Relative Bioavailability Study to Assess Two Solid Formulations Compared to an Oral Solution of AZD3293 in Healthy Male and Non-Fertile Female Subjects (BA)

AstraZeneca

Status and phase: Completed; Phase 1

Conditions: Healthy Volunteers; Pharmacologic Action

Treatments: Drug: AZD3293 tablet formulation B; Drug: AZD3293 oral solution; Drug: AZD3293 tablet formulation A

Study type: Interventional

Funder types: Industry

Identifiers

NCT02039180

D5010C00005

Details and patient eligibility

About

This is an open-label, randomized, 3-period crossover, single dose study. Three (3) single doses of AZD3293 (2 different tablet formulations, and an oral solution) will be administered with a washout period of at least 1 week between the doses to investigate the relative bioavailability of AZD3293 after administration via 2 tablet formulations compared with oral solution and to evaluate basic systemic pharmacokinetic parameters of the tablet formulations compared to the oral solution of AZD3293.

The safety and tolerability of AZD3293 in healthy subjects will also be assessed in the study. AZD3293 is being developed for the treatment of Alzheimer's disease

Enrollment: 1 patient

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. Provision of signed, written, and dated informed consent prior to any study-specific procedures
2. Healthy subjects must be able to understand and be willing to comply with study procedures, restrictions, and requirements.
3. Male and non-fertile female healthy subjects, aged 18 to 55 years
4. Body weight ≥50 to ≤100 kg and body mass index (BMI) ≥19 to ≤30 kg/m2
5. Clinically normal findings on physical examination in relation to age, as judged by the Investigator

Exclusion criteria

1. History of any clinically significant disease or disorder which, in the opinion of the Investigator, may either put the subject at risk because of participation in the study, or influence the results or the subject's ability to participate in the study
2. History or presence of gastrointestinal, hepatic or renal disease or any other condition known to interfere with absorption, distribution, metabolism or excretion of drugs
3. History of previous or ongoing psychiatric disease/condition including psychosis, affective disorder, anxiety disorder, borderline state and personality disorder according to the criteria in the Diagnostic and Statistical Manual of Mental Disorders, 4th edition (DSM IV), as assessed by the Mini-International Neuropsychiatric Interview (MINI)

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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1 participants in 3 patient groups

AZD3293 oral solution

Experimental group

Description:

single doses in random order in 3 study periods for each subject (Day 1 or Day 8 or Day 15)

Treatment:

Drug: AZD3293 oral solution

AZD3293 tablet formulation A

Experimental group

Description:

single doses in random order in 3 study periods for each subject (Day 1 or Day 8 or Day 15)

Treatment:

Drug: AZD3293 tablet formulation A

AZD3293 tablet formulation B

Experimental group

Description:

single doses in random order in 3 study periods for each subject (Day 1 or Day 8 or Day 15)

Treatment:

Drug: AZD3293 tablet formulation B