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

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

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.

Study Overview

• Status: Completed
• Conditions: Healthy Japanese Young and Elderly Male and Non-fertile Female Volunteers
• Intervention / Treatment: Drug: AZD3293; Drug: Placebo

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 114
• Phase: Phase 1

Contacts and Locations

Study Locations

• Japan
  • Fukuoka-shi, Japan
    • Research Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo; Placebo given (2 subjects in each cohort)	Drug: Placebo; Oral solution
Experimental: AZD3293; AZD3293 will be administered as single dose of an oral solution in Part 1 and single and multiple doses of an oral solution in Part 2. The ascending doses are planned to be 15, 50 and 150 mg for young subjects in Part 1 and 15 and 50 mg for elderly subjects in Part 2. Before proceeding to next dose level, safety, tolerability and pharmacokinetic data from the previous cohort(s) will be evaluated by a Safety Review Committee. Part 2 will start after confirming safety and tolerability in Part 1.	Drug: AZD3293; Oral solution

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety - Adverse Events	Safety - Number of subjects reporting any adverse events during the study	Day of first dose to follow up

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
PK Cmax - Overall Study	Pharmacokinetic maximum concentration	0, 0.5,1,2,3,4,8,12,24,48 hr single dose, multiple dose does not include 48 hr
PK AUC - Overall Study (SAD & MAD Parts)	Pharmacokintic Area Under the Curve (0 to t)	0,0.5,1,2,3,4,8,12,24,48 hr single dose, multiple dose does not include 48 hr
Biomarker	Biomarker (Abeta 1-40; A beta 1-42) % change from baseline	Pre dose vs Day 14

Collaborators and Investigators

• Sponsor: AstraZeneca
• Investigators: Study Director: Robert C Alexander, MD, AstraZeneca; Principal Investigator: Kei Sakamoto, MD, PhD, Sugioka Memorial Hospital, Medical Co. LTA

Study record dates

Study Major Dates

• Study Start: December 1, 2013
• Primary Completion (Actual): July 1, 2014
• Study Completion (Actual): July 1, 2014

Study Registration Dates

• First Submitted: December 4, 2013
• First Submitted That Met QC Criteria: December 4, 2013
• First Posted (Estimate): December 9, 2013

Study Record Updates

• Last Update Posted (Estimate): November 4, 2016
• Last Update Submitted That Met QC Criteria: September 16, 2016
• Last Verified: September 1, 2016

More Information

Terms related to this study

• Keywords: Healthy volunteers; Phase 1; AZD3293; Elderly volunteers; Japanese volunteers; Young volunteers; Single and multiple ascending dose study
• Other Study ID Numbers: D5010C00003