NCT02512575

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

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.

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 72 (actual)
• Sponsor: AstraZeneca · Industry
• Sex: Male
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

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.

Detailed description

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. Additional exploratory variables (Inflammation biomarkers, ECG modelling and taste assessment) will also be evaluated. 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. The study will be conducted at a single study centre with a planned number of subjects of up to 72 healthy males, aged 18 to 55 years.

Conditions

• Safety
• Tolerability
• Pharmacokinetics
• Pharmacodynamics
• Healthy Subjects
• Rheumatoid Arthritis

Interventions

Type	Name	Description
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).

Timeline

• Start date: 2015-11-18
• Primary completion: 2016-09-26
• Completion: 2016-09-26
• First posted: 2015-07-31
• Last updated: 2018-10-04
• Results posted: 2018-10-04

Locations

1 site across 1 country: Germany