A Randomized, Open-label, Single-dose, Single-center, Crossover Study in Healthy Subjects to Assess the Relative Bioavailability of PT010

Chronic Obstructive Pulmonary Disease Clinical Trial

Official title:

A Randomized, Open-label, Single-dose, Single-center, Crossover Study in Healthy Subjects to Assess the Relative Bioavailability of PT010 Administered With and Without a Spacer, and With and Without Oral Charcoal

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03311373
• Other study ID #: PT010011
• Status: Completed
• Phase: Phase 1
• Start date: October 17, 2017
• Est. completion date: December 15, 2017

Study information

• Verified date: June 2020
• Source: Pearl Therapeutics, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Randomized, Open-label, Single-dose, Single-center, Crossover Study in Healthy Subjects to Assess the Relative Bioavailability of PT010

Description:

A Randomized, Open-label, Single-dose, Single-center, Crossover Study in Healthy Subjects to Assess the Relative Bioavailability of PT010 Administered With and Without a Spacer, and With and Without Oral Charcoal

Recruitment information / eligibility

• Status: Completed
• Enrollment: 56
• Est. completion date: December 15, 2017
• Est. primary completion date: December 15, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 40 Years

Eligibility

Key Inclusion Criteria:

• Signed and dated Independent Ethics Committee (IEC)/Institutional Review Board (IRB)-approved Informed Consent Form (ICF) before any protocol-specific screening procedures are performed

• Male and female subjects 18 to 40 years of age, inclusive

• Be in good general health as determined by a thorough medical history and physical examination, ECG, vital signs, and clinical laboratory evaluation

• Non-childbearing potential (ie, physiologically incapable of becoming pregnant, including any female who is 2 years post-menopausal, or surgically sterile

• Male subjects who are sexually active must agree to use a double-barrier method of contraception (condom with spermicide) from the first dose of randomized study drug until 2 weeks after their last dose, and must not donate sperm during their study participation period

• Screening laboratory tests must be within normal range or determined to not be clinically significant by the Investigator.

• Demonstrate correct MDI administration technique

Key Exclusion Criteria:

• For female subjects, a positive serum human chorionic gonadotropin (hCG) test at screening or a positive urine hCG at admission for any of the 4 Treatment Periods

• 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 who have cancer that has not been in complete remission for at least 5 years

• Male subjects with a trans-urethral resection of the prostate or full resection of the prostate within 6 months prior to screening

• Subjects with bladder neck obstruction or urinary retention that is clinically significant in the opinion of the Investigator

• History of substance-related disorders (with the exception of caffeine-related and nicotine-related disorders) within 1 year of screening

• History of smoking or the use of nicotine-containing products within 3 months of screening by self-reporting

• A positive alcohol breathalyzer or urine drug screen for drugs of abuse at screening or at the beginning of each Treatment Period

• Treatment with any prescription or non-prescription drugs including vitamins, herbal, and dietary supplements for 28 days or 5 half-lives, whichever is longer, before study drug use

• Treatment with an investigational drug within 30 days or 5 half-lives (whichever is longer) prior to the beginning of the screening Period

• Subjects with any flu-like syndrome or other respiratory infections within 2 weeks of drug administration or who have been vaccinated with an attenuated live virus within 4 weeks of drug administration

• Any other condition and/or situation that causes the Investigator to deem a subject unsuitable for the study (eg, inability to medically tolerate the study procedures, or a subject's unwillingness to comply with study-related procedures)

Related Conditions & MeSH terms

• Chronic Obstructive Pulmonary Disease
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

Intervention

Drug:
• Regimen A
2 inhalations BGF MDI; no spacer device; no oral charcoal - reference formulation/total systemic exposure
• Regimen B
2 inhalations BGF MDI; AeroChamber Plus Flow-Vu spacer device; no oral charcoal - test formulation/total systemic exposure
• Regimen C
2 inhalations BGF MDI; no spacer device; with oral charcoal - reference formulation/lung exposure
• Regimen D
2 inhalations BGF MDI; AeroChamber Plus Flow-Vu spacer device; with oral charcoal - test formulation/lung exposure

Locations

Country	Name	City	State
United States	Pearl Investigative Site	Baltimore	Maryland

Sponsors (1)

Lead Sponsor	Collaborator
Pearl Therapeutics, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maximum Plasma Concentration (Cmax)-Budesonide	Maximum plasma concentration (Cmax) per Regimen	Pre-dose and 2, 6, 20, 40 min, 1, 2, 4, 8, 12 and 24 h post-dose
Primary	Maximum Plasma Concentration (Cmax)-Glycopyrronium	Maximum plasma concentration (Cmax) per Regimen	Pre-dose and 2, 6, 20, 40 min, 1, 2, 4, 8, 12 and 24 h post-dose
Primary	Maximum Plasma Concentration (Cmax)-Formoterol	Maximum plasma concentration (Cmax) per Regimen	Pre-dose and 2, 6, 20, 40 min, 1, 2, 4, 8, 12 and 24 h post-dose
Primary	Area Under the Plasma Concentration-time Curve From 0 the Time of the Last Measurable Plasma Concentration (AUC0-tlast)-Budesonide	Each treatment period is equal to assigned regimen	Pre-dose and 2, 6, 20, 40 min, 1, 2, 4, 8, 12 and 24 h post-dose
Primary	Area Under the Plasma Concentration-time Curve From 0 the Time of the Last Measurable Plasma Concentration (AUC0-tlast)-Glycopyrronium	Each treatment period is equal to assigned regimen	Pre-dose and 2, 6, 20, 40 min, 1, 2, 4, 8, 12 and 24 h post-dose
Primary	Area Under the Plasma Concentration-time Curve From 0 the Time of the Last Measurable Plasma Concentration (AUC0-tlast)-Formoterol	Each treatment period is equal to assigned regimen	Pre-dose and 2, 6, 20, 40 min, 1, 2, 4, 8, 12 and 24 h post-dose
Secondary	Time to Maximum Plasma Concentration (Tmax)-Budesonide	Each treatment period is equal to assigned regimen	Pre-dose and 2, 6, 20, 40 min, 1, 2, 4, 8, 12 and 24 h post-dose
Secondary	Time to Maximum Plasma Concentration (Tmax)-Glycopyrronium	Each treatment period is equal to assigned regimen	Pre-dose and 2, 6, 20, 40 min, 1, 2, 4, 8, 12 and 24 h post-dose
Secondary	Time to Maximum Plasma Concentration (Tmax)-Formoterol	Each treatment period is equal to assigned regimen	Pre-dose and 2, 6, 20, 40 min, 1, 2, 4, 8, 12 and 24 h post-dose
Secondary	Area Under the Plasma Concentration-time Curve From 0 Extrapolated to Infinity (AUC0-8);-Budesonide	Each treatment period is equal to assigned regimen	Pre-dose and 2, 6, 20, 40 min, 1, 2, 4, 8, 12 and 24 h post-dose
Secondary	Area Under the Plasma Concentration-time Curve From 0 Extrapolated to Infinity (AUC0-8);-Glycopyrronium	Each treatment period is equal to assigned regimen	Pre-dose and 2, 6, 20, 40 min, 1, 2, 4, 8, 12 and 24 h post-dose
Secondary	Area Under the Plasma Concentration-time Curve From 0 Extrapolated to Infinity (AUC0-8);-Formoterol	Each treatment period is equal to assigned regimen	24 hrs

External Links

•   Related Info
•   Related Info