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

Healthy Elderly Volunteers Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01739647
• Other study ID #: D5010C00001
• Status: Completed
• Phase: Phase 1
• First received: November 30, 2012
• Last updated: August 26, 2013
• Start date: December 2012
• Est. completion date: May 2013

Study information

• Verified date: August 2013
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationUnited States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 72
• Est. completion date: May 2013
• Est. primary completion date: May 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

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 Elderly Volunteers
• Healthy Young Volunteers

Intervention

Drug:
• AZD3293
Oral solution
• Placebo
Oral solution

Locations

Country	Name	City	State
United States	Research Site	Baltimore	Maryland

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Adverse event monitoring.		From baseline up to 10 days.	Yes
Primary	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.	Yes
Primary	Clinical laboratory tests: hematology.		From baseline up to 10 days.	Yes
Primary	Clinical laboratory tests: urine analysis.		From baseline up to 10 days.	Yes
Primary	Evaluation of 12-lead digital electrocardiogram (ECG).	QT/QTc interval, rhythm, rate, morphology is going to be measured.	From baseline up to 10 days.	Yes
Primary	Assessment of telemetry.	As reported by investigator.	From baseline up to 10 days.	Yes
Primary	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.	Yes
Secondary	Pharmacokinetics (PK) in the terms of AUC, AUC(0-t), AUC(0-24).	Where (AUC(0-t)) is area under the plasma concentration-time curve from zero to the last measurable concentration and (AUC(0-24)) area under the plasma concentration-time curve from zero to 24 hours post-dose.	Up 4 days	No
Secondary	Investigation on the effect of AZD3293 on biomarkers relevant for Pharmacodynamics in plasma.	Biomarker PD Aß (1-40, 1-42) parameters are: Maximum observed plasma concentration (Cmax); Time to Cmax (tmax); Minimum observed plasma concentration (Cmin); Minimum observed plasma concentration below the individual healthy volunteer baseline (pre-dose biomarker concentration prior to dosing) (?Cmin); Time to Cmin (tmin); Duration (T) of concentration below individual healthy volunteer baseline (BBL), if appropriate for the data (tBBL); Area under the plasma concentration-time curve from zero to the time of the last quantifiable concentration (AUC(0-t)); Area under the plasma concentration-time curve from zero to 24 hours post dose (AUC(0-24)); Area under the plasma biomarker concentration curve from time zero to 24 hour that is below individual healthy volunteer baseline (?AUC(0-24)).	Up to 4 days.	No
Secondary	Investigation of the potential influence of food on Pharmacokinetics (PK) following a single dose of AZD3293.	Pharmacokinetics (PK) in the terms of plasma Cmax and AUC.	Up to 4 days.	No
Secondary	Investigation of the relationship between Pharmacokinetics (PK) and Pharmacodynamics (PD) of AZD3293.	The Pharmacokinetics (PK) variables may be plasma concentrations or summary measurements such as Cmax or AUC. The Pharmacodynamics (PD) variables may include biomarkers in plasma such as Aß (1-40, 1-42) or exploratory PD biomarkers, or safety variables.	Up to 4 days.	No
Secondary	Pharmacokinetics assessment in the terms of fu (%) (fraction of unbound AZD3293 and AZ13569724 in plasma).		Up to 4 days.	No
Secondary	Pharmacokinetics in the terms of Cmax (Maximum observed plasma concentration) and tmax (Time to Cmax ).		Up to 4 days.	No