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NCT Number: NCT02039180

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

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

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Key information

Conditions

Healthy Volunteers Pharmacologic Action

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Research Site

Cypress, California, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • 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
  • History or presence of gastrointestinal, hepatic or renal disease or any other condition known to interfere with absorption, distribution, metabolism or excretion of drugs
  • 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)

Treatment and study plan

AZD3293 oral solution

Drug

Subjects will receive AZD3293 as a tablet (Formulation A; Formulation B) and solution as a single dose on Day 1, Day 8 or Day 15.

Other names: Beta secretase inhibitor

AZD3293 tablet formulation A

Drug

Subjects will receive AZD3293 as a tablet (Formulation A; Formulation B) and a solution as a single dose on Day 1, Day 8, or Day 15.

Other names: beta secretase inhibitor

AZD3293 tablet formulation B

Drug

Subjects will receive AZD3293 as a tablet (Formulation A; Formulation B) and a solution as a single dose on Day 1, Day 8 or Day 15.

Other names: Beta secretase inhibitor

Primary outcomes

  1. The relative bioavailability of AZD3293 after administration via 2 tablet formulations compared with oral solution by assessment of the area under the plasma concentration-time curve from zero to infinity for the tablet formulations and the oral solutio

    Time frame: up to day 18 (Day 1 - 72 hrs post-dose on Day 15)

    Blood samples for determination of plasma concentrations of AZD3293 and its active metabolite will be collected at pre-dose (15 or 30 min) and 30 min, 1h, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, 56 and 72 hours post-dose starting on Days 1, 8 & 15 and analyzed according to fully validated methods.

  2. To compare the tablet formulations of AZD3293 with the oral solution of AZD3293 by evaluation of the basic pharmacokinetic parameters for each formulation

    Time frame: up to day 18 (Day 1 - 72 hrs post-dose on Day 15)

    Blood samples for determination of plasma concentrations of AZD3293 and its active metabolite will be collected at pre-dose (15 or 30 min) and 30 min, 1h, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, 56 and 72 hours post-dose starting on Days 1, 8 & 15 and analyzed according to fully validated methods.

Secondary outcomes

  1. Safety profile in terms of Adverse events assessment

    Time frame: From Baseline and up to day 25

  2. Safety and tolerability in terms of lab tests assessment (hematology, chemistry, urinalysis)

    Time frame: From Baseline and up to day 25

  3. Safety and tolerability in terms of vital signs assessment (blood pressure, pulse and body temperature) and physical exams

    Time frame: From baseline and up to day 25

  4. Safety and tolerability by assessing changes in electrocardiogram (ECG) parameters

    Time frame: from baseline and up until day 25

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study title

A Phase 1, Open-label, Randomized, Single-dose, 3-period Cross-over, Relative Bioavailability Study to Assess Two Solid Formulations Compared to an Oral Solution of AZD3293 in Healthy Male and Non-Fertile Female Subjects

Acronym: BA

Important dates

Study start
2014
Primary completion
2014
Study completion
2014
First posted
Jan 17, 2014
Registry last updated
Apr 24, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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