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

NCT00860353 | Terminated Phase 1

• 1 other identifier: D1570C00001
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

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

Conditions

Healthy

Keywords

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

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• Pharmacokinetic profile: concentration of AZD2551 in urine

  Samples collected at Visit 2 from pre-dose up to 48 hours post-dose

Study Arms (2)

1

EXPERIMENTAL

Drug: AZD2551

2

PLACEBO COMPARATOR

Drug: Placebo

Interventions

AZD2551 DRUG

Single dose of oral solution.

1

Placebo DRUG

Single dose of oral solution

2

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• AstraZeneca: lead

Study Sites (1)

Research Site

Nottingham, United Kingdom

Location

Study Officials

• William Fahy, MA, MBBS (Hons)

  AstraZeneca Clinical Pharmacology Unit, E Floor, Queens Medical Centre, Nottingham NG7 2UH

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: March 11, 2009
• First Posted: March 12, 2009
• Study Start: February 1, 2009
• Study Completion: May 1, 2009
• Last Updated: December 3, 2010

Record last verified: 2010-12

Locations

GB (1)