NCT00757419

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
54

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Sep 2008

Shorter than P25 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2008

Completed
21 days until next milestone

First Submitted

Initial submission to the registry

September 22, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 23, 2008

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2008

Completed
Last Updated

December 7, 2010

Status Verified

December 1, 2010

Enrollment Period

3 months

First QC Date

September 22, 2008

Last Update Submit

December 6, 2010

Conditions

Reflux Disease

Keywords

Safetytolerabilityhealthy subjects

Outcome Measures

Primary Outcomes (1)

  • Safety variables (Adverse event reporting, ECG, blood pressure, pulse rate, urine weight and osmolality, body temperature, blood and urine laboratory values)

    During the study

Secondary Outcomes (1)

  • Pharmacokinetic variables

    Several occasions during the study days

Study Arms (2)

1

EXPERIMENTAL
Drug: AZD3355

2

PLACEBO COMPARATOR
Drug: Placebo

Interventions

AZD3355DRUG

capsules, oral, single or twice daily dose

Also known as: Lesogaberan
1
PlaceboDRUG

To match dosing of AZD3355

2

Eligibility Criteria

Age18 Years - 45 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Subjects without concurrent diseases who do not require any medical treatments
  • Provision of signed informed consent.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Research Site

Gothenburg, Sweden

Location

MeSH Terms

Conditions

Gastroesophageal Reflux

Interventions

lesogaberan

Condition Hierarchy (Ancestors)

Esophageal Motility DisordersDeglutition DisordersEsophageal DiseasesGastrointestinal DiseasesDigestive System Diseases

Study Officials

  • Marianne Hartford

    CPU Avd 102, Gröna Stråket 12, Sahlgrenska Universitetssjukhuset, 413 45 Göteborg

    PRINCIPAL INVESTIGATOR

  • Eva Ersdal

    AstraZeneca R&D, Mölndal, Sweden

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

September 22, 2008

First Posted

September 23, 2008

Study Start

September 1, 2008

Primary Completion

December 1, 2008

Study Completion

December 1, 2008

Last Updated

December 7, 2010

Record last verified: 2010-12

Locations

SE(1)