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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)

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ClinicalTrials.gov Identifier: NCT02039180
Recruitment Status : Completed
First Posted : January 17, 2014
Last Update Posted : April 24, 2014
Sponsor:
Information provided by (Responsible Party):
AstraZeneca

Tracking Information
First Submitted Date  ICMJE January 16, 2014
First Posted Date  ICMJE January 17, 2014
Last Update Posted Date April 24, 2014
Study Start Date  ICMJE February 2014
Actual Primary Completion Date March 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 16, 2014)
  • 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.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02039180 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: January 16, 2014)
  • 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 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Relative Bioavailability Study to Assess Two Solid Formulations Compared to an Oral Solution of AZD3293 in Healthy Male and Non-Fertile Female Subjects
Official Title  ICMJE 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
Brief Summary

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

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Condition  ICMJE
  • Healthy Volunteers
  • Pharmacologic Action
Intervention  ICMJE
  • 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
  • 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
  • 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
Study Arms  ICMJE
  • Experimental: AZD3293 oral solution
    single doses in random order in 3 study periods for each subject (Day 1 or Day 8 or Day 15)
    Intervention: Drug: AZD3293 oral solution
  • 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)
    Intervention: Drug: AZD3293 tablet formulation A
  • 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)
    Intervention: Drug: AZD3293 tablet formulation B
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 23, 2014)
1
Original Estimated Enrollment  ICMJE
 (submitted: January 16, 2014)
16
Actual Study Completion Date  ICMJE March 2014
Actual Primary Completion Date March 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 55 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02039180
Other Study ID Numbers  ICMJE D5010C00005
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party AstraZeneca
Study Sponsor  ICMJE AstraZeneca
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account AstraZeneca
Verification Date April 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP