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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

56 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-10-17

Study Completion Date

2017-12-15

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Randomized, Crossover Safety and Pharmacokinetics Study of PT010

NCT02197975

COPD

COMPLETED PHASE1

Clinical Pharmacology Study to Evaluate the Total Systemic Exposure and Lung Bioavailability of CHF 5993 pMDI Combination in Healthy Volunteers

NCT02359292

Asthma

COMPLETED PHASE1

Study to Assess the Safety and Tolerability of PT010, PT009 and PT003 in Subjects With Moderate to Very Severe Chronic Obstructive Pulmonary Disease

NCT02536508

COPD

COMPLETED PHASE3

Pharmacokinetics and Safety Study of PT010 and PT003 in Healthy Chinese Adult Subjects

NCT03075267

Chronic Obstructive Pulmonary Disease

COMPLETED PHASE1

Study to Evaluate the Treatment Effect of PT003 on Cardiovascular Hemodynamics in Subjects With Moderate to Severe COPD

NCT02685293

COPD

TERMINATED PHASE3

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Chronic Obstructive Pulmonary Disease

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Treatment Period 1

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

Group Type EXPERIMENTAL

Regimen A

Intervention Type DRUG

2 inhalations BGF MDI; no spacer device; no oral charcoal - reference formulation/total systemic exposure

Regimen B

Intervention Type DRUG

2 inhalations BGF MDI; AeroChamber Plus Flow-Vu spacer device; no oral charcoal - test formulation/total systemic exposure

Regimen C

Intervention Type DRUG

2 inhalations BGF MDI; no spacer device; with oral charcoal - reference formulation/lung exposure

Regimen D

Intervention Type DRUG

2 inhalations BGF MDI; AeroChamber Plus Flow-Vu spacer device; with oral charcoal - test formulation/lung exposure

Treatment Period 2

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

Group Type EXPERIMENTAL

Regimen A

Intervention Type DRUG

2 inhalations BGF MDI; no spacer device; no oral charcoal - reference formulation/total systemic exposure

Regimen B

Intervention Type DRUG

2 inhalations BGF MDI; AeroChamber Plus Flow-Vu spacer device; no oral charcoal - test formulation/total systemic exposure

Regimen C

Intervention Type DRUG

2 inhalations BGF MDI; no spacer device; with oral charcoal - reference formulation/lung exposure

Regimen D

Intervention Type DRUG

2 inhalations BGF MDI; AeroChamber Plus Flow-Vu spacer device; with oral charcoal - test formulation/lung exposure

Treatment Period 3

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

Group Type EXPERIMENTAL

Regimen A

Intervention Type DRUG

2 inhalations BGF MDI; no spacer device; no oral charcoal - reference formulation/total systemic exposure

Regimen B

Intervention Type DRUG

2 inhalations BGF MDI; AeroChamber Plus Flow-Vu spacer device; no oral charcoal - test formulation/total systemic exposure

Regimen C

Intervention Type DRUG

2 inhalations BGF MDI; no spacer device; with oral charcoal - reference formulation/lung exposure

Regimen D

Intervention Type DRUG

2 inhalations BGF MDI; AeroChamber Plus Flow-Vu spacer device; with oral charcoal - test formulation/lung exposure

Treatment Period 4

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

Group Type EXPERIMENTAL

Regimen A

Intervention Type DRUG

2 inhalations BGF MDI; no spacer device; no oral charcoal - reference formulation/total systemic exposure

Regimen B

Intervention Type DRUG

2 inhalations BGF MDI; AeroChamber Plus Flow-Vu spacer device; no oral charcoal - test formulation/total systemic exposure

Regimen C

Intervention Type DRUG

2 inhalations BGF MDI; no spacer device; with oral charcoal - reference formulation/lung exposure

Regimen D

Intervention Type DRUG

2 inhalations BGF MDI; AeroChamber Plus Flow-Vu spacer device; with oral charcoal - test formulation/lung exposure

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Regimen A

2 inhalations BGF MDI; no spacer device; no oral charcoal - reference formulation/total systemic exposure

Intervention Type DRUG

Regimen B

2 inhalations BGF MDI; AeroChamber Plus Flow-Vu spacer device; no oral charcoal - test formulation/total systemic exposure

Intervention Type DRUG

Regimen C

2 inhalations BGF MDI; no spacer device; with oral charcoal - reference formulation/lung exposure

Intervention Type DRUG

Regimen D

2 inhalations BGF MDI; AeroChamber Plus Flow-Vu spacer device; with oral charcoal - test formulation/lung exposure

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

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)

Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes