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

Pearl Therapeutics

Status and phase: Completed; Phase 1

Conditions: Chronic Obstructive Pulmonary Disease

Treatments: Drug: Regimen C; Drug: Regimen A; Drug: Regimen B; Drug: Regimen D

Study type: Interventional

Funder types: Industry

Identifiers

NCT03311373

PT010011

Details and patient eligibility

About

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

Full 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

Enrollment: 56 patients

Sex: All

Ages: 18 to 40 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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56 participants in 4 patient groups

Treatment Period 1

Experimental group

Description:

Test Formulation (Regimen B or D) or Reference Formulation (Regimen A or C)

Treatment:

Drug: Regimen D

Drug: Regimen B

Drug: Regimen C

Drug: Regimen A

Treatment Period 2

Experimental group

Description:

Test Formulation (Regimen (B or D) or Reference Formulation (Regimen A or C)

Treatment:

Drug: Regimen D

Drug: Regimen B

Drug: Regimen C

Drug: Regimen A

Treatment Period 3

Experimental group

Description:

Test Formulation (Regimen (B or D) or Reference Formulation (Regimen A or C)

Treatment:

Drug: Regimen D

Drug: Regimen B

Drug: Regimen C

Drug: Regimen A

Treatment Period 4

Experimental group

Description:

Test Formulation (Regimen (B or D) or Reference Formulation (Regimen A or C)

Treatment:

Drug: Regimen D

Drug: Regimen B

Drug: Regimen C

Drug: Regimen A