AZD3355 Dose-Escalation Study in Healthy Males - Full Text View

Sponsored by:	AstraZeneca
Information provided by:	AstraZeneca
ClinicalTrials.gov Identifier:	NCT00757419

Purpose

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	Intervention	Phase
Reflux Disease	Drug: AZD3355 Drug: Placebo	Phase I

Drug Information available for: AZD 3355

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Basic Science, Randomized, Single Blind (Subject), Parallel Assignment, Safety Study
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

Further study details as provided by AstraZeneca:

Primary Outcome Measures:

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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Pharmacokinetic variables [ Time Frame: Several occasions during the study days ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	54
Study Start Date:	September 2008
Primary Completion Date:	January 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental	Drug: AZD3355 capsules, oral, single or twice daily dose
2: Placebo Comparator	Drug: Placebo To match dosing of AZD3355

Eligibility

Ages Eligible for Study:	18 Years to 45 Years
Genders Eligible for Study:	Male
Accepts Healthy Volunteers:	Yes

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00757419

Locations

Sweden
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

More Information

No publications provided

Responsible Party:	AstraZeneca Pharmaceuticals ( Debra G. Silberg, MD, PhD, Medical Science Director, AZD3355 )
Study ID Numbers:	D9120C00030, EudraCTnr: 2008-003578-16
Study First Received:	September 22, 2008
Last Updated:	January 15, 2009
ClinicalTrials.gov Identifier:	NCT00757419 History of Changes
Health Authority:	Sweden: Medical Products Agency

Keywords provided by AstraZeneca:

Safety
tolerability
healthy subjects

Study placed in the following topic categories:

Healthy

ClinicalTrials.gov processed this record on May 07, 2009