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A Single Ascending Dose Study To Assess The Safety, Tolerability, Pharmacokinetics And Pharmacodynamics Of AZD9567.

NCT02512575 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 72

Last updated 2018-10-04

Study results available
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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.

Conditions

Interventions

DRUG

AZD9567 Monohydrat

AZD9567 oral suspension 0.5 to 10 mg/ml

DRUG

Placebo oral suspension/ Placebo capsule

Matching placebo

DRUG

Prednisolone

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

Sponsors & Collaborators

Principal Investigators

  • Rainhard Fuhr, Dr. med. · PAREXEL International GmbH, Berlin

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
SINGLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2015-11-18
Primary Completion
2016-09-26
Completion
2016-09-26

Countries

  • Germany

Study Locations

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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 NCT02512575 on ClinicalTrials.gov