A Study Conducted Over 3 Periods to Look at the Drug in the Body
A Randomised, Open-label, Three-way Cross-over, Phase I Study in Healthy Subjects to Assess the Pharmacokinetics of AZD8329 After Single Doses of the Oral Solid Formulation and the Oral Solution
1 other identifier
interventional
18
1 country
1
Brief Summary
A study conducted over 3 periods to look at the drug in the body.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_1 type-2-diabetes-mellitus
Started Nov 2010
Shorter than P25 for phase_1 type-2-diabetes-mellitus
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 20, 2010
CompletedFirst Posted
Study publicly available on registry
October 21, 2010
CompletedStudy Start
First participant enrolled
November 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2010
CompletedMarch 2, 2011
March 1, 2011
1 month
October 20, 2010
March 1, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Compare the pharmacokinetics (Cmax and AUC) of the oral solution and the oral solid formulation of AZD8329.
Information will be collected during 48h after each dose.
Secondary Outcomes (2)
Explore the effect of food on the pharmacokinetics (Tmax, T1/2 and CL/F) of AZD8329 oral solid formulation.
Information will be collected during 48h after dose.
Investigate the safety and tolerability of AZD8329 administered as two different oral formulations.(Safety variables: Adverse events, Vital Signs, Clinical chemistry, Electrocardiogram (p ECG))
Adverse event will be collected from first dose to last visit . Clinical chemistry, Vital Signs and pECG's will be collected at all 5 visits
Study Arms (3)
1
EXPERIMENTALSingle Oral dose AZD8329 tablet (fasting)
2
EXPERIMENTALSingle Oral dose AZD8329 solution (fasting)
3
EXPERIMENTALSingle Oral dose AZD8329 tablet (Fed)
Interventions
Eligibility Criteria
You may qualify if:
- Provision of signed and dated written informed consent before any study specific procedures including consent for genetic research exploring genetic variations in CYP3A5
- suitable veins for cannulation or repeated venepuncture
- Subjects should have a body mass index (BMI) between 18 and 30 kg/m2
You may not qualify if:
- Abnormal vital signs (blood pressure and pulse) after 10 minutes supine rest, as judged by the investigator
- Prolonged QTcF \>450 msec or shortened QTcF \<350 msec or family history of long QT syndrome
- Suspicion of known Gilbert's disease
- History or presence of gastrointestinal, hepatic or renal disease or any other condition known to interfere with absorption, distribution, metabolism or excretion of drugs
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
Study Sites (1)
Research Site
London Bridge, United Kingdom
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
J Ritter, BM BCh, MRCP, FRCP
Quintiles Drug Research Unit at Guy's Hospital
- STUDY CHAIR
Dr. Mirjana Kujacic
AstraZeneca Mölndal
- STUDY DIRECTOR
Jan Eriksson, MD PhD
AstraZeneca Sweden
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
October 20, 2010
First Posted
October 21, 2010
Study Start
November 1, 2010
Primary Completion
December 1, 2010
Study Completion
December 1, 2010
Last Updated
March 2, 2011
Record last verified: 2011-03