Ignite Creation Date:
2024-05-06 @ 10:59 AM
Last Modification Date:
2024-10-26 @ 12:38 PM
Study NCT ID:
NCT03400488
Status:
COMPLETED
Last Update Posted:
2018-06-15
First Post:
2017-12-12
Brief Title:
A Study to Assess the Safety Tolerability Pharmacokinetics and Pharmacodynamics of AZD5718 After Single and Multiple Ascending Dose Administration to Healthy Japanese Men
Sponsor:
AstraZeneca
Organization:
AstraZeneca
Study Overview
Official Title:
A Phase 1 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 Japanese Men
Status:
COMPLETED
Status Verified Date:
2018-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is a Phase I study to investigate the safety tolerability pharmacokinetics PK and pharmacodynamics PD of the novel compound AZD5718 in healthy Japanese men The results from this study will form the basis for decisions on future studies
Detailed Description:
This study will be a Phase 1 randomized single-blind placebo-controlled single and multiple ascending dose sequential group design in up to 48 healthy male Japanese subjects performed at a single study center The planned number of cohorts is 4 but up to 6 cohorts may be included if the Safety Review Committee SRC considers it necessary to repeat a dose level or if additional dose steps are required Screening will be completed between Days -28 and -1 Primarily gradual escalation of the dose will be conducted with the oral suspension Eight subjects will participate in each cohort Four ascending dose levels are planned Within each cohort 6 subjects will be randomised to receive AZD5718 and 2 subjects randomised to receive placebo Each subject will receive one dose of AZD5718 or placebo on the first dosing day Day 1 single ascending dose SAD and on Days 3 to 10 multiple ascending dose MAD On Day 2 no dose will be given to the subject In total each subject will receive 9 doses Dosing for each ascending dose cohort will proceed after the SRC has evaluated the safety tolerability and other relevant data of a completed cohort The subjects will stay at the study site until 48 hours post-dose and will return 7 to 10 days after dosing for a follow-up visit Each subject will be involved in the study for 7 weeks
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None