Healthy VolunteersPhase 1NCT03772223

A Study to Compare the Pharmacokinetics of Budesonide and Albuterol Delivered by PT027 Compared With PT007 and PT008 Administered Separately.

A Phase 1 study testing Treatment A (Budesonide/Albuterol Sulfate metered dose inhaler), Treatment B (Budesonide metered dose inhaler) and Treatment C (Albuterol Sulfate metered dose inhaler) in people with Healthy Volunteers, run by AstraZeneca at 1 site in United Kingdom.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

This is a Phase 1 study to compare the pharmacokinetics of budesonide and albuterol delivered by PT027 compared with PT007 and PT008 administered separately. Read more about this study

Who is it for?: Ages 18 to 55 yearsHealthy volunteers can take part
Conditions the study is for: Healthy Volunteers
What is being tested?: Treatment A (Budesonide/Albuterol Sulfate metered dose inhaler), Treatment B (Budesonide metered dose inhaler) and Treatment C (Albuterol Sulfate metered dose inhaler)
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 91 participants
Where: 1 siteUnited Kingdom
Study dates: 21 Jan 2019to 10 May 2019
Phase: Phase 1
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 55 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

Provision of signed and dated, written informed consent prior to any study specific procedures.
Healthy male and female participants aged 18 to 55 years (inclusive) with suitable veins for cannulation or repeated venipuncture.
Females must have a negative pregnancy test at the Screening Visit and on admission to the Clinical Unit and must not be lactating.
Have a body mass index between 18 and 30 kg/m2 inclusive and weigh at least 50 kg and no more than 100 kg inclusive.
Must be able to demonstrate proper inhalation technique using the AIM device and placebo MDI at the Screening Visit.
Forced expiratory volume in 1 second in litres (FEV1) ≥ 80% of predicted value and forced vital capacity in litres (FEV1)/FVC ratio ≥ 70%.

Who cannot join

Pregnant or nursing female participants or participants who are trying to conceive.
For female participants, a positive serum human chorionic gonadotropin (hCG) test at screening or a positive urine hCG at admission for any of the 3 Treatment Periods.
History of any clinically significant disease or disorder which, in the opinion of the Principal Investigator (PI), may either put the subject at risk because of participation in the study, or influence the results or the participant's ability to participate in the study.
History or presence of gastrointestinal, hepatic or renal disease, or any other condition known to interfere with absorption, distribution, metabolism, or excretion of drugs.
Participants who have cancer that has not been in complete remission for at least 5 years.
Any history of asthma or Chronic obstructive pulmonary disease.

Show all 23Show fewer

Any clinically significant illness, medical/surgical procedure, or trauma within 4 weeks of the first administration of Investigational Medicinal Product (IMP).
Any clinically significant abnormalities in clinical chemistry, haematology, or urinalysis results, at the Screening Visit as judged by the PI.
Any clinically significant abnormal findings in vital signs at the Screening Visit, as judged by the PI.
Any clinically significant abnormalities on 12-lead electrocardiogram at the Screening Visit, as judged by the PI.
Any positive result on screening for serum hepatitis B surface antigen, hepatitis C antibody, and human immunodeficiency virus antibody.
Known or suspected history of drug abuse in the past 2 years, as judged by the PI.
Has received another new chemical entity (defined as a compound which has not been approved for marketing) within 3 months of the first administration of IMP in this study. The period of exclusion begins 3 months after the final dose or 1 month after the last visit whichever is the longest.
Plasma donation within 1 month of screening or any blood donation/loss more than 500 mL during the 3 months prior to screening.
History of severe allergy/hypersensitivity or ongoing allergy/hypersensitivity, as judged by the PI or history of hypersensitivity to drugs with a similar chemical structure or class to budesonide and albuterol sulfate.
Current smokers or those who have smoked or used nicotine products (including e cigarettes) within the 3 months prior to screening.
Positive screen for drugs of abuse, cotinine or alcohol at the Screening Visit or on each admission to the Clinical Unit.
Use of drugs with enzyme-inducing properties such as St John's Wort within 3 weeks prior to the first administration of IMP.
Use of any prescribed or non prescribed medication including antacids, analgesics (other than paracetamol/acetaminophen), herbal remedies, megadose vitamins (intake of 20 to 600 times the recommended daily dose) and minerals during the 2 weeks prior to the first administration of IMP or longer if the medication has a long half life.
Known or suspected history of alcohol or excessive intake of alcohol in the last 2 years as judged by the PI.
Involvement of any AstraZeneca, PAREXEL or study site employee or their close relatives.
Judgment by the PI that the participant should not participate in the study if they have any ongoing or recent (i.e., during the screening period) minor medical complaints that may interfere with the interpretation of study data or are considered unlikely to comply with study procedures, restrictions, and requirements.
Vulnerable participant, e.g., kept in detention, protected adults under guardianship, trusteeship, or committed to an institution by governmental or juridical order.

