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

Phase 1

Completed

• Conditions: Type 2 Diabetes Mellitus
• Interventions: Drug: AZD8329

• Registration Number: NCT01225939
• Lead Sponsor: AstraZeneca

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2010-10-20
• Study First Submitted QC: 2010-10-20
• Study First Posted: 2010-10-21
• Study Start: 2010-11
• Primary Completion: 2010-12
• Study Completion: 2010-12
• Status Verified: 2011-03
• Last Update Submitted: 2011-03-01
• Last Update Posted: 2011-03-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 18

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

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
1	AZD8329	Single Oral dose AZD8329 tablet (fasting)
2	AZD8329	Single Oral dose AZD8329 solution (fasting)
3	AZD8329	Single Oral dose AZD8329 tablet (Fed)

Primary Outcome Measures

Name	Time	Method
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.

Secondary Outcome Measures

Name	Time	Method
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.
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

Trial Locations

Locations (1)

Research Site; 🇬🇧 London Bridge, United Kingdom