HealthyPhase 1NCT03303924
Study to Determine and Compare Plasma and Intrapulmonary Concentrations of ETX2514 and Sulbactam in Healthy Subjects
A Phase 1 study testing ETX2514 and sulbactam in people with Healthy, run by Entasis Therapeutics at 1 site in United States.
Trial summary
This is a Phase 1, multiple dose, open-label pharmacokinetic study conducted in healthy adult male and female subjects to determine and compare plasma, epithelial lining fluid (ELF) and alveolar macrophage (AM) concentrations of ETX2514 and sulbactam in healthy adult subjects after intravenous infusion of ETX2514 1.0… Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- ETX2514 and sulbactam
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Aug 2017to 26 Oct 2017
- 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
- Healthy male or female subject, between 18 and 55 years of age (both inclusive) at the time of screening.
- Body mass index (BMI) ≥ 18.0 kg/m2 and ≤ 32.0 kg/m2 and weight between 55.0 and 100.0 kg (both inclusive).
- Be in general good health without clinically significant medical history as judged by the Principal Investigator.
- Provide voluntary written informed consent prior to any study procedures and is willing and able to comply with the prescribed treatment protocol and evaluations.
- Non-tobacco/nicotine-containing product users for a minimum of 6 months prior to screening.
- Clinical laboratory values within the normal limits as defined by the clinical laboratory, unless the Principal or sub-Investigator decides that out-of-range values are not clinically significant.
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- If male, agree to be sexually abstinent or agree to use two approved methods of contraception when engaging in sexual activity from screening until 90 days following the last administration of the study drug, and to not donate sperm during same time period. In the event that the sexual partner is surgically sterile, contraception is not necessary.
- Female subjects of child bearing potential must agree to practice two highly effective methods of birth control (as determined by the Investigator; one of the methods must be a barrier technique) from Screening until 30 days after the last dose of study drug.
- Postmenopausal females (defined as 12 months spontaneous amenorrhea) with serum follicle stimulating hormone levels ≥ 40 mlU/mL or females who have undergone one of the following sterilization procedures at least 6 months prior to screening (and is documented):
- Bilateral tubal ligation
- Hysterectomy
- Hysterectomy with unilateral or bilateral oophorectomy
- Bilateral oophorectomy.
Who cannot join
- History of any moderate or severe hypersensitivity or allergic reaction to any β-lactam antimicrobial (e.g., penicillin, cephalosporin, sulbactam or carbapenem)
- History or presence of significant oncologic, cardiovascular, pulmonary, hepatic, renal, hematological, gastrointestinal, endocrine, immunologic, dermatologic, neurological, or psychiatric disease.
- Calculated creatinine clearance less than 60 mL/min (Cockcroft-Gault method) at screening or confinement.
- Positive alcohol breath test or urine drug screen test at screening or confinement.
- Positive testing for HIV, Hepatitis B or Hepatitis C.
- History or presence of alcohol or drug abuse within the 2 years prior to screening.
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- Excessive intake of alcohol, defined as an average daily intake of greater than three units, or an average weekly intake of greater than 21 units (one unit is equivalent to 1 can or bottle (12 oz) of beer, or 1 measure (1.5 oz) of spirits, or 1 glass (5 oz) of wine) in the last 6 months prior to screening.
- History of allergic or other serious adverse reactions to lidocaine or amide anesthetic agents.
- Clinically significant pulmonary or any other disease that prevents a subject from undergoing bronchoscopy with pulmonary lavage.
- Spirometry results showing an forced expiratory volume at one second (FEV1) <80% of predicted.
- Use of probenecid within 30 days before confinement.
- Use of medication, except for acetaminophen which is allowed up to 3 days before confinement. Multivitamins and vitamin C are allowed up to 7 days before confinement (Day 1). All other medication (including over the counter medication, health supplements, and herbal remedies such as St. John's Wort extract must have been stopped at least 14 days prior to confinement), unless agreed as non-clinically relevant by the Principal Investigator.
- Engagement in strenuous activity within 96 hours of confinement (Day 1) until discharge.
- History of seizures, head injury or meningitis (e.g., epilepsy).
- History of bleeding disorders.
- History or evidence of difficulty in donating blood.
- Use of any prescription medication (with the exception of hormonal contraceptives or hormone replacement therapy for females) within 14 days prior to confinement.
- Blood donation/plasma donation or significant blood loss (i.e., >500 mL) within 60 days prior to screening.
- Participation in another investigational drug or device study or treated with an investigational drug within 30 days or five half-lives (whichever is longer) prior to screening.
- Females who are pregnant or lactating.
- Surgery within the past three months prior to screening determined by the investigator to be clinically relevant.
- Any acute illness including clinically significant infection within 30 days prior to screening.
- Subjects who have any of the following abnormalities on laboratory values at screening or prior confinement including:
- White blood cell count < 3,000/mm3, hemoglobin < 11g/dL.
- Absolute neutrophil count <1,200/mm3, platelet count <120,000/mm3.
- Unwillingness or inability to comply with the study protocol for any other reason.
- Use of caffeine or xanthine containing products, Seville oranges (sour), grapefruit or grapefruit juice within 48 hours prior to study drug dosing.
- Any other condition or prior therapy, which, in the opinion of the Principal Investigator, would make the subject unsuitable for this study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase I Study to Determine and Compare Plasma, Epithelial Lining Fluid, and Alveolar Macrophage Concentrations of Intravenous ETX2514 and Sulbactam Administered to Healthy Adult Subjects
This is a Phase 1, multiple dose, open-label pharmacokinetic study conducted in healthy adult male and female subjects to determine and compare plasma, epithelial lining fluid (ELF) and alveolar macrophage (AM) concentrations of ETX2514 and sulbactam in healthy adult subjects after intravenous infusion of ETX2514 1.0 g given concurrently with intravenous sulbactam 1.0 g, administered every 6 hours with each infused over 3 hours, for 3 consecutive doses
Read the detailed description
Blood samples for determining plasma concentrations of ETX2514 and sulbactam will be collected within 5 minutes prior to and at 1.0, 2.0, 2.5, 2.95, 3.05, 3.25, 3.5, 4.0, 5.0 and 6.0 hours after start of the third dose (last dose) administered on Day 2.
Each subject will undergo one standardized bronchoscopy with bronchoalveolar lavage (BAL) in the outpatient bronchoscopy suite at 1.0, 2.5, 3.25, 4.0, or 6.0 hours after start of the infusion of the third dose of ETX2514 and sulbactam (6 subjects per timepoint) on Day 2.
Safety will be assessed throughout the study by adverse event monitoring, clinical laboratory tests, ECG, physical examination, and vital sign monitoring.
- Conditions
- Healthy
- Being tested
- ETX2514 and sulbactam
- Keywords
- Pharmacokinetic, Bronchoalveolar Lavage, Epithelial Lining Fluid, Alveolar Macrophage, Gram-negative bacterium, Acinetobacter baumannii
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ETX2514 and sulbactamDrug
Each subject will receive three doses of of ETX2514 1.0 g and sulbactam 1.0 g via intravenous (IV) infusion administered every 6 hours with each drug infused over 3 hours
| Study group | Role | What they receive |
|---|---|---|
| ETX2514 and sulbactam | Experimental | Healthy male and female subjects, non-smoking, will receive multiple doses of ETX2514 1.0 g and sulbactam 1 g via intravenous (IV) infusion every 6 hours with each dose of medication infused over 3 hours. Receives: Drug: ETX2514 and sulbactam |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean maximum observed drug concentration (Cmax) in blood
Venous blood will be collected for ETX2514SUL pharmacokinetic (PK) analysis predose and after the 3 dose. The 3rd dose of ETX2514 and sulbactam will be administered on Day 2
Measured: Predose, 1,2,2,5, 2.95, 3.05, 3.25, 3.5, 4, 5, and 6 hours after the start of the third dose (last dose) on Day 2
Mean Cmax in epithelial lining fluid (ELF)
Bronchoalveolar lavage fluid will be collected for ETX2514SUL PK at 1, 2.5, 3.25, 4, or 6 hours.
