AZD3355 Dose-escalation Study in Healthy Males

AstraZeneca54 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

SINGLE

Enrollment

Conditions

Reflux Disease

Interventions

AZD3355DRUG

capsules, oral, single or twice daily dose

PlaceboDRUG

To match dosing of AZD3355

Eligibility

Sex: MALEMin age: 18 YearsMax age: 45 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Research Site

Gothenburg, Sweden

Outcomes

Primary Outcomes

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

Pharmacokinetic variables

Time frame: Several occasions during the study days

Data from ClinicalTrials.gov

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