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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 Trial)

Phase 1
Waitlist Available
Research Sponsored by AstraZeneca
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to day 18 (day 1 - 72 hrs post-dose on day 15)
Awards & highlights
No Placebo-Only Group

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

Eligible Conditions
  • Healthy Subjects
  • Pharmacology

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to day 18 (day 1 - 72 hrs post-dose on day 15)
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to day 18 (day 1 - 72 hrs post-dose on day 15) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
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
To compare the tablet formulations of AZD3293 with the oral solution of AZD3293 by evaluation of the basic pharmacokinetic parameters for each formulation

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

3Treatment groups
Experimental Treatment
Group I: AZD3293 tablet formulation BExperimental Treatment1 Intervention
single doses in random order in 3 study periods for each subject (Day 1 or Day 8 or Day 15)
Group II: AZD3293 tablet formulation AExperimental Treatment1 Intervention
single doses in random order in 3 study periods for each subject (Day 1 or Day 8 or Day 15)
Group III: AZD3293 oral solutionExperimental Treatment1 Intervention
single doses in random order in 3 study periods for each subject (Day 1 or Day 8 or Day 15)
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
AZD3293 tablet formulation B
2014
Completed Phase 1
~10
AZD3293 tablet formulation A
2014
Completed Phase 1
~10
AZD3293 oral solution
2014
Completed Phase 1
~10

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Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

AstraZenecaLead Sponsor
4,418 Previous Clinical Trials
289,125,372 Total Patients Enrolled
~0 spots leftby Dec 2025