AsthmaPhase 1NCT02512900
A Study to Evaluate the Pharmacokinetics of MEDI9929 (AMG 157) in Adolescents With Mild to Moderate Asthma
A Phase 1 study testing MEDI9929, 140 mg in people with Asthma, run by MedImmune LLC at 4 sites in Poland.
Trial summary
To evaluate the PK profile of a single-dose of 140 mg subcutaneous (SC) administration of MEDI9929 (AMG 157) in adolescent subjects with mild to moderate asthma. Read more about this study
- Who is it for?
- Ages 12 to 17 years
- Conditions the study is for
- Asthma
- What is being tested?
- MEDI9929, 140 mg
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 4 sitesPoland
- Study dates
- 10 Sep 2015to 17 May 2016
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Age 12 to 17 years (inclusive) at both screening and Day 1.
- Physician diagnosed asthma for a minimum of 6 months prior to screening.
- Physician prescribed daily use of asthma controller medication
- Prebronchodilator FEV1 of ≥ 70% of predicted normal value at screening.
- A postbronchodilator increase in FEV1 ≥ 12% and ≥ 200 mL at screening.
- If on allergen immunotherapy, subjects must be on a stable maintenance dose and schedule ≥ 1 month prior to Visit 1.
Show all 10Show fewer
- Weight ≥ 30 kg at both screening and Day 1.
- Body mass index for age at both screening and Day 1 that is between 5th and 95th percentile
- Females of childbearing potential who are sexually active with a nonsterilized male partner must use highly effective contraception from screening
- Nonsterilized males who are sexually active with a female partner of childbearing potential must use a highly effective method of contraception from screening
Who cannot join
- History of a deterioration in asthma that required a burst of systemic corticosteroids within 3 months of screening, up to and including Day 1.
- Clinical characteristics at either screening or Day 1 that are consistent with uncontrolled asthma as described in GINA guideline.
- History of hospitalization (overnight admission) for asthma during the 6 months prior to screening.
- History of intubation for the management of a deterioration in asthma.
- History of systemic corticosteroid use for the maintenance treatment of asthma within 3 months prior to screening.
- History of allergy or reaction to any component of the investigational product formulation or history of anaphylaxis following any biologic therapy.
Show all 18Show fewer
- Any active medical condition other than asthma, that in the opinion of the investigator and/or medical monitor, may compromise the safety of the subject in the study or interfere with evaluation of the investigational product or reduce the subject's ability to participate in the study (subjects with atopic skin conditions and allergic rhinitis are permitted).
- Pregnant or breastfeeding females.
- Current tobacco smoking or cessation of smoking for ≤ 6months prior to screening.
- Any clinically relevant abnormal findings which in the opinion of the investigator or medical monitor, may compromise the safety of the subject in the study or interfere with evaluation of the investigational product or reduce the subject's ability to participate in the study.
- Evidence of active liver disease,
- Positive hepatitis B or hepatitis C virus
- A positive human immunodeficiency virus (HIV) test at screening or subject taking antiretroviral medications
- Major surgery within 8 weeks prior to Visit 1, or planned in-patient surgery or hospitalization during the study period.
- History of any known primary immunodeficiency disorder
- History of a clinically significant infection
- A helminth parasitic infection within 24 weeks of Visit 1 that has not been treated or has not responded to standard of care therapy.
- History of cancer.
Trial locations and contacts
4 sites in 1 country.
Poland4 sites
Research Site
Kielce, 25-040
Research Site
Lodz, 71-329
Research Site
Wroclaw, 51-162
Research Site
Wroclaw, 53-201
About this study
Official title: A Phase 1, Open-label Study to Evaluate the Pharmacokinetics of MEDI9929 (AMG 157) in Adolescents With Mild to Moderate Asthma
To evaluate the PK profile of a single-dose of 140 mg subcutaneous (SC) administration of MEDI9929 (AMG 157) in adolescent subjects with mild to moderate asthma.
