A Study Conducted Over 3 Periods to Look at the Drug in the Body - Full Text View

Purpose

A study conducted over 3 periods to look at the drug in the body.

Condition	Intervention	Phase
Type 2 Diabetes Mellitus	Drug: AZD8329	Phase 1

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety Study Intervention Model: Crossover Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	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

Resource links provided by NLM:

MedlinePlus related topics: Diabetes Diabetes Type 2

U.S. FDA Resources

Further study details as provided by AstraZeneca:

Primary Outcome Measures:

Compare the pharmacokinetics (Cmax and AUC) of the oral solution and the oral solid formulation of AZD8329. [ Time Frame: Information will be collected during 48h after each dose. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Explore the effect of food on the pharmacokinetics (Tmax, T1/2 and CL/F) of AZD8329 oral solid formulation. [ Time Frame: Information will be collected during 48h after dose. ] [ Designated as safety issue: No ]
Investigate the safety and tolerability of AZD8329 administered as two different oral formulations.(Safety variables: Adverse events, Vital Signs, Clinical chemistry, Electrocardiogram (p ECG)) [ Time Frame: 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 ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	18
Study Start Date:	November 2010
Study Completion Date:	December 2010
Primary Completion Date:	December 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: 1 Single Oral dose AZD8329 tablet (fasting)	Drug: AZD8329 tablet
Experimental: 2 Single Oral dose AZD8329 solution (fasting)	Drug: AZD8329 Solution
Experimental: 3 Single Oral dose AZD8329 tablet (Fed)	Drug: AZD8329 tablet

Eligibility

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01225939

Locations

United Kingdom
Research Site
London Bridge, United Kingdom

Sponsors and Collaborators

AstraZeneca

Investigators

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

More Information

No publications provided

Responsible Party:	MSD, AstraZeneca
ClinicalTrials.gov Identifier:	NCT01225939 History of Changes
Other Study ID Numbers:	D2350C00007
Study First Received:	October 20, 2010
Last Updated:	March 1, 2011
Health Authority:	United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by AstraZeneca:

Type 2 diabetes mellitus
Healthy

Additional relevant MeSH terms:

Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on May 16, 2013