Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02005211
Recruitment Status : Completed
First Posted : December 9, 2013
Results First Posted : November 10, 2015
Last Update Posted : November 4, 2016
Sponsor:
Information provided by (Responsible Party):
AstraZeneca

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.

Condition or disease Intervention/treatment Phase
Healthy Japanese Young and Elderly Male and Non-fertile Female Volunteers Drug: AZD3293 Drug: Placebo Phase 1

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 114 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Basic Science
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
Study Start Date : December 2013
Actual Primary Completion Date : July 2014
Actual Study Completion Date : July 2014

Arm Intervention/treatment
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

Placebo Comparator: Placebo
Placebo given (2 subjects in each cohort)
Drug: Placebo
Oral solution




Primary Outcome Measures :
  1. Safety - Adverse Events [ Time Frame: Day of first dose to follow up ]
    Safety - Number of subjects reporting any adverse events during the study


Secondary Outcome Measures :
  1. PK Cmax - Overall Study [ Time Frame: 0, 0.5,1,2,3,4,8,12,24,48 hr single dose, multiple dose does not include 48 hr ]
    Pharmacokinetic maximum concentration

  2. PK AUC - Overall Study (SAD & MAD Parts) [ Time Frame: 0,0.5,1,2,3,4,8,12,24,48 hr single dose, multiple dose does not include 48 hr ]
    Pharmacokintic Area Under the Curve (0 to t)

  3. Biomarker [ Time Frame: Pre dose vs Day 14 ]
    Biomarker (Abeta 1-40; A beta 1-42) % change from baseline



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   20 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02005211


Locations
Layout table for location information
Japan
Research Site
Fukuoka-shi, Japan
Sponsors and Collaborators
AstraZeneca
Investigators
Layout table for investigator information
Study Director: Robert C Alexander, MD AstraZeneca
Principal Investigator: Kei Sakamoto, MD, PhD Sugioka Memorial Hospital, Medical Co. LTA

Layout table for additonal information
Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT02005211     History of Changes
Other Study ID Numbers: D5010C00003
First Posted: December 9, 2013    Key Record Dates
Results First Posted: November 10, 2015
Last Update Posted: November 4, 2016
Last Verified: September 2016

Keywords provided by AstraZeneca:
AZD3293
Healthy volunteers
Young volunteers
Elderly volunteers
Japanese volunteers
Phase 1
Single and multiple ascending dose study