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AZD5718 crystalline form

Phase 1

Healthy Male Subjects | Small molecule | Cardiovascular |AstraZeneca PLC|Last Updated: Mar 21, 2019

Success Probability

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Trial Design

RandomizedCONTROLLED
Total Trials1
Total Enrollment96

FDA Designations

No designations recorded

Clinical trial landscape

AZD5718 crystalline form · 1 trial · 2 indications

Phase 1 1
NCT02632526A Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of AZD5718 After Single and Multiple Ascending Dose Administration to Healthy Male SubjectsHealthy Male Subjects
COMPLETED96 Analytics
PHASE1COMPLETED
A Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of AZD5718 After Single and Multiple Ascending Dose Administration to Healthy Male Subjects
Healthy Male Subjects
NCT0263252696
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Study Endpoints

Primary Endpoints

Safety and Tolerability of AZD5718 by Assessment of the Number of Participants With Adverse Events Following Oral Administration of SAD (Part A) and MAD (Part B).
From screening to last followup visit (7-10 days after last dose), up to 6 weeks (Part A) and up to 8 weeks (Part B)

To assess the safety and tolerability of AZD5718 following oral administration of SAD (Part A) and MAD (Part B).

Secondary Endpoints

Rate and Extent of Absorption of AZD5718 by Assessment of the Area Under the Plasma Concentration-curve From Time Zero Extrapolated to Infinity (AUC) for Part A - Amorphous and Crystalline Suspension
At post-dose (Days 1 to 3); 0.5, 1, 2, 3, 4, 6, 8, 24, 36 and 48 hours post-dose and folow up (Day 4 - 72 hours post-dose) (Part A only)
Rate and Extent of Absorption of AZD5718 by Assessment of the Area Under Plasma Concentration-time Curve From Time Zero Extrapolated to Infinity (AUC) for Part B - Amorphous Suspension
Day 1 of Part B
Rate and Extent of Absorption of AZD5718 by Assessment of the Area Under the Plasma Concentration-curve From Time Zero to Time of Last Quantifiable Concentration (AUC(0-last)) for Part A - Amorphous and Crystalline Suspension
At post-dose (Days 1 to 3); 0.5, 1, 2, 3, 4, 6, 8, 24, 36 and 48 hours post-dose and folow up (Day 4 - 72 hours post-dose) (Part A only)
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Study Design & Arms

AllocationRANDOMIZED
MaskingSINGLE
ModelPARALLEL
PurposeBASIC_SCIENCE

Treatment Arms

ArmTypeDescription
AZD5718 amorphous form, treatment 1 (Part A)EXPERIMENTALStarting dose 25 mg/day, single ascending dose
AZD5718 amorphous form, treatment 2 (Part A)EXPERIMENTALSingle dose of AZD5718 amorphous suspension
AZD5718 amorphous form, treatment 3 (Part A)EXPERIMENTALSingle dose of AZD5718 amorphous suspension
AZD5718 amorphous form, treatment 4 (Part A)EXPERIMENTALSingle dose of AZD5718 amorphous suspension
AZD5718 amorphous form, treatment 5 (Part A)EXPERIMENTALSingle dose of AZD5718 amorphous suspension
AZD5718 amorphous form, treatment 6 (Part A)EXPERIMENTALSingle dose of AZD5718 amorphous suspension
AZD5718, crystalline form, treatment 7 (Part A)EXPERIMENTALCrystalline suspension (Part A), dosage lower than highest dose used with amorphous suspension, single ascending dose
AZD5718 crystalline form, treatment 8 (Part A)EXPERIMENTALCrystalline suspension (Part A), dosage lower than highest dose used with amorphous suspension, single ascending dose
AZD5718 amorphous form, treatment 1 (Part B)EXPERIMENTALOnce 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)EXPERIMENTALOnce 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)EXPERIMENTALOnce 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)EXPERIMENTALOnce 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)EXPERIMENTALSingle 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)EXPERIMENTALSingle 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)EXPERIMENTALSingle 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)EXPERIMENTALTwice daily dosing (Day 1 - 9) and once daily dosing (Day 10), dosage TBD (Part A)
AZD5718 amorphous form, repeat 2 (Part B)EXPERIMENTALTwice daily dosing (Day 1 - 9) and once daily dosing (Day 10), dosage TBD (Part A)

Interventions

NameTypeDescription
AZD5718 oral suspension crystalline form (1 to 100 mg/mL) (Part A)DRUGOral suspension single dose
AZD5718 oral suspension amorphous (1 to 100 mg/mL) (Part A)DRUGSingle and multiple doses
AZD5718 placebo oral suspensionDRUGSingle and multiple doses
AZD5718 oral suspension amorphous (1 to 100 mg/mL) (Part B)DRUGSingle and multiple doses
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Eligibility Criteria

Age Range18 Years to 50 Years
SexMALE
Healthy VolunteersYes
Study Sites1

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...

Countries:United Kingdom
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