Trial locations and contacts

1 site in 1 country.

United Kingdom1 site

Research Site
London, HA1 3UJ

Other trials in United Kingdom

About this study

Official title: A Phase 1, Randomized, Open-label, Single-dose, 3-way Cross-over Study to Compare the Pharmacokinetics of Budesonide and Albuterol Delivered by PT027 Compared With PT007 and PT008 Administered Separately (LOGAN).

This is a Phase 1 study to compare the pharmacokinetics of budesonide and albuterol delivered by PT027 compared with PT007 and PT008 administered separately.

Read the detailed description

This study will be a randomized, 3-way cross-over study in healthy male and female participants, performed at a single study centre. A total of 90 healthy male or female participants will be randomized in this study to ensure that at least 81 participants are evaluable.

The study will comprise:

A screening period of maximum 27 days; Three treatment periods during which participants will be resident from the morning before dosing with Budesonide/Albuterol Sulfate metered dose inhaler (BDA MDI), Budesonide metered dose inhaler (BD MDI), and Albuterol Sulfate metered dose inhaler (AS MDI [Day -1]) until at least 24 hours after dosing; discharged on the morning of Day 2; and A final visit within 5 to 7 days after the last administration of BDA MDI, BD MDI, or AS MDI.

There will be a minimum washout period of 7 days between each dose administration.

Conditions: Healthy Volunteers
Being tested: Treatment A (Budesonide/Albuterol Sulfate metered dose inhaler), Treatment B (Budesonide metered dose inhaler), Treatment C (Albuterol Sulfate metered dose inhaler)
Keywords: Pharmacokinectics, Inhaled corticosteroid

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Treatment A (Budesonide/Albuterol Sulfate metered dose inhaler)Drug
Randomized participants will receive a single-dose (2 inhalations, 2 x 80/90 µg).
Treatment B (Budesonide metered dose inhaler)Drug
Randomized participants will receive a single-dose (2 inhalations, 2 x 80 µg).
Treatment C (Albuterol Sulfate metered dose inhaler)Drug
Randomized participants will receive a single-dose (2 inhalations, 2 x 90 µg).

Study groups in NCT03772223
Study group	Role	What they receive
Treatment sequence 1 (ABC)	Experimental	Participants will be randomized to each of the 6 different treatment sequences. Each treatment sequence consist of Treatment A (Budesonide/Albuterol Sulfate metered dose inhaler [BDA MDI] - PT027) , Treatment B (Budesonide metered dose inhaler [BD MDI] - PT008), and Treatment C (Albuterol Sulfate metered dose inhaler [AS MDI] - PT007). Each randomized participant will receive a single-dose (2 inhalations) on Day 1 of this Treatment Period. Receives: Drug: Treatment A (Budesonide/Albuterol Sulfate metered dose inhaler); Drug: Treatment B (Budesonide metered dose inhaler); Drug: Treatment C (Albuterol Sulfate metered dose inhaler)
Treatment sequence 2 (BCA)	Experimental	Participants will be randomized to each of the 6 different treatment sequences. Each treatment sequence consist of Treatment B (Budesonide metered dose inhaler [BD MDI] - PT008), Treatment C (Albuterol Sulfate metered dose inhaler [AS MDI] - PT007), and Treatment A (Budesonide/Albuterol Sulfate metered dose inhaler [BDA MDI] - PT027). Each randomized participant will receive a single-dose (2 inhalations) on Day 1 of this Treatment Period. Receives: Drug: Treatment A (Budesonide/Albuterol Sulfate metered dose inhaler); Drug: Treatment B (Budesonide metered dose inhaler); Drug: Treatment C (Albuterol Sulfate metered dose inhaler)
Treatment sequence 3 (CBA)	Experimental	Participants will be randomized to each of the 6 different treatment sequences. Each treatment sequence consist of Treatment C (Albuterol Sulfate metered dose inhaler [AS MDI] - PT007), Treatment B (Budesonide metered dose inhaler [BD MDI] - PT008), and Treatment A (Budesonide/Albuterol Sulfate metered dose inhaler [BDA MDI] - PT027). Each randomized participant will receive a single-dose (2 inhalations) on Day 1 of this Treatment Period. Receives: Drug: Treatment A (Budesonide/Albuterol Sulfate metered dose inhaler); Drug: Treatment B (Budesonide metered dose inhaler); Drug: Treatment C (Albuterol Sulfate metered dose inhaler)
Treatment sequence 4 (ACB)	Experimental	Participants will be randomized to each of the 6 different treatment sequences. Each treatment sequence consist of Treatment A (Budesonide/Albuterol Sulfate metered dose inhaler [BDA MDI] - PT027), Treatment C (Albuterol Sulfate metered dose inhaler [AS MDI] - PT007), and Treatment B (Budesonide metered dose inhaler [BD MDI] - PT008). Each randomized participant will receive a single-dose (2 inhalations) on Day 1 of this Treatment Period. Receives: Drug: Treatment A (Budesonide/Albuterol Sulfate metered dose inhaler); Drug: Treatment B (Budesonide metered dose inhaler); Drug: Treatment C (Albuterol Sulfate metered dose inhaler)
Treatment sequence 5 (BAC)	Experimental	Participants will be randomized to each of the 6 different treatment sequences. Each treatment sequence consist of Treatment B (Budesonide metered dose inhaler [BD MDI] - PT008), Treatment A (Budesonide/Albuterol Sulfate metered dose inhaler [BDA MDI] - PT027), and Treatment C (Albuterol Sulfate metered dose inhaler [AS MDI] - PT007). Each randomized participant will receive a single-dose (2 inhalations) on Day 1 of this Treatment Period. Receives: Drug: Treatment A (Budesonide/Albuterol Sulfate metered dose inhaler); Drug: Treatment B (Budesonide metered dose inhaler); Drug: Treatment C (Albuterol Sulfate metered dose inhaler)
Treatment sequence 6 (CAB)	Experimental	Participants will be randomized to each of the 6 different treatment sequences. Each treatment sequence consist of Treatment C (Albuterol Sulfate metered dose inhaler [AS MDI] - PT007), Treatment A (Budesonide/Albuterol Sulfate metered dose inhaler [BDA MDI] - PT027), and Treatment B (Budesonide metered dose inhaler [BD MDI] - PT008). Each randomized participant will receive a single-dose (2 inhalations) on Day 1 of this Treatment Period. Receives: Drug: Treatment A (Budesonide/Albuterol Sulfate metered dose inhaler); Drug: Treatment B (Budesonide metered dose inhaler); Drug: Treatment C (Albuterol Sulfate metered dose inhaler)

What is being measured

The primary outcome is the main question the study is designed to answer.

AUC for albuterol
To determine the area under the plasma concentration-time curve from time zero to infinity (AUC) after single dose administration of albuterol delivered via BDA MDI with BD MDI monotherapy and AS MDI monotherapy.
Measured: At Day 1 (pre-dose and 5, 15, 20, 30 and 45 minutes and 1, 2, 3, 4, 6, 8, 10 and 12 hours post dose), and Day 2 (24 hours post dose)
AUC for budesonide
To determine the AUC after single dose administration of budesonide delivered via BDA MDI with BD MDI monotherapy and AS MDI monotherapy.
Measured: At Day 1 (pre-dose and 5, 15, 20, 30 and 45 minutes and 1, 2, 3, 4, 6, 8, 10 and 12 hours post dose), and Day 2 (24 hours post dose)
AUC(0-t) for albuterol
To determine the area under the plasma concentration time curve from time zero to time of last quantifiable concentration (AUC([0-t]) after single dose administration of albuterol delivered via BDA MDI with BD MDI monotherapy and AS MDI monotherapy.
Measured: At Day 1 (pre-dose and 5, 15, 20, 30 and 45 minutes and 1, 2, 3, 4, 6, 8, 10 and 12 hours post dose), and Day 2 (24 hours post dose)
AUC(0-t) for budesonide
To determine the AUC(0-t) after single dose administration of budesonide delivered via BDA MDI with BD MDI monotherapy and AS MDI monotherapy.
Measured: At Day 1 (pre-dose and 5, 15, 20, 30 and 45 minutes and 1, 2, 3, 4, 6, 8, 10 and 12 hours post dose), and Day 2 (24 hours post dose)
Cmax for albuterol
To determine observed maximum plasma concentration (Cmax) after single dose administration of albuterol delivered via BDA MDI with BD MDI monotherapy and AS MDI monotherapy.
Measured: At Day 1 (pre-dose and 5, 15, 20, 30 and 45 minutes and 1, 2, 3, 4, 6, 8, 10 and 12 hours post dose), and Day 2 (24 hours post dose)
Cmax for budesonide
To determine Cmax after single dose administration of budesonide delivered via BDA MDI with BD MDI monotherapy and AS MDI monotherapy.
Measured: At Day 1 (pre-dose and 5, 15, 20, 30 and 45 minutes and 1, 2, 3, 4, 6, 8, 10 and 12 hours post dose), and Day 2 (24 hours post dose)

Secondary outcomes (13)

tlast for albuterol
To determine the time of last quantifiable plasma concentration (tlast) after single dose administration of albuterol delivered via BDA MDI with BD MDI monotherapy and AS MDI monotherapy.
Measured: At Day 1 (pre-dose and 5, 15, 20, 30 and 45 minutes and 1, 2, 3, 4, 6, 8, 10 and 12 hours post dose), and Day 2 (24 hours post dose)
tlast for budesonide
To determine the tlast after single dose administration of budesonide delivered via BDA MDI with BD MDI monotherapy and AS MDI monotherapy.
Measured: At Day 1 (pre-dose and 5, 15, 20, 30 and 45 minutes and 1, 2, 3, 4, 6, 8, 10 and 12 hours post dose), and Day 2 (24 hours post dose)
tmax for albuterol
To determine time to reach maximum observed plasma concentration (tmax) after single dose administration of albuterol delivered via BDA MDI with BD MDI monotherapy and AS MDI monotherapy.
Measured: At Day 1 (pre-dose and 5, 15, 20, 30 and 45 minutes and 1, 2, 3, 4, 6, 8, 10 and 12 hours post dose), and Day 2 (24 hours post dose)
tmax for budesonide
To determine tmax after single dose administration of budesonide delivered via BDA MDI with BD MDI monotherapy and AS MDI monotherapy.
Measured: At Day 1 (pre-dose and 5, 15, 20, 30 and 45 minutes and 1, 2, 3, 4, 6, 8, 10 and 12 hours post dose), and Day 2 (24 hours post dose)
t1/2λz for albuterol
To determine the time to apparent elimination half-life (t1/2λz)after single dose administration of albuterol delivered via BDA MDI with BD MDI monotherapy and AS MDI monotherapy
Measured: At Day 1 (pre-dose and 5, 15, 20, 30 and 45 minutes and 1, 2, 3, 4, 6, 8, 10 and 12 hours post dose), and Day 2 (24 hours post dose)
t1/2λz for budesonide
To determine t1/2λz after single dose administration of budesonide delivered via BDA MDI with BD MDI monotherapy and AS MDI monotherapy.
Measured: At Day 1 (pre-dose and 5, 15, 20, 30 and 45 minutes and 1, 2, 3, 4, 6, 8, 10 and 12 hours post dose), and Day 2 (24 hours post dose)
λz for albuterol
To determine the terminal elimination rate constant (λz) after single dose administration of albuterol delivered via BDA MDI with BD MDI monotherapy and AS MDI monotherapy.
Measured: At Day 1 (pre-dose and 5, 15, 20, 30 and 45 minutes and 1, 2, 3, 4, 6, 8, 10 and 12 hours post dose), and Day 2 (24 hours post dose)
λz for budesonide
To determine the λz after single dose administration of budesonide delivered via BDA MDI with BD MDI monotherapy and AS MDI monotherapy.
Measured: At Day 1 (pre-dose and 5, 15, 20, 30 and 45 minutes and 1, 2, 3, 4, 6, 8, 10 and 12 hours post dose), and Day 2 (24 hours post dose)
CL/F for albuterol
To determine the apparent total body clearance of drug from plasma after extravascular administration (CL/F) after single dose administration of albuterol delivered via BDA MDI with BD MDI monotherapy and AS MDI monotherapy.
Measured: At Day 1 (pre-dose and 5, 15, 20, 30 and 45 minutes and 1, 2, 3, 4, 6, 8, 10 and 12 hours post dose), and Day 2 (24 hours post dose)
CL/F for budesonide
To determine the CL/F after single dose administration of budesonide delivered via BDA MDI with BD MDI monotherapy and AS MDI monotherapy.
Measured: At Day 1 (pre-dose and 5, 15, 20, 30 and 45 minutes and 1, 2, 3, 4, 6, 8, 10 and 12 hours post dose), and Day 2 (24 hours post dose)
Vz/F for albuterol
To determine the apparent volume of distribution during the terminal phase after extravascular administration (Vz/F) after single dose administration of albuterol delivered via BDA MDI with BD MDI monotherapy and AS MDI monotherapy.
Measured: At Day 1 (pre-dose and 5, 15, 20, 30 and 45 minutes and 1, 2, 3, 4, 6, 8, 10 and 12 hours post dose), and Day 2 (24 hours post dose)
Vz/F for budesonide
To determine the Vz/F after single dose administration of budesonide delivered via BDA MDI with BD MDI monotherapy and AS MDI monotherapy.
Measured: At Day 1 (pre-dose and 5, 15, 20, 30 and 45 minutes and 1, 2, 3, 4, 6, 8, 10 and 12 hours post dose), and Day 2 (24 hours post dose)
Number of participants with adverse events (AEs)/serious AEs (SAEs)
To assess the safety and tolerability of BDA MDI, BD MDI, and AS MDI.
Measured: From Screening to Post-study Visit (5-7 days)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

21 Jan 201910 May 2019

First posted11 Dec 2018
Study start21 Jan 2019
Primary completion10 May 2019
Study completion10 May 2019

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Healthy VolunteersStudies of the same condition, open and under way.
More trials run by AstraZenecaThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Enrolment: 91 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03772223
Sponsor's protocol ID: D6930C00003
Status last verified: May 2019
First submitted: 10 Dec 2018
Last updated: 21 May 2019
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Undecided

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 21 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 1, Randomized, Open-label, Single-dose, 3-way Cross-over Study to Compare the Pharmacokinetics of Budesonide and Albuterol Delivered by PT027 Compared With PT007 and PT008 Administered Separately (LOGAN).
ClinicalTrials.gov ID: NCT03772223
Acronym / sponsor ID: D6930C00003
Conditions: Healthy Volunteers
Keywords: Pharmacokinectics, Inhaled corticosteroid
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 91 participants (actual)
Lead sponsor: AstraZenecaIndustry (pharma, biotech, devices)
Study start: 21 Jan 2019 (actual)
Primary completion: 10 May 2019 (actual)
Study completion: 10 May 2019 (actual)
First posted: 11 Dec 2018 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

This is a Phase 1 study to compare the pharmacokinetics of budesonide and albuterol delivered by PT027 compared with PT007 and PT008 administered separately.

