AZD6423 SAD/MAD Study in Healthy Volunteers

NCT01926366 | Completed Phase 1

• 1 other identifier: D3521C00001
• Study Type: interventional
• Target: 175
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Healthy Volunteers.

Outcome Measures

Primary Outcomes (8)

• Assessment of the safety and tolerability of AZD6423 in healthy subjects via adverse events

  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

  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.

  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

  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).

  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.

  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.

  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.

  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 Outcomes (2)

• 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).

  From Baseline up to 7 days

• Assessment of the pharmacodynamics of AZD6423 in terms of the relationship between plasma concentration of AZD6423 and EEG

  From Baseline up to 7 days

Study Arms (2)

Experimental: AZD6423

EXPERIMENTAL

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

Placebo to match AZD6423

PLACEBO COMPARATOR

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

Interventions

AZD6423 DRUG

Drug: AZD6423 Single or Multiple doses via infusion.

Experimental: AZD6423

Placebo DRUG

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

Placebo to match AZD6423

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• AstraZeneca: lead

Study Sites (1)

Research Site

Glendale, California, United States

Location

Study Officials

• David Han, M.D.

  California Clinical Trials

  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: August 12, 2013
• First Posted: August 20, 2013
• Study Start: September 1, 2013
• Primary Completion: March 1, 2014
• Study Completion: March 1, 2014
• Last Updated: April 4, 2014

Record last verified: 2014-04

Locations

US (1)