CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 96 enrolled
Drug / intervention
AZD5718 oral suspension crystalline form (1 to 100 mg/mL) (Part A) +3 moredrug
Likely dose
AZD5718 oral suspension crystalline form (1 to 100 mg/mL) (Part A)from record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02632526
NCT02632526Phase 1Completed
CompareCT.gov

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

AstraZeneca·interventional·Posted Dec 16, 2015·Updated Mar 21, 2019

In Brief

A Phase 1 clinical trial evaluating AZD5718 oral suspension crystalline form (1 to 100 mg/mL) (Part A), AZD5718 oral suspension amorphous (1 to 100 mg/mL) (Part A), and 2 other interventions for Healthy Male Subjects and Cardiovascular Disease. Completed, enrolled 96 participants across 1 site.

Detailed 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

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHealthy Male Subjects, Cardiovascular Disease
CountriesUnited Kingdom
Collaborators--

Timeline

Phase 1CompletedFinished
20162017201820192020202120222023202420252026
First PostedDec 16, 2015
Enrollment StartFeb 10, 2016
Primary CompletionAug 26, 2016
TodayJul 2, 2026
Enrollment to primary: 7 monthsPosted 10.5 years ago

Interventions

AZD5718 oral suspension crystalline form (1 to 100 mg/mL) (Part A)drug

Oral suspension single dose

AZD5718 oral suspension amorphous (1 to 100 mg/mL) (Part A)drug

Single and multiple doses

AZD5718 placebo oral suspensiondrug

Single and multiple doses

AZD5718 oral suspension amorphous (1 to 100 mg/mL) (Part B)drug

Single and multiple doses