Gadobutrol Pharmacokinetic and Safety Study in Pediatric Subjects Aged <2 Years (Term Newborn Infants to Toddlers 23 Months of Age Inclusive)

PHASE1CompletedINTERVENTIONAL
Enrollment

44

Participants

Timeline

Start Date

May 16, 2012

Primary Completion Date

November 28, 2013

Study Completion Date

November 28, 2013

Conditions
Magnetic Resonance Imaging
Interventions
DRUG

Gadobutrol (Gadavist, BAY86-4875)

Single intravenous bolus injection of gadobutrol 0.1 mmol/kg BW in term newborns to infants \<2 years of age.

Trial Locations (9)

31406

Savannah

45229

Cincinnati

60611

Chicago

77030

Houston

02111

Boston

T6G 2B7

Edmonton

01307

Dresden

06097

Halle

07740

Jena

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Bayer

INDUSTRY

NCT01544166 - Gadobutrol Pharmacokinetic and Safety Study in Pediatric Subjects Aged <2 Years (Term Newborn Infants to Toddlers 23 Months of Age Inclusive) | Biotech Hunter | Biotech Hunter