Detailed description

The study will comprise:

There will be a minimum washout period of 7 days between each dose administration.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Number of arms: 6

Arm	Type	Receives
Treatment sequence 1 (ABC)	Experimental	Drug: Treatment A (Budesonide/Albuterol Sulfate metered dose inhaler), Drug: Treatment B (Budesonide metered dose inhaler), Drug: Treatment C (Albuterol Sulfate metered dose inhaler)Participants will be randomized to each of the 6 different treatment sequences. Each treatment sequence consist of Treatment A (Budesonide/Albuterol Sulfate metered dose inhaler [BDA MDI] - PT027) , Treatment B (Budesonide metered dose inhaler [BD MDI] - PT008), and Treatment C (Albuterol Sulfate metered dose inhaler [AS MDI] - PT007). Each randomized participant will receive a single-dose (2 inhalations) on Day 1 of this Treatment Period.
Treatment sequence 2 (BCA)	Experimental	Drug: Treatment A (Budesonide/Albuterol Sulfate metered dose inhaler), Drug: Treatment B (Budesonide metered dose inhaler), Drug: Treatment C (Albuterol Sulfate metered dose inhaler)Participants will be randomized to each of the 6 different treatment sequences. Each treatment sequence consist of Treatment B (Budesonide metered dose inhaler [BD MDI] - PT008), Treatment C (Albuterol Sulfate metered dose inhaler [AS MDI] - PT007), and Treatment A (Budesonide/Albuterol Sulfate metered dose inhaler [BDA MDI] - PT027). Each randomized participant will receive a single-dose (2 inhalations) on Day 1 of this Treatment Period.
Treatment sequence 3 (CBA)	Experimental	Drug: Treatment A (Budesonide/Albuterol Sulfate metered dose inhaler), Drug: Treatment B (Budesonide metered dose inhaler), Drug: Treatment C (Albuterol Sulfate metered dose inhaler)Participants will be randomized to each of the 6 different treatment sequences. Each treatment sequence consist of Treatment C (Albuterol Sulfate metered dose inhaler [AS MDI] - PT007), Treatment B (Budesonide metered dose inhaler [BD MDI] - PT008), and Treatment A (Budesonide/Albuterol Sulfate metered dose inhaler [BDA MDI] - PT027). Each randomized participant will receive a single-dose (2 inhalations) on Day 1 of this Treatment Period.
Treatment sequence 4 (ACB)	Experimental	Drug: Treatment A (Budesonide/Albuterol Sulfate metered dose inhaler), Drug: Treatment B (Budesonide metered dose inhaler), Drug: Treatment C (Albuterol Sulfate metered dose inhaler)Participants will be randomized to each of the 6 different treatment sequences. Each treatment sequence consist of Treatment A (Budesonide/Albuterol Sulfate metered dose inhaler [BDA MDI] - PT027), Treatment C (Albuterol Sulfate metered dose inhaler [AS MDI] - PT007), and Treatment B (Budesonide metered dose inhaler [BD MDI] - PT008). Each randomized participant will receive a single-dose (2 inhalations) on Day 1 of this Treatment Period.
Treatment sequence 5 (BAC)	Experimental	Drug: Treatment A (Budesonide/Albuterol Sulfate metered dose inhaler), Drug: Treatment B (Budesonide metered dose inhaler), Drug: Treatment C (Albuterol Sulfate metered dose inhaler)Participants will be randomized to each of the 6 different treatment sequences. Each treatment sequence consist of Treatment B (Budesonide metered dose inhaler [BD MDI] - PT008), Treatment A (Budesonide/Albuterol Sulfate metered dose inhaler [BDA MDI] - PT027), and Treatment C (Albuterol Sulfate metered dose inhaler [AS MDI] - PT007). Each randomized participant will receive a single-dose (2 inhalations) on Day 1 of this Treatment Period.
Treatment sequence 6 (CAB)	Experimental	Drug: Treatment A (Budesonide/Albuterol Sulfate metered dose inhaler), Drug: Treatment B (Budesonide metered dose inhaler), Drug: Treatment C (Albuterol Sulfate metered dose inhaler)Participants will be randomized to each of the 6 different treatment sequences. Each treatment sequence consist of Treatment C (Albuterol Sulfate metered dose inhaler [AS MDI] - PT007), Treatment A (Budesonide/Albuterol Sulfate metered dose inhaler [BDA MDI] - PT027), and Treatment B (Budesonide metered dose inhaler [BD MDI] - PT008). Each randomized participant will receive a single-dose (2 inhalations) on Day 1 of this Treatment Period.

Who may qualify

Ages: 18 to 55 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (6 listed)

Provision of signed and dated, written informed consent prior to any study specific procedures.
Healthy male and female participants aged 18 to 55 years (inclusive) with suitable veins for cannulation or repeated venipuncture.
Females must have a negative pregnancy test at the Screening Visit and on admission to the Clinical Unit and must not be lactating.
Have a body mass index between 18 and 30 kg/m2 inclusive and weigh at least 50 kg and no more than 100 kg inclusive.
Must be able to demonstrate proper inhalation technique using the AIM device and placebo MDI at the Screening Visit.

Key exclusion criteria (23 listed)

Pregnant or nursing female participants or participants who are trying to conceive.
For female participants, a positive serum human chorionic gonadotropin (hCG) test at screening or a positive urine hCG at admission for any of the 3 Treatment Periods.
History of any clinically significant disease or disorder which, in the opinion of the Principal Investigator (PI), may either put the subject at risk because of participation in the study, or influence the results or the participant's ability to participate in the study.
History or presence of gastrointestinal, hepatic or renal disease, or any other condition known to interfere with absorption, distribution, metabolism, or excretion of drugs.
Participants who have cancer that has not been in complete remission for at least 5 years.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Treatment A (Budesonide/Albuterol Sulfate metered dose inhaler)Randomized participants will receive a single-dose (2 inhalations, 2 x 80/90 µg).	Drug	Treatment sequence 1 (ABC), Treatment sequence 2 (BCA), Treatment sequence 3 (CBA), Treatment sequence 4 (ACB), Treatment sequence 5 (BAC), Treatment sequence 6 (CAB)
Treatment B (Budesonide metered dose inhaler)Randomized participants will receive a single-dose (2 inhalations, 2 x 80 µg).	Drug	Treatment sequence 1 (ABC), Treatment sequence 2 (BCA), Treatment sequence 3 (CBA), Treatment sequence 4 (ACB), Treatment sequence 5 (BAC), Treatment sequence 6 (CAB)
Treatment C (Albuterol Sulfate metered dose inhaler)Randomized participants will receive a single-dose (2 inhalations, 2 x 90 µg).	Drug	Treatment sequence 1 (ABC), Treatment sequence 2 (BCA), Treatment sequence 3 (CBA), Treatment sequence 4 (ACB), Treatment sequence 5 (BAC), Treatment sequence 6 (CAB)

Primary outcome

AUC for albuterol
Time frame: At Day 1 (pre-dose and 5, 15, 20, 30 and 45 minutes and 1, 2, 3, 4, 6, 8, 10 and 12 hours post dose), and Day 2 (24 hours post dose)
To determine the area under the plasma concentration-time curve from time zero to infinity (AUC) after single dose administration of albuterol delivered via BDA MDI with BD MDI monotherapy and AS MDI monotherapy.
AUC for budesonide
Time frame: At Day 1 (pre-dose and 5, 15, 20, 30 and 45 minutes and 1, 2, 3, 4, 6, 8, 10 and 12 hours post dose), and Day 2 (24 hours post dose)
To determine the AUC after single dose administration of budesonide delivered via BDA MDI with BD MDI monotherapy and AS MDI monotherapy.
AUC(0-t) for albuterol
Time frame: At Day 1 (pre-dose and 5, 15, 20, 30 and 45 minutes and 1, 2, 3, 4, 6, 8, 10 and 12 hours post dose), and Day 2 (24 hours post dose)
To determine the area under the plasma concentration time curve from time zero to time of last quantifiable concentration (AUC([0-t]) after single dose administration of albuterol delivered via BDA MDI with BD MDI monotherapy and AS MDI monotherapy.
AUC(0-t) for budesonide
Time frame: At Day 1 (pre-dose and 5, 15, 20, 30 and 45 minutes and 1, 2, 3, 4, 6, 8, 10 and 12 hours post dose), and Day 2 (24 hours post dose)
To determine the AUC(0-t) after single dose administration of budesonide delivered via BDA MDI with BD MDI monotherapy and AS MDI monotherapy.
Cmax for albuterol
Time frame: At Day 1 (pre-dose and 5, 15, 20, 30 and 45 minutes and 1, 2, 3, 4, 6, 8, 10 and 12 hours post dose), and Day 2 (24 hours post dose)
To determine observed maximum plasma concentration (Cmax) after single dose administration of albuterol delivered via BDA MDI with BD MDI monotherapy and AS MDI monotherapy.
Cmax for budesonide
Time frame: At Day 1 (pre-dose and 5, 15, 20, 30 and 45 minutes and 1, 2, 3, 4, 6, 8, 10 and 12 hours post dose), and Day 2 (24 hours post dose)
To determine Cmax after single dose administration of budesonide delivered via BDA MDI with BD MDI monotherapy and AS MDI monotherapy.

