Formulation and Food Effect Study of AZD1386 in Healthy Volunteers

AstraZeneca

Status and phase: Completed; Phase 1

Conditions: Pharmacokinetics

Treatments: Drug: AZD1386

Study type: Interventional

Funder types: Industry

Identifiers

NCT00714337

EudraCT 2008-002150-37

D5090C00007

Details and patient eligibility

About

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

Enrollment: 12 estimated patients

Sex: All

Ages: 20 to 45 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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12 participants in 5 patient groups

1

Experimental group

Description:

fasting state

Treatment:

Drug: AZD1386

Drug: AZD1386

Drug: AZD1386

2

Experimental group

Description:

fasting state

Treatment:

Drug: AZD1386

Drug: AZD1386

Drug: AZD1386

3

Experimental group

Description:

non-fasting state

Treatment:

Drug: AZD1386

Drug: AZD1386

Drug: AZD1386

4

Experimental group

Description:

fasting state

Treatment:

Drug: AZD1386

Drug: AZD1386

Drug: AZD1386

5

Experimental group

Description:

non-fasting state

Treatment:

Drug: AZD1386

Drug: AZD1386

Drug: AZD1386