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Human Mass Balance Study With Bilastine

This study is currently recruiting participants.
Verified by Faes Farma, S.A., December 2007

Sponsors and Collaborators: Faes Farma, S.A.
Charles River Clinical Services Edinburgh Ltd
Charles River Laboratories Preclinical Services Ltd
MDS Pharma Services Switzerland AG
Kendle International
Information provided by: Faes Farma, S.A.
ClinicalTrials.gov Identifier: NCT00572611
  Purpose

The primary objective of the study is to define the absorption and excretion kinetics of bilastine in man following oral administration, and to investigate the nature of the metabolites present in plasma and excreta. The secondary objective of the study is to assess the safety and tolerability of bilastine


Condition Intervention Phase
Healthy
Drug: [14C]-bilastine
Phase I

Drug Information available for:   Bilastine   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Basic Science, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Pharmacokinetics Study
Official Title:   A Phase I Study to Investigate the Absorption, Metabolism and Excretion of [14C]-Bilastine Following Oral Administration to Healthy Volunteers

Further study details as provided by Faes Farma, S.A.:

Primary Outcome Measures:
  • Whole blood and plasma concentrations of total radioactivity and parent drug [ Time Frame: 168-216 h after dosing, depending on the radioactivity recovery ] [ Designated as safety issue: No ]
  • Urine and faecal recovery of total radioactivity [ Time Frame: 168-216 h after dosing, depending on the radioactivity recovery ] [ Designated as safety issue: No ]
  • Characterisation and identification of metabolites in plasma, urine and faeces [ Time Frame: 168-216 h after dosing, depending on the radioactivity recovery ] [ Designated as safety issue: No ]

Estimated Enrollment:   6
Study Start Date:   December 2007
Estimated Study Completion Date:   December 2007

Arms Assigned Interventions
I: Experimental
Single oral dose of 20 mg [14C]-bilastine
Drug: [14C]-bilastine
Single oral dose of 20 mg [14C]-bilastine. 1 capsule. 1 day dosing only

Detailed Description:

Primary Endpoints are: Whole blood and plasma concentrations of total radioactivity and parent drug. Urine and faecal recovery of total radioactivity. Characterisation and identification of metabolites in plasma, urine and faeces.

  Eligibility
Ages Eligible for Study:   30 Years to 60 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes

Criteria

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.
  • Able to communicate well with the investigator and to comply with the requirements of the entire study.
  • Provision of written informed consent to participate.
  • Subjects must agree to use an adequate method of contraception during the study and for 12 weeks after dosing.
  • Subjects must have a negative urine screen for drugs of abuse.
  • Subjects must have a regular bowel habit.

Exclusion Criteria:

  • Administration of any IMP within 12 weeks before entry to the study.
  • Use of any prescribed medication or St John's Wort within 14 days or OTC medication within 5 days of dosing.
  • Existence of any surgical or medical condition which, in the judgement of the investigator, might interfere with the absorption, distribution, metabolism or excretion of the IMP.
  • History of any drug or alcohol abuse in the past 2 years, or alcohol consumption greater than 21 units per week.
  • Presence or history of allergy requiring treatment.
  • Hayfever is allowed unless it is active or has required treatment within the previous 2 months.
  • Donation or loss of greater than 400 mL of blood within 12 weeks before entry to the study.
  • Serious adverse reaction or serious hypersensitivity to any drug.
  • Presence of hepatitis B surface antigen (HBsAg), hepatitis C antibody (HCV Ab) or HIV 1 or HIV 2 antibodies at screening.
  • Administration of radiolabelled substances or exposure to significant radiation (eg serial x-ray or CT scans, barium meal etc) within the past 12 months.
  • Any ECG abnormality at screening (including QTc intervals of >430 ms).
  • Past medical history of clinically significant ECG abnormalities, or a family history of a prolonged QT interval syndrome.
  • Abnormal diet or substantial changes in eating habits within 30 days prior to study initiation.
  • Treatment with any known enzyme altering agents (barbiturates, phenothiazines, cimetidine, etc.) within 2 months prior to or during the study.
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00572611

Contacts
Contact: Lindsay McGregor, Study director     +44 (0) 1875 614545     Lindsay.McGregor@eur.crl.com    
Contact: Penny Forster, Project Manager     +44 (0) 1875 614545     Penny.Forster@crl.com    

Locations
United Kingdom, Edinburgh
Charles River Laboratories Clinical Services Ltd, Origo Centre     Recruiting
      Riccarton, Edinburgh, United Kingdom, EH14 4AP
      Principal Investigator: Stuart J Mair, MD            
      Sub-Investigator: Janet Dickson, MD            

Sponsors and Collaborators
Faes Farma, S.A.
Charles River Clinical Services Edinburgh Ltd
Charles River Laboratories Preclinical Services Ltd
MDS Pharma Services Switzerland AG
Kendle International

Investigators
Principal Investigator:     Stuart J Mair, MD     Charles River Clinical Services Edinburgh Ltd    
Study Director:     Lindsay McGregor     Charles River Laboratories Preclinical Services Ltd    
  More Information


Responsible Party:   Charles River Clinical Services Edinburgh Ltd ( Dr Stuart Mair, Principal Investigator. Medical Advisor )
Study ID Numbers:   BILA 459-13, EudraCT Number: 2007-003373-12, CR Study Number: 186781
First Received:   December 12, 2007
Last Updated:   December 12, 2007
ClinicalTrials.gov Identifier:   NCT00572611
Health Authority:   United Kingdom: Medicines and Healthcare Products Regulatory Agency;   United Kingdom: Administration of Radioactive Substances Advisory Committee

Keywords provided by Faes Farma, S.A.:
Mass Balance  
Metabolism  
Absorption  
Excretion  
Pharmacokinetics  

Study placed in the following topic categories:
Healthy

ClinicalTrials.gov processed this record on October 23, 2008




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