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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00757419
Other study ID # D9120C00030
Secondary ID EudraCTnr: 2008-
Status Completed
Phase Phase 1
First received September 22, 2008
Last updated December 6, 2010
Start date September 2008
Est. completion date December 2008

Study information

Verified date December 2010
Source AstraZeneca
Contact n/a
Is FDA regulated No
Health authority Sweden: Medical Products Agency
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 54
Est. completion date December 2008
Est. primary completion date December 2008
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Male
Age group 18 Years to 45 Years
Eligibility 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

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Basic Science


Related Conditions & MeSH terms


Intervention

Drug:
AZD3355
capsules, oral, single or twice daily dose
Placebo
To match dosing of AZD3355

Locations

Country Name City State
Sweden Research Site Gothenburg

Sponsors (1)

Lead Sponsor Collaborator
AstraZeneca

Country where clinical trial is conducted

Sweden, 

Outcome

Type Measure Description Time frame Safety issue
Primary Safety variables (Adverse event reporting, ECG, blood pressure, pulse rate, urine weight and osmolality, body temperature, blood and urine laboratory values) During the study Yes
Secondary Pharmacokinetic variables Several occasions during the study days Yes
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