Relative Bioavailability Study to Assess Two Solid Formulations Compared to an Oral Solution of AZD3293 in Healthy Male and Non-Fertile Female Subjects
| Status: | Completed |
|---|---|
| Conditions: | Healthy Studies |
| Therapuetic Areas: | Other |
| Healthy: | No |
| Age Range: | 18 - 55 |
| Updated: | 5/3/2014 |
| Start Date: | February 2014 |
| End Date: | March 2014 |
| Contact: | Laura Rosen, MD |
| Email: | ClinicalTrialTransparency@astrazeneca.com |
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
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
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
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)
We found this trial at
1
site
Click here to add this to my saved trials
