CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 72 enrolled
Drug / intervention
AZD9567 Monohydrat +2 moredrug
Likely dose
AZD9567 Monohydrat 10 mgfrom 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/NCT02512575
NCT02512575Phase 1Completed
CompareCT.gov

A Phase I, Randomized, Single-Blind, Placebo-Controlled Study To Assess The Safety, Tolerability, Pharmacokinetics And Pharmacodynamics Of Single Ascending Oral Doses Of AZD9567 In Healthy Subjects.

AstraZeneca·interventional·Posted Jul 31, 2015·Updated Oct 4, 2018

In Brief

A Phase 1 clinical trial evaluating AZD9567 Monohydrat, Placebo oral suspension/ Placebo capsule, and 1 other intervention for Safety and 5 related conditions. Completed, enrolled 72 participants across 1 site.

Detailed Summary

This is a Phase I, first-in-human (FIH), randomized, single-blind, placebo-controlled, single ascending dose sequential group study in healthy male subjects. The objectives are to study the safety, tolerability, pharmacokinetics and effects on glucose homeostasis (pharmacodynamics) of AZD9567, an oral differentiated non-steroidal selective glucocorticoid receptor modulator (SGRM). The study will also assess the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of prednisolone 60 mg in comparison with high doses of AZD9567 and placebo.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSafety, Tolerability, Pharmacokinetics, Pharmacodynamics, Healthy Subjects, Rheumatoid Arthritis
CountriesGermany
Collaborators--

Timeline

Phase 1CompletedFinished
20162017201820192020202120222023202420252026
First PostedJul 31, 2015
Enrollment StartNov 18, 2015
Primary CompletionSep 26, 2016
TodayJul 2, 2026
Enrollment to primary: 10 monthsPosted 10.9 years ago

Interventions

AZD9567 Monohydratdrug

AZD9567 oral suspension 0.5 to 10 mg/ml

Placebo oral suspension/ Placebo capsuledrug

Matching placebo

Prednisolonedrug

Prednisolone 60mg oral capsules (12 capsules of 5 mg each).