NCT00935662CompletedPhase 1
A Randomised, Single-blind, Placebo-controlled, Two-centre Phase I Study in Healthy Volunteers to Assess the Safety, Tolerability and Pharmacokinetics of AZD8329 After Single Ascending Oral Doses
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- AstraZeneca
- Enrollment
- 119
- Locations
- 1
- Primary Endpoint
- Safety measurements (ECG's, Pulse, Blood Pressure, Safety Laboratory and Adverse Events)
Study Overview
Brief Summary
The primary objective for this study is to assess the safety and tolerability of AZD8329 when given as a single dose in increasing dose strength, and also to identify the highest tolerated dose for future studies.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Single Group
- Primary Purpose
- Basic Science
- Masking
- Single (Participant)
Eligibility Criteria
- Ages
- 20 Years to 45 Years (Adult)
- Sex
- Male
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Provision of informed consent prior to any study specific procedures
- •Have a body mass index between 19 and 30 kg/m2 and weigh at least 50 kg
Exclusion Criteria
- •Any clinically significant disease or disorder which, in the opinion of the investigator, may either put the subject at risk because of participation in the study, or influence the result of the study, or the subject´s ability to participate
- •Any clinically significant abnormalities in clinical chemistry, haematology or urinalysis results as judged by the investigator
- •Any clinically important abnormalities in rhythm, conduction or morphology of resting ECG that may interfere with the interpretation of QTc interval changes.
Arms & Interventions
AZD8329
Experimental
AZD8329 oral solution
Intervention: AZD8329 (Drug)
Placebo
Placebo Comparator
Placebo for AZD8329 oral solution
Intervention: Placebo (Drug)
Outcomes
Primary Outcomes
Safety measurements (ECG's, Pulse, Blood Pressure, Safety Laboratory and Adverse Events)
Time Frame: Safety will be monitored continously and safety assessments will be made on several occasions throughout the whole study.
Secondary Outcomes
- PK samples for AZD8329(Intense PK-sampling during the 24 hours following administration of investigational product and additional samples up to 72 hours after dose.)
Investigators
Study Sites (1)
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