Alzheimer DiseasePhase 1COG0108NCT05225389
Study to Assess the Absorption, Metabolism, Excretion, and Mass Balance of CT1812 in Healthy Adult Male Subjects
A Phase 1 study testing 300 mg [C14] CT1812 in people with Alzheimer Disease, run by Cognition Therapeutics at 1 site in United States.
Trial summary
Open-label, single-dose study to assess the absorption, metabolism, excretion and mass balance of [C14] CT1812 Read more about this study
- Who is it for?
- Ages 19 to 55 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Alzheimer Disease
- What is being tested?
- 300 mg [C14] CT1812
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteUnited States
- Study dates
- 31 Dec 2021to 24 Jan 2022
- 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 19 to 55 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy, adult, male, 19 - 55 years of age
- Male subjects must follow protocol specified contraception guidance as described in the protocol
- Continuous non smoker who has not used tobacco/nicotine containing products for at least 3 months prior to dosing.
- Body mass index (BMI) ≥18.0 and ≤30.0 kg/m2 at the Screening visit (subjects must not have experienced a weight loss or gain of >10% within 4 weeks of dosing).
- Medically healthy with no clinically significant medical history, physical examination, laboratory profiles, vital signs or ECGs, as deemed by the PI/designee at the Screening visit.
- History of a minimum of 1 bowel movement per day.
- Able to swallow multiple capsules.
- Understands the study procedures in the informed consent form (ICF), and be willing and able to comply with the protocol.
Who cannot join
- Evidence of disease that, in the opinion of the PI/designee, may influence the outcome of the study within 4 weeks before dosing
- Clinically significant illness, in the opinion of the PI/designee, that requires medical treatment within 8 weeks prior to dosing, or a clinically significant infection that requires medical treatment within 4 weeks prior to dosing.
- Any history of GI surgery that may affect PK profiles of CT1812
- Has evidence of a clinically significant abnormality in physical examination findings, vital signs, or clinical laboratory determinations at the Screening visit or Check-in.
- Has a clinically significant ECG abnormality at the Screening visit or Check-in.
- Estimated creatinine clearance <80 ml/min/1.73 m2 at the Screening visit.
Show all 24Show fewer
- Known history of clinically significant allergy to CT1812 or excipients at the Screening visit.
- Has been diagnosed with acquired immune deficiency syndrome, or tests positive for human immunodeficiency virus (HIV), Hepatitis B virus surface antigen (HBsAg), or Hepatitis C virus (HCV) at the Screening visit.
- Has a history of alcohol use disorder within the 2 years before the Screening visit.
- Positive urine drug or alcohol results at the Screening visit or Check in.
- Positive cotinine result at the Screening visit.
- Unable to refrain from or anticipates the use of:
- Any drugs, including prescription and non prescription medications, herbal remedies, or vitamin supplements beginning 14 days prior to dosing except for those allowed in the protocol
- Any drugs known to be significant inducers of CYP2D6 and CYP3A4 for 28 days prior to dosing.
- Donation of blood or significant blood loss within 56 days prior to dosing.
- Plasma donation within 7 days prior to dosing.
- Poor peripheral venous access.
- Recent history (within 2 weeks of Day 1) of abnormal bowel movements, such as diarrhea, loose stools, or constipation.
- Has exposure to significant diagnostic or therapeutic radiation (e.g., serial X-ray, computed tomography scan, barium meal) or current employment in a job requiring radiation exposure monitoring within 12 months prior to Check-in.
- Has participated in a radiolabeled drug study where exposures are known to the PI within the previous 3 months prior to admission to the clinic for this study or participated in a radiolabeled drug study where exposures are not known to the PI within the previous 6 months prior to admission to the clinic for this study.
- Has previously participated in a CT1812 investigational study.
- Evidence or history of active suicidal thoughts in the 6 months preceding the screening visit; or have a history of a suicide attempt in the previous 2 years, or more than 1 lifetime suicide attempt; or are at serious suicide risk per the PIs clinical judgment.
- Has any condition that would, in the opinion of the PI/designee or Sponsor, make the subject unsuitable for the study or is, in the opinion of the PI/designee, not likely to complete the study for any reason.
- Participation in another clinical study within 30 days prior to dosing.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 1, Open-Label Study to Assess the Absorption, Metabolism, Excretion, and Mass Balance of a Single Oral Dose of [14C] CT1812 in Healthy Adult Male Subjects
Open-label, single-dose study to assess the absorption, metabolism, excretion and mass balance of [C14] CT1812
Read the detailed description
Open-label, single-dose study to assess the absorption, metabolism, excretion and mass balance of [C14] CT1812 in 8 healthy male subjects
Subjects will be screened 28-days prior to dosing to determine eligibility.
Eligible subjects will be admitted to the clinical research unit (CRU) on Day -1. On Day 1, subjects will receive a single dose of CT1812 with a microtracer dose of [14C] CT1812. Whole blood, plasma, urine and fecal samples will be collection during the confinement period. Safety will be monitored throughout the study by repeated clinical and laboratory evaluations.
Subjects will be and discharged from the CRU following completion of procedures 168 hours post dose (Day 8)
- Conditions
- Alzheimer Disease
- Being tested
- 300 mg [C14] CT1812
- Medical subject headings
- Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
300 mg [C14] CT1812Drug
Single dose of 300 mg CT1812 with microtracer dose of [C14]
| Study group | Role | What they receive |
|---|---|---|
| CT1812 | Experimental | Investigational Drug Receives: Drug: 300 mg [C14] CT1812 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Plasma CT1812 Concentration at 96 Hours Timepoint
Plasma concentrations of CT1812 were determined using a validated liquid chromatography with tandem mass spectrometry (LC-MS/MS) following a single oral dose of 300 mg (~1 μCi) [14C]-CT1812 administered in healthy adult male subjects.
Measured: Predose through 96 hours postdose
Plasma M6/CP199 Concentration at 144 Hours Timepoint
Plasma concentrations of M6/CP199 were determined using a validated liquid chromatography with tandem mass spectrometry (LC-MS/MS) following a single oral dose of 300 mg (~1 μCi) [14C]-CT1812 administered in healthy adult male subjects.
Measured: Predose through 144 hours postdose
Plasma Total Radioactivity (TRA) Concentration CT1812-Equivalents at 168 Hours Timepoint
Plasma Total Radioactivity Concentration of CT1812-Equivalents was performed using Liquid Scintillation Counting (LSC) method following a single oral dose of 300 mg (~1 μCi) [14C]-CT1812 administered in healthy adult male subjects.
Measured: Predose, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, 72, 96, 120, 144, 168 hours postdose
Whole Blood Total Radioactivity (TRA) Concentration CT1812-Equivalents at 144 Hours Timepoint
The analysis of Whole Blood Total Radioactivity Concentration of CT1812-Equivalents was performed using combustion followed by Liquid Scintillation Counting (LSC) method following a single oral dose of 300 mg (~1 μCi) [14C]-CT1812 administered in healthy adult male subjects.
Measured: Predose through 144 hours postdose
Cumulative Percentage of Radioactive Dose (Cum%Dose) Excreted in the Urine
Cumulative radioactive dose (Cum%Dose) excreted in the urine was determined using Liquid Scintillation Counting (LSC) following a single oral dose of 300 mg (~1 μCi) [14C]-CT1812 administered in healthy adult male subjects.
Measured: Predose and 0 to 4, 4 to 8, 8 to 12, and 12 to 24 hours postdose, and every 24 hours (pooled) until Day 8 (168 hours postdose).
Cumulative Percentage of Radioactive Dose (Cum%Dose) Excreted in the Feces
Cumulative radioactive dose (Cum%Dose) excreted in the feces was performed using combustion followed by Liquid Scintillation Counting (LSC) method following a single oral dose of 300 mg (~1 μCi) [14C]-CT1812 administered in healthy adult male subjects.
Measured: Predose, 0-24, 24-48, 48-72, 72-96, 96-120, 120-144, 144-168 hours postdose
CT1812 Plasma Exposure According to AUC0-last Pharmacokinetic Parameter
Plasma CT1812 Concentration were measured using the area under the concentration-time curve, from time 0 to the last observed non-zero concentration, as calculated by the linear trapezoidal method following a single oral dose of 300 mg (~1 μCi) [14C]-CT1812 administered in healthy adult male subjects. Plasma concentrations of CT1812 were determined using a validated liquid chromatography with tandem mass spectrometry (LC-MS/MS).
Measured: Predose, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, 72, 96, 120, 144, 168 hours postdose
M6/CP199 Plasma Exposure According to AUC0-last Pharmacokinetic Parameter
M6/CP199 Plasma Concentration was measured using the area under the concentration-time curve, from time 0 to the last observed non-zero concentration, as calculated by the linear trapezoidal method following a single oral dose of 300 mg (~1 μCi) [14C]-CT1812 administered in healthy adult male subjects. M6/CP199 plasma concentrations were determined using a validated liquid chromatography with tandem mass spectrometry (LC-MS/MS).
Measured: Predose, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, 72, 96, 120, 144, 168 hours postdose
Plasma Total Radioactivity According to AUC0-last Pharmacokinetic Parameter
Plasma Total Radioactivity was measured using the area under the concentration-time curve, from time 0 to the last observed non-zero concentration, as calculated by the linear trapezoidal method following a single oral dose of 300 mg (~1 μCi) [14C]-CT1812 administered in healthy adult male subjects. Plasma Total Radioactivity Concentration of CT1812-Equivalents was performed using Liquid Scintillation Counting (LSC).
Measured: Predose, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, 72, 96, 120, 144, 168 hours postdose
Whole Blood Total Radioactivity According to AUC0-last Pharmacokinetic Parameter
Whole Blood Total Radioactivity was measured using the area under the concentration-time curve, from time 0 to the last observed non-zero concentration, as calculated by the linear trapezoidal method following a single oral dose of 300 mg (~1 μCi) [14C]-CT1812 administered in healthy adult male subjects. Plasma Total Radioactivity Concentration of CT1812-Equivalents was performed using Liquid Scintillation Counting (LSC)
Measured: Predose, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, 72, 96, 120, 144, 168 hours postdose
Secondary outcomes (2)
Whole Blood:Plasma Total Radioactivity Partitioning Ratios Over Time up to 144 Hours Timepoint
This measure describes the percentage of TRA in whole blood relative to plasma. The fraction of [14C]-radioactivity associated with whole blood and plasma and with red blood cells and other cellular components of whole blood was determined by using the concentration of [14C]-radioactivity in whole blood and plasma.
Measured: Predose through 144 hours postdose
Number of TEAEs, Related TEAEs, SAEs, and Related SAEs
Incidence and Severity of Adverse Events. All AEs that occurred during this clinical trial were coded using the Medical Dictionary for Regulatory Activities (MedDRA®), Version 24.1.
Measured: Predose, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, 72, 96, 120, 144, 168 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Feb 2022
- Study start31 Dec 2021
- Primary completion17 Jan 2022
- Study completion24 Jan 2022
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 Alzheimer DiseaseStudies 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
- Model description
- Open-label, single-dose study
- Masking
- None (open label)
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cognition Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- National Institute on Aging (NIA)
- Responsible party
- Sponsor
- Investigators
- Anthony Caggiano, MD, Study director, Cognition Therapeutics Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05225389
- Sponsor's protocol ID
- COG0108
- Other IDs
- SB1AG073028
- Acronym
- COG0108
- Status last verified
- Jul 2023
- First submitted
- 11 Jan 2022
- Last updated
- 21 Jul 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Open-Label Study to Assess the Absorption, Metabolism, Excretion, and Mass Balance of a Single Oral Dose of [14C] CT1812 in Healthy Adult Male Subjects
- ClinicalTrials.gov ID
- NCT05225389
- Acronym / sponsor ID
- COG0108 / COG0108
- Conditions
- Alzheimer Disease
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Cognition TherapeuticsIndustry (pharma, biotech, devices)
- Collaborators
- National Institute on Aging (NIA)
- Study start
- 31 Dec 2021 (actual)
- Primary completion
- 17 Jan 2022 (actual)
- Study completion
- 24 Jan 2022 (actual)
- First posted
- 4 Feb 2022 (actual)
- Results
- Posted 21 Jul 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Open-label, single-dose study to assess the absorption, metabolism, excretion and mass balance of [C14] CT1812
Detailed description
Open-label, single-dose study to assess the absorption, metabolism, excretion and mass balance of [C14] CT1812 in 8 healthy male subjects
Subjects will be screened 28-days prior to dosing to determine eligibility.
Eligible subjects will be admitted to the clinical research unit (CRU) on Day -1. On Day 1, subjects will receive a single dose of CT1812 with a microtracer dose of [14C] CT1812. Whole blood, plasma, urine and fecal samples will be collection during the confinement period. Safety will be monitored throughout the study by repeated clinical and laboratory evaluations.
Subjects will be and discharged from the CRU following completion of procedures 168 hours post dose (Day 8)
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Open-label, single-dose study
| Arm | Type | Receives |
|---|---|---|
| CT1812 | Experimental | Drug: 300 mg [C14] CT1812Investigational Drug |
Who may qualify
- Ages
- 19 to 55 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Healthy, adult, male, 19 - 55 years of age
- Male subjects must follow protocol specified contraception guidance as described in the protocol
- Continuous non smoker who has not used tobacco/nicotine containing products for at least 3 months prior to dosing.
- Body mass index (BMI) ≥18.0 and ≤30.0 kg/m2 at the Screening visit (subjects must not have experienced a weight loss or gain of >10% within 4 weeks of dosing).
- Medically healthy with no clinically significant medical history, physical examination, laboratory profiles, vital signs or ECGs, as deemed by the PI/designee at the Screening visit.
Key exclusion criteria (24 listed)
- Evidence of disease that, in the opinion of the PI/designee, may influence the outcome of the study within 4 weeks before dosing
- Clinically significant illness, in the opinion of the PI/designee, that requires medical treatment within 8 weeks prior to dosing, or a clinically significant infection that requires medical treatment within 4 weeks prior to dosing.
- Any history of GI surgery that may affect PK profiles of CT1812
- Has evidence of a clinically significant abnormality in physical examination findings, vital signs, or clinical laboratory determinations at the Screening visit or Check-in.
- Has a clinically significant ECG abnormality at the Screening visit or Check-in.
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 |
|---|---|---|
| 300 mg [C14] CT1812Single dose of 300 mg CT1812 with microtracer dose of [C14] | Drug | CT1812 |
Primary outcome
Plasma CT1812 Concentration at 96 Hours Timepoint
Time frame: Predose through 96 hours postdose
Plasma concentrations of CT1812 were determined using a validated liquid chromatography with tandem mass spectrometry (LC-MS/MS) following a single oral dose of 300 mg (~1 μCi) [14C]-CT1812 administered in healthy adult male subjects.
Plasma M6/CP199 Concentration at 144 Hours Timepoint
Time frame: Predose through 144 hours postdose
Plasma concentrations of M6/CP199 were determined using a validated liquid chromatography with tandem mass spectrometry (LC-MS/MS) following a single oral dose of 300 mg (~1 μCi) [14C]-CT1812 administered in healthy adult male subjects.
Plasma Total Radioactivity (TRA) Concentration CT1812-Equivalents at 168 Hours Timepoint
Time frame: Predose, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, 72, 96, 120, 144, 168 hours postdose
Plasma Total Radioactivity Concentration of CT1812-Equivalents was performed using Liquid Scintillation Counting (LSC) method following a single oral dose of 300 mg (~1 μCi) [14C]-CT1812 administered in healthy adult male subjects.
Whole Blood Total Radioactivity (TRA) Concentration CT1812-Equivalents at 144 Hours Timepoint
Time frame: Predose through 144 hours postdose
The analysis of Whole Blood Total Radioactivity Concentration of CT1812-Equivalents was performed using combustion followed by Liquid Scintillation Counting (LSC) method following a single oral dose of 300 mg (~1 μCi) [14C]-CT1812 administered in healthy adult male subjects.
Cumulative Percentage of Radioactive Dose (Cum%Dose) Excreted in the Urine
Time frame: Predose and 0 to 4, 4 to 8, 8 to 12, and 12 to 24 hours postdose, and every 24 hours (pooled) until Day 8 (168 hours postdose).
Cumulative radioactive dose (Cum%Dose) excreted in the urine was determined using Liquid Scintillation Counting (LSC) following a single oral dose of 300 mg (~1 μCi) [14C]-CT1812 administered in healthy adult male subjects.
Cumulative Percentage of Radioactive Dose (Cum%Dose) Excreted in the Feces
Time frame: Predose, 0-24, 24-48, 48-72, 72-96, 96-120, 120-144, 144-168 hours postdose
Cumulative radioactive dose (Cum%Dose) excreted in the feces was performed using combustion followed by Liquid Scintillation Counting (LSC) method following a single oral dose of 300 mg (~1 μCi) [14C]-CT1812 administered in healthy adult male subjects.
CT1812 Plasma Exposure According to AUC0-last Pharmacokinetic Parameter
Time frame: Predose, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, 72, 96, 120, 144, 168 hours postdose
Plasma CT1812 Concentration were measured using the area under the concentration-time curve, from time 0 to the last observed non-zero concentration, as calculated by the linear trapezoidal method following a single oral dose of 300 mg (~1 μCi) [14C]-CT1812 administered in healthy adult male subjects. Plasma concentrations of CT1812 were determined using a validated liquid chromatography with tandem mass spectrometry (LC-MS/MS).
M6/CP199 Plasma Exposure According to AUC0-last Pharmacokinetic Parameter
Time frame: Predose, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, 72, 96, 120, 144, 168 hours postdose
M6/CP199 Plasma Concentration was measured using the area under the concentration-time curve, from time 0 to the last observed non-zero concentration, as calculated by the linear trapezoidal method following a single oral dose of 300 mg (~1 μCi) [14C]-CT1812 administered in healthy adult male subjects. M6/CP199 plasma concentrations were determined using a validated liquid chromatography with tandem mass spectrometry (LC-MS/MS).
Plasma Total Radioactivity According to AUC0-last Pharmacokinetic Parameter
Time frame: Predose, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, 72, 96, 120, 144, 168 hours postdose
Plasma Total Radioactivity was measured using the area under the concentration-time curve, from time 0 to the last observed non-zero concentration, as calculated by the linear trapezoidal method following a single oral dose of 300 mg (~1 μCi) [14C]-CT1812 administered in healthy adult male subjects. Plasma Total Radioactivity Concentration of CT1812-Equivalents was performed using Liquid Scintillation Counting (LSC).
Whole Blood Total Radioactivity According to AUC0-last Pharmacokinetic Parameter
Time frame: Predose, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, 72, 96, 120, 144, 168 hours postdose
Whole Blood Total Radioactivity was measured using the area under the concentration-time curve, from time 0 to the last observed non-zero concentration, as calculated by the linear trapezoidal method following a single oral dose of 300 mg (~1 μCi) [14C]-CT1812 administered in healthy adult male subjects. Plasma Total Radioactivity Concentration of CT1812-Equivalents was performed using Liquid Scintillation Counting (LSC)
2 secondary outcomes
Whole Blood:Plasma Total Radioactivity Partitioning Ratios Over Time up to 144 Hours Timepoint
Time frame: Predose through 144 hours postdose
Number of TEAEs, Related TEAEs, SAEs, and Related SAEs
Time frame: Predose, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, 72, 96, 120, 144, 168 hours
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jul 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Anthony Caggiano, MD study director
Cognition Therapeutics Inc.
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 300 mg [C14] CT1812 in people with Alzheimer Disease, run by Cognition 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 8 inclusion and 24 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 Jul 2023. 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?
Yes. Results are posted in the registry (first posted 21 Jul 2023). 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?
Plasma CT1812 Concentration at 96 Hours Timepoint (time frame: Predose through 96 hours postdose). The study lists 10 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 Jul 2023.