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

This study has been terminated.
(AZD1704 has essentially similar PK profile in Japanese subjects as in Caucasians. One of the main purposes of the study has thereby been achieved.)
Sponsor:
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00736788
First received: August 14, 2008
Last updated: December 8, 2010
Last verified: December 2010
  Purpose

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.


Condition Intervention Phase
Healthy Volunteers
Drug: AZD1704
Drug: Placebo
Phase 1

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

Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • 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) [ Time Frame: From dosing to follow up ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Pharmacodynamic VAMS scores of different adjectives (stimulated, anxious, sedated, down and high). [ Time Frame: During residential period ] [ Designated as safety issue: No ]
  • Pharmacokinetic profile of AZD1704 following single ascending doses in healthy Japanese male and non-fertile female volunteers [ Time Frame: During residential period ] [ Designated as safety issue: No ]

Enrollment: 16
Study Start Date: August 2008
Study Completion Date: September 2008
Primary Completion Date: September 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Four different oral dose levels of a suspension containing AZD1704
Drug: AZD1704
single dose oral suspension, 4 different dose levels
Placebo Comparator: 2
oral suspension
Drug: Placebo
single dose oral suspension

  Eligibility

Ages Eligible for Study:   20 Years to 45 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00736788

Locations
United Kingdom
Research Site
London, United Kingdom
Sponsors and Collaborators
AstraZeneca
Investigators
Study Director: Rolf Karlsten AstraZeneca R&D Södertälje
Principal Investigator: Ulrike Lorch Richmond Pharmacology Limited
  More Information

No publications provided

Responsible Party: Rolf Karlsten, MD, PhD, Medical Science Director, Emerging Analgesia, AstraZeneca R&D Södertälje Sweden
ClinicalTrials.gov Identifier: NCT00736788     History of Changes
Other Study ID Numbers: D0980C00005, 2008-002153-20
Study First Received: August 14, 2008
Last Updated: December 8, 2010
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by AstraZeneca:
AZD1704,
Japanese
Healthy
Volunteers,
Phase I study,
Single Ascending Dose
Safety,
Tolerability
Pharmacokinetics

ClinicalTrials.gov processed this record on July 23, 2014