Study to Investigate the Safety, Tolerability and Pharmacokinetics of Single Doses ofAZD2551

Phase 1

Terminated

• Conditions: Healthy
• Interventions: Drug: AZD2551; Drug: Placebo

• Registration Number: NCT00860353
• Lead Sponsor: AstraZeneca

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

Detailed Description

Not available

Study Timeline

• Study Start: 2009-02
• Study First Submitted: 2009-03-11
• Study First Submitted QC: 2009-03-11
• Study First Posted: 2009-03-12
• Study Completion: 2009-05
• Status Verified: 2010-12
• Last Update Submitted: 2010-12-02
• Last Update Posted: 2010-12-03

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Male
• Target Recruitment: 90

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	AZD2551	-
2	Placebo	-

Primary Outcome Measures

Name	Time	Method
Safety and tolerability of AZD2551 by assessment of vital signs, ECG, laboratory variables and adverse events	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	Samples taken at Visit 2. Up to 15 samples to be taken at defined timepoints post-dose, plus one sample pre-dose

Secondary Outcome Measures

Name	Time	Method
Pharmacokinetic profile: concentration of AZD2551 in urine	Samples collected at Visit 2 from pre-dose up to 48 hours post-dose

Trial Locations

Locations (1)

Research Site; 🇬🇧 Nottingham, United Kingdom