13 secondary outcomes

tlast for albuterol
Time frame: At Day 1 (pre-dose and 5, 15, 20, 30 and 45 minutes and 1, 2, 3, 4, 6, 8, 10 and 12 hours post dose), and Day 2 (24 hours post dose)
tlast for budesonide
Time frame: At Day 1 (pre-dose and 5, 15, 20, 30 and 45 minutes and 1, 2, 3, 4, 6, 8, 10 and 12 hours post dose), and Day 2 (24 hours post dose)
tmax for albuterol
Time frame: At Day 1 (pre-dose and 5, 15, 20, 30 and 45 minutes and 1, 2, 3, 4, 6, 8, 10 and 12 hours post dose), and Day 2 (24 hours post dose)
tmax for budesonide
Time frame: At Day 1 (pre-dose and 5, 15, 20, 30 and 45 minutes and 1, 2, 3, 4, 6, 8, 10 and 12 hours post dose), and Day 2 (24 hours post dose)
t1/2λz for albuterol
Time frame: At Day 1 (pre-dose and 5, 15, 20, 30 and 45 minutes and 1, 2, 3, 4, 6, 8, 10 and 12 hours post dose), and Day 2 (24 hours post dose)
t1/2λz for budesonide
Time frame: At Day 1 (pre-dose and 5, 15, 20, 30 and 45 minutes and 1, 2, 3, 4, 6, 8, 10 and 12 hours post dose), and Day 2 (24 hours post dose)
λz for albuterol
Time frame: At Day 1 (pre-dose and 5, 15, 20, 30 and 45 minutes and 1, 2, 3, 4, 6, 8, 10 and 12 hours post dose), and Day 2 (24 hours post dose)
λz for budesonide
Time frame: At Day 1 (pre-dose and 5, 15, 20, 30 and 45 minutes and 1, 2, 3, 4, 6, 8, 10 and 12 hours post dose), and Day 2 (24 hours post dose)
CL/F for albuterol
Time frame: At Day 1 (pre-dose and 5, 15, 20, 30 and 45 minutes and 1, 2, 3, 4, 6, 8, 10 and 12 hours post dose), and Day 2 (24 hours post dose)
CL/F for budesonide
Time frame: At Day 1 (pre-dose and 5, 15, 20, 30 and 45 minutes and 1, 2, 3, 4, 6, 8, 10 and 12 hours post dose), and Day 2 (24 hours post dose)
Vz/F for albuterol
Time frame: At Day 1 (pre-dose and 5, 15, 20, 30 and 45 minutes and 1, 2, 3, 4, 6, 8, 10 and 12 hours post dose), and Day 2 (24 hours post dose)
Vz/F for budesonide
Time frame: At Day 1 (pre-dose and 5, 15, 20, 30 and 45 minutes and 1, 2, 3, 4, 6, 8, 10 and 12 hours post dose), and Day 2 (24 hours post dose)
Number of participants with adverse events (AEs)/serious AEs (SAEs)
Time frame: From Screening to Post-study Visit (5-7 days)

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 21 May 2019.
Individual participant dataSharing planned: Undecided

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Pablo Forte Soto principal investigator

Parexel

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 21 May 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

AUC for albuterol (time frame: At Day 1 (pre-dose and 5, 15, 20, 30 and 45 minutes and 1, 2, 3, 4, 6, 8, 10 and 12 hours post dose), and Day 2 (24 hours post dose)). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03772223.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 May 2019.