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bilastine

Phase 2

Healthy | Small molecule | Other |Charles River Laboratories International, Inc.|Last Updated: Sep 26, 2012

Development status

Highest phase Phase 2 run by Faes Farma, S.A. (NCT00574379)
Phase scored for CRLPhase 1
Registered trials 1 across 1 sponsor since Dec 2001

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLEDBiomarker
Total Trials1
Total Enrollment6

FDA Designations

No designations recorded

Clinical trial landscape

bilastine · 1 trial · 1 indication

Phase 1 1
NCT00572611Human Mass Balance Study With BilastineHealthy
COMPLETED6 Analytics
PHASE1COMPLETED
Human Mass Balance Study With Bilastine
Healthy
NCT005726116
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Study Endpoints

Primary Endpoints

Whole blood and plasma concentrations of total radioactivity and parent drug
168-216 h after dosing, depending on the radioactivity recovery
Urine and faecal recovery of total radioactivity
168-216 h after dosing, depending on the radioactivity recovery
Characterisation and identification of metabolites in plasma, urine and faeces
168-216 h after dosing, depending on the radioactivity recovery
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Study Design & Arms

AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeBASIC_SCIENCE

Treatment Arms

ArmTypeDescription
IEXPERIMENTALSingle oral dose of 20 mg \[14C\]-bilastine

Interventions

NameTypeDescription
[14C]-bilastineDRUGSingle oral dose of 20 mg \[14C\]-bilastine. 1 capsule. 1 day dosing only
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Eligibility Criteria

Age Range30 Years to 60 Years
SexMALE
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * No clinically important abnormal physical findings. * No clinically significant abnormalities in the results of laboratory evaluation. * Normal ECG. * Normal supine blood pressure and heart rate. * Body weight between 50 and 100 kg and body mass index between 18 and 30 kg/m2. ...

Countries:United Kingdom
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