Relative Bioavailability of Phase II and Phase III Formulations of AZD0530
This study has been completed.
Sponsor:
AstraZeneca
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00771979
First received: October 14, 2008
Last updated: June 17, 2009
Last verified: June 2009
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Purpose
The aim of the study is to compare how different formulations of AZD0530 are absorbed by the body. As for all clinical trials, safety and tolerability of the drug will be evaluated.
| Condition | Intervention | Phase |
|---|---|---|
|
Healthy |
Drug: AZD0530 |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Bio-availability Study Intervention Model: Crossover Assignment Masking: Open Label Primary Purpose: Basic Science |
| Official Title: | A Phase I, Randomised, Open-Label, Cross-Over, Single Centre Study in Healthy Volunteers to Determine the Relative Bioavailability of the Phase III Tablet Formulation to the Phase II Tablet Formulation of AZD0530 |
Further study details as provided by AstraZeneca:
Primary Outcome Measures:
- To compare the pharmacokinetic parameters for AZD0530 when administered as Phase III formulation in relation to Phase II formulation. [ Time Frame: Pre-dose sample, 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 48, 72, 120, 168 hours post dose samples. ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- To monitor the safety of all subjects by assessment of vital signs, ECG, clinical chemistry, haematology, urinalysis and adverse events. [ Time Frame: From time of consent to last visit. ] [ Designated as safety issue: Yes ]
- An exploratory objective is to characterise the Pharmacokinetic profile of an oral solution of AZD0530 and 4 additional tablet variants of the Phase III formulation of AZD0530 [ Time Frame: Pre-dose sample, 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 48, 72, 120, 168 hours post dose samples. ] [ Designated as safety issue: No ]
| Enrollment: | 18 |
| Study Start Date: | November 2008 |
| Study Completion Date: | March 2009 |
| Arms | Assigned Interventions |
|---|---|
| Experimental: 1 |
Drug: AZD0530
of both the Phase II and Phase III AZD0530 125mg tablet variants (A and B) in a random order.
Drug: AZD0530
Part II: Single doses of AZD0530 125mg oral solution and 2 out of 4 125mg tablet variants (C, D, E and F) in a random order.
|
Eligibility| Ages Eligible for Study: | 18 Years to 45 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Criteria
Inclusion Criteria:
- Female subjects must be of Non- child-bearing potential
- Body mass index between 19 and 30 kg/m2 and weigh between 50-100 kg
Exclusion Criteria:
- Presence of any clinically significant illness
- Abnormal vital signs
- History of any conditions that may put the subject at risk by participating in the study
- Participation in another clinical study.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00771979
Locations
| United Kingdom | |
| Research Site | |
| Alderley Park, United Kingdom | |
Sponsors and Collaborators
AstraZeneca
Investigators
| Principal Investigator: | Raj Chetty, MD | AstraZeneca, Clinical Pharmacology Unit, Alderley Park |
| Study Director: | Mary Stuart, MD | AstraZeneca,Parklands, Alderley Park |
More Information
No publications provided
| Responsible Party: | Mary Stuart, MD, Medical Science Director, Emerging Product Team 1, Oncology, AstraZeneca Pharmaceuticals |
| ClinicalTrials.gov Identifier: | NCT00771979 History of Changes |
| Other Study ID Numbers: | D8180C00033 |
| Study First Received: | October 14, 2008 |
| Last Updated: | June 17, 2009 |
| Health Authority: | United Kingdom: Medicines and Healthcare Products Regulatory Agency |
Keywords provided by AstraZeneca:
|
Healthy Volunteers Relative Bioavailability |
ClinicalTrials.gov processed this record on May 22, 2013