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Completed

NCT Number: NCT01739647

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

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

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Key information

Conditions

Healthy Young Volunteers Healthy Elderly Volunteers

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Research Site

Baltimore, Maryland, United States

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

AZD3293

Drug

Oral solution

Placebo

Drug

Oral solution

Primary outcomes

  1. Adverse event monitoring.

    Time frame: From baseline up to 10 days.

  2. Assessment of vital signs and physical examination.

    Time frame: From baseline up to 10 days.

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

  3. Clinical laboratory tests: hematology.

    Time frame: From baseline up to 10 days.

  4. Clinical laboratory tests: urine analysis.

    Time frame: From baseline up to 10 days.

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

    Time frame: From baseline up to 10 days.

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

  6. Assessment of telemetry.

    Time frame: From baseline up to 10 days.

    As reported by investigator.

  7. Columbia-Suicide Severity Rating Scale (C-SSRS)

    Time frame: From baseline up to 10 days.

    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.

Secondary outcomes

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

    Time frame: Up 4 days

    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.

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

    Time frame: Up to 4 days.

    Biomarker PD Aβ (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) (ΔCmin)
    • 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 (ΔAUC(0-24)).

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

    Time frame: Up to 4 days.

    Pharmacokinetics (PK) in the terms of plasma Cmax and AUC.

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

    Time frame: Up to 4 days.

    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 Aβ (1-40, 1-42) or exploratory PD biomarkers, or safety variables.

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

    Time frame: Up to 4 days.

  6. Pharmacokinetics in the terms of Cmax (Maximum observed plasma concentration) and tmax (Time to Cmax ).

    Time frame: Up to 4 days.

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study 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

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Dec 3, 2012
Registry last updated
Aug 27, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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