AsthmaPhase 1NCT04002427
Mass Balance Recovery, Pharmacokinetics and Metabolite Profile and Identification of [14C]AZD7594
A Phase 1 study testing Intravenous Infusion and Inhaled dose in people with Asthma, run by AstraZeneca at 1 site in United Kingdom.
Trial summary
AZD7594 is in clinical development for the treatment of asthma. This is a single centre, open-label, single period study in 6 healthy subjects, to determine the mass balance recovery and generate samples to enable metabolite profiling and structural identification of AZD7594. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Asthma
- What is being tested?
- Intravenous Infusion and Inhaled dose
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 11 Jun 2019to 5 Jul 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 or non-pregnant, non-lactating female subjects aged 18 to 55 years with suitable veins for cannulation or repeated venepuncture.
- Have a body mass index of 18.5 to 35.0 kg/m2, and weigh at least 50 kg and no more than 100 kg, as measured at screening.
- Must have regular bowel movements (ie, average stool production of ≥1 and ≤3 stools per day).
- Must be willing and able to communicate and participate in the whole study.
- Must agree to adhere to the contraception requirements defined in Section 9.4 of the protocol.
- Must demonstrate the ability to use the study inhalation device properly.
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 of the volunteer's ability to participate in the study.
- History or presence of clinically significant gastrointestinal, hepatic or renal disease, or any other condition known to interfere with absorption, distribution, metabolism or excretion of drugs.
- Any clinically significant illness, medical/surgical procedure, or trauma within 4 weeks of the first administration of IMP.
- Subjects with Gilbert's syndrome or subjects with a history of cholecystectomy or gall stones.
- Subjects with pregnant partners
- Any confirmed clinically significant abnormalities in clinical chemistry, haematology or urinalysis as judged by the investigator.
Show all 27Show fewer
- Any confirmed clinically significant abnormal findings in vital signs or 12-lead ECG as judged by the investigator.
- Any positive result at screening for serum hepatitis B surface antigen (HBsAg), hepatitis C virus antibody (HCV Ab) or human immunodeficiency virus (HIV) results.
- Has received any other 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. Note: subjects consented and screened, but not randomised in this study or a previous Phase I study are not excluded.
- Plasma donation within 1 month of screening or any blood donation/loss of more than 500 mL of blood during the 3 months prior to screening.
- 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 the formulation excipients including lactose. Hay fever is allowed unless it is active.
- Current smokers and those who have smoked within the last 12 months. A breath carbon monoxide reading of greater than 10 ppm at screening and admission.
- Current users of e-cigarettes and nicotine replacement products and those who have used these products within the last 12 months.
- Females of childbearing potential who are pregnant or lactating (all female subjects must have a negative urine pregnancy test and screening and admission). A woman is considered of childbearing potential unless she is permanently sterile (hysterectomy, bilateral salpingectomy and bilateral oophorectomy) or is postmenopausal (had no menses for 12 months without an alternative medical cause and a serum follicle stimulating hormone [FSH] concentration ≥40 IU/L).
- Confirmed positive screen for drugs of abuse at screening or admission to the clinical unit or positive screen for alcohol at screening or admission to the clinical unit.
- Herbal preparations/medications are not allowed throughout the study. These herbal medications include, but are not limited to, St. John's wort, kava, ephedra (ma huang), gingko biloba, dehydroepiandrosterone, yohimbe, saw palmetto, and ginseng. Subjects should stop using these herbal medications 14 days prior to administration of AZD7594.
- Use of any prescribed or nonprescribed medication including antacids, H2 antagonists, PPI, analgesics (other than paracetamol/acetaminophen up to 4 g/day), vitamins and minerals during the 14 days prior to administration of AZD7594 or longer if the medication has a longer half-life (see Section 11.4 of the protocol). Exceptions may apply on a case by case basis, if considered not to interfere with the objectives of the study, as agreed by the PI and sponsor's medical monitor.
- Known or suspected history of alcohol or drug abuse within the past 2 years or regular alcohol consumption in males >21 units per week and females >14 units per week (1 unit = ½ pint beer, or a 25 mL shot of 40% spirit, 1.5 to 2 Units = 125 mL glass of wine, depending on type)
- Subjects who are study site employees, or immediate family members of a study site or sponsor employee
- Subjects who have previously been enrolled in this study.
- Radiation exposure, including that from the present study, excluding background radiation but including diagnostic x-rays and other medical exposures, exceeding 5 mSv in the last 12 months or 10 mSv in the last 5 years. No occupationally exposed worker, as defined in the Ionising Radiation Regulations 2017, shall participate in the study.
- Subjects who have been enrolled in an ADME study in the last 12 months
- Judgment by the investigator that the volunteer should not participate in the study if they have any ongoing or recent (ie during the screening period) minor medical complaints that may interfere with the interpretation of the study data or are considered unlikely to comply with the study procedures, restrictions and requirements.
- History of infantile bronchiolitis, a history of asthma, adverse reaction or allergy to the inhaled medication or any excipients
- Upper respiratory tract infection (excluding otitis media) within 14 days of the first study day, or lower respiratory tract infection within the last 3 months
- Subjects who are unable to demonstrate their ability to fulfil the physical demands of the study
- Failure to satisfy the investigator of fitness to participate for any other reason.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase I, Open-Label Study to Assess Mass Balance Recovery, Pharmacokinetics, Metabolite Profile & Metabolite Identification After Intravenous Microdose Administration of [14C]AZD7594 & Inhaled Administration of AZD7594 in Healthy Subjects
AZD7594 is in clinical development for the treatment of asthma.
This is a single centre, open-label, single period study in 6 healthy subjects, to determine the mass balance recovery and generate samples to enable metabolite profiling and structural identification of AZD7594.
Each subject will receive a single inhaled 792 µg nominal dose (720 µg delivered dose) of AZD7594 followed by an IV dose of 30 µg [14C]AZD7594 containing not more than (NMT) 6.7 kBq (180 nCi) carbon-14 (14C) as a 1 h infusion. The IV dose will be administered approximately 10 min after the inhaled dose. Subjects will remain resident in the clinical unit up to 168 h post dose (up to Day 8).
Read the detailed description
This is a single centre, open-label, single period study in 6 healthy male and non-pregnant, non-lactating female subjects to determine the mass balance recovery after a single intravenous (IV) dose of [14C]AZD7594 and to generate samples to enable metabolite profiling and structural identification of AZD7594 in plasma, urine and faeces. It is planned to enrol 6 subjects to ensure data in at least 4 evaluable subjects. A subject will be considered evaluable if they have provided mass balance and PK samples for up to 48 h after drug administration.
Subjects will be screened for eligibility to participate in the study up to 28 days before dosing. Eligible subjects will be admitted to the clinical unit in the afternoon on the day before dosing (Day 1). Subjects will be dosed on the morning of Day 1 in the fasted state (8 h overnight fast). Before oral inhalation of AZD7594 using the Dry Powder Inhaler (DPI), all subjects must demonstrate their ability to use the DPI as intended. Subjects will receive training with an empty DPI at screening, Day -1 and pre-dose (optional) in accordance with study specific instructions. Each subject will receive a single inhaled 792 µg nominal dose (720 µg delivered dose) of AZD7594 followed by an IV dose of 30 µg [14C]AZD7594 containing 6.7 kBq (180 nCi) carbon-14 (14C) as a 1 h infusion. The infusion of the IV dose will be started approximately 15 min after the inhaled dose. Subjects will remain resident in the clinical unit up to 168 h post dose (up to Day 8).
Whole blood, plasma, urine and faeces will be collected from pre-dose until discharge (168 h post-dose; Day 8). Any accidental sources of elimination (eg emesis) will be collected and sent to the mass balance laboratory for total radioactivity analysis.
- Conditions
- Asthma
- Being tested
- Intravenous Infusion, Inhaled dose
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intravenous InfusionDrug
30 µg [14C]AZD7594 containing 6.7 kBq (180 nCi) carbon-14 (14C) as a 1 hour infusion.
Inhaled doseDrug
A single inhalation on one occasion.
| Study group | Role | What they receive |
|---|---|---|
| Only one study arm | Experimental | [14C]AZD7594 Solution for Infusion 5 µg/mL (1.1 kBq/mL)
AZD7594 Inhalation Powder, SD3FL Inhaler Receives: Drug: Intravenous Infusion; Drug: Inhaled dose |
What is being measured
The primary outcome is the main question the study is designed to answer.
AZD7594 excreted (Ae)
Assessment of total radioactivity by measuring AZD7594 excreted (Ae)
Measured: Urine and faecal samples collected from pre-dose until 168 hours post-dose
AZD7594 excreted and expressed as a percentage of the administered dose (Fe)
Assessment of total radioactivity by measuring AZD7594 excreted and expressed as a percentage of the administered dose (Fe)
Measured: Urine and faecal samples colected from pre-dose until 168 hours post-dose
Cumulative amount of AZD7594 excreted (CumAe)
Assessment of total radioactivity by measuring the cumulative amount of AZD7594 excreted (CumAe)
Measured: Urine and faecal samples collected from pre-dose until 168 hours post-dose
Cumulative amount of AZD7594 excreted and expressed as a percentage of the administered dose (CumFe)
Assessment of total radioactivity by measuring AZD7594 excreted and expressed as a percentage of the administered dose (CumFe)
Measured: Urine and faecal samples collected from pre-dose until 168 hours post-dose
Assessment of metabolites in plasma by liquid chromatography-radiochemical-detection and subsequent mass spectrometry
Assessment of metabolites and structural identification by assessing liquid chromatography-radiochemical-detection and subsequent mass spectrometry
Measured: Collection of plasma samples from pre-dose until 168 hours post-dose
Assessment of metabolites in faeces by liquid chromatography-radiochemical-detection and subsequent mass spectrometry
Assessment of metabolites and structural identification by assessing liquid chromatography-radiochemical-detection and subsequent mass spectrometry
Measured: Collection of faecal samples from pre-dose until 168 hours post-dose
Assessment of metabolites in urine by liquid chromatography-radiochemical-detection and subsequent mass spectrometry
Assessment of metabolites and structural identification by assessing liquid chromatography-radiochemical-detection and subsequent mass spectrometry
Measured: Collection of urine samples from pre-dose until 168 hours post-dose
Secondary outcomes (25)
Determination of routes and rates of elimination of [14C]AZD7594
Assessment of total radioactivity by measuring AZD7594 excreted (Ae), cumulative recovery (Cumae), Ae as a percentage of the administered dose (Fe) and cumulative recovery expressed as a percentage of the dose (CumFe)
Measured: Collection of urine and faecal samples from pre-dose until 168 hours post-dose
Determination of the chemical structure of the "major" metabolites of [14C]AZD7594
Structural identification by assessing liquid chromatography-radiochemical-detection and subsequent mass spectrometry
Measured: Collection of urine adn faeces samples from pre-dose until 168 hours post-dose
Evaluation of whole blood:plasma concentration ratios for total radioactivity
Assessment of total radioactivity by measuring AZD7594 in blood and plasma
Measured: Collection of plasma samples from pre-dose until 168 hours post-dose
Assessment of the IV PK of [14C]AZD7594 and total radioactivity
Time from dosing at which Cmax was apparent (tmax)
Measured: Collection of plasma samples from pre-dose until 168 hours post-dose
Assessment of the IV PK of [14C]AZD7594 and total radioactivity
The maximum observed plasma concentration (Cmax)
Measured: Collection of plasma samples from pre-dose until 168 hours post-dose
Assessment of the IV PK of [14C]AZD7594 and total radioactivity
The area under the concentration-time curve from dosing to the last measurable concentration (AUClast)
Measured: Collection of plasma samples from pre-dose until 168 hours post-dose
Assessment of the IV PK of [14C]AZD7594 and total radioactivity
The area under the concentration-time curve from dosing extrapolated to infinity (AUC0-inf)
Measured: Collection of plasma samples from pre-dose until 168 hours post-dose
Assessment of the IV PK of [14C]AZD7594 and total radioactivity
The percentage of AUC extrapolated beyond the last measured time point (AUC%extr)
Measured: Collection of plasma samples from pre-dose until 168 hours post-dose
Assessment of the IV PK of [14C]AZD7594 and total radioactivity
The terminal elimination rate constant calculated from the slope of the apparent elimination phase (λz)
Measured: Collection of plasma samples from pre-dose until 168 hours post-dose
Assessment of the IV PK of [14C]AZD7594 and total radioactivity
The apparent terminal elimination half-life (t½)
Measured: Collection of plasma samples from pre-dose until 168 hours post-dose
Assessment of the IV PK of [14C]AZD7594 and total radioactivity
Total clearance (CL)
Measured: Collection of plasma samples from pre-dose until 168 hours post-dose
Assessment of the IV PK of [14C]AZD7594 and total radioactivity
Volume of distribution (Vz)
Measured: Collection of plasma samples from pre-dose until 168 hours post-dose
Assessment of the IV PK of [14C]AZD7594 and total radioactivity
Volume of distribution at steady state (Vss)
Measured: Collection of plasma samples from pre-dose until 168 hours post-dose
Assessment of the IV PK of [14C]AZD7594 and total radioactivity
Mean residence time (MRT)
Measured: Collection of plasma samples from pre-dose until 168 hours post-dose
Assessment of the inhaled PK of AZD7594
The time from dosing at which Cmax was apparent (tmax)
Measured: Collection of plasma samples from pre-dose until 168 hours post-dose
Assessment of the inhaled PK of AZD7594
The maximum observed plasma concentration (Cmax)
Measured: Collection of plasma samples from pre-dose until 168 hours post-dose
Assessment of the inhaled PK of AZD7594
The area under the concentration-time curve from dosing to the last measurable concentration (AUClast)
Measured: Collection of plasma samples from pre-dose until 168 hours post-dose
Assessment of the inhaled PK of AZD7594
The area under the concentration-time curve from dosing extrapolated to infinity (AUC0-inf)
Measured: Collection of plasma samples from pre-dose until 168 hours post-dose
Assessment of the inhaled PK of AZD7594
The percentage of AUC extrapolated beyond the last measured time point(AUC%exre)
Measured: Collection of plasma samples from pre-dose until 168 hours post-dose
Assessment of the inhaled PK of AZD7594
The terminal elimination rate constant calculated from the slope of the apparent elimination phase (λz)
Measured: Collection of plasma samples from pre-dose until 168 hours post-dose
Assessment of the inhaled PK of AZD7594
The apparent terminal elimination half-life (t½)
Measured: Collection of plasma samples from pre-dose until 168 hours post-dose
Assessment of the inhaled PK of AZD7594
Apparent total clearance (CL/F)
Measured: Collection of plasma samples from pre-dose until 168 hours post-dose
Assessment of the inhaled PK of AZD7594
Apparent volume of distribution (Vz/F)
Measured: Collection of plasma samples from pre-dose until 168 hours post-dose
Assessment of the inhaled PK of AZD7594
Absolute bioavailability (F)
Measured: Collection of plasma samples from pre-dose until 168 hours post-dose
Number of adverse events (AE)
Safety and tolerability assessed through incidence of AE
Measured: AEs recorded from the time of informed consent until discharge from the study (168 hours post-dose)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2019
- Study start11 Jun 2019
- Primary completion5 Jul 2019
- Study completion5 Jul 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Quotient Sciences
- Responsible party
- Sponsor
- Investigators
- Sharan Sidhu, MBChB, BAO, MRCS, MFPM, Principal investigator, Quotient Sciences Limited (indemnified by
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04002427
- Sponsor's protocol ID
- D3741C00010
- Status last verified
- Jul 2019
- First submitted
- 18 Apr 2019
- Last updated
- 25 Jul 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I, Open-Label Study to Assess Mass Balance Recovery, Pharmacokinetics, Metabolite Profile & Metabolite Identification After Intravenous Microdose Administration of [14C]AZD7594 & Inhaled Administration of AZD7594 in Healthy Subjects
- ClinicalTrials.gov ID
- NCT04002427
- Acronym / sponsor ID
- D3741C00010
- Conditions
- Asthma
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Collaborators
- Quotient Sciences
- Study start
- 11 Jun 2019 (actual)
- Primary completion
- 5 Jul 2019 (actual)
- Study completion
- 5 Jul 2019 (actual)
- First posted
- 28 Jun 2019 (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.
AZD7594 is in clinical development for the treatment of asthma.
This is a single centre, open-label, single period study in 6 healthy subjects, to determine the mass balance recovery and generate samples to enable metabolite profiling and structural identification of AZD7594.
Each subject will receive a single inhaled 792 µg nominal dose (720 µg delivered dose) of AZD7594 followed by an IV dose of 30 µg [14C]AZD7594 containing not more than (NMT) 6.7 kBq (180 nCi) carbon-14 (14C) as a 1 h infusion. The IV dose will be administered approximately 10 min after the inhaled dose. Subjects will remain resident in the clinical unit up to 168 h post dose (up to Day 8).
Detailed description
This is a single centre, open-label, single period study in 6 healthy male and non-pregnant, non-lactating female subjects to determine the mass balance recovery after a single intravenous (IV) dose of [14C]AZD7594 and to generate samples to enable metabolite profiling and structural identification of AZD7594 in plasma, urine and faeces. It is planned to enrol 6 subjects to ensure data in at least 4 evaluable subjects. A subject will be considered evaluable if they have provided mass balance and PK samples for up to 48 h after drug administration.
Subjects will be screened for eligibility to participate in the study up to 28 days before dosing. Eligible subjects will be admitted to the clinical unit in the afternoon on the day before dosing (Day 1). Subjects will be dosed on the morning of Day 1 in the fasted state (8 h overnight fast). Before oral inhalation of AZD7594 using the Dry Powder Inhaler (DPI), all subjects must demonstrate their ability to use the DPI as intended. Subjects will receive training with an empty DPI at screening, Day -1 and pre-dose (optional) in accordance with study specific instructions. Each subject will receive a single inhaled 792 µg nominal dose (720 µg delivered dose) of AZD7594 followed by an IV dose of 30 µg [14C]AZD7594 containing 6.7 kBq (180 nCi) carbon-14 (14C) as a 1 h infusion. The infusion of the IV dose will be started approximately 15 min after the inhaled dose. Subjects will remain resident in the clinical unit up to 168 h post dose (up to Day 8).
Whole blood, plasma, urine and faeces will be collected from pre-dose until discharge (168 h post-dose; Day 8). Any accidental sources of elimination (eg emesis) will be collected and sent to the mass balance laboratory for total radioactivity analysis.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Only one study arm | Experimental | Drug: Intravenous Infusion, Drug: Inhaled dose[14C]AZD7594 Solution for Infusion 5 µg/mL (1.1 kBq/mL) AZD7594 Inhalation Powder, SD3FL Inhaler |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Provision of signed and dated, written informed consent prior to any study specific procedures.
- Healthy male or non-pregnant, non-lactating female subjects aged 18 to 55 years with suitable veins for cannulation or repeated venepuncture.
- Have a body mass index of 18.5 to 35.0 kg/m2, and weigh at least 50 kg and no more than 100 kg, as measured at screening.
- Must have regular bowel movements (ie, average stool production of ≥1 and ≤3 stools per day).
- Must be willing and able to communicate and participate in the whole study.
Key exclusion criteria (27 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 of the volunteer's ability to participate in the study.
- History or presence of clinically significant gastrointestinal, hepatic or renal disease, or any other condition known to interfere with absorption, distribution, metabolism or excretion of drugs.
- Any clinically significant illness, medical/surgical procedure, or trauma within 4 weeks of the first administration of IMP.
- Subjects with Gilbert's syndrome or subjects with a history of cholecystectomy or gall stones.
- Subjects with pregnant partners
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 |
|---|---|---|
| Intravenous Infusion30 µg [14C]AZD7594 containing 6.7 kBq (180 nCi) carbon-14 (14C) as a 1 hour infusion. | Drug | Only one study arm |
| Inhaled doseA single inhalation on one occasion. | Drug | Only one study arm |
Primary outcome
AZD7594 excreted (Ae)
Time frame: Urine and faecal samples collected from pre-dose until 168 hours post-dose
Assessment of total radioactivity by measuring AZD7594 excreted (Ae)
AZD7594 excreted and expressed as a percentage of the administered dose (Fe)
Time frame: Urine and faecal samples colected from pre-dose until 168 hours post-dose
Assessment of total radioactivity by measuring AZD7594 excreted and expressed as a percentage of the administered dose (Fe)
Cumulative amount of AZD7594 excreted (CumAe)
Time frame: Urine and faecal samples collected from pre-dose until 168 hours post-dose
Assessment of total radioactivity by measuring the cumulative amount of AZD7594 excreted (CumAe)
Cumulative amount of AZD7594 excreted and expressed as a percentage of the administered dose (CumFe)
Time frame: Urine and faecal samples collected from pre-dose until 168 hours post-dose
Assessment of total radioactivity by measuring AZD7594 excreted and expressed as a percentage of the administered dose (CumFe)
Assessment of metabolites in plasma by liquid chromatography-radiochemical-detection and subsequent mass spectrometry
Time frame: Collection of plasma samples from pre-dose until 168 hours post-dose
Assessment of metabolites and structural identification by assessing liquid chromatography-radiochemical-detection and subsequent mass spectrometry
Assessment of metabolites in faeces by liquid chromatography-radiochemical-detection and subsequent mass spectrometry
Time frame: Collection of faecal samples from pre-dose until 168 hours post-dose
Assessment of metabolites and structural identification by assessing liquid chromatography-radiochemical-detection and subsequent mass spectrometry
Assessment of metabolites in urine by liquid chromatography-radiochemical-detection and subsequent mass spectrometry
Time frame: Collection of urine samples from pre-dose until 168 hours post-dose
Assessment of metabolites and structural identification by assessing liquid chromatography-radiochemical-detection and subsequent mass spectrometry
25 secondary outcomes
Determination of routes and rates of elimination of [14C]AZD7594
Time frame: Collection of urine and faecal samples from pre-dose until 168 hours post-dose
Determination of the chemical structure of the "major" metabolites of [14C]AZD7594
Time frame: Collection of urine adn faeces samples from pre-dose until 168 hours post-dose
Evaluation of whole blood:plasma concentration ratios for total radioactivity
Time frame: Collection of plasma samples from pre-dose until 168 hours post-dose
Assessment of the IV PK of [14C]AZD7594 and total radioactivity
Time frame: Collection of plasma samples from pre-dose until 168 hours post-dose
Assessment of the IV PK of [14C]AZD7594 and total radioactivity
Time frame: Collection of plasma samples from pre-dose until 168 hours post-dose
Assessment of the IV PK of [14C]AZD7594 and total radioactivity
Time frame: Collection of plasma samples from pre-dose until 168 hours post-dose
Assessment of the IV PK of [14C]AZD7594 and total radioactivity
Time frame: Collection of plasma samples from pre-dose until 168 hours post-dose
Assessment of the IV PK of [14C]AZD7594 and total radioactivity
Time frame: Collection of plasma samples from pre-dose until 168 hours post-dose
Assessment of the IV PK of [14C]AZD7594 and total radioactivity
Time frame: Collection of plasma samples from pre-dose until 168 hours post-dose
Assessment of the IV PK of [14C]AZD7594 and total radioactivity
Time frame: Collection of plasma samples from pre-dose until 168 hours post-dose
Assessment of the IV PK of [14C]AZD7594 and total radioactivity
Time frame: Collection of plasma samples from pre-dose until 168 hours post-dose
Assessment of the IV PK of [14C]AZD7594 and total radioactivity
Time frame: Collection of plasma samples from pre-dose until 168 hours post-dose
Assessment of the IV PK of [14C]AZD7594 and total radioactivity
Time frame: Collection of plasma samples from pre-dose until 168 hours post-dose
Assessment of the IV PK of [14C]AZD7594 and total radioactivity
Time frame: Collection of plasma samples from pre-dose until 168 hours post-dose
Assessment of the inhaled PK of AZD7594
Time frame: Collection of plasma samples from pre-dose until 168 hours post-dose
Assessment of the inhaled PK of AZD7594
Time frame: Collection of plasma samples from pre-dose until 168 hours post-dose
Assessment of the inhaled PK of AZD7594
Time frame: Collection of plasma samples from pre-dose until 168 hours post-dose
Assessment of the inhaled PK of AZD7594
Time frame: Collection of plasma samples from pre-dose until 168 hours post-dose
Assessment of the inhaled PK of AZD7594
Time frame: Collection of plasma samples from pre-dose until 168 hours post-dose
Assessment of the inhaled PK of AZD7594
Time frame: Collection of plasma samples from pre-dose until 168 hours post-dose
Assessment of the inhaled PK of AZD7594
Time frame: Collection of plasma samples from pre-dose until 168 hours post-dose
Assessment of the inhaled PK of AZD7594
Time frame: Collection of plasma samples from pre-dose until 168 hours post-dose
Assessment of the inhaled PK of AZD7594
Time frame: Collection of plasma samples from pre-dose until 168 hours post-dose
Assessment of the inhaled PK of AZD7594
Time frame: Collection of plasma samples from pre-dose until 168 hours post-dose
Number of adverse events (AE)
Time frame: AEs recorded from the time of informed consent until discharge from the study (168 hours post-dose)
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 25 Jul 2019.
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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.
Sharan Sidhu, MBChB, BAO, MRCS, MFPM principal investigator
Quotient Sciences Limited (indemnified by
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Intravenous Infusion and Inhaled dose in people with Asthma, run by AstraZeneca at 1 site in United Kingdom.
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 7 inclusion and 27 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 25 Jul 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?
AZD7594 excreted (Ae) (time frame: Urine and faecal samples collected from pre-dose until 168 hours post-dose). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 25 Jul 2019.