NCT02712372

A Study to Assess the Safety and Tolerability of Single and Multiple Doses of AZD4831 in Healthy Male Subjects

A Phase I, Randomised, Single-Blind, Placebo-controlled Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of AZD4831 After Single and Multiple Ascending Dose Administration to Healthy Male Subjects

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 104 (actual)
• Sponsor: AstraZeneca · Industry
• Sex: Male
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

Summary

This is a Phase I, first-in-human (FIH) study to assess the safety, tolerability, pharmacokinetics (PK) and Pharmacodynamics (PD) of AZD4831 after single and multiple ascending doses in healthy male subjects

Detailed description

This is a Phase I, FIH, randomized, single-blind, placebo-controlled study to assess the safety, tolerability, pharmacokinetics (PK) and Pharmacodynamics (PD) of AZD4831 after single (Part 1) and multiple (Part 2) ascending doses in healthy male subjects. The study will be conducted at a single study center with a planned number of subjects of up to 125 healthy males, aged 18 to 50 years.

Conditions

• Cardiovascular Disease

Interventions

Type	Name	Description
DRUG	AZD4831	AZD4831 1-50 mg/g oral suspension
DRUG	AZD4831 placebo	AZD4831 placebo oral suspension

Timeline

• Start date: 2016-06-01
• Primary completion: 2016-10-01
• Completion: 2016-10-01
• First posted: 2016-03-18
• Last updated: 2017-01-06