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

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ClinicalTrials.gov Identifier: NCT01225939
Recruitment Status : Completed
First Posted : October 21, 2010
Last Update Posted : March 2, 2011
Information provided by:

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

Condition or disease Intervention/treatment Phase
Type 2 Diabetes Mellitus Drug: AZD8329 Phase 1

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 18 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (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
Study Start Date : November 2010
Primary Completion Date : December 2010
Study Completion Date : December 2010

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: 1
Single Oral dose AZD8329 tablet (fasting)
Drug: AZD8329
Experimental: 2
Single Oral dose AZD8329 solution (fasting)
Drug: AZD8329
Experimental: 3
Single Oral dose AZD8329 tablet (Fed)
Drug: AZD8329

Primary Outcome Measures :
  1. 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. ]

Secondary Outcome Measures :
  1. 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. ]
  2. 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 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01225939

United Kingdom
Research Site
London Bridge, United Kingdom
Sponsors and Collaborators
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

Responsible Party: MSD, AstraZeneca
ClinicalTrials.gov Identifier: NCT01225939     History of Changes
Other Study ID Numbers: D2350C00007
First Posted: October 21, 2010    Key Record Dates
Last Update Posted: March 2, 2011
Last Verified: March 2011

Keywords provided by AstraZeneca:
Type 2 diabetes mellitus

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases