Back to resultsAZD3355 Dose-escalation Study in Healthy Males
Primary Purpose
Reflux Disease
Status
Completed
Phase
Phase 1
Locations
Sweden
Study Type
Interventional
Intervention
AZD3355
Placebo
Sponsored by
About this trial
This is an interventional basic science trial for Reflux Disease focused on measuring Safety, tolerability, healthy subjects
Eligibility Criteria
Inclusion Criteria:
- Subjects without concurrent diseases who do not require any medical treatments
- Provision of signed informed consent.
Exclusion Criteria:
- History of somatic disease/condition, which may interfere with the objectives for the study, as judged by the investigator.
- Clinically significant illness or clinically relevant trauma within the 2 weeks prior to the administration of the investigational product, as judged by the investigator.
- History of clinically significant orthostatic reaction or syncope
- Clinically important abnormalities related to the heart function
Sites / Locations
- Research Site
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
1
2
Arm Description
Outcomes
Primary Outcome Measures
Safety variables (Adverse event reporting, ECG, blood pressure, pulse rate, urine weight and osmolality, body temperature, blood and urine laboratory values)
Secondary Outcome Measures
Pharmacokinetic variables
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00757419
Brief Title
AZD3355 Dose-escalation Study in Healthy Males
Official Title
A Phase 1 Single Centre Single-blind Randomised Placebo-controlled Study to Assess the Safety, Tolerability and Pharmacokinetics of Oral AZD3355 After Administration of Single Ascending Doses and Multiple Repeated Doses in Healthy Male Volunteers
Study Type
Interventional
2. Study Status
Record Verification Date
December 2010
Overall Recruitment Status
Completed
Study Start Date
September 2008 (undefined)
Primary Completion Date
December 2008 (Actual)
Study Completion Date
December 2008 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
AstraZeneca
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The aim is to establish the maximal tolerated dose of AZD3355 for the selection of doses in the up-coming studies. This will be done by comparing single and repeated doses of AZD3355 to placebo ("inactive substance"). Safety and tolerability variables will be closely monitored throughout the study.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Reflux Disease
Keywords
Safety, tolerability, healthy subjects
7. Study Design
Primary Purpose
Basic Science
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
54 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Title
2
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
AZD3355
Other Intervention Name(s)
Lesogaberan
Intervention Description
capsules, oral, single or twice daily dose
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
To match dosing of AZD3355
Primary Outcome Measure Information:
Title
Safety variables (Adverse event reporting, ECG, blood pressure, pulse rate, urine weight and osmolality, body temperature, blood and urine laboratory values)
Time Frame
During the study
Secondary Outcome Measure Information:
Title
Pharmacokinetic variables
Time Frame
Several occasions during the study days
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Subjects without concurrent diseases who do not require any medical treatments
Provision of signed informed consent.
Exclusion Criteria:
History of somatic disease/condition, which may interfere with the objectives for the study, as judged by the investigator.
Clinically significant illness or clinically relevant trauma within the 2 weeks prior to the administration of the investigational product, as judged by the investigator.
History of clinically significant orthostatic reaction or syncope
Clinically important abnormalities related to the heart function
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marianne Hartford
Organizational Affiliation
CPU Avd 102, Gröna Stråket 12, Sahlgrenska Universitetssjukhuset, 413 45 Göteborg
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Eva Ersdal
Organizational Affiliation
AstraZeneca R&D, Mölndal, Sweden
Official's Role
Study Director
Facility Information:
Facility Name
Research Site
City
Gothenburg
Country
Sweden
12. IPD Sharing Statement
Learn more about this trial
AZD3355 Dose-escalation Study in Healthy Males
We'll reach out to this number within 24 hrs