Assess Safety, Tolerability and Pharmacokinetic (PK) of AZD1704 in Healthy Japanese Male and Non-Fertile Female Volunteers

Healthy Volunteers Clinical Trial

Official title:

A Phase 1, Single-Centre, Randomised, Double-Blind (Within Panels), Placebo-Controlled Study to Investigate Safety, Tolerability and Pharmacokinetics of AZD1704 After Administration of Oral Single Ascending Doses in Healthy Japanese Male and Non-Fertile Female Volunteers

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00736788
• Other study ID #: D0980C00005
• Secondary ID: 2008-002153-20
• Status: Terminated
• Phase: Phase 1
• First received: August 14, 2008
• Last updated: December 8, 2010
• Start date: August 2008
• Est. completion date: September 2008

Study information

• Verified date: December 2010
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency
• Study type: Interventional

Clinical Trial Summary

The primary objective of this study is to investigate the safety and tolerability of AZD1704 following single ascending doses in healthy Japanese male and non-fertile female volunteers by assessment of adverse events (AEs), vital signs (supine and standing blood pressure, pulse rate, respiratory rate and body temperature), safety laboratory variables and 12 lead electrocardiography (ECG). The secondary objectives of the study are: to investigate the subjective CNS effects of orally administered AZD1704 in healthy Japanese male and non-fertile female volunteers on a psychometric rating scale by assessment of specific adjectives (stimulated, anxious, sedated, down and high) rated on visual analogue mood scale (VAMS) and to investigate the pharmacokinetic profile of AZD1704 following single ascending doses in healthy Japanese male and non-fertile female volunteers.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 16
• Est. completion date: September 2008
• Est. primary completion date: September 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 20 Years to 45 Years

Eligibility

Inclusion Criteria:

• Healthy Japanese males and non-fertile females, defined as first generation Japanese (both parents and grandparents are of Japanese origin, the subject is born in Japan and has not been living outside of Japan for more than 5 years) aged 20-45 years .

• Clinical normal physical findings

• BMI 19 - 27, weight 50 - 95 kg

Exclusion Criteria:

• History of somatic disease/condition or ongoing psychiatric disease/condition that may interfere with the objectives of the study.

• History of psychotic disorder among first-degree relatives.

• History of use of antipsychotic, antidepressant or anxiolytic drugs, prescribed as well as non-prescribed use.

• Smoking more than 7 cigarettes per week or consumption of more than 3 portion of snuff or equivalent per day within 30 days before administration of study drug.

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Healthy Volunteers

Intervention

Drug:
• AZD1704
single dose oral suspension, 4 different dose levels
• Placebo
single dose oral suspension

Locations

Country	Name	City	State
United Kingdom	Research Site	London

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety/Tolerability - adverse events (AEs), vital signs (supine and standing blood pressure, pulse rate, respiratory rate and body temperature), safety laboratory variables and 12 lead electrocardiography (ECG)		From dosing to follow up	No
Secondary	Pharmacodynamic VAMS scores of different adjectives (stimulated, anxious, sedated, down and high).		During residential period	No
Secondary	Pharmacokinetic profile of AZD1704 following single ascending doses in healthy Japanese male and non-fertile female volunteers		During residential period	No