Read the detailed description
The primary objective is to evaluate the PK profile of a single-dose of 140 mg subcutaneous (SC) administration of MEDI9929 (AMG 157) in adolescent subjects with mild to moderate asthma. The secondary objective is to evaluate the safety and tolerability of MEDI9929 and to evaluate the immunogenicity of MEDI9929 (AMG 157). The exploratory objective is to evaluate the effect of MEDI9929 (AMG 157) on pulmonary function
- Conditions
- Asthma
- Being tested
- MEDI9929, 140 mg
- Keywords
- Asthma
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MEDI9929, 140 mgDrug
Also called Subcutaneous single-dose
On Day 1, two MEDI9929 subcutaneous injection of 70 mg each were given into the anterior aspect of one thigh immediately followed by the second injection into the anterior aspect of the contralateral thigh to make the required dose of 140 mg in participants of 12 to 17 years of age.
| Study group | Role | What they receive |
|---|---|---|
| MEDI9929, 140 mg, Cohort 1 (12 to 14 years) | Experimental | On Day 1, one MEDI9929 subcutaneous injection of 70 mg was given into the anterior aspect of one thigh immediately followed by the second injection of 70 mg into the anterior aspect of the contralateral thigh to make the required dose of 140 mg in participants with 12 to 14 years of age. Receives: Drug: MEDI9929, 140 mg |
| MEDI9929, 140 mg, Cohort 2 (15 to 17 years) | Experimental | On Day 1, one MEDI9929 subcutaneous injection of 70 mg was given into the anterior aspect of one thigh immediately followed by the second injection of 70 mg into the anterior aspect of the contralateral thigh to make the required dose of 140 mg in participants with 15 to 17 years of age. Receives: Drug: MEDI9929, 140 mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area Under the Concentration-time Curve From Zero to Infinity (AUC [0-infinity])
The pharmacokinetic (PK) parameter AUC (0 to infinity) was estimated based on the serum concentrations of MEDI9929. Serum concentrations of MEDI9929 were measured by enzyme-linked immunosorbent assay.
Measured: Predose on Day 1 and Day 2, 4, 7, 11, 15, 22, 29, 43, 57 and 85 post-dose.
Area Under the Concentration-Time Curve From Zero to Last Observation (AUC [0-t])
The PK parameter AUC (0-t) was estimated based on the serum concentrations of MEDI9929. Serum concentrations of MEDI9929 were measured by enzyme-linked immunosorbent assay.
Measured: Predose on Day 1 and Day 2, 4, 7, 11, 15, 22, 29, 43, 57 and 85 post-dose.
Dose-normalized AUC (0-infinity) (AUC [0 Infinity]/D)
The AUC (0-infinity)/D is the area under concentration-time curve extrapolated to infinity postdose normalized by MEDI9929 dose. The PK parameter was estimated based on the serum concentrations of MEDI9929. Serum concentrations of MEDI9929 were measured by enzyme-linked immunosorbent assay.
Measured: Predose on Day 1 and Day 2, 4, 7, 11, 15, 22, 29, 43, 57 and 85 post-dose.
Maximum Observed Serum Concentration (Cmax)
The PK parameter Cmax was estimated based on the serum concentrations of MEDI9929. Serum concentrations of MEDI9929 were measured by enzyme-linked immunosorbent assay.
Measured: Predose on Day 1 and Day 2, 4, 7, 11, 15, 22, 29, 43, 57 and 85 post-dose.
Dose-normalized Cmax (Cmax/D)
The Cmax/D is the maximum observed concentration post dose normalized by MEDI9929 dose. The PK parameter was estimated based on the serum concentrations of MEDI9929. Serum concentrations of MEDI9929 were measured by enzyme-linked immunosorbent assay.
Measured: Predose on Day 1 and Day 2, 4, 7, 11, 15, 22, 29, 43, 57 and 85 post-dose.
Time to Reach Cmax (Tmax)
The Tmax is the time to maximum observed serum concentration of MEDI9929. The PK parameter was estimated based on the serum concentrations of MEDI9929. Serum concentrations of MEDI9929 were measured by enzyme-linked immunosorbent assay.
Measured: Predose on Day 1 and Day 2, 4, 7, 11, 15, 22, 29, 43, 57 and 85 post-dose.
Terminal Phase Elimination Half Life (t1/2,z)
The t½,z is the time measured for the serum drug concentration of MEDI9929 to decrease by one half. The PK parameter was estimated based on the serum concentrations of MEDI9929. Serum concentrations of MEDI9929 were measured by enzyme-linked immunosorbent assay.
Measured: Predose on Day 1 and Day 2, 4, 7, 11, 15, 22, 29, 43, 57 and 85 post-dose.
Apparent Clearance (CL/F)
The PK parameter CL/F was estimated based on the serum concentrations of MEDI9929. Serum concentrations of MEDI9929 were measured by enzyme-linked immunosorbent assay.
Measured: Predose on Day 1 and Day 2, 4, 7, 11, 15, 22, 29, 43, 57 and 85 post-dose.
Apparent Steady-state Volume of Distribution (Vss/F)
The PK parameter Vss/F was estimated based on the serum concentrations of MEDI9929. Serum concentrations of MEDI9929 were measured by enzyme-linked immunosorbent assay.
Measured: Predose on Day 1 and Day 2, 4, 7, 11, 15, 22, 29, 43, 57 and 85 post-dose.
Secondary outcomes (5)
Number of Participants Reporting Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events
An adverse event (AE) is any unfavorable and unintended sign, symptom, or disease temporally associated with the use of study drug, whether or not considered related to the study drug. A serious adverse event (SAE) is any AE resulting in any of the following outcomes such as death; initial or prolonged inpatient hospitalization; life-threatening; persistent or significant disability/incapacity; congenital anomaly or birth defect, or is an important medical event that may jeopardize the participant or may require medical intervention to prevent one of the outcomes listed above. A TEAE is defined as events present at baseline that worsened in intensity after administration of study drug or events absent at baseline that emerged after administration of study drug. The AEs were summarized using Medical Dictionary for Regulatory Activities version 19.0
Measured: From the start of study drug administration up to end of follow-up period, assessed up to Day 85
Treatment-emergent Adverse Events Related to Vital Sign Parameters and Physical Findings
Vital signs (blood pressure, temperature, pulse, and respiratory rate) were performed throughout the study. The TEAEs related to vital signs in participants were reported.
Measured: From the start of study drug administration up to end of follow-up period, assessed up to Day 85
Treatment-emergent Adverse Events Related to Laboratory Parameters
Laboratory evaluations of blood and urine samples were performed, including hematology (white blood cell count with differential, red blood cell count, hematocrit, hemoglobin and platelet count); serum chemistry: calcium, chloride, potassium, sodium, bicarbonate, aspartate transaminase, alanine transaminase, albumin, uric acid, creatinine, total bilirubin, glucose, alkaline phosphatase, blood urea nitrogen, total protein, and gamma glutamyl transferase; and urinalysis (nitrites, protein, glucose, ketones, urine drug screen, blood, and bilirubin). Number of participants with TEAEs related to laboratory evaluations were reported.
Measured: From the start of study drug administration up to end of follow-up period, assessed up to Day 85
Treatment-emergent Adverse Events Related to Electrocardiogram Evaluations
Computerized triplicate 12-lead ECGs as well as Qualitative 12-lead ECGs were obtained during the study. ECG parameters included heart rate, PR, QRS, QT, and corrected QT (QTc) intervals. Number of participants with TEAEs related to ECG after the start of study drug were to be reported.
Measured: From the start of study drug administration up to end of follow-up period, assessed up to Day 85
Number of Participants Positive for Anti-drug Antibodies and With Neutralizing Antibodies for MEDI9929 at Any Visit
Blood samples for immunogenicity assessment included the determination of anti-drug antibodies (ADA) for MEDI9929. The incidence rate of positive serum antibodies to MEDI9929 were presented.
Measured: Days 1 (predose), 29, 57 and 85
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2015 (estimated)
- Study start10 Sep 2015
- Primary completion17 May 2016
- Study completion17 May 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for AsthmaStudies of the same condition, open and under way.
- 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- MedImmune LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Amgen
- Responsible party
- Sponsor
- Investigators
- Rene van der Merwe, MBChB, MSc, FFPM, Study director, MedImmune LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02512900
- Sponsor's protocol ID
- D5180C00002
- Other IDs
- 2014-005450-19, 2014
- Status last verified
- May 2017
- First submitted
- 24 Jul 2015
- Last updated
- 21 Jun 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Open-label Study to Evaluate the Pharmacokinetics of MEDI9929 (AMG 157) in Adolescents With Mild to Moderate Asthma
- ClinicalTrials.gov ID
- NCT02512900
- Acronym / sponsor ID
- D5180C00002
- Conditions
- Asthma
- Keywords
- Asthma
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- MedImmune LLCIndustry (pharma, biotech, devices)
- Collaborators
- Amgen
- Study start
- 10 Sep 2015 (actual)
- Primary completion
- 17 May 2016 (actual)
- Study completion
- 17 May 2016 (actual)
- First posted
- 31 Jul 2015 (estimated)
- Results
- Posted 23 Feb 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To evaluate the PK profile of a single-dose of 140 mg subcutaneous (SC) administration of MEDI9929 (AMG 157) in adolescent subjects with mild to moderate asthma.
