MedTrace Logo

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

NCT02632526 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 96

Last updated 2019-03-21

Study results available
· View outcomes & findings →

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

Conditions

Interventions

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

Sponsors & Collaborators

Principal Investigators

  • Annelize Koch, MBChB, FFPM · Parexel

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2016-02-10
Primary Completion
2016-08-26
Completion
2016-08-26

Countries

  • United Kingdom

Study Locations

More Related Trials

Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02632526 on ClinicalTrials.gov