AsthmaPhase 1NCT03976869
A Study to Assess the Pharmacokinetics (PK), Pharmacodynamics (PD) and Safety of 2-Week Treatment With Inhaled AZD7594 in Adolescents (12 to 17 Years) With Asthma
A Phase 1 study testing AZD7594 in people with Asthma, run by AstraZeneca at 10 sites in United States.
Trial summary
This is an open-label, multi-centre, Phase I study to assess the PK, PD and safety of 2 week treatment with inhaled AZD7594 in adolescent patients with asthma. The study is planned to be conducted at 4-10 study sites in the United States. The study intends to include 24 patients (12 to 17-year-old patients). Read more about this study
- Who is it for?
- Ages 12 to 17 years
- Conditions the study is for
- Asthma
- What is being tested?
- AZD7594
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 10 sitesUnited States
- Study dates
- 24 Jul 2019to 9 Jul 2020
- 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 12 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Provision of signed and dated informed consent form (ICF) prior to any study-specific procedures from patient's parents/legal guardians is required and signed and dated informed assent from the patient.
- Patient must be 12 to 17 years of age inclusive, at the time of signing the ICF/assent.
- A minimum of 6-month documented history of asthma treated (daily or intermittently) for at least 3 months before screening (Visit 1) with either low dose inhaled corticosteroid (ICS) monotherapy or leukotriene receptor antagonist (LTRA) monotherapy.
- Pre-bronchodilator FEV1 ≥70% of the predicted normal value at screening (Visit 1).
- An ACQ-5 score <1.5 at screening (Visit 1).
- Be non-smoker or ex-smoker who has stopped smoking (or using other nicotine products) for >6 months prior to screening (Visit 1).
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- Body mass index (BMI) above the 5th percentile for the patient's age and gender and a minimum weight of 30 kg at screening (Visit 1).
- Male or female
- Negative pregnancy test (urine or serum) for post-menarcheal female patients at screening (Visit 1).
- Post-menarcheal female patients must be willing to use a highly effective method of contraception which results in a low failure rate (ie, less than 1% per year). Sexual abstinence will be accepted as an effective method of contraception, provided a discussion occurred between the subject and investigator to confirm this lifestyle.
- After the washout period, patients are eligible to enter the treatment period only if all of the following inclusion criteria apply:
- Negative pregnancy test (urine or serum) for post-menarcheal female patients at baseline (Visit 4).
- FEV1 increase of at least 12% and 200 mL from baseline 15 to 30 minutes after 400 μg salbutamol (or albuterol equivalent of 360 µg) documented in the patient's medical history within 6 months of Visit 1, or confirmed at Visit 1 or Visit 2. In 12 to 14-year-old patients (who are likely to have a smaller forced vital capacity), positive reversibility testing could be based solely on the relative post bronchodilator response (at least 12%).
Who cannot join
- Patients are eligible to enter the washout period if none of the following exclusion criteria apply:
- Medical conditions
- Any clinically significant disease or disorder (eg, cardiovascular, pulmonary other than asthma, gastrointestinal, liver, renal, neurological, musculoskeletal including bone fractures, endocrine including adrenal insufficiency, metabolic, malignant, psychiatric, major physical impairment, severe obesity including weight-related health problems) which, in the opinion of the Investigator, may either put the patient at risk because of participation in the study, or influence the result of the study, or the patient's ability to participate in the study.
- Any clinically relevant abnormal findings in physical examination, clinical chemistry, haematology, urinalysis, vital signs, at screening (Visit 1), which, in the opinion of the Investigator, may put the patient at risk because of his/her participation in the study.
- Prolonged QT interval corrected using Fridericia's formula (QTcF) ≥440 msec based on ECG at screening (Visit 1) or pre-dose at Visit 4, or family history of long QT syndrome.
- Prolonged PR interval (>180 msec for ≤16-year-old patients and >200 msec for >16 year old patients) at screening (Visit 1) or pre-dose at Visit 4.
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- Heart rate <50 beats per minute (bpm) or >110 bpm.
- History of or current alcohol or drug abuse (including marijuana), as judged by the Investigator.
- Patients who are positive for hepatitis B surface antigen (HBsAg), hepatitis C virus (HCV) antibody or human immunodeficiency virus (HIV) at screening (Visit 1).
- Hospitalisation due to asthma exacerbation or asthma exacerbation within 1 month prior to screening (Visit 1).
- Lower respiratory tract infection within 1 month prior to screening (Visit 1).
- Prior/concomitant therapy
- Patient who, in the opinion of the Investigator, is unable to abstain from protocol-defined prohibited medications during the study.
- Prior/concurrent clinical study experience
- Participation in another clinical study with an investigational drug administered in the last 3 months before Visit 1, or participation in a method development study (no drug) 1 month prior to Visit 1.
- Note: Participation is identified as the completion of a treatment related visit.
- A definite or suspected personal history of intolerance or hypersensitivity to drugs and/or their excipients, judged to be clinically relevant by the Investigator.
- Other exclusions
- Inability to perform the required spirometry assessments, to use the AZD7594 inhaler or the short-acting beta agonist (SABA) inhaler, or to undergo blood sampling.
- Parent/legal guardian involvement in the planning and/or conduct of the study (applies to both AstraZeneca staff and/or staff at the study site).
- Judgement by the Investigator that the patient should not participate in the study if the patient is unlikely to comply with study procedures, restrictions and requirements.
- Previous enrolment in the present study.
- For post-menarcheal female patients only - currently pregnant, breastfeeding, or planning to become pregnant during the study.
- After the washout period, patients are eligible to enter the treatment period if none of the following exclusion criteria apply:
- An ACQ-5 score ≥3 at Visit 4.
- SABA use of ≥12 puffs/day for ≥3 consecutive days during the washout period.
- An asthma exacerbation that required treatment with ICSs or systemic steroids during the washout period.
- A <70% compliance in completing asthma symptom score during the last 7 days of the washout period (ie, <5 out of 7 days with both morning and evening assessments completed).
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
United States10 sites
Research Site
Bethesda, Maryland, 20814
Research Site
Boerne, Texas, 78006
Research Site
Columbus, Ohio, 43207
Research Site
Dallas, Texas, 75225
Research Site
Kansas City, Missouri, 64114
Research Site
Miami, Florida, 33165
Research Site
Miami Lakes, Florida, 33015
Research Site
Murray, Utah, 84107
Research Site
Oklahoma City, Oklahoma, 73106
Research Site
Rolling Hills Estates, California, 90274
About this study
Official title: An Open-Label, Multi-Centre, Phase I Study to Assess the Pharmacokinetics, Pharmacodynamics and Safety of 2-Week Treatment With Inhaled AZD7594 in Adolescents (12 to 17 Years) With Asthma
This is an open-label, multi-centre, Phase I study to assess the PK, PD and safety of 2 week treatment with inhaled AZD7594 in adolescent patients with asthma.
The study is planned to be conducted at 4-10 study sites in the United States. The study intends to include 24 patients (12 to 17-year-old patients). For each patient, the duration of participation in the study will be approximately 5 to 7 weeks (37 to 52 days).
Read the detailed description
This is an open-label, multi-centre, Phase I study to assess the PK, PD and safety of 2 week treatment with inhaled AZD7594 in adolescent patients with asthma.
The study is planned to be conducted at 4-10 study sites in the United States. Eligible 12 to 17-year-old patients with asthma controlled on Global Initiative for Asthma (GINA) step 2 medication (ie, low dose inhaled corticosteroid [ICS] or leukotriene receptor antagonist [LTRA]), as evidenced by an asthma control questionnaire (ACQ-5) score ≤1.5, will be asked to stop their ongoing asthma maintenance treatment. After a washout period (14 to 21 days), all patients with confirmed reversibility will start study treatment, consisting of inhalations of AZD7594 (360 µg, delivered dose, via dry powder inhaler [DPI]) once daily for 15 to 16 days.
The study intends to include 24 patients in order to have 18 evaluable patients, enrolled in equal proportion in the age group of 12 to 14 years (inclusive), and the age group of 15 to 17 years (inclusive), with at least 7 patients in each subgroup.
For each patient, the duration of participation in the study will be approximately 5 to 7 weeks (37 to 52 days)
- Conditions
- Asthma
- Being tested
- AZD7594
- Keywords
- glucocorticoid receptor (GR) modulator (SGRM), non-steroidal, Asthma, Adolescents
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AZD7594Drug
During treatment period, AZD7594 (360 µg per day) will be administered as oral inhalation via dry powder inhaler or DPI (SD3FL inhaler).
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 | Experimental | The study will include adolescent patients of 12 to 17 years of age, with subgroups of 12-14 years age and 15-17 years age. Receives: Drug: AZD7594 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum observed plasma concentration at steady state (Cmax,ss) at Day 15 as part of PK evaluation
To assess the PK profile of AZD7594 at steady state following daily inhalations for 2 weeks in adolescent patients with asthma
Measured: Pre-dose and 15, 30 minutes, 2, 4, 6, 8, 12 hours post-dose at Day 15
Minimum observed plasma concentration at steady state (Cmin,ss) at Day 15 as part of PK evaluation
To assess the PK profile of AZD7594 at steady state following daily inhalations for 2 weeks in adolescent patients with asthma.
Measured: Pre-dose and 15, 30 minutes, 2, 4, 6, 8, 12 hours post-dose at Day 15
Observed trough plasma concentration at end of dosing interval (τ) (Ctrough) at Day 15 as part of PK evaluation
To assess the PK profile of AZD7594 at steady state following daily inhalations for 2 weeks in adolescent patients with asthma
Measured: Pre-dose and 15, 30 minutes, 2, 4, 6, 8, 12 hours post-dose at Day 15
Time of maximum observed plasma concentration at steady state (tmax,ss) at Day 15 as part of PK evaluation
To assess the PK profile of AZD7594 at steady state following daily inhalations for 2 weeks in adolescent patients with asthma.
Measured: Pre-dose and 15, 30 minutes, 2, 4, 6, 8, 12 hours post-dose at Day 15
Area under the plasma concentration-time curve over a dosing interval (τ) at steady state (AUCτ) at Day 15 as part of PK evaluation
To assess the PK profile of AZD7594 at steady state following daily inhalations for 2 weeks in adolescent patients with asthma.
Measured: Pre-dose and 15, 30 minutes, 2, 4, 6, 8, 12 hours post-dose at Day 15
Area under the plasma concentration curve from time zero to 12 hours post-dose (AUC0-12) under plasma concentration at Day 15 as part of PK evaluation
To assess the PK profile of AZD7594 at steady state following daily inhalations for 2 weeks in adolescent patients with asthma.
Measured: Pre-dose and 15, 30 minutes, 2, 4, 6, 8, 12 hours post-dose at Day 15
Apparent total body clearance after extravascular administration at steady state (CLss/F) at Day 15 as part of PK evaluation
To assess the PK profile of AZD7594 at steady state following daily inhalations for 2 weeks in adolescent patients with asthma.
Measured: Pre-dose and 15, 30 minutes, 2, 4, 6, 8, 12 hours post-dose at Day 15
Secondary outcomes (3)
Relative change from baseline in plasma cortisol area under the effect curve from time zero to 12 hours post-dose (AUEC0-12) on Day 15 as part of PD evaluation
To evaluate the PD of AZD7594 following daily inhalations for 2 weeks in adolescent patients with asthma.
Measured: Pre-dose and 2, 4, 6, 8, 12 hours post-dose at Day 15
Change from baseline in morning trough forced expiratory volume in 1 second (FEV1) on Day 15 as part of PD evaluation
To evaluate the PD of AZD7594 following daily inhalations for 2 weeks in adolescent patients with asthma.
Measured: At screening, Day 1 (pre-dose and 5, 15, 60 minutes post dose), Day 15 (pre-dose) and at end of study
Change from baseline in asthma control questionnaire (ACQ-5) on Day 15 as part of PD evaluation
To evaluate the PD of AZD7594 following daily inhalations for 2 weeks in adolescent patients with asthma. ACQ-5 is a 5 item questionnaire that scores symptoms on a 0-6 scale (where 0=none/no symptoms and 6=worst symptoms) . The form is completed by the patient during visits.
Measured: At screening, Day 1 (pre-dose) and Day 15 (pre-dose)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2019
- Study start24 Jul 2019
- Primary completion9 Jul 2020
- Study completion9 Jul 2020
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
- 36 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
- NCT03976869
- Sponsor's protocol ID
- D3741C00012
- Status last verified
- Jan 2021
- First submitted
- 5 Jun 2019
- Last updated
- 29 Jan 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label, Multi-Centre, Phase I Study to Assess the Pharmacokinetics, Pharmacodynamics and Safety of 2-Week Treatment With Inhaled AZD7594 in Adolescents (12 to 17 Years) With Asthma
- ClinicalTrials.gov ID
- NCT03976869
- Acronym / sponsor ID
- D3741C00012
- Conditions
- Asthma
- Keywords
- glucocorticoid receptor (GR) modulator (SGRM), non-steroidal, Asthma, Adolescents
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Collaborators
- Parexel
- Study start
- 24 Jul 2019 (actual)
- Primary completion
- 9 Jul 2020 (actual)
- Study completion
- 9 Jul 2020 (actual)
- First posted
- 6 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.
This is an open-label, multi-centre, Phase I study to assess the PK, PD and safety of 2 week treatment with inhaled AZD7594 in adolescent patients with asthma.
The study is planned to be conducted at 4-10 study sites in the United States. The study intends to include 24 patients (12 to 17-year-old patients). For each patient, the duration of participation in the study will be approximately 5 to 7 weeks (37 to 52 days).
Detailed description
This is an open-label, multi-centre, Phase I study to assess the PK, PD and safety of 2 week treatment with inhaled AZD7594 in adolescent patients with asthma.
The study is planned to be conducted at 4-10 study sites in the United States. Eligible 12 to 17-year-old patients with asthma controlled on Global Initiative for Asthma (GINA) step 2 medication (ie, low dose inhaled corticosteroid [ICS] or leukotriene receptor antagonist [LTRA]), as evidenced by an asthma control questionnaire (ACQ-5) score ≤1.5, will be asked to stop their ongoing asthma maintenance treatment. After a washout period (14 to 21 days), all patients with confirmed reversibility will start study treatment, consisting of inhalations of AZD7594 (360 µg, delivered dose, via dry powder inhaler [DPI]) once daily for 15 to 16 days.
The study intends to include 24 patients in order to have 18 evaluable patients, enrolled in equal proportion in the age group of 12 to 14 years (inclusive), and the age group of 15 to 17 years (inclusive), with at least 7 patients in each subgroup.
For each patient, the duration of participation in the study will be approximately 5 to 7 weeks (37 to 52 days)
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 | Experimental | Drug: AZD7594The study will include adolescent patients of 12 to 17 years of age, with subgroups of 12-14 years age and 15-17 years age. |
Who may qualify
- Ages
- 12 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (13 listed)
- Provision of signed and dated informed consent form (ICF) prior to any study-specific procedures from patient's parents/legal guardians is required and signed and dated informed assent from the patient.
- Patient must be 12 to 17 years of age inclusive, at the time of signing the ICF/assent.
- A minimum of 6-month documented history of asthma treated (daily or intermittently) for at least 3 months before screening (Visit 1) with either low dose inhaled corticosteroid (ICS) monotherapy or leukotriene receptor antagonist (LTRA) monotherapy.
- Pre-bronchodilator FEV1 ≥70% of the predicted normal value at screening (Visit 1).
- An ACQ-5 score <1.5 at screening (Visit 1).
Key exclusion criteria (28 listed)
- Patients are eligible to enter the washout period if none of the following exclusion criteria apply:
- Medical conditions
- Any clinically significant disease or disorder (eg, cardiovascular, pulmonary other than asthma, gastrointestinal, liver, renal, neurological, musculoskeletal including bone fractures, endocrine including adrenal insufficiency, metabolic, malignant, psychiatric, major physical impairment, severe obesity including weight-related health problems) which, in the opinion of the Investigator, may either put the patient at risk because of participation in the study, or influence the result of the study, or the patient's ability to participate in the study.
- Any clinically relevant abnormal findings in physical examination, clinical chemistry, haematology, urinalysis, vital signs, at screening (Visit 1), which, in the opinion of the Investigator, may put the patient at risk because of his/her participation in the study.
- Prolonged QT interval corrected using Fridericia's formula (QTcF) ≥440 msec based on ECG at screening (Visit 1) or pre-dose at Visit 4, or family history of long QT syndrome.
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 |
|---|---|---|
| AZD7594During treatment period, AZD7594 (360 µg per day) will be administered as oral inhalation via dry powder inhaler or DPI (SD3FL inhaler). | Drug | Cohort 1 |
Primary outcome
Maximum observed plasma concentration at steady state (Cmax,ss) at Day 15 as part of PK evaluation
Time frame: Pre-dose and 15, 30 minutes, 2, 4, 6, 8, 12 hours post-dose at Day 15
To assess the PK profile of AZD7594 at steady state following daily inhalations for 2 weeks in adolescent patients with asthma
Minimum observed plasma concentration at steady state (Cmin,ss) at Day 15 as part of PK evaluation
Time frame: Pre-dose and 15, 30 minutes, 2, 4, 6, 8, 12 hours post-dose at Day 15
To assess the PK profile of AZD7594 at steady state following daily inhalations for 2 weeks in adolescent patients with asthma.
Observed trough plasma concentration at end of dosing interval (τ) (Ctrough) at Day 15 as part of PK evaluation
Time frame: Pre-dose and 15, 30 minutes, 2, 4, 6, 8, 12 hours post-dose at Day 15
To assess the PK profile of AZD7594 at steady state following daily inhalations for 2 weeks in adolescent patients with asthma
Time of maximum observed plasma concentration at steady state (tmax,ss) at Day 15 as part of PK evaluation
Time frame: Pre-dose and 15, 30 minutes, 2, 4, 6, 8, 12 hours post-dose at Day 15
To assess the PK profile of AZD7594 at steady state following daily inhalations for 2 weeks in adolescent patients with asthma.
Area under the plasma concentration-time curve over a dosing interval (τ) at steady state (AUCτ) at Day 15 as part of PK evaluation
Time frame: Pre-dose and 15, 30 minutes, 2, 4, 6, 8, 12 hours post-dose at Day 15
To assess the PK profile of AZD7594 at steady state following daily inhalations for 2 weeks in adolescent patients with asthma.
Area under the plasma concentration curve from time zero to 12 hours post-dose (AUC0-12) under plasma concentration at Day 15 as part of PK evaluation
Time frame: Pre-dose and 15, 30 minutes, 2, 4, 6, 8, 12 hours post-dose at Day 15
To assess the PK profile of AZD7594 at steady state following daily inhalations for 2 weeks in adolescent patients with asthma.
Apparent total body clearance after extravascular administration at steady state (CLss/F) at Day 15 as part of PK evaluation
Time frame: Pre-dose and 15, 30 minutes, 2, 4, 6, 8, 12 hours post-dose at Day 15
To assess the PK profile of AZD7594 at steady state following daily inhalations for 2 weeks in adolescent patients with asthma.
3 secondary outcomes
Relative change from baseline in plasma cortisol area under the effect curve from time zero to 12 hours post-dose (AUEC0-12) on Day 15 as part of PD evaluation
Time frame: Pre-dose and 2, 4, 6, 8, 12 hours post-dose at Day 15
Change from baseline in morning trough forced expiratory volume in 1 second (FEV1) on Day 15 as part of PD evaluation
Time frame: At screening, Day 1 (pre-dose and 5, 15, 60 minutes post dose), Day 15 (pre-dose) and at end of study
Change from baseline in asthma control questionnaire (ACQ-5) on Day 15 as part of PD evaluation
Time frame: At screening, Day 1 (pre-dose) and Day 15 (pre-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 29 Jan 2021.
- Individual participant dataSharing planned: Yes. Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.
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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.
10 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 AZD7594 in people with Asthma, run by AstraZeneca at 10 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 13 inclusion and 28 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 29 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 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?
Maximum observed plasma concentration at steady state (Cmax,ss) at Day 15 as part of PK evaluation (time frame: Pre-dose and 15, 30 minutes, 2, 4, 6, 8, 12 hours post-dose at Day 15). 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 29 Jan 2021.