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

NCT02005211 | Completed Phase 1 Results

• 1 other identifier: D5010C00003
• Study Type: interventional
• Target: 114
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

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

Keywords

AZD3293; Healthy volunteers; Young volunteers; Elderly volunteers; Japanese volunteers; Phase 1; Single and multiple ascending dose study

Outcome Measures

Primary Outcomes (1)

• Safety - Adverse Events

  Safety - Number of subjects reporting any adverse events during the study

  Day of first dose to follow up

Secondary Outcomes (3)

• PK Cmax - Overall Study

  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)

  0,0.5,1,2,3,4,8,12,24,48 hr single dose, multiple dose does not include 48 hr

• Biomarker

  Pre dose vs Day 14

Study Arms (2)

AZD3293

EXPERIMENTAL

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

Placebo

PLACEBO COMPARATOR

Placebo given (2 subjects in each cohort)

Drug: Placebo

Interventions

AZD3293 DRUG

Oral solution

AZD3293

Placebo DRUG

Oral solution

Placebo

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• AstraZeneca: lead

Study Sites (1)

Research Site

Fukuoka, Japan

Location

MeSH Terms

Interventions

lanabecestat

Results Point of Contact

• Title: Vice President, Neuroscience iMed
• Organization: AstraZeneca

ClinicalTrialTransparency@astrazeneca.com

Study Officials

• Robert C Alexander, MD

  AstraZeneca

  STUDY DIRECTOR

• Kei Sakamoto, MD, PhD

  Sugioka Memorial Hospital, Medical Co. LTA

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 4, 2013
• First Posted: December 9, 2013
• Study Start: December 1, 2013
• Primary Completion: July 1, 2014
• Study Completion: July 1, 2014
• Last Updated: November 4, 2016
• Results First Posted: November 10, 2015

Record last verified: 2016-09

Locations

JP (1)