Pharmacokinetics and Safety Study of PT010 and PT003 in Healthy Chinese Adult Subjects
NCT ID: NCT03075267
Last Updated: 2021-01-19
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE1
96 participants
INTERVENTIONAL
2017-04-17
2017-09-05
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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PT010 (BGF MDI) 320/14.4/9.6 µg
PT010 Budesonide, Glycopyrronium and Formoterol Fumurate Metered Dose Inhaler (BGF MDI) 320/14.4/9.6 µg
PT010 (BGF MDI) 320/14.4/9.6 µg
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 µg
PT010 (BGF MDI) 160/14.4/9.6 µg
PT010 (BGF MDI) 160/14.4/9.6 µg
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 µg
PT003 (GFF MDI) 14.4/9.6 µg
PT003 (GFF MDI) 14.4/9.6 µg
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.
Interventions
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PT010 (BGF MDI) 320/14.4/9.6 µg
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 µg
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 µg
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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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.
Exclusion Criteria
* 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
* 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
18 Years
45 Years
ALL
Yes
Sponsors
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Pearl Therapeutics, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Paul M. Dorinsky, MD
Role: STUDY_DIRECTOR
Pearl Therapeutics
Locations
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Research Site
Shanghai, , China
Countries
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References
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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.
Chen 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.
Provided Documents
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Document Type: Statistical Analysis Plan
Document Type: Study Protocol
Related Links
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Other Identifiers
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PT010010
Identifier Type: -
Identifier Source: org_study_id
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