AZD3355 Dose-escalation Study in Healthy Males

This study has been completed.
Sponsor:
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00757419
First received: September 22, 2008
Last updated: December 6, 2010
Last verified: December 2010

September 22, 2008
December 6, 2010
September 2008
December 2008   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT00757419 on ClinicalTrials.gov Archive Site
Pharmacokinetic variables [ Time Frame: Several occasions during the study days ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
AZD3355 Dose-escalation Study in Healthy Males
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

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.

Not Provided
Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Basic Science
Reflux Disease
  • Drug: AZD3355
    capsules, oral, single or twice daily dose
    Other Name: Lesogaberan
  • Drug: Placebo
    To match dosing of AZD3355
  • Experimental: 1
    Intervention: Drug: AZD3355
  • Placebo Comparator: 2
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
54
December 2008
December 2008   (final data collection date for primary outcome measure)

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
Male
18 Years to 45 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Sweden
 
NCT00757419
D9120C00030, EudraCTnr: 2008-003578-16
No
Debra G. Silberg, MD, PhD, Medical Science Director, AZD3355, AstraZeneca Pharmaceuticals
AstraZeneca
Not Provided
Principal Investigator: Marianne Hartford CPU Avd 102, Gröna Stråket 12, Sahlgrenska Universitetssjukhuset, 413 45 Göteborg
Study Director: Eva Ersdal AstraZeneca R&D, Mölndal, Sweden
AstraZeneca
December 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP