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

Healthy Volunteers Clinical Trial

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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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02039180
• Other study ID #: D5010C00005
• Status: Completed
• Phase: Phase 1
• First received: January 16, 2014
• Last updated: April 23, 2014
• Start date: February 2014
• Est. completion date: March 2014

Study information

• Verified date: April 2014
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1
• Est. completion date: March 2014
• Est. primary completion date: March 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 55 Years

Eligibility

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)

Study Design

Allocation: Randomized, Endpoint Classification: Bio-availability Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Healthy Volunteers
• Pharmacologic Action

Intervention

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.
• 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.
• 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.

Locations

Country	Name	City	State
United States	Research Site	Cypress	California

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.	up to day 18 (Day 1 - 72 hrs post-dose on Day 15)	No
Primary	To compare the tablet formulations of AZD3293 with the oral solution of AZD3293 by evaluation of the basic pharmacokinetic parameters for each formulation	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.	up to day 18 (Day 1 - 72 hrs post-dose on Day 15)	No
Secondary	Safety profile in terms of Adverse events assessment		From Baseline and up to day 25	Yes
Secondary	Safety and tolerability in terms of lab tests assessment (hematology, chemistry, urinalysis)		From Baseline and up to day 25	Yes
Secondary	Safety and tolerability in terms of vital signs assessment (blood pressure, pulse and body temperature) and physical exams		From baseline and up to day 25	Yes
Secondary	Safety and tolerability by assessing changes in electrocardiogram (ECG) parameters		from baseline and up until day 25	Yes