Clinical trial NCT02632526
Conditions: Healthy Male Subjects Cardiovascular Disease
Keywords: AZD5718 oral suspension crystalline AZD5718 oral suspension amorphous Single ascending dose/multiple ascending dose (SAD/MAD) Placebo-controlled Safety Tolerability Pharmacokinetics Pharmacodynamics
Sponsor: AstraZeneca
Start date: 2016-02-10; Completion date: 2016-08-26
Enrollment: 96 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a phase I, randomised, single-blind, placebo-controlled, first-in-human (FIH) single and multiple ascending dose study consisting of two parts (Part A \[SAD\] and Part B \[MAD\]) to assess the safety, tolerability, pharmacokinetics and pharmacodynamics of AZD5718 in healthy male subjects

Detailed description:
This is a phase I, randomised, single-blind, placebo-controlled, first-in-human (FIH) single and multiple ascending dose study consisting of two parts (Part A \[SAD\] and Part B \[MAD\]) to assess the safety, tolerability, pharmacokinetics and pharmacodynamics of AZD5718 in healthy male subjects

Arms: arm 1: Starting dose 25 mg/day, single ascending dose arm 2: Single dose of AZD5718 amorphous suspension arm 3: Single dose of AZD5718 amorphous suspension arm 4: Single dose of AZD5718 amorphous suspension arm 5: Single dose of AZD5718 amorphous suspension arm 6: Single dose of AZD5718 amorphous suspension arm 7: Crystalline suspension (Part A), dosage lower than highest dose used with amorphous suspension, single ascending dose arm 8: Crystalline suspension (Part A), dosage lower than highest dose used with amorphous suspension, single ascending dose arm 9: Once or twice daily from Days 2 to 9 and single doses on Days 1 and 10, dosage TBD (Part A) arm 10: Once or twice daily from Days 2 to 9 and single doses on Days 1 and 10, dosage TBD (Part A) arm 11: Once or twice daily from Days 2 to 9 and single doses on Days 1 and 10, dosage TBD (Part A) arm 12: Once or twice daily from Days 2 to 9 and single doses on Days 1 and 10, dosage TBD (Part A) arm 13: Single dose of AZD5718 amorphous form (Part A) Crystalline form (Part A), dosage lower than highest dose used with amorphous form, single ascending dose arm 14: Single dose of AZD5718 amorphous form (Part A) Crystalline form (Part A), dosage lower than highest dose used with amorphous form, single ascending dose arm 15: Single dose of AZD5718 amorphous form (Part A) Crystalline form (Part A), dosage lower than highest dose used with amorphous form, single ascending dose arm 16: Twice daily dosing (Day 1 - 9) and once daily dosing (Day 10), dosage TBD (Part A) arm 17: Twice daily dosing (Day 1 - 9) and once daily dosing (Day 10), dosage TBD (Part A)
Interventions: intervention 1: AZD5718 oral suspension crystalline form (1 to 100 mg/mL) (Part A) intervention 2: AZD5718 oral suspension amorphous (1 to 100 mg/mL) (Part A) intervention 3: AZD5718 placebo oral suspension intervention 4: AZD5718 oral suspension amorphous (1 to 100 mg/mL) (Part B)
Intervention descriptions: intervention 1: Oral suspension single dose intervention 2: Single and multiple doses intervention 3: Single and multiple doses intervention 4: Single and multiple doses

Protocol documents: