AsthmaPhase 1NCT02648438

A Study to Assess the Bioavailability and to Compare the Pharmacokinetics of AZD7594 Inhaled Via Monodose Inhaler and Multiple-dose Dry Powder Inhalers (DPI) or Pressurized Metered-dose Inhaler (pMDI) in Healthy Male Subjects

A Phase 1 study testing AZD7594 Solution for infusion (150 μg intravenous formulation), AZD7594 Oral suspension (1200 μg oral formulation) and AZD7594 Inhalation powder (400 μg) by DPI Device 1 (monodose inhaler) in people with Asthma and Chronic Obstructive Pulmonary Disease (COPD), run by AstraZeneca at 1 site in United States.

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 an open-label,partially randomized, four-period study in healthy male subjects to assess the bioavailability and pharmacokinetics of a single dose of AZD7594 when administered intravenously, orally and inhaled via two different dry powder inhalers (DPIs) and a pressurized meter-dose inhaler (pMDI) Read more about this study

Who is it for?: Ages 18 to 45 years, men onlyHealthy volunteers can take part
Conditions the study is for: Asthma, Chronic Obstructive Pulmonary Disease (COPD)
What is being tested?: AZD7594 Solution for infusion (150 μg intravenous formulation), AZD7594 Oral suspension (1200 μg oral formulation) and AZD7594 Inhalation powder (400 μg) by DPI Device 1 (monodose inhaler)
Type of treatment: Pill or oral medicine, Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 30 participants
Where: 1 siteUnited States
Study dates: 12 Jan 2016to 1 Jun 2016
Phase: Phase 1
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 45 years
Men only
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 subjects aged 18 - 45 years with suitable veins for cannulation or repeated venipuncture.
Have a body mass index (BMI) between 18 and 30 kg/m2, inclusive, and weigh at least 50 kg.
Subjects should be willing to follow reproductive restrictions to prevent pregnancy and drug exposure of a female partner and refrain from donating sperm or fathering a child from the first day of dosing until 3 months after the last dose of investigational product.
Be able to inhale from the dry powder inhaler (DPI) devices and the pressurized metered-dose inhaler (pMDI) device according to given instructions.

Who cannot join

History of any clinically significant disease or disorder which, in the opinion of the Investigator, may either put the volunteer at risk because of participation in the study, or influence the results or the volunteer's ability to participate in the study.
History or presence of gastrointestinal (GI), hepatic or renal disease, or any other condition known to interfere with absorption, distribution, metabolism, or excretion of drugs.
Any clinically significant illness, major medical/surgical procedure, or trauma within 4 weeks of the first administration of Investigational medicinal product (IMP).
Any clinically significant abnormalities in clinical chemistry, hematology, or urinalysis results at screening and check-in, as judged by the investigator.
Any clinically significant abnormal findings in vital signs after a 5 minute rest at screening and check-in, as judged by the investigator, defined as any of the following:
Systolic blood pressure (BP) > 140 mm Hg;

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Systolic BP < 90 mm Hg;
Diastolic BP > 90 mm Hg;
Diastolic BP < 60 mm Hg; or
Heart rate < 40 or > 85 beats per minute (bpm).
Any clinically significant abnormities in physical examination or lung function, as judged by the investigator.
Any clinically significant abnormalities on 12-lead electrocardiogram (ECG) at screening and check-in, as judged by the investigator.
Any clinically important abnormalities in rhythm, conduction or morphology of resting ECG that may interfere with the interpretation of QTc (QT interval corrected) interval changes. This includes subjects with any of the following:
Clinically significant PR (PQ) (ECG interval measured from the onset of the P wave to the onset of the QRS complex) interval prolongation;
Intermittent or persistent second or third degree AV block;
Persistent or intermittent complete bundle branch block (BBB), incomplete bundle branch block (IBBB), or intraventricular conduction delay (IVCD) with QRS (ECG interval measured from the onset of the QRS complex to the J point) > 110 ms. Subjects with QRS > 110 ms but < 115 ms are acceptable if there is no evidence of, for example, ventricular hypertrophy or pre-excitation; or
Abnormal T wave morphology, particularly in the protocol defined primary lead.
Prolonged QTcF (QT interval corrected for heart rate using Fridericia's formula) > 450 msec or family history of long QT (ECG interval measured from the onset of the QRS complex to the end of the T wave) syndrome.
Known or suspected history of drug abuse, as judged by the investigator
Current smokers or those who have smoked or used nicotine products within the previous 3 months.
History of alcohol abuse or excessive intake of alcohol as judged by the investigator.
Positive screen for drugs of abuse, alcohol, and cotinine at screening or on each admission to the study center.
History of severe allergy/hypersensitivity or ongoing allergy/hypersensitivity, as judged by the investigator or history of hypersensitivity to drugs with a similar chemical structure or class to AZD7594 or to excipients.
Excessive intake of caffeine containing drinks e.g., coffee, tea, caffeine containing energy drinks and cola (in total no more than 3 cups per day).
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 vaccines, antacids, analgesics (other than paracetamol/acetaminophen), herbal remedies, vitamins and minerals during the 2 weeks prior to the first administration of IMP or longer if the medication has a long half-life. Occasional use of paracetamol/acetaminophen is allowed for minor pains and headaches (no more than 3000 mg/day).
Plasma donation within 1 month of screening or any blood donation/loss more than 500 mL during the 3 months prior to screening.
Has participated in a clinical study investigating clinical evaluation methods 1 month (or at least 5 half-lives) prior to the administration of investigational product.
Known Gilbert's syndrome, family history of Gilbert's syndrome or suspicion of Gilbert's syndrome based on liver function tests.
Any contraindication against the use of vagolytic or sympaticomimetic drugs, as judged by the investigator.
Involvement of any AstraZeneca, PAREXEL or study site employee or their close relatives.
Any positive result on screening for serum hepatitis B surface antigen (HBsAg), hepatitis C antibody and human immunodeficiency virus (HIV) antibody.
Judgment by the investigator that the subject 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 subjects, 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 States1 site

Research Site
Baltimore, Maryland

Other trials in United States

About this study

Official title: An Open Label, Partially Randomized, Four-period Study in Healthy Male Subjects to Investigate the Bioavailability and Pharmacokinetics of a Single Dose of AZD7594 When Administered Intravenously, Orally and Inhaled Via Two Different Dry Powder Inhalers (DPI) and a Pressurized Metered-dose Inhaler (pMDI)

Read the detailed description

This study is an open-label, partially randomized, 4-period, 5-treatment study in healthy male subjects, performed at a single study center. All subjects will receive the 4 of the 5 treatments. The IV infusion will be fixed as the first treatment (Period 1), the Monodose inhaler will be fixed as the second treatment (Period 2) and the oral formulation will be fixed as the fourth treatment (Period 4). During Period 3, subjects are split into 2 equal cohorts, multiple-dose DPI and pMDI.

Conditions: Asthma, Chronic Obstructive Pulmonary Disease (COPD)
Being tested: AZD7594 Solution for infusion (150 μg intravenous formulation), AZD7594 Oral suspension (1200 μg oral formulation), AZD7594 Inhalation powder (400 μg) by DPI Device 1 (monodose inhaler), AZD7594 Inhalation powder (400 μg) by DPI device 2 (multiple-dose inhaler), AZD7594 Pressurized inhalation suspension (400 μg) by pMDI
Keywords: AZD7594, Bioavailability, Healthy male subjects, Safety, Tolerability, Pharmacokinetics, Monodose inhaler, Multiple-dose dry powder inhaler
Medical subject headings: Asthma, Pulmonary Disease, Chronic Obstructive

What participants receive

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

AZD7594 Solution for infusion (150 μg intravenous formulation)Drug
Solution for infusion 0.01 mg/ml; AZD7594 150 μg IV
AZD7594 Oral suspension (1200 μg oral formulation)Drug
0.1 - 10 mg/g oral solution; AZD7594 1200 μg oral
AZD7594 Inhalation powder (400 μg) by DPI Device 1 (monodose inhaler)Drug
Inhalation powder, hard capsules 400 μg Monodose inhaler; AZD7594 400 μg by dry powder inhaler (DPI) Device 1 (Monodose inhaler)
AZD7594 Inhalation powder (400 μg) by DPI device 2 (multiple-dose inhaler)Drug
Inhalation powder, multiple-dose dry powder inhaler (DPI) 400 μg; AZD7594 400 μg by DPI Device 2 (multiple-dose DPI)
AZD7594 Pressurized inhalation suspension (400 μg) by pMDIDrug
Inhalation suspension 200 μg; AZD7594 400 μg by pressurized metered-dose inhaler (pMDI); 2 puffs x 200 μg = 400 μg

Study groups in NCT02648438
Study group	Role	What they receive
Treatment sequence 1	Experimental	Treatment Period 1:AZD7594 Solution for infusion (150 μg intravenous formulation) Treatment Period 2:AZD7594 Inhalation powder (400 μg) by dry powder inhaler (DPI) Device 1 (monodose inhaler) Treatment Period 3:AZD7594 Inhalation powder (400 μg) by DPI device 2 (multiple-dose inhaler) Treatment Period 4:AZD7594 Oral suspension (1200 μg oral formulation) Receives: Drug: AZD7594 Solution for infusion (150 μg intravenous formulation); Drug: AZD7594 Oral suspension (1200 μg oral formulation); Drug: AZD7594 Inhalation powder (400 μg) by DPI Device 1 (monodose inhaler); Drug: AZD7594 Inhalation powder (400 μg) by DPI device 2 (multiple-dose inhaler)
Treatment sequence 2	Experimental	Treatment Period 1:AZD7594 Solution for infusion (150 μg intravenous formulation) Treatment Period 2:AZD7594 Inhalation powder (400 μg) by dry powder inhaler (DPI) Device 1 (monodose inhaler) Treatment Period 3:AZD7594 Pressurized inhalation suspension (400 μg) by pressurized metered-dose inhaler (pMDI) Treatment Period 4:AZD7594 Oral suspension (1200 μg oral formulation) Receives: Drug: AZD7594 Solution for infusion (150 μg intravenous formulation); Drug: AZD7594 Oral suspension (1200 μg oral formulation); Drug: AZD7594 Inhalation powder (400 μg) by DPI Device 1 (monodose inhaler); Drug: AZD7594 Pressurized inhalation suspension (400 μg) by pMDI

What is being measured

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

Pharmacokinetics (PK) of AZD7594 Delivered by Monodose Inhaler and Multiple-dose DPI or pMDI in Terms of Pulmonary Bioavailability After Inhalation (Fpulmonary)
For oral and inhalation administrations: pre-dose (0 hour) and post-dose at 15, 30 and 45 minutes and 1.0, 2.0, 4.0, 6.0, 8.0, 12.0, 16.0, 24.0, 36.0, 48.0, 72.0 and 96.0 hours following the administration of the investigational product AZD7594. For IV administration: pre-dose (0 hour) and post-dose at 5, 10, 15 (end of infusion), 30, 45, 60 and 90 minutes and 2.0, 4.0, 6.0, 8.0, 12.0, 16.0, 48.0, 72.0 and 96.0 hours following the start of the IV infusion of the investigational product AZD7594
Measured: 0-96 hours

Secondary outcomes (6)

PK of AZD7594 Following Oral Administration by Assessment of the Absolute Systemic Bioavailability After Oral Administration (Fpo)
For oral and inhalation administrations: pre-dose (0 hour) and post-dose at 15, 30 and 45 minutes and 1.0, 2.0, 4.0, 6.0, 8.0, 12.0, 16.0, 24.0, 36.0, 48.0, 72.0 and 96.0 hours following the administration of the investigational product AZD7594. For IV administration: pre-dose (0 hour) and post-dose at 5, 10, 15 (end of infusion), 30, 45, 60 and 90 minutes and 2.0, 4.0, 6.0, 8.0, 12.0, 16.0, 48.0, 72.0 and 96.0 hours following the start of the IV infusion of the investigational product AZD7594
Measured: 0-96 hours
Observed Maximum Plasma Concentration (Cmax)
For oral and inhalation administrations: pre-dose (0 hour) and post-dose at 15, 30 and 45 minutes and 1.0, 2.0, 4.0, 6.0, 8.0, 12.0, 16.0, 24.0, 36.0, 48.0, 72.0 and 96.0 hours following the administration of the investigational product AZD7594. For IV administration: pre-dose (0 hour) and post-dose at 5, 10, 15 (end of infusion), 30, 45, 60 and 90 minutes and 2.0, 4.0, 6.0, 8.0, 12.0, 16.0, 48.0, 72.0 and 96.0 hours following the start of the IV infusion of the investigational product AZD7594
Measured: 0-96 hours
Area Under the Plasma Concentration-curve From Time Zero to Time of Last Quantifiable Concentration (AUC0-t)
For oral and inhalation administrations: pre-dose (0 hour) and post-dose at 15, 30 and 45 minutes and 1.0, 2.0, 4.0, 6.0, 8.0, 12.0, 16.0, 24.0, 36.0, 48.0, 72.0 and 96.0 hours following the administration of the investigational product AZD7594. For IV administration: pre-dose (0 hour) and post-dose at 5, 10, 15 (end of infusion), 30, 45, 60 and 90 minutes and 2.0, 4.0, 6.0, 8.0, 12.0, 16.0, 48.0, 72.0 and 96.0 hours following the start of the IV infusion of the investigational product AZD7594
Measured: 0-96 hours
Absolute Systemic Bioavailability After Inhalation (F Inhalation, Total)
For oral and inhalation administrations: pre-dose (0 hour) and post-dose at 15, 30 and 45 minutes and 1.0, 2.0, 4.0, 6.0, 8.0, 12.0, 16.0, 24.0, 36.0, 48.0, 72.0 and 96.0 hours following the administration of the investigational product AZD7594. For IV administration: pre-dose (0 hour) and post-dose at 5, 10, 15 (end of infusion), 30, 45, 60 and 90 minutes and 2.0, 4.0, 6.0, 8.0, 12.0, 16.0, 48.0, 72.0 and 96.0 hours following the start of the IV infusion of the investigational product AZD7594
Measured: 0-96 hours
Oral Bioavailability After Inhaled Treatment (F Oral)
For oral and inhalation administrations: pre-dose (0 hour) and post-dose at 15, 30 and 45 minutes and 1.0, 2.0, 4.0, 6.0, 8.0, 12.0, 16.0, 24.0, 36.0, 48.0, 72.0 and 96.0 hours following the administration of the investigational product AZD7594. For IV administration: pre-dose (0 hour) and post-dose at 5, 10, 15 (end of infusion), 30, 45, 60 and 90 minutes and 2.0, 4.0, 6.0, 8.0, 12.0, 16.0, 48.0, 72.0 and 96.0 hours following the start of the IV infusion of the investigational product AZD7594
Measured: 0-96 hours
Area Under Plasma Concentration-time Curve From Time Zero Extrapolated to Infinity (AUC)
For oral and inhalation administrations: pre-dose (0 hour) and post-dose at 15, 30 and 45 minutes and 1.0, 2.0, 4.0, 6.0, 8.0, 12.0, 16.0, 24.0, 36.0, 48.0, 72.0 and 96.0 hours following the administration of the investigational product AZD7594. For IV administration: pre-dose (0 hour) and post-dose at 5, 10, 15 (end of infusion), 30, 45, 60 and 90 minutes and 2.0, 4.0, 6.0, 8.0, 12.0, 16.0, 48.0, 72.0 and 96.0 hours following the start of the IV infusion of the investigational product AZD7594
Measured: 0-96 hours

Timeline

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

12 Jan 20161 Jun 2016

First posted7 Jan 2016 (estimated)
Study start12 Jan 2016
Primary completion1 Jun 2016
Study completion1 Jun 2016

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for AsthmaStudies 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: Basic science
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 30 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02648438
Sponsor's protocol ID: D3741C00004
Status last verified: Mar 2017
First submitted: 26 Dec 2015
Last updated: 15 Jun 2017
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

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?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 15 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: An Open Label, Partially Randomized, Four-period Study in Healthy Male Subjects to Investigate the Bioavailability and Pharmacokinetics of a Single Dose of AZD7594 When Administered Intravenously, Orally and Inhaled Via Two Different Dry Powder Inhalers (DPI) and a Pressurized Metered-dose Inhaler (pMDI)
ClinicalTrials.gov ID: NCT02648438
Acronym / sponsor ID: D3741C00004
Conditions: Asthma, Chronic Obstructive Pulmonary Disease (COPD)
Keywords: AZD7594, Bioavailability, Healthy male subjects, Safety, Tolerability, Pharmacokinetics, Monodose inhaler, Multiple-dose dry powder inhaler
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 30 participants (actual)
Lead sponsor: AstraZenecaIndustry (pharma, biotech, devices)
Study start: 12 Jan 2016 (actual)
Primary completion: 1 Jun 2016 (actual)
Study completion: 1 Jun 2016 (actual)
First posted: 7 Jan 2016 (estimated)
Results: Posted 15 Jun 2017

