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

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

Status

Terminated

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00860353

Enrollment

Registered

2009-03-12

Start date

2009-02-28

Completion date

2009-05-31

Last updated

2010-12-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

Keywords

Healthy Volunteer, Single Ascending Dose, Safety, Tolerability, AZD2551, Healthy Volunteer Study

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

Interventions

DRUGAZD2551

Single dose of oral solution.

DRUGPlacebo

Single dose of oral solution

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

BASIC_SCIENCE

Masking

TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

MALE

Age

18 Years to 45 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame
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

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

Countries

United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026