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AZD5718 crystalline form · 1 trial · 2 indications
To assess the safety and tolerability of AZD5718 following oral administration of SAD (Part A) and MAD (Part B).
| Arm | Type | Description |
|---|---|---|
| AZD5718 amorphous form, treatment 1 (Part A) | EXPERIMENTAL | Starting dose 25 mg/day, single ascending dose |
| AZD5718 amorphous form, treatment 2 (Part A) | EXPERIMENTAL | Single dose of AZD5718 amorphous suspension |
| AZD5718 amorphous form, treatment 3 (Part A) | EXPERIMENTAL | Single dose of AZD5718 amorphous suspension |
| AZD5718 amorphous form, treatment 4 (Part A) | EXPERIMENTAL | Single dose of AZD5718 amorphous suspension |
| AZD5718 amorphous form, treatment 5 (Part A) | EXPERIMENTAL | Single dose of AZD5718 amorphous suspension |
| AZD5718 amorphous form, treatment 6 (Part A) | EXPERIMENTAL | Single dose of AZD5718 amorphous suspension |
| AZD5718, crystalline form, treatment 7 (Part A) | EXPERIMENTAL | Crystalline suspension (Part A), dosage lower than highest dose used with amorphous suspension, single ascending dose |
| AZD5718 crystalline form, treatment 8 (Part A) | EXPERIMENTAL | Crystalline suspension (Part A), dosage lower than highest dose used with amorphous suspension, single ascending dose |
| AZD5718 amorphous form, treatment 1 (Part B) | EXPERIMENTAL | Once or twice daily from Days 2 to 9 and single doses on Days 1 and 10, dosage TBD (Part A) |
| AZD5718 amorphous form, treatment 2 (Part B) | EXPERIMENTAL | Once or twice daily from Days 2 to 9 and single doses on Days 1 and 10, dosage TBD (Part A) |
| AZD5718 amorphous form, treatment 3 (Part B) | EXPERIMENTAL | Once or twice daily from Days 2 to 9 and single doses on Days 1 and 10, dosage TBD (Part A) |
| AZD5718 amorphous form, treatment 4 (Part B) | EXPERIMENTAL | Once or twice daily from Days 2 to 9 and single doses on Days 1 and 10, dosage TBD (Part A) |
| AZD5718 amorphous/crystalline form, repeat 1 (Part A) | EXPERIMENTAL | Single dose of AZD5718 amorphous form (Part A) Crystalline form (Part A), dosage lower than highest dose used with amorphous form, single ascending dose |
| AZD5718 amorphous/crystalline form, repeat 2 (Part A) | EXPERIMENTAL | Single dose of AZD5718 amorphous form (Part A) Crystalline form (Part A), dosage lower than highest dose used with amorphous form, single ascending dose |
| AZD5718 amorphous/crystalline, repeat 3 (Part A) | EXPERIMENTAL | Single dose of AZD5718 amorphous form (Part A) Crystalline form (Part A), dosage lower than highest dose used with amorphous form, single ascending dose |
| AZD5718 amorphous form, repeat 1 (Part B) | EXPERIMENTAL | Twice daily dosing (Day 1 - 9) and once daily dosing (Day 10), dosage TBD (Part A) |
| AZD5718 amorphous form, repeat 2 (Part B) | EXPERIMENTAL | Twice daily dosing (Day 1 - 9) and once daily dosing (Day 10), dosage TBD (Part A) |
| Name | Type | Description |
|---|---|---|
| AZD5718 oral suspension crystalline form (1 to 100 mg/mL) (Part A) | DRUG | Oral suspension single dose |
| AZD5718 oral suspension amorphous (1 to 100 mg/mL) (Part A) | DRUG | Single and multiple doses |
| AZD5718 placebo oral suspension | DRUG | Single and multiple doses |
| AZD5718 oral suspension amorphous (1 to 100 mg/mL) (Part B) | DRUG | Single and multiple doses |
Inclusion Criteria: 1. Provision of signed and dated, written informed consent prior to any study specific procedures 2. Healthy male subjects aged 18 - 50 years, inclusive, with suitable veins for cannulation or repeated venepuncture 3. Have a body mass index (BMI) between 18 and 30 kg/m2 inclusiv...
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AZD5718 crystalline form is an investigational small molecule developed by AstraZeneca PLC for cardiovascular disease. It is an oral suspension crystalline form studied at concentrations of 1 to 100 mg/mL in Part A of a Phase 1 clinical program. It has been evaluated in healthy male volunteers in the United Kingdom.
AZD5718 crystalline form is being studied for cardiovascular disease. Its only recorded clinical trial enrolled healthy male subjects rather than patients with an active cardiovascular condition, so the program remains at an early research stage. No approved indication exists for this asset.
AstraZeneca PLC, which trades under the ticker AZN, is the developer of AZD5718 crystalline form. The company sponsored the Phase 1 study of the oral suspension crystalline form conducted in the United Kingdom.
AZD5718 crystalline form is in Phase 1 development. It is investigational and has not been approved for any indication. One Phase 1 trial has been completed, and no active trials of this crystalline form are currently listed.
AZD5718 crystalline form was evaluated in trial NCT02632526, a Phase 1 study assessing safety, tolerability, pharmacokinetics, and pharmacodynamics after single and multiple ascending doses in healthy male subjects. The trial enrolled 96 participants in the United Kingdom and is completed.