Pulmonary/Respiratory DiseasesPhase 1NCT02950805
A Study to Assess the Effect of AZD5634 on Mucociliary Clearance, Safety, Tolerability and Pharmacokinetic Parameters in Patients With Cystic Fibrosis
A Phase 1 study testing AZD5634 in people with Pulmonary/Respiratory Diseases, run by AstraZeneca at 3 sites in United States.
Trial summary
This study will assess the effect of inhaled AZD5634 on Mucociliary clearance (MCC) in patients with Cystic fibrosis (CF) after single-dose administration. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Pulmonary/Respiratory Diseases
- What is being tested?
- AZD5634
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 9 participants
- Where
- 3 sitesUnited States
- Study dates
- 30 May 2017to 12 Apr 2018
- 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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Provision of signed and dated written informed consent prior to any study-specific procedures.
- Male or female patients aged 18-60 years old inclusive.
- Diagnosed of CF at Screening as evidenced in medical records by one of the following criteria:
- sweat chloride ≥ 60 mmol/L
- presence of 2 mutations in the Cystic Fibrosis Transmembrane Conductance Regulator (CFTR) gene.
- Chronic sinopulmonary disease or pancreatic insufficiency.
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- FEV1measurement at Screening ≥ 40% of the predicted normal value of age, height, gender, and race.
- Stable CF regimen for at least 2 months before Screening.
- Body mass index (BMI) between 15-30 kg/m2 inclusive.
- Female patients are not pregnant and do not plan to become pregnant during the study, are not lactating, or are of non-childbearing potential. Females of childbearing potential must provide a negative serum pregnancy test and have a date of last menstruation consistent with non-pregnancy, negative urine pregnancy tests at each visit, and must be using at least one highly effective method of contraception.
- Ability of the patient to correctly perform the inhalation procedure after training during the Screening Visit.
Who cannot join
- Had a pulmonary exacerbation requiring change in antibiotics and/or hospitalization within 28 days before the first dose of Investigational product.
- History of lung transplant or any other transplantation.
- Currently being treated with ivacaftor monotherapy at Screening or received ivacaftor monotherapy within 30 days before Screening.
- History of severe allergy/hypersensitivity or ongoing clinically significant allergy/hypersensitivity, as judged by the Investigator, to drugs in a similar class to AZD5634.
- History or presence of hepatic cirrhosis.
- Creatinine clearance <60 mL/min/m2 using the Cockroft-Gault Equation.
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- Liver function test results >2x upper limit of normal (aspartate aminotransferase [AST], alanine aminotransferase [ALT], gamma-glutamyl transpeptidase [GGT], or bilirubin)
- History of any clinically significant disease or disorder which, in the opinion of the Investigator, may either put the patient at risk because of participation in the study, or influence the results or the patient's ability to participate in the study.
- Received treatment with the following medications within the 3 weeks before Screening: strong or moderate Cytochrome P450 (CYP) 3A inhibitors, as classified by the Food and Drug Administration (FDA).
- Likely to require treatment during the study with drugs not permitted by the study protocol.
- Any clinically significant abnormalities in clinical chemistry, hematology, or urinalysis results.
- Serum potassium levels are outside the normal range (3.5-5.1 mmol/L).
- Serum sodium levels <135 mmol/L.
- Abnormal vital signs, after 5 minutes rest, at Screening or Visit 2 (seated or supine; position should be consistent for a given patient at both visits), defined as any of the following:
- Systolic blood pressure (B.P) < 90 or ≥ 150 mmHg
- Diastolic B.P < 45 or ≥ 90 mmHg
- Pulse rate < 45 or >110 beats/minute
- Any clinically significant abnormalities in rhythm, conduction, or morphology of the resting ECG and any clinically significant abnormalities in the 12-lead ECG, as considered by the Investigator, that may interfere with the interpretation of corrected ECG interval measured from the onset of the QRS complex to the offset of the T wave (QTc) interval changes.
- QTc prolongation defined as QT interval corrected for heart rate using Fridericia's formula (QTcF) >450 ms.
- ECG interval measured from the onset of the P wave to the onset of the QRS complex (PR/PQ) interval prolongation (>240 ms), intermittent second or third degree atrioventricular (AV) block, or AV dissociation.
- Persistent or intermittent complete bundle branch block (BBB) with ECG interval measured from the onset of the QRS complex to the J point (QRS) >120 ms or evidence of pre-excitation.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Research Site
Baltimore, Maryland, 21205
Research Site
Birmingham, Alabama, 35294-1785
Research Site
Chapel Hill, North Carolina, 27517
About this study
Official title: A Phase 1b Randomized Blinded Placebo-Controlled, Cross-Over Study to Assess the Effect of AZD5634 on Mucociliary Clearance as Well as Safety, Tolerability, and Pharmacokinetic Parameters Following Single Inhaled Dose Administration to Patients With Cystic Fibrosis.
This study will assess the effect of inhaled AZD5634 on Mucociliary clearance (MCC) in patients with Cystic fibrosis (CF) after single-dose administration.
Read the detailed description
The primary pharmacodynamic endpoint will be the average whole lung particle clearance between 0 and 60 minutes after administration of aerosolized radiolabelled particles (colloids) at Visits 2 and 3 (%MCC 0-60, whole).
- Conditions
- Pulmonary/Respiratory Diseases
- Being tested
- Placebo, AZD5634
- Keywords
- AZD5634, Mucociliary Clearance, Safety, Tolerability, Pharmacokinetic, Cystic Fibrosis, Cross-Over Study
- Medical subject headings
- Respiratory Tract Diseases, Cystic Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboDrug
Subjects will receive a placebo in either period 1 or period 2 by inhalation.
AZD5634Drug
Subjects will receive a single tentative dose of 625 μg of AZD5634 in either period 1 or period 2 by inhalation.
| Study group | Role | What they receive |
|---|---|---|
| Placebo + AZD5634 | Experimental | Subjects were administered single dose of placebo in period 1 and AZD5634 in period 2. Receives: Drug: Placebo; Drug: AZD5634 |
| AZD5634 + Placebo | Experimental | Subjects were administered single dose of AZD5634 in period 1 and placebo in period 2. Receives: Drug: Placebo; Drug: AZD5634 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of average whole lung particle clearance between 0 and 60 minutes after administration of aerosolized radiolabelled particles
Assessment of the average whole lung clearance between 0 and 60 minutes after administration of single inhaled dose of aerosolized radiolabelled particles (colloids) of AZD5634, (%MCC 0--60, whole) in subjects with cystic fibrosis (CF).
Measured: 0 to 60 minutes
Secondary outcomes (35)
Percentage of average central clearance between 0 and 60 minutes after administration of aerosolized radiolabelled particles
Assessment and comparison of the average central clearance between 0 and 60 minutes after administration of single inhaled dose of aerosolized radiolabelled particles (colloids) of AZD5634, in subjects with CF.
Measured: 0 to 60 minutes
Percentage of average peripheral clearance between 0 and 60 minutes after administration of aerosolized radiolabelled particles
Assessment and comparison of the average peripheral clearance between 0 and 60 minutes after administration of single inhaled dose of aerosolized radiolabelled particles (colloids) of AZD5634 in subjects with CF.
Measured: 0 to 60 minutes
Percentage of average tracheobronchial clearance between 0 and 60 minutes after administration of aerosolized radiolabelled particles
Assessment and comparison of the average tracheobronchial clearance between 0 and 60 minutes after administration of single inhaled dose of aerosolized radiolabelled particles (colloids) of AZD5634 in subjects with CF.
Measured: 0 to 60 minutes
Percentage of particle clearance at 6-hour
Assessment and comparison the 6-hour clearance after administration of aerosolized radiolabelled particles (colloids) of AZD5634 in subjects with CF.
Measured: 6 hours
Percentage of average whole lung cough clearance between 60 minutes and 90 minutes after administration of aerosolized radiolabelled particles
Assessment of the average whole lung cough clearance between 60 minutes and 90 minutes after administration of single inhaled dose of aerosolized radiolabelled particles (colloids) of AZD5634 in subjects with CF.
Measured: 60 minutes to 90 minutes
Percentage of average central cough clearance between 60 minutes and 90 minutes after administration of aerosolized radiolabelled particles
Assessment and comparison of the average central cough clearance between 60 minutes and 90 minutes after administration of single inhaled dose of aerosolized radiolabelled particles (colloids) of AZD5634 in subjects with CF.
Measured: 60 minutes to 90 minutes
Percentage of average peripheral cough clearance between 60 minutes and 90 minutes after administration of aerosolized radiolabelled particles
Assessment and comparison of the average peripheral cough clearance between 60 minutes and 90 minutes after administration of single inhaled dose of aerosolized radiolabelled particles (colloids) of AZD5634 in subjects with CF.
Measured: 60 minutes to 90 minutes
Percentage of average tracheobronchial cough clearance between 60 minutes and 90 minutes after administration of aerosolized radiolabelled particles
Assessment and comparison of the average tracheobronchial cough clearance between 60 minutes and 90 minutes after administration of single inhaled dose of aerosolized radiolabelled particles (colloids) of AZD5634 in subjects with CF.
Measured: 60 minutes to 90 minutes
Maximum observed plasma concentration (Cmax)
Assessment of Cmax in subjects with CF after the administration of single inhaled dose of AZD5634.
Measured: Pre-dose and up to 6 hours post-dose
Area under the concentration-time curve from time zero extrapolated to infinity (AUC)
Assessment of AUC in subjects with CF after the administration of single inhaled dose of AZD5634.
Measured: Pre-dose and up to 6 hours post-dose
Area under the plasma concentration-time curve from time zero to time of last quantifiable concentration (AUC 0-last)
Assessment of AUC 0-last in subjects with CF after the administration of single inhaled dose of AZD5634.
Measured: Pre-dose and up to 6 hours post-dose
Area under the plasma concentration-time curve from time zero to 6 hours post-dose (AUC 0-6)
Assessment of AUC 0-6 in subjects with CF after the administration of single inhaled dose of AZD5634.
Measured: Pre-dose and up to 6 hours post-dose
Observed last quantifiable concentration (C last)
Assessment of C last in subjects with CF after the administration of single inhaled dose of AZD5634.
Measured: Pre-dose and up to 6 hours post-dose
Time of last quantifiable concentration (t last)
Assessment of t last in subjects with CF after the administration of single inhaled dose of AZD5634.
Measured: Pre-dose and up to 6 hours post-dose
Time to reach maximum plasma concentration (t max)
Assessment of t max in subjects with CF after the administration of single inhaled dose of AZD5634.
Measured: Pre-dose and up to 6 hours post-dose
Terminal elimination rate constant (λz)
Assessment of λz in subjects with CF after the administration of single inhaled dose of AZD5634.
Measured: Pre-dose and up to 6 hours post-dose
Terminal elimination half-life (t1/2,λz)
Assessment of t1/2,λz in subjects with CF after the administration of single inhaled dose of AZD5634.
Measured: Pre-dose and up to 6 hours post-dose
Apparent clearance (CL/F)
Assessment of CL/F in subjects with CF after the administration of single inhaled dose of AZD5634.
Measured: Pre-dose and up to 6 hours post-dose
Apparent volume of distribution at terminal phase (Vz/F)
Assessment of Vz/F in subjects with CF after the administration of single inhaled dose of AZD5634.
Measured: Pre-dose and up to 6 hours post-dose
Cumulative amount of AZD5634 excreted in urine from time zero to 6 hours (Ae 0-6)
Assessment of Ae 0-6 in subjects with CF after the administration of single inhaled dose of AZD5634.
Measured: Pre-dose and up to 6 hours post-dose
Cumulative percentage of dose excreted unchanged in urine from time zero to 6 hours (fe(0-6)%)
Assessment of fe(0-6)% in subjects with CF after the administration of single inhaled dose of AZD5634.
Measured: Pre-dose and up to 6 hours post-dose
Renal clearance, estimated by dividing Ae(0-t) (CLR)
Assessment of CLR in subjects with CF after the administration of single inhaled dose of AZD5634.
CLR is defined as renal clearance, estimated by dividing Ae(0-t) cumulative amount of AZD5634 excreted in urine from time zero up to time t) by AUC 0-t (area under the plasma concentration-time curve from time zero to time t), where t represents a matching time point for plasma and urine sampling.
Measured: Pre-dose and up to 6 hours post-dose
Safety of subjects by evaluating the incidence of adverse events (AEs)
Assessment of the safety in terms of the incidences of the AEs after the administration of single inhaled dose of AZD5634 in subjects with CF.
Measured: From screening (≤28 days) up to 14-21 days post dosing
Safety of subjects by evaluating the systolic and diastolic blood pressure
Assessment of the safety in terms of systolic and diastolic blood pressure after the administration of single inhaled dose of AZD5634 in subjects with CF.
Measured: From screening (≤28 days) up to 14-21 days post dosing
Safety of subjects by evaluating the pulse rate.
Assessment of the safety in terms of pulse rate after the administration of single inhaled dose of AZD5634 in subjects with CF.
Measured: From screening (≤28 days) up to 14-21 days post dosing
Safety of subjects by evaluating spirometry results
Assessment of the safety by evaluating the spirometry results after administration of the of single inhaled dose of AZD5634 in subjects with CF.
Measured: From screening (≤28 days) up to 14-21 days post dosing
Safety of subjects by evaluating the ECG results
Assessment of the safety by evaluating the ECG results after administration of the of single inhaled dose of AZD5634 in subjects with CF.
Measured: Pre-dose and up to 6 hours post-dose
Safety of subjects by the physical examination
Assessment of the safety by physical examination after administration of the of single inhaled dose of AZD5634 in subjects with CF.
Measured: From screening (≤28 days) up to 14-21 days post dosing
Safety of subjects by evaluating the respiratory rate.
Assessment of the safety in terms of respiratory rate after the administration of single inhaled dose of AZD5634 in subjects with CF.
Measured: From screening (≤28 days) up to 14-21 days post dosing
Safety of subjects by evaluating fractional excretion of potassium (FEK)
Assessment of FEK after the administration of single inhaled dose of AZD5634 in subjects with CF.
Measured: Pre-dose and at 0-6 hours post-dose
Safety of subjects by evaluating urine sodium/potassium (Na/K) ratio
Assessment of ratio of Na/K after the administration of single inhaled dose of AZD5634 in subjects with CF.
Measured: Pre-dose and at 0-6 hours post-dose
Safety of subjects by evaluating the pulse oximetry
Assessment of the safety in terms of pulse rate after the administration of single inhaled dose of AZD5634 in subjects with CF.
Measured: From screening (≤28 days) up to 14-21 days post dosing
Safety of subjects by evaluating the clinical laboratory test results for biochemistry
Assessment of the clinical laboratory test results in terms of biochemistry after the administration of single inhaled dose of AZD5634 in subjects with CF.
Measured: From screening (≤28 days) until 14-21 days post dosing
Safety of subjects by evaluating the clinical laboratory test results for urinalysis
Assessment of the clinical laboratory test results in terms of urinalysis after the administration of single inhaled dose of AZD5634 in subjects with CF.
Measured: From screening (≤28 days) until 14-21 days post dosing
Safety of subjects by evaluating the clinical laboratory test results for hematology
Assessment of the clinical laboratory test results in terms of hematology after the administration of single inhaled dose of AZD5634 in subjects with CF.
Measured: From screening (≤28 days) until 14-21 days post dosing
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2016 (estimated)
- Study start30 May 2017
- Primary completion12 Apr 2018
- Study completion12 Apr 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pulmonary/Respiratory DiseasesStudies 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Parexel
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02950805
- Sponsor's protocol ID
- D6600C00002
- Status last verified
- Jul 2018
- First submitted
- 23 Aug 2016
- Last updated
- 13 Jul 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Kristensson C, Astrand A, Donaldson S, Goldwater R, Abdulai R, Patel N, Gardiner P, Tehler U, Mercier AK, Olsson M, Ersdal E, Maenpaa J, Bramer T, Malmgren A, Bennett W, Keen C. AZD5634, an inhaled ENaC inhibitor, in healthy subjects and patients with cystic fibrosis. J Cyst Fibros. 2022 Jul;21(4):684-690. doi: 10.1016/j.jcf.2022.02.010. Epub 2022 Feb 26.
PubMed 35227647
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1b Randomized Blinded Placebo-Controlled, Cross-Over Study to Assess the Effect of AZD5634 on Mucociliary Clearance as Well as Safety, Tolerability, and Pharmacokinetic Parameters Following Single Inhaled Dose Administration to Patients With Cystic Fibrosis.
- ClinicalTrials.gov ID
- NCT02950805
- Acronym / sponsor ID
- D6600C00002
- Conditions
- Pulmonary/Respiratory Diseases
- Keywords
- AZD5634, Mucociliary Clearance, Safety, Tolerability, Pharmacokinetic, Cystic Fibrosis, Cross-Over Study
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 9 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Collaborators
- Parexel
- Study start
- 30 May 2017 (actual)
- Primary completion
- 12 Apr 2018 (actual)
- Study completion
- 12 Apr 2018 (actual)
- First posted
- 1 Nov 2016 (estimated)
- 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 study will assess the effect of inhaled AZD5634 on Mucociliary clearance (MCC) in patients with Cystic fibrosis (CF) after single-dose administration.
Detailed description
The primary pharmacodynamic endpoint will be the average whole lung particle clearance between 0 and 60 minutes after administration of aerosolized radiolabelled particles (colloids) at Visits 2 and 3 (%MCC 0-60, whole).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo + AZD5634 | Experimental | Drug: Placebo, Drug: AZD5634Subjects were administered single dose of placebo in period 1 and AZD5634 in period 2. |
| AZD5634 + Placebo | Experimental | Drug: Placebo, Drug: AZD5634Subjects were administered single dose of AZD5634 in period 1 and placebo in period 2. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (11 listed)
- Provision of signed and dated written informed consent prior to any study-specific procedures.
- Male or female patients aged 18-60 years old inclusive.
- Diagnosed of CF at Screening as evidenced in medical records by one of the following criteria:
- Chronic sinopulmonary disease or pancreatic insufficiency.
- FEV1measurement at Screening ≥ 40% of the predicted normal value of age, height, gender, and race.
Key exclusion criteria (21 listed)
- Had a pulmonary exacerbation requiring change in antibiotics and/or hospitalization within 28 days before the first dose of Investigational product.
- History of lung transplant or any other transplantation.
- Currently being treated with ivacaftor monotherapy at Screening or received ivacaftor monotherapy within 30 days before Screening.
- History of severe allergy/hypersensitivity or ongoing clinically significant allergy/hypersensitivity, as judged by the Investigator, to drugs in a similar class to AZD5634.
- History or presence of hepatic cirrhosis.
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 |
|---|---|---|
| PlaceboSubjects will receive a placebo in either period 1 or period 2 by inhalation. | Drug | AZD5634 + Placebo, Placebo + AZD5634 |
| AZD5634Subjects will receive a single tentative dose of 625 μg of AZD5634 in either period 1 or period 2 by inhalation. | Drug | AZD5634 + Placebo, Placebo + AZD5634 |
Primary outcome
Percentage of average whole lung particle clearance between 0 and 60 minutes after administration of aerosolized radiolabelled particles
Time frame: 0 to 60 minutes
Assessment of the average whole lung clearance between 0 and 60 minutes after administration of single inhaled dose of aerosolized radiolabelled particles (colloids) of AZD5634, (%MCC 0--60, whole) in subjects with cystic fibrosis (CF).
35 secondary outcomes
Percentage of average central clearance between 0 and 60 minutes after administration of aerosolized radiolabelled particles
Time frame: 0 to 60 minutes
Percentage of average peripheral clearance between 0 and 60 minutes after administration of aerosolized radiolabelled particles
Time frame: 0 to 60 minutes
Percentage of average tracheobronchial clearance between 0 and 60 minutes after administration of aerosolized radiolabelled particles
Time frame: 0 to 60 minutes
Percentage of particle clearance at 6-hour
Time frame: 6 hours
Percentage of average whole lung cough clearance between 60 minutes and 90 minutes after administration of aerosolized radiolabelled particles
Time frame: 60 minutes to 90 minutes
Percentage of average central cough clearance between 60 minutes and 90 minutes after administration of aerosolized radiolabelled particles
Time frame: 60 minutes to 90 minutes
Percentage of average peripheral cough clearance between 60 minutes and 90 minutes after administration of aerosolized radiolabelled particles
Time frame: 60 minutes to 90 minutes
Percentage of average tracheobronchial cough clearance between 60 minutes and 90 minutes after administration of aerosolized radiolabelled particles
Time frame: 60 minutes to 90 minutes
Maximum observed plasma concentration (Cmax)
Time frame: Pre-dose and up to 6 hours post-dose
Area under the concentration-time curve from time zero extrapolated to infinity (AUC)
Time frame: Pre-dose and up to 6 hours post-dose
Area under the plasma concentration-time curve from time zero to time of last quantifiable concentration (AUC 0-last)
Time frame: Pre-dose and up to 6 hours post-dose
Area under the plasma concentration-time curve from time zero to 6 hours post-dose (AUC 0-6)
Time frame: Pre-dose and up to 6 hours post-dose
Observed last quantifiable concentration (C last)
Time frame: Pre-dose and up to 6 hours post-dose
Time of last quantifiable concentration (t last)
Time frame: Pre-dose and up to 6 hours post-dose
Time to reach maximum plasma concentration (t max)
Time frame: Pre-dose and up to 6 hours post-dose
Terminal elimination rate constant (λz)
Time frame: Pre-dose and up to 6 hours post-dose
Terminal elimination half-life (t1/2,λz)
Time frame: Pre-dose and up to 6 hours post-dose
Apparent clearance (CL/F)
Time frame: Pre-dose and up to 6 hours post-dose
Apparent volume of distribution at terminal phase (Vz/F)
Time frame: Pre-dose and up to 6 hours post-dose
Cumulative amount of AZD5634 excreted in urine from time zero to 6 hours (Ae 0-6)
Time frame: Pre-dose and up to 6 hours post-dose
Cumulative percentage of dose excreted unchanged in urine from time zero to 6 hours (fe(0-6)%)
Time frame: Pre-dose and up to 6 hours post-dose
Renal clearance, estimated by dividing Ae(0-t) (CLR)
Time frame: Pre-dose and up to 6 hours post-dose
Safety of subjects by evaluating the incidence of adverse events (AEs)
Time frame: From screening (≤28 days) up to 14-21 days post dosing
Safety of subjects by evaluating the systolic and diastolic blood pressure
Time frame: From screening (≤28 days) up to 14-21 days post dosing
Safety of subjects by evaluating the pulse rate.
Time frame: From screening (≤28 days) up to 14-21 days post dosing
Safety of subjects by evaluating spirometry results
Time frame: From screening (≤28 days) up to 14-21 days post dosing
Safety of subjects by evaluating the ECG results
Time frame: Pre-dose and up to 6 hours post-dose
Safety of subjects by the physical examination
Time frame: From screening (≤28 days) up to 14-21 days post dosing
Safety of subjects by evaluating the respiratory rate.
Time frame: From screening (≤28 days) up to 14-21 days post dosing
Safety of subjects by evaluating fractional excretion of potassium (FEK)
Time frame: Pre-dose and at 0-6 hours post-dose
Safety of subjects by evaluating urine sodium/potassium (Na/K) ratio
Time frame: Pre-dose and at 0-6 hours post-dose
Safety of subjects by evaluating the pulse oximetry
Time frame: From screening (≤28 days) up to 14-21 days post dosing
Safety of subjects by evaluating the clinical laboratory test results for biochemistry
Time frame: From screening (≤28 days) until 14-21 days post dosing
Safety of subjects by evaluating the clinical laboratory test results for urinalysis
Time frame: From screening (≤28 days) until 14-21 days post dosing
Safety of subjects by evaluating the clinical laboratory test results for hematology
Time frame: From screening (≤28 days) until 14-21 days post dosing
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 13 Jul 2018.
- Derived from this study: PubMed 35227647Kristensson C, Astrand A, Donaldson S, Goldwater R, Abdulai R, Patel N, Gardiner P, Tehler U, Mercier AK, Olsson M, Ersdal E, Maenpaa J, Bramer T, Malmgren A, Bennett W, Keen C. AZD5634, an inhaled ENaC inhibitor, in healthy subjects and patients with cystic fibrosis. J Cyst Fibros. 2022 Jul;21(4):684-690. doi: 10.1016/j.jcf.2022.02.010. Epub 2022 Feb 26.
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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.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing AZD5634 in people with Pulmonary/Respiratory Diseases, run by AstraZeneca at 3 sites in United States.
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 11 inclusion and 21 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 13 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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?
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?
Percentage of average whole lung particle clearance between 0 and 60 minutes after administration of aerosolized radiolabelled particles (time frame: 0 to 60 minutes). 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 NCT02950805, which also lists 1 linked publication.
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 13 Jul 2018.