AZD3355 Dose-escalation Study in Healthy Males

Reflux Disease Clinical Trial

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

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

• Reflux Disease

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