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

Type 2 Diabetes Mellitus Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01225939
• Other study ID #: D2350C00007
• Status: Completed
• Phase: Phase 1
• First received: October 20, 2010
• Last updated: March 1, 2011
• Start date: November 2010
• Est. completion date: December 2010

Study information

• Verified date: March 2011
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: December 2010
• Est. primary completion date: December 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 45 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Type 2 Diabetes Mellitus

Intervention

Drug:
• AZD8329
tablet
• AZD8329
Solution

Locations

Country	Name	City	State
United Kingdom	Research Site	London Bridge

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	No
Secondary	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.	No
Secondary	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	Yes