Study to Investigate the Safety, Tolerability and Pharmacokinetics of Single Doses ofAZD2551
This study has been terminated.
(Due to portfolio and logistical issues, this study will not be re-started at the present time. The study is not being terminated for safety reasons.)
Sponsor:
AstraZeneca
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00860353
First received: March 11, 2009
Last updated: December 2, 2010
Last verified: December 2010
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Purpose
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
| Condition | Intervention | Phase |
|---|---|---|
|
Healthy |
Drug: AZD2551 Drug: Placebo |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator, Outcomes Assessor) Primary Purpose: Basic Science |
| 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 |
Further study details as provided by AstraZeneca:
Primary Outcome Measures:
- 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 ] [ Designated as safety issue: Yes ]
- 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 ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Pharmacokinetic profile: concentration of AZD2551 in urine [ Time Frame: Samples collected at Visit 2 from pre-dose up to 48 hours post-dose ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 90 |
| Study Start Date: | February 2009 |
| Study Completion Date: | May 2009 |
| Arms | Assigned Interventions |
|---|---|
| Experimental: 1 |
Drug: AZD2551
Single dose of oral solution.
|
| Placebo Comparator: 2 |
Drug: Placebo
Single dose of oral solution
|
Eligibility| Ages Eligible for Study: | 18 Years to 45 Years |
| Genders Eligible for Study: | Male |
| Accepts Healthy Volunteers: | Yes |
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00860353
Locations
| United Kingdom | |
| Research Site | |
| Nottingham, United Kingdom | |
Sponsors and Collaborators
AstraZeneca
Investigators
| Principal Investigator: | William Fahy, MA, MBBS (Hons) | AstraZeneca Clinical Pharmacology Unit, E Floor, Queens Medical Centre, Nottingham NG7 2UH |
More Information
No publications provided
| Responsible Party: | Harsukh Parmar MD, ChB, Global Head of Early Development, Respiratory and Inflammation Area, AstraZeneca Pharmaceuticals |
| ClinicalTrials.gov Identifier: | NCT00860353 History of Changes |
| Other Study ID Numbers: | D1570C00001 |
| Study First Received: | March 11, 2009 |
| Last Updated: | December 2, 2010 |
| Health Authority: | United Kingdom: Medicines and Healthcare Products Regulatory Agency United Kingdom: Research Ethics Committee |
Keywords provided by AstraZeneca:
|
Healthy Volunteer Single Ascending Dose Safety |
Tolerability AZD2551 Healthy Volunteer Study |
ClinicalTrials.gov processed this record on May 21, 2013