AZD6423 SAD/MAD Study in Healthy Volunteers (AZD6423)

April 3, 2014 updated by: AstraZeneca

A Randomized, Double-Blind, Third-Party-Unblinded, Placebo-Controlled Study of the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single and Multiple Ascending Doses of AZD6423 in Healthy Volunteers

This is a randomized, double-blind, placebo-controlled study of single and multiple ascending dosage levels of AZD6423 in healthy volunteers. The study includes an up to 28-day screening period, an in-house period during which AZD6423 or placebo will be administered IV, and a 4- to 10-day follow-up period after discharge.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

In Part 1 of the study (single ascending dose portion), approximately 40 subjects will be randomly assigned. Eight (8) subjects will be randomized in each of 5 dosage-level cohorts (AZD6423 or placebo). Within each cohort, 6 subjects will be randomized to receive AZD6423 and 2 subjects will be randomized to receive placebo. Each subject will receive only one dose of either AZD6423 or placebo on Day 1. In Part 2 of the study (multiple ascending dose portion), approximately 24 subjects will be randomly assigned. Eight (8) subjects will be randomized in each of 3 dosage-level cohorts. Within each cohort, 6 subjects will be randomized to receive AZD6423 and 2 subjects will be randomized to receive placebo. Each subject will receive three doses of either AZD6423 or placebo.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
175

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Glendale, California, United States
        • Research Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Subjects must understand the nature of the study and must provide signed and dated written informed consent in accordance with local regulations before the conduct of any study-specific procedures.
  2. All male subjects who are biologically capable of having children must agree and commit to the use of a reliable method of birth control for the duration of the study and for 15 days after dose administration. A male subject is considered biologically capable of having children even if his sexual partner is sterile or using contraceptives.
  3. Subjects must have a body mass index (BMI) between 19 and 30, inclusive and weigh between 50kg and 100kg inclusive.
  4. Subjects must be fluent in English.

Exclusion Criteria:

  1. A history or presence of a clinically significant hepatic, renal, gastrointestinal, cardiovascular, endocrine, respiratory, immunologic, hematologic, dermatologic, or neurologic abnormality.
  2. A clinically significant abnormality on physical examination, neurological examination, EEG, ECG, vital signs or laboratory evaluations at screen or between screen and dose administration.
  3. A history of seizure.
  4. A history of head trauma, including closed head injury with loss of consciousness.
  5. Any history of suicide attempt or suicidal behavior, or, in the opinion of the investigator, clinically significant risk of suicide or violent behavior.
  6. Urine drug screen positive for a drug of abuse
  7. A family history of schizophrenia, schizoaffective disorder, or psychosis in first degree relatives.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Experimental: AZD6423
Subjects will participate in 1 of 8 groups and receive single or multiple doses of AZD6423 or matching placebo. In each group 6 subjects will receive AZD6423 and 2 subjects will receive matching placebo.
Drug: AZD6423
Drug: AZD6423 Single or Multiple doses via infusion.
Placebo Comparator: Placebo to match AZD6423
Subjects will participate in 1 of 8 groups and receive single or multiple doses of AZD6423 or matching placebo. In each group 6 subjects will receive AZD6423 and 2 subjects will receive matching placebo.
Drug: Placebo
Placebo to match AZD6423 Single or Multiple doses of matching placebo delivered via infusion

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Assessment of the safety and tolerability of AZD6423 in healthy subjects via adverse events
Time Frame: From Baseline up to 18 days
The primary objectives of this study are to assess the safety and tolerability of single and multiple ascending dosage levels of AZD6423 versus placebo in healthy volunteers.
From Baseline up to 18 days
Assessment of the safety and tolerability of AZD6423 in healthy subjects via EEG
Time Frame: From Baseline up to 6 days
The primary objectives of this study are to assess the safety and tolerability of single and multiple ascending dosage levels of AZD6423 versus placebo in healthy volunteers.
From Baseline up to 6 days
Assessment of the safety and tolerability of AZD6423 in healthy subjects via ECG.
Time Frame: From Baseline up to 18 days
The primary objectives of this study are to assess the safety and tolerability of single and multiple ascending dosage levels of AZD6423 versus placebo in healthy volunteers.
From Baseline up to 18 days
Assessment of the safety and tolerability of AZD6423 in healthy subjects via vital signs (blood pressure and pulse). as well as body temperature and weight
Time Frame: From Baseline up to 18 days
The primary objectives of this study are to assess the safety and tolerability of single and multiple ascending dosage levels of AZD6423 versus placebo in healthy volunteers.
From Baseline up to 18 days
Assessment of the safety and tolerability of AZD6423 in healthy subjects via clinical laboratory tests (chemistry, hematology and urinalysis).
Time Frame: From Baseline up to 18 days
The primary objectives of this study are to assess the safety and tolerability of single and multiple ascending dosage levels of AZD6423 versus placebo in healthy volunteers.
From Baseline up to 18 days
Assessment of the safety and tolerability of AZD6423 in healthy subjects via psychiatric assessments.
Time Frame: From Baseline up to 18 days
The primary objectives of this study are to assess the safety and tolerability of single and multiple ascending dosage levels of AZD6423 versus placebo in healthy volunteers.
From Baseline up to 18 days
Assessment of the safety and tolerability of AZD6423 in healthy subjects via neurological exams.
Time Frame: From Baseline up to 18 days
The primary objectives of this study are to assess the safety and tolerability of single and multiple ascending dosage levels of AZD6423 versus placebo in healthy volunteers.
From Baseline up to 18 days
Assessment of the safety and tolerability of AZD6423 in healthy subjects via physical exams.
Time Frame: From Baseline up to 18 days
The primary objectives of this study are to assess the safety and tolerability of single and multiple ascending dosage levels of AZD6423 versus placebo in healthy volunteers.
From Baseline up to 18 days

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Description of the PK profile for AZD6423 in terms of: observed maximum plasma concentration (Cmax), time to reach maximum plasma concentration (tmax), terminal rate constant (λz), terminal half-life (t½ z), and area under the curve (AUC).
Time Frame: From Baseline up to 7 days
Secondary objectives are to assess the pharmacokinetics and pharmacodynamics of AZD6423 in healthy volunteers.
From Baseline up to 7 days
Assessment of the pharmacodynamics of AZD6423 in terms of the relationship between plasma concentration of AZD6423 and EEG
Time Frame: From Baseline up to 7 days
Secondary objectives are to assess the pharmacokinetics and pharmacodynamics of AZD6423 in healthy volunteers.
From Baseline up to 7 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
AstraZeneca

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: David Han, M.D., California Clinical Trials

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 1, 2013

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 1, 2014

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 1, 2014

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 12, 2013

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 19, 2013

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 20, 2013

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 4, 2014

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 3, 2014

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2014

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • D3521C00001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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