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:
AstraZeneca
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00736788
First received: August 14, 2008
Last updated: December 8, 2010
Last verified: December 2010
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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
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 May 23, 2013