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

AstraZeneca1 site in 1 country54 target enrollmentSeptember 2008

ConditionsReflux Disease

InterventionsAZD3355 Placebo

DrugsAZD3355 Placebo

Overview

Phase: Phase 1
Intervention: AZD3355
Conditions: Reflux Disease
Sponsor: AstraZeneca
Enrollment: 54
Locations: 1
Primary Endpoint: Safety variables (Adverse event reporting, ECG, blood pressure, pulse rate, urine weight and osmolality, body temperature, blood and urine laboratory values)
Status: Completed
Last Updated: 15 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

September 2008

End Date

December 2008

Last Updated

15 years ago

Study Type

Interventional

Study Design

Parallel

Sex

Male

Investigators

Sponsor

AstraZeneca

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

Arms & Interventions

1

Intervention: AZD3355

2

Intervention: Placebo

Outcomes

Primary Outcomes

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