A Study Conducted Over 3 Periods to Look at the Drug in the Body

March 1, 2011 updated by: AstraZeneca

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

18

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 45 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
Single Oral dose AZD8329 tablet (fasting)
Drug: AZD8329
tablet
Drug: AZD8329
Solution
Experimental: 2
Single Oral dose AZD8329 solution (fasting)
Drug: AZD8329
tablet
Drug: AZD8329
Solution
Experimental: 3
Single Oral dose AZD8329 tablet (Fed)
Drug: AZD8329
tablet
Drug: AZD8329
Solution

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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.
Information will be collected during 48h after each dose.

Secondary Outcome Measures

Outcome Measure
Time Frame
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.
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))
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
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2010

Primary Completion (Actual)

December 1, 2010

Study Completion (Actual)

December 1, 2010

Study Registration Dates

First Submitted

October 20, 2010

First Submitted That Met QC Criteria

October 20, 2010

First Posted (Estimate)

October 21, 2010

Study Record Updates

Last Update Posted (Estimate)

March 2, 2011

Last Update Submitted That Met QC Criteria

March 1, 2011

Last Verified

March 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • D2350C00007

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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