Effect of breathing 100% oxygen on brain metabolites measured by 7-Tesla MRI

Phase 1

• Conditions: brain metabolism; MedDRA version: 14.1Level: PTClassification code 10033316Term: Oxygen saturationSystem Organ Class: 10022891 - Investigations; Therapeutic area: Body processes [G] - Metabolic Phenomena [G03]

• Registration Number: EUCTR2012-005299-32-AT
• Lead Sponsor: Medizinische Universität Wien, Universitätsklinik für Klinische Pharmakologie

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-12-17
• Last Update Posted: 29 August 2016

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

-Men and women aged between 18 and 35 years
-Non-smokers
-Normal findings in the medical history and physical examination unless the investigator considers an abnormality to be clinically irrelevant
-Normal laboratory values unless the investigator considers an abnormality to be clinically irrelevant
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 15
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range 0

Exclusion Criteria

Exclusion criteria

Any of the following will exclude a subject from the study:

-Symptoms of a clinically relevant illness in the 3 weeks before the first study day
-Presence or history of a severe medical condition as judged by the clinical investigator
-Presence or history of arterial hypertension
-Regular use of medication, abuse of alcoholic beverages, participation in a clinical trial in the 3 weeks preceding the study (except oral contraceptive)
-Blood donation during the previous three weeks
-Abnormalities in the 12-lead electrocardiogram

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified