AZD6423 SAD/MAD Study in Healthy Volunteers

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT01926366
• Date of registration: 12/08/2013
• Prospective Registration: Yes
• Primary sponsor: AstraZeneca
• Public title: AZD6423 SAD/MAD Study in Healthy Volunteers AZD6423
• Scientific 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
• Date of first enrolment: September 2013
• Target sample size: 175
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT01926366
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Basic Science
• Phase: Phase 1

Countries of recruitment

United States

Contacts

• Name: David Han, M.D.
• Affiliation: California Clinical Trials

Key inclusion & exclusion criteria

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.



Age minimum: N/A
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Healthy Volunteers.

Intervention(s)

Drug: Placebo

Drug: AZD6423

Primary Outcome(s)

Assessment of the safety and tolerability of AZD6423 in healthy subjects via physical exams. [Time Frame: From Baseline up to 18 days]

Assessment of the safety and tolerability of AZD6423 in healthy subjects via ECG. [Time Frame: 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]

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]

Assessment of the safety and tolerability of AZD6423 in healthy subjects via EEG [Time Frame: From Baseline up to 6 days]

Assessment of the safety and tolerability of AZD6423 in healthy subjects via adverse events [Time Frame: 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]

Assessment of the safety and tolerability of AZD6423 in healthy subjects via psychiatric assessments. [Time Frame: From Baseline up to 18 days]

Secondary Outcome(s)

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]

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 (?z), terminal half-life (t½ z), and area under the curve (AUC). [Time Frame: From Baseline up to 7 days]

Secondary ID(s)

D3521C00001

Source(s) of Monetary Support

Please refer to primary and secondary sponsors