AZD8108 SAD/MAD in Healthy Volunteers

Healthy Volunteers Clinical Trial

— AZD8108  

Official title:

A Randomized, Double-Blind, Placebo-Controlled Study of the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single and Multiple Ascending Doses of AZD8108 in Healthy Volunteers

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02248818
• Other study ID #: D5800C00001
• Status: Completed
• Phase: Phase 1
• First received: September 23, 2014
• Last updated: September 23, 2015
• Start date: November 2014
• Est. completion date: September 2015

Study information

• Verified date: September 2015
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationUnited States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

This is a randomized, double-blind, placebo-controlled study of single and multiple ascending dosage levels of AZD8108 in healthy volunteers. The study includes an up to 28-day screening period, an in-house period during which AZD8108 or placebo will be administered orally as a solution, and a 4- to 10-day follow-up period after discharge.

Description:

In Part 1 of the study (single ascending dose portion), approximately 32 subjects will be randomly assigned. Eight (8) subjects will be randomized in each of 4 dosage-level cohorts (AZD8108 or placebo). Within each cohort, 6 subjects will be randomized to receive AZD8108 and 2 subjects will be randomized to receive placebo. Each subject will receive only one dose of either AZD8108 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 AZD8108 and 2 subjects will be randomized to receive placebo. Each subject will receive twelve doses of either AZD8108 or placebo

Recruitment information / eligibility

• Status: Completed
• Enrollment: 258
• Est. completion date: September 2015
• Est. primary completion date: September 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 55 Years

Eligibility

Inclusion 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. Men and postmenopausal or surgically sterile women age 18-55 years inclusive. 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 Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Healthy Volunteers

Intervention

Drug:
• AZD8108
Drug: AZD8108 Single or Multiple doses administered orally as a solution.
• Placebo
Placebo to match AZD8108 Single or Multiple doses of matching placebo administered orally as a solution

Locations

Country	Name	City	State
United States	Clinilabs, Inc.	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Assessment of the safety and tolerability of AZD8108 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 AZD8108 versus placebo in healthy volunteers.	From Screen up to 25 days	Yes
Primary	Assessment of the safety and tolerability of AZD8108 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 AZD8108 versus placebo in healthy volunteers.	From Screen up to 12 days	Yes
Primary	Assessment of the safety and tolerability of AZD8108 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 AZD8108 versus placebo in healthy volunteers.	From Screen up to 25 days	Yes
Primary	Assessment of the safety and tolerability of AZD8108 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 AZD8108 versus placebo in healthy volunteers	From Screen up to 25 days	Yes
Primary	Assessment of the safety and tolerability of AZD8108 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 AZD8108 versus placebo in healthy volunteers.	From Screen up to 25 days	Yes
Primary	Assessment of the safety and tolerability of AZD8108 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 AZD8108 versus placebo in healthy volunteers. Psychiatric assessments include the Columbia Suicide Severity Rating Scale (C-SSRS), Brief Psychiatric Rating Scale [BPRS], and Clinician-Administered Dissociative States Scale [CADSS].	From Screen up to 25 days	Yes
Primary	Assessment of the safety and tolerability of AZD8108 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 AZD8108 versus placebo in healthy volunteers. A full neurological exam by a licensed neurologist as well as a brief neurological exam will be employed. This includes an assessment of motor and sensory skills, balance and coordination, mental status (the patient's level of awareness and interaction with the environment), reflexes, and functioning of the nerves.	From Screen up to 25 days	Yes
Primary	Assessment of the safety and tolerability of AZD8108 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 AZD8108 versus placebo in healthy volunteers.	From Screen up to 25 days	Yes
Secondary	Description of the PK profile for AZD8108 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).	Secondary objectives are to assess the pharmacokinetics and pharmacodynamics of AZD8108 in healthy volunteers.	From Baseline up to 15 days	Yes
Secondary	Assessment of the pharmacodynamics of AZD8108 in terms of the relationship between plasma concentration of AZD8108 and EEG	Secondary objectives are to assess the pharmacokinetics and pharmacodynamics of AZD8108 in healthy volunteers.	From Baseline up to 12 days	Yes