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| Name | Class |
|---|---|
| Parexel | INDUSTRY |
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A thorough QT study of AZD3293
A Single-Center, Randomized, Double-Blinded, Placebo-Controlled, 4-way Cross-over Study to Assess the Effect of a Single Oral Dose of AZD3293 Administration on QTc Interval Compared to Placebo, Using Open-Label AVELOX (moxifloxacin) as a Positive Control, in Healthy Male Subjects
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AZD3293 | Drug | AZD3293 oral solution - one single dose (low dose). |
|
| Measure | Description | Time Frame |
|---|---|---|
| The effect of a single dose of AZD3293 low dose and high dose on the change in time-matched QTcF intervals compared with placebo. | The heart rate corrected QT (QTcF) will be calculated using Fridericia's formula | Up to 69 days |
| Measure | Description | Time Frame |
|---|---|---|
| The effect of a single oral dose of moxifloxacin on the changes in time-matched QTcF intervals compared with placebo. | The heart rate corrected QT (QTcF) will be calculated using Fridericia's formula. | Up to 69 days |
| The safety and tolerability of AZD3293 in healthy male subjects by assessing a panel of adverse events measures |
| Measure | Description | Time Frame |
|---|---|---|
| The relationship between plasma concentrations of AZD3293 and changes in QTcF parameters | The heart rate corrected QT (QTcF) will be calculated using Fridericia's formula | Up to 69 days |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ronald Goldwater, MD | Parexel ECPU Baltimore | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Baltimore | Maryland | United States |
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| ID | Term |
|---|---|
| D000544 | Alzheimer Disease |
| ID | Term |
|---|---|
| D003704 | Dementia |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| C000608388 | lanabecestat |
| D000077266 | Moxifloxacin |
| ID | Term |
|---|---|
| D024841 | Fluoroquinolones |
| D042462 | 4-Quinolones |
| D015363 | Quinolones |
| D011804 | Quinolines |
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| AZD3293 | Drug | AZD3293 oral solution - one single dose (high dose). |
|
| Placebo | Drug | Placebo oral solution - one single dose |
|
| Moxifloxacin | Drug | Moxifloxacin tablet - one single dose |
|
Physical examination, electrocardiogram, pulse and blood pressure, weight and laboratory variables |
| Up to 69 days |
| Plasma concentrations, AUC, Cmax and tmax of single dose AZD3293 and moxifloxacin in healthy male subjects | AUC(0-t): Area under the concentration versus time curve from time 0 to the time of the last quantifiable concentration to be calculated by a combination of linear and logarithmic trapezoidal methods (linear up-log down) Cmax: Maximum observed plasma concentration obtained directly from the concentration vs. time data tmax: Time to reach Cmax following dose, obtained directly from the concentration vs. time data | Up to 69 days |
| The effect of AZD3293 on additional electrocardiogram (ECG) variables (heart rate, RR, PR, QRS, QT and QTcB) | RR: The time between corresponding points on 2 consecutive R waves on ECG. PR: ECG interval measured from the onset of the P wave to the onset of the QRS complex. QRS: ECG interval measured from the onset of the QRS complex to the J point. QT: ECG interval measured from the onset of the QRS complex to the offset of the T wave. QTcB: The heart rate corrected QT calculated using Bazett's formula. | Up to 69 days |
| D024801 |
| Tauopathies |
| D019636 | Neurodegenerative Diseases |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
| D006574 |
| Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |