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Completed

NCT Number: NCT01225939

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

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

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Key information

Conditions

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

Age range

18 year–45 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Research Site

London Bridge, United Kingdom

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

AZD8329

Drug

tablet

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study 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

Important dates

Study start
2010
Primary completion
2010
Study completion
2010
First posted
Oct 21, 2010
Registry last updated
Mar 2, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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