Clinical trial NCT02189304: Pharmacokinetics and Safety Study of PT010 in Healthy Subjects
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: COPD
Keywords: Healthy volunteers
Lead sponsor: Pearl Therapeutics, Inc.
Sponsor class: INDUSTRY
First posted: 2014-07-14
Enrollment: 59
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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


Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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
* 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

Primary outcomes:
measure: Overall Safety of PT010, PT009 and Symbicort Turbohaler
timeFrame: 12 hours post dose
Secondary outcomes:
measure: ◦Maximum plasma concentration (Cmax) of PT010, PT009 and Symbicort Turbohaler
timeFrame: 12 Hour post dose
measure: ◦Area under the curve from 0 to 12 hours (AUC0 12) of PT010, PT009 and Symbicort Turbohaler
timeFrame: 12 Hour post dose
measure: ◦Area under the curve from 0 to the time of the last measureable plasma concentration (AUC0 t) of PT010, PT009 and Symbicort Turbohaler
timeFrame: 12 Hour post dose
measure: ◦Area under the curve from 0 extrapolated to infinity (AUC0-∞) of PT010, PT009, and Symbicort Turbohaler
timeFrame: 12 Hour post dose
measure: ◦Time to maximum plasma concentration (tmax) of PT010, PT009, and Symbicort Turbohaler
timeFrame: 12 Hour post dose
measure: ◦Apparent terminal elimination half life (t½) of PT010, PT009, and Symbicort Turbohaler
timeFrame: 12 Hour post dose
measure: ◦Apparent total body clearance (CL/F) of PT010, PT009, and Symbicort Turbohaler
timeFrame: 12 Hour post dose
measure: ◦Apparent volume of distribution (Vd/F) of PT010, PT009, and Symbicort Turbohaler
timeFrame: 12 Hour post dose
measure: ◦Termination elimination rate constant (λz) of PT010, PT009, and Symbicort Turbohaler
timeFrame: 12 Hour post dose
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: SNBL Clinical Pharmacology Center
state: Maryland
Study officials:
affiliation: Pearl Therapeutics
name: Chadwick Orevillo
role: STUDY_CHAIR
References:
citation: 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.
citation: 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.