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AZD3355 Dose-escalation Study in Healthy Males

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ClinicalTrials.gov Identifier: NCT00757419
Recruitment Status : Completed
First Posted : September 23, 2008
Last Update Posted : December 7, 2010
Sponsor:
Information provided by:
AstraZeneca

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 Type : Interventional  (Clinical Trial)
Estimated 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 : September 2008
Actual Primary Completion Date : December 2008
Actual Study Completion Date : December 2008

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



Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. Pharmacokinetic variables [ Time Frame: Several occasions during the study days ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

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
First Posted: September 23, 2008    Key Record Dates
Last Update Posted: December 7, 2010
Last Verified: December 2010

Keywords provided by AstraZeneca:
Safety
tolerability
healthy subjects

Additional relevant MeSH terms:
Lesogaberan
Gastrointestinal Agents
GABA-A Receptor Agonists
GABA Agonists
GABA Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs