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

NCT00736788 | Terminated Phase 1 DMC

• 2 other identifiers: D0980C000052008-002153-20
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy Volunteers

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• 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

Study Arms (2)

1

EXPERIMENTAL

Four different oral dose levels of a suspension containing AZD1704

Drug: AZD1704

2

PLACEBO COMPARATOR

oral suspension

Drug: Placebo

Interventions

AZD1704 DRUG

single dose oral suspension, 4 different dose levels

1

Placebo DRUG

single dose oral suspension

2

Eligibility Criteria

• Age: 20 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• AstraZeneca: lead

Study Sites (1)

Research Site

London, United Kingdom

Location

Study Officials

• Rolf Karlsten

  AstraZeneca R&D Södertälje

  STUDY DIRECTOR

• Ulrike Lorch

  Richmond Pharmacology Limited

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: August 14, 2008
• First Posted: August 18, 2008
• Study Start: August 1, 2008
• Primary Completion: September 1, 2008
• Study Completion: September 1, 2008
• Last Updated: December 10, 2010

Record last verified: 2010-12

Locations

GB (1)