-t)
- area under the plasma concentration-time curve from 0 extrapolated to infinity (AUC0-∞) (only calculated for Day 1)
- time to maximum plasma concentration (tmax)
- apparent terminal elimination half-life (t½)
- apparent total body clearance (CL/F)
- apparent volume of distribution (Vd/F)
- terminal elimination rate constant (λz)
- accumulation ratio for Cmax (RAC [Cmax])
- accumulation ratio for AUC0 12 (RAC [AUC0 12]) Other PK parameters may be calculated, as appropriate.
Measured: 12 hours
Secondary outcomes (1)
Overall safety of PT010
The safety associated with the use of PT010 will be assessed from physical examination findings, adverse event (AE) reporting, vital signs, clinical laboratory values, and findings from 12 lead electrocardiograms (ECGs).
Measured: 12 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2014 (estimated)
- Study startAug 2014
- Primary completionOct 2014
- Study completionOct 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pearl Therapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Chadwick Orevillo, Study chair, Pearl Therapeutics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02197975
- Sponsor's protocol ID
- PT010003-00
- Status last verified
- Oct 2014
- First submitted
- 21 Jul 2014
- Last updated
- 28 Oct 2014
- Results posted
- No
- Data monitoring committee
- 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
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I, Randomized, Double Blind, Placebo-Controlled, Two Period, Ascending Dose, Crossover Study to Assess the Safety and Pharmacokinetics of Two Doses of PT010 in Healthy Adult Subjects of Japanese Descent Following a Single Dose and After Chronic Dosing for 7 Days
- ClinicalTrials.gov ID
- NCT02197975
- Acronym / sponsor ID
- PT010003-00
- Conditions
- COPD
- Keywords
- Healthy Volunteers
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Pearl Therapeutics, Inc.Industry (pharma, biotech, devices)
- Study start
- Aug 2014
- Primary completion
- Oct 2014 (actual)
- Study completion
- Oct 2014 (actual)
- First posted
- 23 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.
Safety and Pharmacokinetics of Two Doses of PT010 in Healthy Adult Subjects of Japanese Descent Following a Single Dose and After Chronic Dosing for 7 Days.
Detailed description
This is a Phase I, single-center, randomized, double-blind, placebo-controlled, two period, ascending dose, cross-over study to assess safety and PK of two doses of PT010 in healthy adult subjects of Japanese descent. Safety and PK will be assessed following a single dose and during twice-daily (BID) chronic dosing for 7 days.
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 Dose 1 | Experimental | Drug: PT010 Dose 1PT010 Dose 1; Budesonide, Glycopyrrolate, and Formoterol Fumarate (BGF) Inhalation Aerosol. Administered as 2 inhalations. |
| PT010 Dose 2 | Experimental | Drug: PT010 Dose 2PT010 Dose 2; Budesonide, Glycopyrrolate, and Formoterol Fumarate (BGF) Inhalation Aerosol. Administered as 2 inhalations. |
| Placebo MDI | Placebo comparator | Drug: Placebo MDIPlacebo MDI. Administered as 2 inhalations |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Informed Consent Form (ICF) prior to any study related procedures
- Male and female subjects first generation Japanese subjects 18 to 55 years, inclusive
- Body weight ≥50 kg (110 lbs) at the Screening Visit and body mass index between 18.5 and 32 kg/m2, inclusive
- Good general health
- Medically acceptable contraception for women of child-bearing potential and males with female partners of childbearing potential
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 |
|---|---|---|
| PT010 Dose 1PT010 Dose 1; Budesonide, Glycopyrrolate, and Formoterol Fumarate (BGF) Inhalation Aerosol. Administered as 2 inhalations. | Drug | PT010 Dose 1 |
| PT010 Dose 2PT010 Dose 2; Budesonide, Glycopyrrolate, and Formoterol Fumarate (BGF) Inhalation Aerosol. Administered as 2 inhalations. | Drug | PT010 Dose 2 |
| Placebo MDIPlacebo MDI. Administered as 2 inhalations | Drug | Placebo MDI |
Primary outcome
The pharmacokinetic profile of PT010
Time frame: 12 hours
The pharmacokinetic profile of PT010 will be assessed at the first day (Day 1) and last dose (Day 8) in each Treatment Period based on: * maximum plasma concentration (Cmax) * area under the plasma concentration-time curve from 0 to 12 hours (AUC0 12) * area under the plasma concentration-time curve from 0 to the time of the last measureable plasma concentration (AUC0-t) * area under the plasma concentration-time curve from 0 extrapolated to infinity (AUC0-∞) (only calculated for Day 1) * time to maximum plasma concentration (tmax) * apparent terminal elimination half-life (t½) * apparent total body clearance (CL/F) * apparent volume of distribution (Vd/F) * terminal elimination rate constant (λz) * accumulation ratio for Cmax (RAC [Cmax]) * accumulation ratio for AUC0 12 (RAC [AUC0 12]) Other PK parameters may be calculated, as appropriate.
1 secondary outcome
Overall safety of PT010
Time frame: 12 hours
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 28 Oct 2014.
- 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.
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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 Dose 1 and PT010 Dose 2 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 6 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 28 Oct 2014. 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. Some participants in this study may receive a placebo. 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?
The pharmacokinetic profile of PT010 (time frame: 12 hours). 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 NCT02197975, 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 28 Oct 2014.