Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
AZD3293 · 6 trials · 8 indications
Maximum observed concentration (Cmax) parameters will be calculated, for AZD3293, its metabolite; and \[14C\]-AZD3293-derived total radioactivity.
Blood samples for determination of plasma concentrations of AZD3293 and its active metabolite will be collected at pre-dose (15 or 30 min) and 30 min, 1h, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, 56 and 72 hours post-dose starting on Days 1, 8 \& 15 and analyzed according to fully validated methods.
Blood samples for determination of plasma concentrations of AZD3293 and its active metabolite will be collected at pre-dose (15 or 30 min) and 30 min, 1h, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, 56 and 72 hours post-dose starting on Days 1, 8 \& 15 and analyzed according to fully validated methods.
The heart rate corrected QT (QTcF) will be calculated using Fridericia's formula
Safety - Number of subjects reporting any adverse events during the study
Columbia-Suicide Severity Rating Scale (C-SSRS) captures the occurrence, severity, and frequency of suicide-related thoughts and behaviors during the assessment period. Some questions are yes/no and some are on a scale of 1 (low severity) to 5 (high severity). Completed suicide and non-fatal suicide events are yes/no questions and results presented are the number of participants with these events. Worsening of suicidal ideation was an increase in severity of suicidal ideation from baseline.
The vital signs of body temperature, blood pressure and pulse are going to be measured.
QT/QTc interval, rhythm, rate, morphology is going to be measured.
As reported by investigator.
Columbia-Suicide Severity Rating Scale (C-SSRS) captures the occurrence, severity, and frequency of suicide-related thoughts and behaviors during the assessment period. Some questions are yes/no and some are on a scale of 1 (low severity) to 5 (high severity). Completed suicide and non-fatal suicide events are yes/no questions and results presented are the number of participants with these events. Worsening of suicidal ideation was an increase in severity of suicidal ideation from baseline.
| Arm | Type | Description |
|---|---|---|
| AZD3293 | EXPERIMENTAL | 7 subjects will receive AZD3293 |
| AZD3293 oral solution | EXPERIMENTAL | single doses in random order in 3 study periods for each subject (Day 1 or Day 8 or Day 15) |
| AZD3293 tablet formulation A | EXPERIMENTAL | single doses in random order in 3 study periods for each subject (Day 1 or Day 8 or Day 15) |
| AZD3293 tablet formulation B | EXPERIMENTAL | single doses in random order in 3 study periods for each subject (Day 1 or Day 8 or Day 15) |
| AZD3293 dose A | EXPERIMENTAL | AZD3293 therapeutic dose oral solution (low dose) |
| AZD3293 dose B | EXPERIMENTAL | AZD3293 supratherapeutic dose oral solution (high dose) |
| Placebo | PLACEBO_COMPARATOR | Placebo oral solution |
| Moxifloxacin | ACTIVE_COMPARATOR | Moxifloxacin tablet |
| Name | Type | Description |
|---|---|---|
| AZD3293 | DRUG | 7 subjects will receive AZD3293 |
| AZD3293 oral solution | DRUG | Subjects will receive AZD3293 as a tablet (Formulation A; Formulation B) and solution as a single dose on Day 1, Day 8 or Day 15. |
| AZD3293 tablet formulation A | DRUG | Subjects will receive AZD3293 as a tablet (Formulation A; Formulation B) and a solution as a single dose on Day 1, Day 8, or Day 15. |
| AZD3293 tablet formulation B | DRUG | Subjects will receive AZD3293 as a tablet (Formulation A; Formulation B) and a solution as a single dose on Day 1, Day 8 or Day 15. |
| Placebo | DRUG | Placebo oral solution - one single dose |
| Moxifloxacin | DRUG | Moxifloxacin tablet - one single dose |
Inclusion Criteria: Healthy male subjects between 18 and 55 years of age, inclusive, at the time of consent with suitable veins for cannulation or repeated venipuncture; 2) Body weight between 50 to 100 kg, inclusive; 3) Within BMI range 19 to 30 kg/m2, inclusive; 4) In good health, as determined by...
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AZD3293 is an investigational small molecule being studied for use in Alzheimer's disease and in healthy volunteers, including elderly and Japanese participants. Clinical trials have assessed its safety and effects in healthy young and elderly subjects as well as in patients with mild-to-moderate Alzheimer's disease.
AZD3293 is being developed by AstraZeneca PLC, a biopharmaceutical company listed on the stock exchange under the ticker symbol AZN. The company has sponsored Phase 1 clinical trials of this investigational drug in the United States and Japan.
AZD3293 is in Phase 1 clinical development. All completed trials for this drug are Phase 1 studies, and it remains an investigational agent that has not been approved by regulatory authorities. Its safety and effects are still being evaluated in early-stage clinical research.
AZD3293 has been studied in several completed Phase 1 trials, including NCT01739647, NCT01795339, NCT02005211, and NCT02040987. These trials assessed single and multiple doses, safety, pharmacokinetics, and cardiac effects in healthy volunteers and Alzheimer's patients across the United States and Japan.
AZD3293 is the investigational name used in clinical trials for this drug candidate. No alternative names have been reported in the trial records. It is identified solely as AZD3293 in the context of the studies conducted by AstraZeneca.
The mechanism of action for AZD3293 has not been disclosed in the available clinical trial information. The drug is being studied for its safety and effects in healthy volunteers and Alzheimer's disease patients, but its specific molecular target has not been publicly detailed in these records.