Clinical summary

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

Detailed description

Study design

Primary purpose: Basic science
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Treatment sequence 1	Experimental	Drug: AZD7594 Solution for infusion (150 μg intravenous formulation), Drug: AZD7594 Oral suspension (1200 μg oral formulation), Drug: AZD7594 Inhalation powder (400 μg) by DPI Device 1 (monodose inhaler), Drug: AZD7594 Inhalation powder (400 μg) by DPI device 2 (multiple-dose inhaler)Treatment Period 1:AZD7594 Solution for infusion (150 μg intravenous formulation) Treatment Period 2:AZD7594 Inhalation powder (400 μg) by dry powder inhaler (DPI) Device 1 (monodose inhaler) Treatment Period 3:AZD7594 Inhalation powder (400 μg) by DPI device 2 (multiple-dose inhaler) Treatment Period 4:AZD7594 Oral suspension (1200 μg oral formulation)
Treatment sequence 2	Experimental	Drug: AZD7594 Solution for infusion (150 μg intravenous formulation), Drug: AZD7594 Oral suspension (1200 μg oral formulation), Drug: AZD7594 Inhalation powder (400 μg) by DPI Device 1 (monodose inhaler), Drug: AZD7594 Pressurized inhalation suspension (400 μg) by pMDITreatment Period 1:AZD7594 Solution for infusion (150 μg intravenous formulation) Treatment Period 2:AZD7594 Inhalation powder (400 μg) by dry powder inhaler (DPI) Device 1 (monodose inhaler) Treatment Period 3:AZD7594 Pressurized inhalation suspension (400 μg) by pressurized metered-dose inhaler (pMDI) Treatment Period 4:AZD7594 Oral suspension (1200 μg oral formulation)

Who may qualify

Ages: 18 to 45 years
Sex: Male only
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (5 listed)

Provision of signed and dated, written informed consent prior to any study specific procedures.
Healthy male subjects aged 18 - 45 years with suitable veins for cannulation or repeated venipuncture.
Have a body mass index (BMI) between 18 and 30 kg/m2, inclusive, and weigh at least 50 kg.
Subjects should be willing to follow reproductive restrictions to prevent pregnancy and drug exposure of a female partner and refrain from donating sperm or fathering a child from the first day of dosing until 3 months after the last dose of investigational product.
Be able to inhale from the dry powder inhaler (DPI) devices and the pressurized metered-dose inhaler (pMDI) device according to given instructions.

Key exclusion criteria (34 listed)

History of any clinically significant disease or disorder which, in the opinion of the Investigator, may either put the volunteer at risk because of participation in the study, or influence the results or the volunteer's ability to participate in the study.
History or presence of gastrointestinal (GI), hepatic or renal disease, or any other condition known to interfere with absorption, distribution, metabolism, or excretion of drugs.
Any clinically significant illness, major medical/surgical procedure, or trauma within 4 weeks of the first administration of Investigational medicinal product (IMP).
Any clinically significant abnormalities in clinical chemistry, hematology, or urinalysis results at screening and check-in, as judged by the investigator.
Any clinically significant abnormal findings in vital signs after a 5 minute rest at screening and check-in, as judged by the investigator, defined as any of the following:

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
AZD7594 Solution for infusion (150 μg intravenous formulation)Solution for infusion 0.01 mg/ml; AZD7594 150 μg IV	Drug	Treatment sequence 1, Treatment sequence 2
AZD7594 Oral suspension (1200 μg oral formulation)0.1 - 10 mg/g oral solution; AZD7594 1200 μg oral	Drug	Treatment sequence 1, Treatment sequence 2
AZD7594 Inhalation powder (400 μg) by DPI Device 1 (monodose inhaler)Inhalation powder, hard capsules 400 μg Monodose inhaler; AZD7594 400 μg by dry powder inhaler (DPI) Device 1 (Monodose inhaler)	Drug	Treatment sequence 1, Treatment sequence 2
AZD7594 Inhalation powder (400 μg) by DPI device 2 (multiple-dose inhaler)Inhalation powder, multiple-dose dry powder inhaler (DPI) 400 μg; AZD7594 400 μg by DPI Device 2 (multiple-dose DPI)	Drug	Treatment sequence 1
AZD7594 Pressurized inhalation suspension (400 μg) by pMDIInhalation suspension 200 μg; AZD7594 400 μg by pressurized metered-dose inhaler (pMDI); 2 puffs x 200 μg = 400 μg	Drug	Treatment sequence 2

Primary outcome

Pharmacokinetics (PK) of AZD7594 Delivered by Monodose Inhaler and Multiple-dose DPI or pMDI in Terms of Pulmonary Bioavailability After Inhalation (Fpulmonary)
Time frame: 0-96 hours
For oral and inhalation administrations: pre-dose (0 hour) and post-dose at 15, 30 and 45 minutes and 1.0, 2.0, 4.0, 6.0, 8.0, 12.0, 16.0, 24.0, 36.0, 48.0, 72.0 and 96.0 hours following the administration of the investigational product AZD7594. For IV administration: pre-dose (0 hour) and post-dose at 5, 10, 15 (end of infusion), 30, 45, 60 and 90 minutes and 2.0, 4.0, 6.0, 8.0, 12.0, 16.0, 48.0, 72.0 and 96.0 hours following the start of the IV infusion of the investigational product AZD7594

6 secondary outcomes

PK of AZD7594 Following Oral Administration by Assessment of the Absolute Systemic Bioavailability After Oral Administration (Fpo)
Time frame: 0-96 hours
Observed Maximum Plasma Concentration (Cmax)
Time frame: 0-96 hours
Area Under the Plasma Concentration-curve From Time Zero to Time of Last Quantifiable Concentration (AUC0-t)
Time frame: 0-96 hours
Absolute Systemic Bioavailability After Inhalation (F Inhalation, Total)
Time frame: 0-96 hours
Oral Bioavailability After Inhaled Treatment (F Oral)
Time frame: 0-96 hours
Area Under Plasma Concentration-time Curve From Time Zero Extrapolated to Infinity (AUC)
Time frame: 0-96 hours

Results and safety

Results posted to the registry on 15 Jun 2017, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
IV, DPI 1, DPI 2, Oral	12	9
IV, DPI 1, pMDI, Oral	12	9
pMDI (Additional)	6	6

Primary outcome: Pharmacokinetics (PK) of AZD7594 Delivered by Monodose Inhaler and Multiple-dose DPI or pMDI in Terms of Pulmonary Bioavailability After Inhalation (Fpulmonary)

Time frame: 0-96 hours. Geometric mean (Geometric Coefficient of Variation). Unit: Percentage

Measure	400 µg DPI Device 1 n = 1	400 µg DPI Device 2 n = 1	400 µg pMDI n = 10	400 µg pMDI (Additional) n = 6
Value	27.49 (NA)	30.73 (NA)	NA (NA)	NA (NA)

Population analysed: The PK analysis set will consist of all subjects in the safety analysis set for whom at least 1 PK parameters can be calculated for at least 1 treatment period and who have no major protocol deviations thought to impact on the analysis of the PK data.

6 secondary outcomes are reported in the full results.

Adverse events

Time frame: Serious adverse events (SAEs) were collected from the signing of informed consent and AEs from check-in for the first treatment period until the final follow-up phone-call i.e., from Visit 1 to Visit 6 (Day -21 to Day 5).. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
IV Formulation	0 of 24 (0%)	2 of 24 (8.3%)	Not reported
DPI Device 1	0 of 23 (0%)	0 of 23 (0%)	Not reported
DPI Device 2	0 of 9 (0%)	2 of 9 (22.2%)	Not reported
pMDI	0 of 10 (0%)	1 of 10 (10%)	Not reported
Oral Formulation	0 of 18 (0%)	1 of 18 (5.6%)	Not reported
pMDI (Additional)	0 of 6 (0%)	1 of 6 (16.7%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 15 Jun 2017.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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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.

Ronald Goldwater, M.D 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 5 inclusion and 34 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 15 Jun 2017. 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 States. 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?

Yes. Results are posted in the registry (first posted 15 Jun 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Pharmacokinetics (PK) of AZD7594 Delivered by Monodose Inhaler and Multiple-dose DPI or pMDI in Terms of Pulmonary Bioavailability After Inhalation (Fpulmonary) (time frame: 0-96 hours). 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 NCT02648438.

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 15 Jun 2017.