Measured: Predose, 1,2,2,5, 2.95, 3.05, 3.25, 3.5, 4, 5, and 6 hours after the start of the third dose (last dose) on Day 2
Mean area under the curve (AUC) 0-6h in blood
AUC0-6h defined as the area under the concentration versus time curve from time zero to 6 hours postdose. Venous blood will be collected for ETX2514SUL pharmacokinetic (PK) analysis predose and after the 3 dose. The 3rd dose of ETX2514 and sulbactam will be administered on Day 2
Measured: Predose, 1,2,2,5, 2.95, 3.05, 3.25, 3.5, 4, 5, and 6 hours after the start of the third dose (last dose) on Day 2
Mean terminal half-life (t1/2) in blood
Venous blood will be collected for ETX2514SUL pharmacokinetic (PK) analysis predose and after the 3 dose. The 3rd dose of ETX2514 and sulbactam will be administered on Day 2
Measured: Predose, 1,2,2,5, 2.95, 3.05, 3.25, 3.5, 4, 5, and 6 hours after the start of the third dose (last dose) on Day 2
Mean volume of distribution in the terminal elimination phase (Vdss) in blood
Venous blood will be collected for ETX2514SUL pharmacokinetic (PK) analysis predose and after the 3 dose. The 3rd dose of ETX2514 and sulbactam will be administered on Day 2 .
Measured: Predose, 1,2,2,5, 2.95, 3.05, 3.25, 3.5, 4, 5, and 6 hours after the start of the third dose (last dose) on Day 2
Mean clearance (CL) in blood
Venous blood will be collected for ETX2514SUL pharmacokinetic (PK) analysis predose, and 1,2,2,5, 2.95, 3.05, 3.25, 3.5, 4, 5, and 6 hours after the start of the third (last) dose.
Measured: Predose, 1,2,2,5, 2.95, 3.05, 3.25, 3.5, 4, 5, and 6 hours after the start of the third dose (last dose) on Day 2
Ratio of AUC 0-6 for ELF to the corresponding AUC0-6 Plasma
defined as the area under the concentration versus time curve from time zero to 6 hours. Venous blood will be collected for ETX2514SUL pharmacokinetic (PK) analysis predose and after the 3 dose. The 3rd dose of ETX2514 and sulbactam will be administered on Day 2. Bronchoalveolar lavage fluid will be collected for ETX2514SUL PK at 1, 2.5, 3.25, 4, or 6 hours after the 3 dose (last dose) on Day 2.
Measured: Predose, 1,2,2,5, 2.95, 3.05, 3.25, 3.5, 4, 5, and 6 hours after the start of the third dose (last dose) on Day 2
Secondary outcomes (5)
Number of participants with any non serious adverse event (AE)
An AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
Measured: Day 1-14
Number of participants with any serious adverse event (SAE)
An SAE is defined as any event that results in death; is immediately life threatening; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; or is a congenital anomaly/birth defect.
Measured: Day 1- 14
Change from Baseline in electrocardiogram (ECG) parameters at the indicated time points
Change in baseline is calculated as the post-baseline value minus the baseline value
Measured: Day 1, 2, and 4
Change from baseline in vital signs at the indicated time points
change from baseline in calculated as the post baseline value minus the Baseline value
Measured: Days 1, 2,and 4
Number of participants with abnormal, clinical significant hematology and chemistry laboratory values at the indicated time points
Change from baseline is calculated as the post-Baseline value minus the Baseline value
Measured: Day 1-14
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2017
- Study start21 Aug 2017
- Primary completion17 Oct 2017
- Study completion26 Oct 2017
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 HealthyStudies 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
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Entasis Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Clinartis
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03303924
- Sponsor's protocol ID
- CS2514-2017-0001
- Status last verified
- Nov 2017
- First submitted
- 22 Aug 2017
- Last updated
- 9 Nov 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Rodvold KA, Gotfried MH, Isaacs RD, O'Donnell JP, Stone E. Plasma and Intrapulmonary Concentrations of ETX2514 and Sulbactam following Intravenous Administration of ETX2514SUL to Healthy Adult Subjects. Antimicrob Agents Chemother. 2018 Oct 24;62(11):e01089-18. doi: 10.1128/AAC.01089-18. Print 2018 Nov.
