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OpenTrials
Completed

NCT Number: NCT00757419

AZD3355 Dose-escalation Study in Healthy Males

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.

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Key information

Conditions

Reflux Disease Deglutition Disorders Digestive System Diseases Esophageal Diseases Esophageal Motility Disorders Gastroesophageal Reflux Gastrointestinal Diseases

Age range

18 year–45 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Research Site

Gothenburg, Sweden

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

AZD3355

Drug

capsules, oral, single or twice daily dose

Other names: Lesogaberan

Placebo

Drug

To match dosing of AZD3355

Primary outcomes

  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 outcomes

  1. Pharmacokinetic variables

    Time frame: Several occasions during the study days

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study 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

Important dates

Study start
2008
Primary completion
2008
Study completion
2008
First posted
Sep 23, 2008
Registry last updated
Dec 7, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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