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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02039180
First Posted: January 17, 2014
Last Update Posted: April 24, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
AstraZeneca
  Purpose

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


Condition Intervention Phase
Healthy Volunteers Pharmacologic Action Drug: AZD3293 oral solution Drug: AZD3293 tablet formulation A Drug: AZD3293 tablet formulation B Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official 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

Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • 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.

  • 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 Outcome Measures:
  • Safety profile in terms of Adverse events assessment [ Time Frame: From Baseline and up to day 25 ]
  • Safety and tolerability in terms of lab tests assessment (hematology, chemistry, urinalysis) [ Time Frame: From Baseline and up to day 25 ]
  • 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 ]
  • Safety and tolerability by assessing changes in electrocardiogram (ECG) parameters [ Time Frame: from baseline and up until day 25 ]

Enrollment: 1
Study Start Date: February 2014
Study Completion Date: March 2014
Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: AZD3293 oral solution
single doses in random order in 3 study periods for each subject (Day 1 or Day 8 or Day 15)
Drug: AZD3293 oral solution
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 Name: Beta secretase inhibitor
Experimental: AZD3293 tablet formulation A
single doses in random order in 3 study periods for each subject (Day 1 or Day 8 or Day 15)
Drug: AZD3293 tablet formulation A
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 Name: beta secretase inhibitor
Experimental: AZD3293 tablet formulation B
single doses in random order in 3 study periods for each subject (Day 1 or Day 8 or Day 15)
Drug: AZD3293 tablet formulation B
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 Name: Beta secretase inhibitor

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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)
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02039180


Locations
United States, California
Research Site
Cypress, California, United States
Sponsors and Collaborators
AstraZeneca
  More Information

Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT02039180     History of Changes
Other Study ID Numbers: D5010C00005
First Submitted: January 16, 2014
First Posted: January 17, 2014
Last Update Posted: April 24, 2014
Last Verified: April 2014

Keywords provided by AstraZeneca:
phase I
healthy volunteers
AZD3293
bioavailability
Pharmacokinetics

Additional relevant MeSH terms:
Pharmaceutical Solutions