Pharmacokinetics and Safety Study of PT010 in Healthy Subjects

NCT02189304 | Completed Phase 1 FDA Drug

• 1 other identifier: PT010002-00
• Study Type: interventional
• Target: 59
• Locations: 1 country
• Sites: 1

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.

Conditions

COPD

Keywords

Healthy volunteers

Outcome Measures

Primary Outcomes (1)

• Overall Safety of PT010, PT009 and Symbicort Turbohaler

  The safety of PT010 and PT009 and Symbicort Turbohaler will be assessed based on physical examination, adverse events, vital signs, clinical laboratory values, and electrocardiogram

  12 hours post dose

Secondary Outcomes (9)

• ◦Maximum plasma concentration (Cmax) of PT010, PT009 and Symbicort Turbohaler

  12 Hour post dose

• ◦Area under the curve from 0 to 12 hours (AUC0 12) of PT010, PT009 and Symbicort Turbohaler

  12 Hour post dose

• ◦Area under the curve from 0 to the time of the last measureable plasma concentration (AUC0 t) of PT010, PT009 and Symbicort Turbohaler

  12 Hour post dose

• ◦Area under the curve from 0 extrapolated to infinity (AUC0-∞) of PT010, PT009, and Symbicort Turbohaler

  12 Hour post dose

• ◦Time to maximum plasma concentration (tmax) of PT010, PT009, and Symbicort Turbohaler

  12 Hour post dose

Study Arms (3)

PT010

EXPERIMENTAL

PT010; Budesonide, Glycopyrrolate, and Formoterol Fumarate Inhalation Aerosol. Administered as 2 inhalations

Drug: PT009; Drug: Symbicort Turbohaler

PT009

EXPERIMENTAL

PT009; Budesonide and Formoterol Fumarate Inhalation Aerosol. Administered as 2 inhalations

Drug: PT010; Drug: Symbicort Turbohaler

Symbicort Turbohaler

ACTIVE COMPARATOR

Symbicort Turbohaler; Budesonide and Formoterol Fumarate Inhalation Powder taken as 2 inhalations

Drug: PT010; Drug: PT009

Interventions

PT010 DRUG

PT010; Budesonide, Glycopyrrolate, and Formoterol Fumarate Inhalation Aerosol. Administered as 2 inhalations

Also known as: PT010; Budesonide, Glycopyrrolate, and Formoterol Fumarate Inhalation Aerosol

PT009; Symbicort Turbohaler

PT009 DRUG

PT009 administered as 2 inhalations

Also known as: PT009; Budesonide and Formoterol Fumarate Inhalation Aerosol. Administered as 2 inhalations

PT010; Symbicort Turbohaler

Symbicort Turbohaler DRUG

Symbicort Turbohaler taken as 2 inhalations

Also known as: Symbicort Turbohaler; Budesonide and Formoterol Fumarate Inhalation Powder

PT009; PT010

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Pearl Therapeutics, Inc.: lead

Study Sites (1)

SNBL Clinical Pharmacology Center

Baltimore, Maryland, 21201, United States

Location

Related Publications (2)

• 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.

  PMID: 33152467 DERIVED

• 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.

  PMID: 29901860 DERIVED

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

Budesonide; Glycopyrrolate

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Pregnenediones; Pregnenes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Quaternary Ammonium Compounds; Amines; Organic Chemicals; Onium Compounds; Pyrrolidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Chadwick Orevillo

  Pearl Therapeutics

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 9, 2014
• First Posted: July 14, 2014
• Study Start: June 1, 2014
• Primary Completion: September 1, 2014
• Study Completion: September 1, 2014
• Last Updated: June 13, 2018

Record last verified: 2018-06

Locations

US (1)