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

AstraZeneca

Status and phase: Completed; Phase 1

Conditions: Type 2 Diabetes Mellitus

Treatments: Drug: AZD8329

Study type: Interventional

Funder types: Industry

Identifiers

NCT01225939

D2350C00007

Details and patient eligibility

About

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

Enrollment: 18 estimated patients

Sex: Male

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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18 participants in 3 patient groups

1

Experimental group

Description:

Single Oral dose AZD8329 tablet (fasting)

Treatment:

Drug: AZD8329

Drug: AZD8329

2

Experimental group

Description:

Single Oral dose AZD8329 solution (fasting)

Treatment:

Drug: AZD8329

Drug: AZD8329

3

Experimental group

Description:

Single Oral dose AZD8329 tablet (Fed)

Treatment:

Drug: AZD8329

Drug: AZD8329