A Double Blind, Randomised, Placebo-controlled, Phase I Trial to Assess the Safety, Tolerability and Pharmacokinetics of Single, Ascending, Oral Doses of AZD2551 in Healthy Male Subjects

AstraZeneca1 site in 1 country90 target enrollmentFebruary 2009

ConditionsHealthy

InterventionsAZD2551 Placebo

DrugsAZD2551 Placebo

Overview

Phase: Phase 1
Intervention: AZD2551
Conditions: Healthy
Sponsor: AstraZeneca
Enrollment: 90
Locations: 1
Primary Endpoint: Safety and tolerability of AZD2551 by assessment of vital signs, ECG, laboratory variables and adverse events
Status: Terminated
Last Updated: 15 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

The purpose of this study is to determine how well tolerated and safe AZD2551 is at different dose levels in healthy, non-smoking males. It will also investigate how quickly AZD2551 is absorbed into and cleared by the body

Registry

clinicaltrials.gov

Start Date

February 2009

End Date

May 2009

Last Updated

15 years ago

Study Type

Interventional

Study Design

Parallel

Sex

Male

Investigators

Sponsor

AstraZeneca

Eligibility Criteria

Inclusion Criteria

•Provision of signed, written and dated informed consent prior to any study specific procedures
•Be willing to use barrier methods of contraception unless their partners are post-menopausal, surgically sterile or using accepted contraceptive methods
•Have a body mass index between 18 and 30 kg/m2 inclusive and weight at least 50kg and no more than 100kg

Exclusion Criteria

•Use of any prescribed or non-prescribed medication during the two weeks prior to the administration of study drug
•History or presence of conditions known to interfere with the absorption, distribution, metabolism or excretion of drugs
•Any impairment of kidney function or laboratory results for markers of kidney function that are outside the reference range and considered clinically significant
•Underlying musculoskeletal symptoms of unknown origin, subjects with shoulder girdle musculoskeletal symptoms or Dupuytrens syndrome

Arms & Interventions

1

Intervention: AZD2551

2

Intervention: Placebo

Outcomes

Primary Outcomes

Safety and tolerability of AZD2551 by assessment of vital signs, ECG, laboratory variables and adverse events

Time Frame: Baseline assessments at Visit 1 (enrolment). Assessments pre-dose and at defined timepoints post-dose at Visit 2. Follow up assessment at Visit 3

Pharmacokinetic profile: concentration of AZD2551 in blood

Time Frame: Samples taken at Visit 2. Up to 15 samples to be taken at defined timepoints post-dose, plus one sample pre-dose