PubMed 30126953
Study at a glance
From the registry record, last updated by the sponsor on 9 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Study to Determine and Compare Plasma, Epithelial Lining Fluid, and Alveolar Macrophage Concentrations of Intravenous ETX2514 and Sulbactam Administered to Healthy Adult Subjects
- ClinicalTrials.gov ID
- NCT03303924
- Acronym / sponsor ID
- CS2514-2017-0001
- Conditions
- Healthy
- Keywords
- Pharmacokinetic, Bronchoalveolar Lavage, Epithelial Lining Fluid, Alveolar Macrophage, Gram-negative bacterium, Acinetobacter baumannii
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Entasis TherapeuticsIndustry (pharma, biotech, devices)
- Collaborators
- Clinartis
- Study start
- 21 Aug 2017 (actual)
- Primary completion
- 17 Oct 2017 (actual)
- Study completion
- 26 Oct 2017 (actual)
- First posted
- 6 Oct 2017 (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 a Phase 1, multiple dose, open-label pharmacokinetic study conducted in healthy adult male and female subjects to determine and compare plasma, epithelial lining fluid (ELF) and alveolar macrophage (AM) concentrations of ETX2514 and sulbactam in healthy adult subjects after intravenous infusion of ETX2514 1.0 g given concurrently with intravenous sulbactam 1.0 g, administered every 6 hours with each infused over 3 hours, for 3 consecutive doses
Detailed description
Blood samples for determining plasma concentrations of ETX2514 and sulbactam will be collected within 5 minutes prior to and at 1.0, 2.0, 2.5, 2.95, 3.05, 3.25, 3.5, 4.0, 5.0 and 6.0 hours after start of the third dose (last dose) administered on Day 2.
Each subject will undergo one standardized bronchoscopy with bronchoalveolar lavage (BAL) in the outpatient bronchoscopy suite at 1.0, 2.5, 3.25, 4.0, or 6.0 hours after start of the infusion of the third dose of ETX2514 and sulbactam (6 subjects per timepoint) on Day 2.
Safety will be assessed throughout the study by adverse event monitoring, clinical laboratory tests, ECG, physical examination, and vital sign monitoring.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ETX2514 and sulbactam | Experimental | Drug: ETX2514 and sulbactamHealthy male and female subjects, non-smoking, will receive multiple doses of ETX2514 1.0 g and sulbactam 1 g via intravenous (IV) infusion every 6 hours with each dose of medication infused over 3 hours. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (13 listed)
- Healthy male or female subject, between 18 and 55 years of age (both inclusive) at the time of screening.
- Body mass index (BMI) ≥ 18.0 kg/m2 and ≤ 32.0 kg/m2 and weight between 55.0 and 100.0 kg (both inclusive).
- Be in general good health without clinically significant medical history as judged by the Principal Investigator.
- Provide voluntary written informed consent prior to any study procedures and is willing and able to comply with the prescribed treatment protocol and evaluations.
- Non-tobacco/nicotine-containing product users for a minimum of 6 months prior to screening.
Key exclusion criteria (28 listed)
- History of any moderate or severe hypersensitivity or allergic reaction to any β-lactam antimicrobial (e.g., penicillin, cephalosporin, sulbactam or carbapenem)
- History or presence of significant oncologic, cardiovascular, pulmonary, hepatic, renal, hematological, gastrointestinal, endocrine, immunologic, dermatologic, neurological, or psychiatric disease.
- Calculated creatinine clearance less than 60 mL/min (Cockcroft-Gault method) at screening or confinement.
- Positive alcohol breath test or urine drug screen test at screening or confinement.
- Positive testing for HIV, Hepatitis B or Hepatitis C.
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 |
|---|---|---|
| ETX2514 and sulbactamEach subject will receive three doses of of ETX2514 1.0 g and sulbactam 1.0 g via intravenous (IV) infusion administered every 6 hours with each drug infused over 3 hours | Drug | ETX2514 and sulbactam |
Primary outcome
Mean maximum observed drug concentration (Cmax) in blood
Time frame: Predose, 1,2,2,5, 2.95, 3.05, 3.25, 3.5, 4, 5, and 6 hours after the start of the third dose (last dose) on Day 2
Venous blood will be collected for ETX2514SUL pharmacokinetic (PK) analysis predose and after the 3 dose. The 3rd dose of ETX2514 and sulbactam will be administered on Day 2
Mean Cmax in epithelial lining fluid (ELF)
Time frame: Predose, 1,2,2,5, 2.95, 3.05, 3.25, 3.5, 4, 5, and 6 hours after the start of the third dose (last dose) on Day 2
Bronchoalveolar lavage fluid will be collected for ETX2514SUL PK at 1, 2.5, 3.25, 4, or 6 hours.
Mean area under the curve (AUC) 0-6h in blood
Time frame: Predose, 1,2,2,5, 2.95, 3.05, 3.25, 3.5, 4, 5, and 6 hours after the start of the third dose (last dose) on Day 2
AUC0-6h defined as the area under the concentration versus time curve from time zero to 6 hours postdose. Venous blood will be collected for ETX2514SUL pharmacokinetic (PK) analysis predose and after the 3 dose. The 3rd dose of ETX2514 and sulbactam will be administered on Day 2
Mean terminal half-life (t1/2) in blood
Time frame: Predose, 1,2,2,5, 2.95, 3.05, 3.25, 3.5, 4, 5, and 6 hours after the start of the third dose (last dose) on Day 2
Venous blood will be collected for ETX2514SUL pharmacokinetic (PK) analysis predose and after the 3 dose. The 3rd dose of ETX2514 and sulbactam will be administered on Day 2
Mean volume of distribution in the terminal elimination phase (Vdss) in blood
Time frame: Predose, 1,2,2,5, 2.95, 3.05, 3.25, 3.5, 4, 5, and 6 hours after the start of the third dose (last dose) on Day 2
Venous blood will be collected for ETX2514SUL pharmacokinetic (PK) analysis predose and after the 3 dose. The 3rd dose of ETX2514 and sulbactam will be administered on Day 2 .
Mean clearance (CL) in blood
Time frame: Predose, 1,2,2,5, 2.95, 3.05, 3.25, 3.5, 4, 5, and 6 hours after the start of the third dose (last dose) on Day 2
Venous blood will be collected for ETX2514SUL pharmacokinetic (PK) analysis predose, and 1,2,2,5, 2.95, 3.05, 3.25, 3.5, 4, 5, and 6 hours after the start of the third (last) dose.
Ratio of AUC 0-6 for ELF to the corresponding AUC0-6 Plasma
Time frame: Predose, 1,2,2,5, 2.95, 3.05, 3.25, 3.5, 4, 5, and 6 hours after the start of the third dose (last dose) on Day 2
defined as the area under the concentration versus time curve from time zero to 6 hours. Venous blood will be collected for ETX2514SUL pharmacokinetic (PK) analysis predose and after the 3 dose. The 3rd dose of ETX2514 and sulbactam will be administered on Day 2. Bronchoalveolar lavage fluid will be collected for ETX2514SUL PK at 1, 2.5, 3.25, 4, or 6 hours after the 3 dose (last dose) on Day 2.
5 secondary outcomes
Number of participants with any non serious adverse event (AE)
Time frame: Day 1-14
Number of participants with any serious adverse event (SAE)
Time frame: Day 1- 14
Change from Baseline in electrocardiogram (ECG) parameters at the indicated time points
Time frame: Day 1, 2, and 4
Change from baseline in vital signs at the indicated time points
Time frame: Days 1, 2,and 4
Number of participants with abnormal, clinical significant hematology and chemistry laboratory values at the indicated time points
Time frame: Day 1-14
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 9 Nov 2017.
- Derived from this study: PubMed 30126953Rodvold KA, Gotfried MH, Isaacs RD, O'Donnell JP, Stone E. Plasma and Intrapulmonary Concentrations of ETX2514 and Sulbactam following Intravenous Administration of ETX2514SUL to Healthy Adult Subjects. Antimicrob Agents Chemother. 2018 Oct 24;62(11):e01089-18. doi: 10.1128/AAC.01089-18. Print 2018 Nov.
- Individual participant dataSharing planned: No
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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.
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 ETX2514 and sulbactam in people with Healthy, run by Entasis Therapeutics at 1 site 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 9 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
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?
Mean maximum observed drug concentration (Cmax) in blood (time frame: Predose, 1,2,2,5, 2.95, 3.05, 3.25, 3.5, 4, 5, and 6 hours after the start of the third dose (last dose) on Day 2). 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?
On the ClinicalTrials.gov record for NCT03303924, 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 9 Nov 2017.