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Study to Investigate Safety, Tolerability and Pharmacokinetics of a Single Ascending Dose of AZD1704

A Phase I, First Time in Man, Single-Centre, Randomised, Double-Blind (Within Panels), Placebo-Controller Study to Investigate Safety, Tolerability and Pharmacokinetics of AZD1704 After Administration of Oral Single Ascending Doses in Healthy Volunteers

Status
Completed
Phases
Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00692042
Enrollment
80
Registered
2008-06-06
Start date
2008-03-31
Completion date
2008-06-30
Last updated
2008-06-24

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

Conditions

Pain

Keywords

Safety, tolerability

Brief summary

The primary aim for this study is to investigate the safety and tolerability of the AZD1704, first time in man.

Interventions

One dose, by mouth

Sponsors

AstraZeneca
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
20 Years to 45 Years
Healthy volunteers
Yes

Inclusion criteria

* Healthy volunteers, man or woman of non child-bearing potential * Provision of signed informed consent.

Exclusion criteria

* History of somatic disease/condition that may interfere with the objectives ot the study, as judged by the Investigator. History of seizures, with the exception of single occasions fever induced seizures in childhood. * History of previous or ongoing psychiatric disease/condition including psychosis, affective disorder, anxiety disorder, borderline state and personality disorder according to the criteria in the DSM of Mental Disorder, 4th edition * History of use of antipsychotic, antidepressant or anxiolytic drugs for the treatment of psychiatric disease or symptoms, prescribed as well as non-prescribed use.

Design outcomes

Primary

MeasureTime frame
To investigate the safety and tolerability of AZD1704 following single ascending doses in healthy volunteers.At screening, during residential period (daily) and at follow-up

Secondary

MeasureTime frame
To investigate the subjective CNS effects of specific adjectives (stimulated, anxious, sedated, down and high) rated on visual analogue mood scale (VAMS).During residential period (daily)

Countries

United Kingdom

Outcome results

None listed

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