AZD3355 Dose-escalation Study in Healthy Males

Sponsor

AstraZeneca (Industry)

Overall Status

Completed

CT.gov ID

NCT00757419

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

18.1

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Reflux Disease	Drug: AZD3355 Drug: Placebo	Phase 1

Study Design

Study Type:

Interventional

Anticipated Enrollment :

54 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Participant)

Primary Purpose:

Basic Science

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 Start Date :

Sep 1, 2008

Actual Primary Completion Date :

Dec 1, 2008

Actual Study Completion Date :

Dec 1, 2008

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 1	Drug: AZD3355 capsules, oral, single or twice daily dose Other Names: Lesogaberan
Placebo Comparator: 2	Drug: Placebo To match dosing of AZD3355

Arm

Intervention/Treatment

Experimental: 1

Drug: AZD3355

capsules, oral, single or twice daily dose

Other Names:

Lesogaberan

Placebo Comparator: 2

Drug: Placebo

To match dosing of AZD3355

Outcome Measures

Primary Outcome Measures

Safety variables (Adverse event reporting, ECG, blood pressure, pulse rate, urine weight and osmolality, body temperature, blood and urine laboratory values) [During the study]

Secondary Outcome Measures

Pharmacokinetic variables [Several occasions during the study days]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 45 Years

Sexes Eligible for Study:

Male

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Research Site	Gothenburg		Sweden

Sponsors and Collaborators

AstraZeneca

Investigators

Principal Investigator: Marianne Hartford, CPU Avd 102, Gröna Stråket 12, Sahlgrenska Universitetssjukhuset, 413 45 Göteborg
Study Director: Eva Ersdal, AstraZeneca R&D, Mölndal, Sweden