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

Study Overview
=================
Brief Summary
-----------------
A study conducted over 3 periods to look at the drug in the body.

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

Conditions
-----------------
Type 2 Diabetes Mellitus

Intervention / Treatment
-----------------
* Drug: AZD8329
* Drug: AZD8329


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
-----------------
Male

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Single Oral dose AZD8329 tablet (fasting) | Drug: AZD8329<br>* tablet<br>|
| Experimental: 2<br>Single Oral dose AZD8329 solution (fasting) | Drug: AZD8329<br>* Solution<br>|
| Experimental: 3<br>Single Oral dose AZD8329 tablet (Fed) | Drug: AZD8329<br>* tablet<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Type 2 diabetes mellitus, Healthy