A Two-part Single and Multiple Dose Study to Assess the Safety , Pharmacokinetics and Effects of AZD3293 in Healthy Japanese Young and Elderly Volunteers

Healthy Japanese Young and Elderly Male and Non-fertile Female Volunteers Clinical Trial

Official title:

A Phase I, Randomized, Double-Blind, Placebo-Controlled, Single and Multiple Ascending Dose Study to Assess the Safety, Tolerability, Pharmacokinetics and Effect on Biomarkers of AZD3293 in Healthy Japanese Male and Non-Fertile Female Volunteers Including Elderly

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02005211
• Other study ID #: D5010C00003
• Status: Completed
• Phase: Phase 1
• First received: December 4, 2013
• Last updated: October 13, 2015
• Start date: December 2013
• Est. completion date: July 2014

Study information

• Verified date: September 2015
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Ministry of Health, Labor and WelfareJapan: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

This study consists of two parts, ie, single dose part with young healthy subjects (Part 1) and single and multiple dose part with elderly healthy subjects (Part 2), to assess the safety, tolerability, pharmacokinetics and pharmacodynamics of AZD3293 following single and multiple ascending dose administration to healthy subjects.

Description:

This is a Phase I, randomised, double-blind, placebo-controlled, single centre study to assess the safety, tolerability, pharmacokinetics and pharmacodynamics of AZD3293 following single and multiple ascending dose administration to healthy subjects. This study consists of two parts, ie, single dose part with young healthy subjects (Part 1) and single and multiple dose part with elderly healthy subjects (Part 2). The study design allows a gradual escalation of dosage levels between sequential cohorts with safety monitoring to ensure the safety of the healthy subjects.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 114
• Est. completion date: July 2014
• Est. primary completion date: July 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 20 Years to 80 Years

Eligibility

Inclusion Criteria:

• Healthy Japanese elderly and young males and females (of non-childbearing potential)

• Body mass index (BMI) between 17 and 27 kg/m2 and weigh at least 40 kg and no more than 100 kg

Exclusion Criteria:

• Psychiatric disease/condition, GI, renal, hepatic, cardiovascular, psychiatric, or retinal diseases or disorders

• Use of antipsychotic drugs , or chronic use of antidepressant or anxiolytic drugs.

• Frequent use (more than 2 days per week during the last 12 weeks) of tobacco or other nicotine products.

• Neurological disease, including seizures, recent memory impairment, or clinically significant head injury.

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Healthy Japanese Young and Elderly Male and Non-fertile Female Volunteers

Intervention

Drug:
• AZD3293
Oral solution
• Placebo
Oral solution

Locations

Country	Name	City	State
Japan	Research Site	Fukuoka-shi

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Adverse Events - Overall Study	Number of treatment emergent adverse events	Day 1 to 7 - 10 days after last dose	Yes
Secondary	PK Cmax - Overall Study	Pharmacokinetic maximum concentration	0 to 72 hours	No
Secondary	PK AUC - Overall Study (SAD & MAD Parts)	Pharmacokintic Area Under the Curve (0 to t)	0-72 hours	Yes
Secondary	Biomarker	Biomarker (Abeta 1-40; A beta 1-42) % change from baseline	Pre dose vs Day 14	No