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

Healthy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00860353
• Other study ID #: D1570C00001
• Status: Terminated
• Phase: Phase 1
• First received: March 11, 2009
• Last updated: December 2, 2010
• Start date: February 2009
• Est. completion date: May 2009

Study information

• Verified date: December 2010
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Medicines and Healthcare Products Regulatory AgencyUnited Kingdom: Research Ethics Committee
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 90
• Est. completion date: May 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 45 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Healthy

Intervention

Drug:
• AZD2551
Single dose of oral solution.
• Placebo
Single dose of oral solution

Locations

Country	Name	City	State
United Kingdom	Research Site	Nottingham

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Primary	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	No
Secondary	Pharmacokinetic profile: concentration of AZD2551 in urine		Samples collected at Visit 2 from pre-dose up to 48 hours post-dose	No