Study identifier:D7550C00001
ClinicalTrials.gov identifier:NCT02632526
EudraCT identifier:N/A
CTIS identifier:N/A
A phase I, randomized, single-blind, placebo-controlled 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, cardiovascular disease
Phase 1
Yes
AZD5718 oral suspension crystalline form (1 to 100 mg/mL) (Part A), AZD5718 oral suspension crystalline form (1 to 100 mg/mL) (Part A), AZD5718 oral suspension crystalline form (1 to 100 mg/mL) (Part A), AZD5718 oral suspension crystalline form (1 to 100 mg/mL) (Part A), AZD5718 oral suspension crystalline form (1 to 100 mg/mL) (Part A), AZD5718 oral suspension amorphous (1 to 100 mg/mL) (Part A), AZD5718 oral suspension amorphous (1 to 100 mg/mL) (Part A), AZD5718 oral suspension amorphous (1 to 100 mg/mL) (Part A), AZD5718 oral suspension amorphous (1 to 100 mg/mL) (Part A), AZD5718 oral suspension amorphous (1 to 100 mg/mL) (Part A), AZD5718 oral suspension amorphous (1 to 100 mg/mL) (Part A), AZD5718 oral suspension amorphous (1 to 100 mg/mL) (Part A), AZD5718 oral suspension amorphous (1 to 100 mg/mL) (Part A), AZD5718 oral suspension amorphous (1 to 100 mg/mL) (Part A), AZD5718 placebo oral suspension, AZD5718 placebo oral suspension, AZD5718 placebo oral suspension, AZD5718 placebo oral suspension, AZD5718 placebo oral suspension, AZD5718 placebo oral suspension, AZD5718 placebo oral suspension, AZD5718 placebo oral suspension, AZD5718 placebo oral suspension, AZD5718 placebo oral suspension, AZD5718 placebo oral suspension, AZD5718 placebo oral suspension, AZD5718 placebo oral suspension, AZD5718 placebo oral suspension, AZD5718 placebo oral suspension, AZD5718 placebo oral suspension, AZD5718 oral suspension amorphous (1 to 100 mg/mL) (Part B), AZD5718 oral suspension amorphous (1 to 100 mg/mL) (Part B), AZD5718 oral suspension amorphous (1 to 100 mg/mL) (Part B), AZD5718 oral suspension amorphous (1 to 100 mg/mL) (Part B), AZD5718 oral suspension amorphous (1 to 100 mg/mL) (Part B), AZD5718 oral suspension amorphous (1 to 100 mg/mL) (Part B)
Male
96
Interventional
18 Years - 50 Years
Allocation: Randomized
Endpoint Classification: Safety
Intervention Model: Parallel Assignment
Masking: Single Blind
Primary Purpose: Basic Science
Verified 01 Apr 2018 by AstraZeneca
AstraZeneca
-
No locations available
Arms | Assigned Interventions |
---|---|
Experimental: AZD5718 amorphous form, treatment 1 (Part A) Starting dose 25 mg/day, single ascending dose | Drug: AZD5718 oral suspension amorphous (1 to 100 mg/mL) (Part A) Single and multiple doses Drug: AZD5718 placebo oral suspension Single and multiple doses |
Experimental: AZD5718 amorphous form, treatment 2 (Part A) Single dose of AZD5718 amorphous suspension | Drug: AZD5718 oral suspension amorphous (1 to 100 mg/mL) (Part A) Single and multiple doses Drug: AZD5718 placebo oral suspension Single and multiple doses |
Experimental: AZD5718 amorphous form, treatment 3 (Part A) Single dose of AZD5718 amorphous suspension | Drug: AZD5718 oral suspension amorphous (1 to 100 mg/mL) (Part A) Single and multiple doses Drug: AZD5718 placebo oral suspension Single and multiple doses |
Experimental: AZD5718 amorphous form, treatment 4 (Part A) Single dose of AZD5718 amorphous suspension | Drug: AZD5718 oral suspension amorphous (1 to 100 mg/mL) (Part A) Single and multiple doses Drug: AZD5718 placebo oral suspension Single and multiple doses |
Experimental: AZD5718 amorphous form, treatment 5 (Part A) Single dose of AZD5718 amorphous suspension | Drug: AZD5718 oral suspension amorphous (1 to 100 mg/mL) (Part A) Single and multiple doses Drug: AZD5718 placebo oral suspension Single and multiple doses |
Experimental: AZD5718 amorphous form, treatment 6 (Part A) Single dose of AZD5718 amorphous suspension | Drug: AZD5718 oral suspension amorphous (1 to 100 mg/mL) (Part A) Single and multiple doses Drug: AZD5718 placebo oral suspension Single and multiple doses |
