Clinical trial NCT00736788: Assess Safety, Tolerability and Pharmacokinetic (PK) of AZD1704 in Healthy Japanese Male and Non-Fertile Female Volunteers
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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
Conditions: Healthy Volunteers
Keywords: AZD1704,
Japanese
Healthy
Volunteers,
Phase I study,
Single Ascending Dose
Safety,
Tolerability
Pharmacokinetics
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2008-08-18
Enrollment: 16
Sex: ALL
Minimum age (years): 20
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: 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)
timeFrame: From dosing to follow up
Secondary outcomes:
measure: Pharmacodynamic VAMS scores of different adjectives (stimulated, anxious, sedated, down and high).
timeFrame: During residential period
measure: Pharmacokinetic profile of AZD1704 following single ascending doses in healthy Japanese male and non-fertile female volunteers
timeFrame: During residential period
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: Research Site
Study officials:
affiliation: AstraZeneca R&D Södertälje
name: Rolf Karlsten
role: STUDY_DIRECTOR
affiliation: Richmond Pharmacology Limited
name: Ulrike Lorch
role: PRINCIPAL_INVESTIGATOR
References: