A Single Dose Study to Assess the Safety, Effects, and Blood and Urine Drug Levels of AZD3293 in Healthy Subjects

NCT01739647 | Completed Phase 1

• 1 other identifier: D5010C00001
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

Brief Summary

This is a single dose study in healthy male and female (of non-child bearing potential) volunteers, to assess the safety, effects on the body, and blood and urine drug levels of AZD3293. AZD3293 is being developed for the treatment of Alzheimer's Disease

Conditions

Healthy Young Volunteers; Healthy Elderly Volunteers

Keywords

AZD3293; Healthy volunteers; Elderly volunteers; Phase 1; Single Ascending Dose Study

Outcome Measures

Primary Outcomes (7)

• Adverse event monitoring.

  From baseline up to 10 days.

• Assessment of vital signs and physical examination.

  The vital signs of body temperature, blood pressure and pulse are going to be measured.

  From baseline up to 10 days.

• Clinical laboratory tests: hematology.

  From baseline up to 10 days.

• Clinical laboratory tests: urine analysis.

  From baseline up to 10 days.

• Evaluation of 12-lead digital electrocardiogram (ECG).

  QT/QTc interval, rhythm, rate, morphology is going to be measured.

  From baseline up to 10 days.

• Assessment of telemetry.

  As reported by investigator.

  From baseline up to 10 days.

• Columbia-Suicide Severity Rating Scale (C-SSRS)

  Columbia-Suicide Severity Rating Scale (C-SSRS) captures the occurrence, severity, and frequency of suicide-related thoughts and behaviors during the assessment period. Some questions are yes/no and some are on a scale of 1 (low severity) to 5 (high severity). Completed suicide and non-fatal suicide events are yes/no questions and results presented are the number of participants with these events. Worsening of suicidal ideation was an increase in severity of suicidal ideation from baseline.

  From baseline up to 10 days.

Secondary Outcomes (6)

• Pharmacokinetics (PK) in the terms of AUC, AUC(0-t), AUC(0-24).

  Up 4 days

• Investigation on the effect of AZD3293 on biomarkers relevant for Pharmacodynamics in plasma.

  Up to 4 days.

• Investigation of the potential influence of food on Pharmacokinetics (PK) following a single dose of AZD3293.

  Up to 4 days.

• Investigation of the relationship between Pharmacokinetics (PK) and Pharmacodynamics (PD) of AZD3293.

  Up to 4 days.

• Pharmacokinetics assessment in the terms of fu (%) (fraction of unbound AZD3293 and AZ13569724 in plasma).

  Up to 4 days.

Study Arms (2)

AZD3293

EXPERIMENTAL

Up to 11 sequential cohorts of healthy young and healthy elderly subjects are planned, with single ascending doses ranging from 1mg to a maximum of 1000mg

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

You may qualify if:

• Healthy male and female (of non-childbearing potential) subjects
• Body mass index (BMI) between 19 and 30 kg/m2 and weigh at least 50 kg and no more than 100 kg

You may not qualify if:

• History or presence of psychiatric disease/condition, GI, renal, hepatic, cardiovascular, psychiatric, or retinal diseases or disorders
• History of neurological disease, including seizures, recent memory impairment, or clinically significant head injury
• History of 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

Sponsors & Collaborators

• AstraZeneca: lead

Study Sites (1)

Research Site

Baltimore, Maryland, United States

Location

MeSH Terms

Interventions

lanabecestat

Study Officials

• Robert C Alexander, MD

  AstraZeneca

  STUDY DIRECTOR

• Ronald Goldwater, MD

  Parexel

  PRINCIPAL INVESTIGATOR

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: November 30, 2012
• First Posted: December 3, 2012
• Study Start: December 1, 2012
• Primary Completion: May 1, 2013
• Study Completion: May 1, 2013
• Last Updated: August 27, 2013

Record last verified: 2013-08

Locations

US (1)