NCT02632526

A Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of AZD5718 After Single and Multiple Ascending Dose Administration to Healthy Male Subjects

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 96 (actual)
• Sponsor: AstraZeneca · Industry
• Sex: Male
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

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

Conditions

• Healthy Male Subjects
• Cardiovascular Disease

Interventions

Type	Name	Description
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
DRUG	AZD5718 oral suspension amorphous (1 to 100 mg/mL) (Part B)	Single and multiple doses

Timeline

• Start date: 2016-02-10
• Primary completion: 2016-08-26
• Completion: 2016-08-26
• First posted: 2015-12-16
• Last updated: 2019-03-21
• Results posted: 2019-03-21

Locations

1 site across 1 country: United Kingdom