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

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

Status

Terminated

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00736788

Enrollment

Registered

2008-08-18

Start date

2008-08-31

Completion date

2008-09-30

Last updated

2010-12-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy Volunteers

Keywords

AZD1704,, Japanese, Healthy, Volunteers,, Phase I study,, Single Ascending Dose, Safety,, Tolerability, Pharmacokinetics

Brief 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.

Interventions

DRUGAZD1704

single dose oral suspension, 4 different dose levels

DRUGPlacebo

single dose oral suspension

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

20 Years to 45 Years

Healthy volunteers

Yes

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.

Design outcomes

Primary

Measure	Time frame
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

Secondary

Measure	Time frame
Pharmacodynamic VAMS scores of different adjectives (stimulated, anxious, sedated, down and high).	During residential period
Pharmacokinetic profile of AZD1704 following single ascending doses in healthy Japanese male and non-fertile female volunteers	During residential period

Countries

United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026