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Human Mass Balance Study With Bilastine

This study has been completed.
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.
ClinicalTrials.gov Identifier:
NCT00572611
First received: December 12, 2007
Last updated: September 25, 2012
Last verified: September 2012
History of Changes
  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 1

Study Type: Interventional
Study Design: Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Basic Science
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 ]

Enrollment: 6
Study Start Date: November 2007
Study Completion Date: December 2007
Primary Completion Date: December 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: I
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

Locations
United Kingdom
Charles River Laboratories Clinical Services Ltd, Origo Centre
Riccarton, Edinburgh, United Kingdom, EH14 4AP
Sponsors and Collaborators
Faes Farma, S.A.
Charles River Clinical Services Edinburgh Ltd and CR Laboratories Preclinical Services Ltd
MDS Pharma Services Switzerland AG
Investigators
Principal Investigator: Stuart J Mair, MD INC Research
Study Director: Lindsay McGregor INC Research
  More Information

Publications:

Responsible Party: Faes Farma, S.A.
ClinicalTrials.gov Identifier: NCT00572611     History of Changes
Other Study ID Numbers: BILA 459-13, EudraCT Number: 2007-003373-12, CR Study Number: 186781
Study First Received: December 12, 2007
Last Updated: September 25, 2012
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

ClinicalTrials.gov processed this record on May 16, 2013