Double-blind Placebo-controlled 2-part Study Assessing the Safety, Tolerability and PK of AZD1386 in Healthy Volunteers

Study Overview
=================
Brief Summary
-----------------
The study will investigate how a new formulation of the study drug is absorbed, metabolised and distributed through the body, as well as its safety and tolerability in higher doses when given as single and multiple doses and as a single dose in the presence and absence of naproxen.

Official Title
-----------------
A Single-centre, Randomised, Double-blind, Placebo-controlled, Two-part Study to Assess Safety, Tolerability, Pharmacokinetics of Orally Administered AZD1386

Conditions
-----------------
Healthy Volunteers

Intervention / Treatment
-----------------
* Drug: AZD1386
* Drug: Placebo for AZD1386
* Drug: Naproxen
* Drug: Placebo for Naproxen


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Provision of signed, written and dated informed consent prior to any study specific procedures Healthy male and female (of non childbearing potential) Body Mass Index (BMI) of ≥19 to ≤28 kg/m2 and a weight of ≥50 to ≤100 kg Exclusion Criteria: History or presence of any clinically significant disease or disorder in the opinion of the investigator. Any clinically relevant abnormal findings in physical examination, clinical chemistry, haematology, urinalysis, vital signs or ECG at baseline in the opinion of the investigator.

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 45 Years

Sexes Eligible for Study
-----------------
All

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

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

Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Part A: A<br>AZD1386 | Drug: AZD1386<br>* Single ascending and multiple (twice daily) oral doses, capsule<br>|
| Experimental: Part A: B<br>Placebo for AZD1386 | Drug: Placebo for AZD1386<br>* Single ascending and multiple (twice daily) oral doses, capsule<br>|
| Experimental: Part B: A<br>Naproxen | Drug: Naproxen<br>* Tablet, single oral dose, 500mg<br>|
| Experimental: Part B: B<br>Placebo for Naproxen | Drug: Placebo for Naproxen<br>* Tablet, single oral dose<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety variables (adverse events, vital signs, ECG, safety lab) |  | Assessments performed at frequent timepoints (predose then ranging from 15 minutes to every 12 hours) on Days -1 to Day 3 (Part A: treatment period 1 and Part B) or Day-1 to Day 9 (Part A: treatment period 2) and at follow-up 4-14 days after discharge. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To characterize the pharmacokinetics of AZD1386 in plasma |  | Assessments performed at frequent timepoints (predose then ranging from 15 minutes to every 12 hours) on Days -1 to Day 3 (Part A: treatment period 1 and Part B) or Day-1 to Day 9 (Part A: treatment period 2). | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Safety, Tolerability, Healthy, Pharmacokinetics