Experimental: AZD5718, crystalline form, treatment 7 (Part A) Crystalline suspension (Part A), dosage lower than highest dose used with amorphous suspension, single ascending dose | Drug: AZD5718 oral suspension crystalline form (1 to 100 mg/mL) (Part A) Oral suspension single dose Drug: AZD5718 placebo oral suspension Single and multiple doses |
Experimental: AZD5718 crystalline form, treatment 8 (Part A) Crystalline suspension (Part A), dosage lower than highest dose used with amorphous suspension, single ascending dose | Drug: AZD5718 oral suspension crystalline form (1 to 100 mg/mL) (Part A) Oral suspension single dose Drug: AZD5718 placebo oral suspension Single and multiple doses |
Experimental: AZD5718 amorphous form, treatment 1 (Part B) Once or twice daily from Days 2 to 9 and single doses on Days 1 and 10, dosage TBD (Part A) | Drug: AZD5718 placebo oral suspension Single and multiple doses Drug: AZD5718 oral suspension amorphous (1 to 100 mg/mL) (Part B) Single and multiple doses |
Experimental: AZD5718 amorphous form, treatment 2 (Part B) Once or twice daily from Days 2 to 9 and single doses on Days 1 and 10, dosage TBD (Part A) | Drug: AZD5718 placebo oral suspension Single and multiple doses Drug: AZD5718 oral suspension amorphous (1 to 100 mg/mL) (Part B) Single and multiple doses |
Experimental: AZD5718 amorphous form, treatment 3 (Part B) Once or twice daily from Days 2 to 9 and single doses on Days 1 and 10, dosage TBD (Part A) | Drug: AZD5718 placebo oral suspension Single and multiple doses Drug: AZD5718 oral suspension amorphous (1 to 100 mg/mL) (Part B) Single and multiple doses |
Experimental: AZD5718 amorphous form, treatment 4 (Part B) Once or twice daily from Days 2 to 9 and single doses on Days 1 and 10, dosage TBD (Part A) | Drug: AZD5718 placebo oral suspension Single and multiple doses Drug: AZD5718 oral suspension amorphous (1 to 100 mg/mL) (Part B) Single and multiple doses |
Experimental: AZD5718 amorphous/crystalline form, repeat 1 (Part A) Single dose of AZD5718 amorphous form (Part A) Crystalline form (Part A), dosage lower than highest dose used with amorphous form, single ascending dose | Drug: AZD5718 oral suspension crystalline form (1 to 100 mg/mL) (Part A) Oral suspension single dose Drug: AZD5718 oral suspension amorphous (1 to 100 mg/mL) (Part A) Single and multiple doses Drug: AZD5718 placebo oral suspension Single and multiple doses |
Experimental: AZD5718 amorphous/crystalline form, repeat 2 (Part A) Single dose of AZD5718 amorphous form (Part A) Crystalline form (Part A), dosage lower than highest dose used with amorphous form, single ascending dose | Drug: AZD5718 oral suspension crystalline form (1 to 100 mg/mL) (Part A) Oral suspension single dose Drug: AZD5718 oral suspension amorphous (1 to 100 mg/mL) (Part A) Single and multiple doses Drug: AZD5718 placebo oral suspension Single and multiple doses |
Experimental: AZD5718 amorphous/crystalline, repeat 3 (Part A) Single dose of AZD5718 amorphous form (Part A) Crystalline form (Part A), dosage lower than highest dose used with amorphous form, single ascending dose | Drug: AZD5718 oral suspension crystalline form (1 to 100 mg/mL) (Part A) Oral suspension single dose Drug: AZD5718 oral suspension amorphous (1 to 100 mg/mL) (Part A) Single and multiple doses |
Experimental: AZD5718 amorphous form, repeat 1 (Part B) Twice daily dosing (Day 1 - 9) and once daily dosing (Day 10), dosage TBD (Part A) | Drug: AZD5718 placebo oral suspension Single and multiple doses Drug: AZD5718 oral suspension amorphous (1 to 100 mg/mL) (Part B) Single and multiple doses |
Experimental: AZD5718 amorphous form, repeat 2 (Part B) Twice daily dosing (Day 1 - 9) and once daily dosing (Day 10), dosage TBD (Part A) | Drug: AZD5718 placebo oral suspension Single and multiple doses Drug: AZD5718 oral suspension amorphous (1 to 100 mg/mL) (Part B) Single and multiple doses |