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Human Mass Balance Study With Bilastine

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ClinicalTrials.gov Identifier: NCT00572611
Recruitment Status : Completed
First Posted : December 13, 2007
Last Update Posted : September 26, 2012
Sponsor:
Collaborators:
Charles River Clinical Services Edinburgh Ltd and CR Laboratories Preclinical Services Ltd
MDS Pharma Services Switzerland AG
Information provided by (Responsible Party):
Faes Farma, S.A.

December 12, 2007
December 13, 2007
September 26, 2012
November 2007
December 2007   (Final data collection date for primary outcome measure)
  • Whole blood and plasma concentrations of total radioactivity and parent drug [ Time Frame: 168-216 h after dosing, depending on the radioactivity recovery ]
  • Urine and faecal recovery of total radioactivity [ Time Frame: 168-216 h after dosing, depending on the radioactivity recovery ]
  • Characterisation and identification of metabolites in plasma, urine and faeces [ Time Frame: 168-216 h after dosing, depending on the radioactivity recovery ]
Same as current
Complete list of historical versions of study NCT00572611 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Human Mass Balance Study With Bilastine
A Phase I Study to Investigate the Absorption, Metabolism and Excretion of [14C]-Bilastine Following Oral Administration to Healthy Volunteers
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
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.
Interventional
Phase 1
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Healthy
Drug: [14C]-bilastine
Single oral dose of 20 mg [14C]-bilastine. 1 capsule. 1 day dosing only
Experimental: I
Single oral dose of 20 mg [14C]-bilastine
Intervention: Drug: [14C]-bilastine

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
6
Same as current
December 2007
December 2007   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: Male
30 Years to 60 Years   (Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
United Kingdom
 
 
NCT00572611
BILA 459-13
EudraCT Number: 2007-003373-12
CR Study Number: 186781
No
Not Provided
Not Provided
Faes Farma, S.A.
Faes Farma, S.A.
  • Charles River Clinical Services Edinburgh Ltd and CR Laboratories Preclinical Services Ltd
  • MDS Pharma Services Switzerland AG
Principal Investigator: Stuart J Mair, MD INC Research
Study Director: Lindsay McGregor INC Research
Faes Farma, S.A.
September 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP