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

Phase 1CompletedNCT01225939

AstraZeneca18 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Type 2 Diabetes Mellitus

Interventions

AZD8329DRUG

tablet

AZD8329DRUG

Solution

Eligibility

Sex: MALEMin age: 18 YearsMax age: 45 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Research Site

London Bridge, United Kingdom

Outcomes

Primary Outcomes

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

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.

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

Data from ClinicalTrials.gov

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