Detailed description
The primary objective is to evaluate the PK profile of a single-dose of 140 mg subcutaneous (SC) administration of MEDI9929 (AMG 157) in adolescent subjects with mild to moderate asthma. The secondary objective is to evaluate the safety and tolerability of MEDI9929 and to evaluate the immunogenicity of MEDI9929 (AMG 157). The exploratory objective is to evaluate the effect of MEDI9929 (AMG 157) on pulmonary function
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MEDI9929, 140 mg, Cohort 1 (12 to 14 years) | Experimental | Drug: MEDI9929, 140 mgOn Day 1, one MEDI9929 subcutaneous injection of 70 mg was given into the anterior aspect of one thigh immediately followed by the second injection of 70 mg into the anterior aspect of the contralateral thigh to make the required dose of 140 mg in participants with 12 to 14 years of age. |
| MEDI9929, 140 mg, Cohort 2 (15 to 17 years) | Experimental | Drug: MEDI9929, 140 mgOn Day 1, one MEDI9929 subcutaneous injection of 70 mg was given into the anterior aspect of one thigh immediately followed by the second injection of 70 mg into the anterior aspect of the contralateral thigh to make the required dose of 140 mg in participants with 15 to 17 years of age. |
Who may qualify
- Ages
- 12 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (10 listed)
- Age 12 to 17 years (inclusive) at both screening and Day 1.
- Physician diagnosed asthma for a minimum of 6 months prior to screening.
- Physician prescribed daily use of asthma controller medication
- Prebronchodilator FEV1 of ≥ 70% of predicted normal value at screening.
- A postbronchodilator increase in FEV1 ≥ 12% and ≥ 200 mL at screening.
Key exclusion criteria (18 listed)
- History of a deterioration in asthma that required a burst of systemic corticosteroids within 3 months of screening, up to and including Day 1.
- Clinical characteristics at either screening or Day 1 that are consistent with uncontrolled asthma as described in GINA guideline.
- History of hospitalization (overnight admission) for asthma during the 6 months prior to screening.
- History of intubation for the management of a deterioration in asthma.
- History of systemic corticosteroid use for the maintenance treatment of asthma within 3 months prior to screening.
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 |
|---|---|---|
| MEDI9929, 140 mgAlso: Subcutaneous single-doseOn Day 1, two MEDI9929 subcutaneous injection of 70 mg each were given into the anterior aspect of one thigh immediately followed by the second injection into the anterior aspect of the contralateral thigh to make the required dose of 140 mg in participants of 12 to 17 years of age. | Drug | MEDI9929, 140 mg, Cohort 1 (12 to 14 years), MEDI9929, 140 mg, Cohort 2 (15 to 17 years) |
Primary outcome
Area Under the Concentration-time Curve From Zero to Infinity (AUC [0-infinity])
Time frame: Predose on Day 1 and Day 2, 4, 7, 11, 15, 22, 29, 43, 57 and 85 post-dose.
The pharmacokinetic (PK) parameter AUC (0 to infinity) was estimated based on the serum concentrations of MEDI9929. Serum concentrations of MEDI9929 were measured by enzyme-linked immunosorbent assay.
Area Under the Concentration-Time Curve From Zero to Last Observation (AUC [0-t])
Time frame: Predose on Day 1 and Day 2, 4, 7, 11, 15, 22, 29, 43, 57 and 85 post-dose.
The PK parameter AUC (0-t) was estimated based on the serum concentrations of MEDI9929. Serum concentrations of MEDI9929 were measured by enzyme-linked immunosorbent assay.
Dose-normalized AUC (0-infinity) (AUC [0 Infinity]/D)
Time frame: Predose on Day 1 and Day 2, 4, 7, 11, 15, 22, 29, 43, 57 and 85 post-dose.
The AUC (0-infinity)/D is the area under concentration-time curve extrapolated to infinity postdose normalized by MEDI9929 dose. The PK parameter was estimated based on the serum concentrations of MEDI9929. Serum concentrations of MEDI9929 were measured by enzyme-linked immunosorbent assay.
Maximum Observed Serum Concentration (Cmax)
Time frame: Predose on Day 1 and Day 2, 4, 7, 11, 15, 22, 29, 43, 57 and 85 post-dose.
The PK parameter Cmax was estimated based on the serum concentrations of MEDI9929. Serum concentrations of MEDI9929 were measured by enzyme-linked immunosorbent assay.
Dose-normalized Cmax (Cmax/D)
Time frame: Predose on Day 1 and Day 2, 4, 7, 11, 15, 22, 29, 43, 57 and 85 post-dose.
The Cmax/D is the maximum observed concentration post dose normalized by MEDI9929 dose. The PK parameter was estimated based on the serum concentrations of MEDI9929. Serum concentrations of MEDI9929 were measured by enzyme-linked immunosorbent assay.
Time to Reach Cmax (Tmax)
Time frame: Predose on Day 1 and Day 2, 4, 7, 11, 15, 22, 29, 43, 57 and 85 post-dose.
The Tmax is the time to maximum observed serum concentration of MEDI9929. The PK parameter was estimated based on the serum concentrations of MEDI9929. Serum concentrations of MEDI9929 were measured by enzyme-linked immunosorbent assay.
Terminal Phase Elimination Half Life (t1/2,z)
Time frame: Predose on Day 1 and Day 2, 4, 7, 11, 15, 22, 29, 43, 57 and 85 post-dose.
The t½,z is the time measured for the serum drug concentration of MEDI9929 to decrease by one half. The PK parameter was estimated based on the serum concentrations of MEDI9929. Serum concentrations of MEDI9929 were measured by enzyme-linked immunosorbent assay.
Apparent Clearance (CL/F)
Time frame: Predose on Day 1 and Day 2, 4, 7, 11, 15, 22, 29, 43, 57 and 85 post-dose.
The PK parameter CL/F was estimated based on the serum concentrations of MEDI9929. Serum concentrations of MEDI9929 were measured by enzyme-linked immunosorbent assay.
Apparent Steady-state Volume of Distribution (Vss/F)
Time frame: Predose on Day 1 and Day 2, 4, 7, 11, 15, 22, 29, 43, 57 and 85 post-dose.
The PK parameter Vss/F was estimated based on the serum concentrations of MEDI9929. Serum concentrations of MEDI9929 were measured by enzyme-linked immunosorbent assay.
5 secondary outcomes
Number of Participants Reporting Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events
Time frame: From the start of study drug administration up to end of follow-up period, assessed up to Day 85
Treatment-emergent Adverse Events Related to Vital Sign Parameters and Physical Findings
Time frame: From the start of study drug administration up to end of follow-up period, assessed up to Day 85
Treatment-emergent Adverse Events Related to Laboratory Parameters
Time frame: From the start of study drug administration up to end of follow-up period, assessed up to Day 85
Treatment-emergent Adverse Events Related to Electrocardiogram Evaluations
Time frame: From the start of study drug administration up to end of follow-up period, assessed up to Day 85
Number of Participants Positive for Anti-drug Antibodies and With Neutralizing Antibodies for MEDI9929 at Any Visit
Time frame: Days 1 (predose), 29, 57 and 85
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jun 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Click here to search for drug information provided by the FDALink provided by the sponsor.
Related trials for Asthma
RecruitingPhase 1
Pilot Study to Identify the Mediators and Inflammatory Cell Surface Receptors Involved in Allergic Airway Inflammation
Asthma
RecruitingPhase 1
A Study to Compare the Relative Potency of Salbutamol Administered Via Metered Dose Inhalers (MDI) Containing Propellants HFA-152a to HFA-134a in Mild Asthmatics Aged 18 to 65 Inclusive
Asthma, Mild Asthma
RecruitingPhase 3
A Study Assessing the Effect of Dupilumab on Inducing Clinical Remission in Asthma
Asthma Control
Active, not recruitingPhase 2/3
Local Antibiotic Delivery for Community Acquired Pneumonia
Community Acquired Pneumonia (CAP)
RecruitingPhase 2
A Study to Learn About the Study Medicine Called PF-07275315 in People With Moderate-To-Severe Asthma
Asthma
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.
Rene van der Merwe, MBChB, MSc, FFPM study director
MedImmune LLC
4 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 MEDI9929, 140 mg in people with Asthma, run by MedImmune LLC at 4 sites in Poland.
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 10 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Jun 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 23 Feb 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Area Under the Concentration-time Curve From Zero to Infinity (AUC [0-infinity]) (time frame: Predose on Day 1 and Day 2, 4, 7, 11, 15, 22, 29, 43, 57 and 85 post-dose.). The study lists 9 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 21 Jun 2017.