Formulation and Food Effect Study of AZD1386 in Healthy Volunteers

A Phase I, Single-Centre, Randomised, Open-Label, Five-Way Cross-Over Formulation- and Food-Effect Study in Healthy Volunteers to Assess the Pharmacokinetics of AZD1386 After Single Doses of Two Oral Solid Formulations and an Oral Solution

To investigate the pharmacokinetics of two oral solid formulations of AZD1386 in relation to the AZD1386 oral solution.

Study Overview

• Status: Completed
• Conditions: Pharmacokinetics
• Intervention / Treatment: Drug: AZD1386; Drug: AZD1386; Drug: AZD1386

• Study Type: Interventional
• Enrollment (Anticipated): 12
• Phase: Phase 1

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 45 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Females must be non-fertile (Amenorrhea and no pregnancy in the last 12 months prior to enrolment or documentation of being irreversible surgically sterile).
• Healthy male volunteers with BMI between 18 and 30 kg/m2
• Clinical normal physical findings, including blood pressure, pulse rate above 45 bpm, ECG, and laboratory assessments.
• Normal QTc interval on baseline ECG, between 360-450 msec, according to the Fridericia formula.

Exclusion Criteria:

• History of severe allergy/hypersensitivity or symptoms/signs of ongoing allergy/hypersensitivity as judged by the Investigator.
• Requirement of concomitant medication during the study, excluding hormone replacement therapy (HRT) or use of drugs with enzyme inducing properties with 3 weeks of first dose
• Smoking more than 7 cigarettes per week or consumption of more than 3 portion of snuff or equivalent per day within 30 days before first administration of study drug
• A family history of short QT syndrome (SQTS) or sudden cardiac death (SCD) amongst first degree relatives and who have a QT/QTc <360 ms

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

5

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 1; fasting state	Drug: AZD1386; One single oral dose of 90mg (36mL of AZD1386 2.5mg/mL oral solution).; Drug: AZD1386; One single oral dose of 90mg (3 x 30mg AZD1386 capsules); Drug: AZD1386; One single oral dose of 90mg (6 x 15mg AZD1386 tablets)
Experimental: 2; fasting state	Drug: AZD1386; One single oral dose of 90mg (36mL of AZD1386 2.5mg/mL oral solution).; Drug: AZD1386; One single oral dose of 90mg (3 x 30mg AZD1386 capsules); Drug: AZD1386; One single oral dose of 90mg (6 x 15mg AZD1386 tablets)
Experimental: 3; non-fasting state	Drug: AZD1386; One single oral dose of 90mg (36mL of AZD1386 2.5mg/mL oral solution).; Drug: AZD1386; One single oral dose of 90mg (3 x 30mg AZD1386 capsules); Drug: AZD1386; One single oral dose of 90mg (6 x 15mg AZD1386 tablets)
Experimental: 4; fasting state	Drug: AZD1386; One single oral dose of 90mg (36mL of AZD1386 2.5mg/mL oral solution).; Drug: AZD1386; One single oral dose of 90mg (3 x 30mg AZD1386 capsules); Drug: AZD1386; One single oral dose of 90mg (6 x 15mg AZD1386 tablets)
Experimental: 5; non-fasting state	Drug: AZD1386; One single oral dose of 90mg (36mL of AZD1386 2.5mg/mL oral solution).; Drug: AZD1386; One single oral dose of 90mg (3 x 30mg AZD1386 capsules); Drug: AZD1386; One single oral dose of 90mg (6 x 15mg AZD1386 tablets)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
PK variables	Frequent sampling occasions during study days

Secondary Outcome Measures

Outcome Measure	Time Frame
Safety variables (adverse events, blood pressure, pulse, safety lab)	During the whole treatment period

Collaborators and Investigators

• Sponsor: AstraZeneca
• Investigators: Principal Investigator: Klaus Francke, MD, PAREXEL Clinical Pharmacology Research Unit

Study record dates

Study Major Dates

• Study Start: June 1, 2008
• Primary Completion (Actual): August 1, 2008
• Study Completion (Actual): August 1, 2008

Study Registration Dates

• First Submitted: July 10, 2008
• First Submitted That Met QC Criteria: July 11, 2008
• First Posted (Estimate): July 14, 2008

Study Record Updates

• Last Update Posted (Estimate): December 10, 2010
• Last Update Submitted That Met QC Criteria: December 8, 2010
• Last Verified: December 1, 2010

More Information

Terms related to this study

• Keywords: pharmacokinetics; Formulation
• Other Study ID Numbers: D5090C00007; EudraCT 2008-002150-37