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Completed

NCT Number: NCT01926366

AZD6423 SAD/MAD Study 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.

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Key information

Conditions

Healthy Volunteers.

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Research Site

Glendale, California, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • 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.
  • 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.
  • Subjects must have a body mass index (BMI) between 19 and 30, inclusive and weigh between 50kg and 100kg inclusive.
  • Subjects must be fluent in English.

Exclusion criteria

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

Treatment and study plan

AZD6423

Drug

Drug: AZD6423 Single or Multiple doses via infusion.

Placebo

Drug

Placebo to match AZD6423 Single or Multiple doses of matching placebo delivered via infusion

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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.

Secondary outcomes

  1. 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.

  2. 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.

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study title

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

Acronym: AZD6423

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Aug 20, 2013
Registry last updated
Apr 4, 2014

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.