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
  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 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
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

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
Study Completion Date: December 2008
Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: AZD3355
capsules, oral, single or twice daily dose
Other Name: Lesogaberan
Placebo Comparator: 2 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: Debra G. Silberg, MD, PhD, Medical Science Director, AZD3355, AstraZeneca Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00757419     History of Changes
Other Study ID Numbers: D9120C00030, EudraCTnr: 2008-003578-16
Study First Received: September 22, 2008
Last Updated: December 6, 2010
Health Authority: Sweden: Medical Products Agency

Keywords provided by AstraZeneca:
Safety
tolerability
healthy subjects

ClinicalTrials.gov processed this record on April 22, 2014