Formulation and Food Effect Study of AZD1386 in Healthy Volunteers

Study Overview
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Brief Summary
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To investigate the pharmacokinetics of two oral solid formulations of AZD1386 in relation to the AZD1386 oral solution.

Official Title
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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

Conditions
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Pharmacokinetics

Intervention / Treatment
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* Drug: AZD1386
* Drug: AZD1386
* Drug: AZD1386


Participation Criteria
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Eligibility Criteria
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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

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

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Formulation, pharmacokinetics