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Effect of Charcoal on Gastrointestinal Absorption of Tiotropium (TIOBLOCK)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03945344
Recruitment Status : Completed
First Posted : May 10, 2019
Last Update Posted : September 23, 2019
Sponsor:
Information provided by (Responsible Party):
Orion Corporation, Orion Pharma

Study Description
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Brief Summary:
The study will assess how efficiently activated charcoal will block absorption of tiotropium via the gastro intestinal track. Pharmacokinetics of tiotropium will be compared after orally administered tiotropium capsule with and without concomitant activated charcoal administration in healthy volunteers.

Condition or disease Intervention/treatment Phase
Healthy Volunteer Study Drug: Tiotropium Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effect of Charcoal on Gastrointestinal Absorption of Tiotropium; A Randomised, Open, Single Centre, Single Dose, Crossover Study in Healthy Subjects
Actual Study Start Date : May 27, 2019
Actual Primary Completion Date : June 19, 2019
Actual Study Completion Date : June 19, 2019

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Arms and Interventions
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Arm Intervention/treatment
Experimental: Treatment A
Tiotropium with concomitant charcoal
 Drug: Tiotropium
Oral capsule 20 μg
Experimental: Treatment B
Tiotropium without concomitant charcoal.
 Drug: Tiotropium
Oral capsule 20 μg


Outcome Measures
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Primary Outcome Measures :
  1. The pharmacokinetic parameter Area Under Curve (AUC) [ Time Frame: 24 hours ]

Secondary Outcome Measures :
  1. Peak concentration in plasma (Cmax) and time to reach peak concentration in plasma (tmax) [ Time Frame: (0 hours) and at 15, 30 and 45 minutes, and 1,1.5, 2, 3, 3.5, 4, 4.5, 5, 6, 8, 12 and 24 hours after the administration ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Written informed consent (IC) obtained.
  2. Healthy males and females, aged 18-60
  3. Normal weight at least 50 kg.

Exclusion Criteria:

  1. Evidence of a clinically significant cardiovascular, renal, hepatic, haematological, gastrointestinal, pulmonary, metabolic-endocrine, neurological or psychiatric disease.
  2. Any condition requiring regular concomitant treatment (including vitamins and herbal products) or likely to need any concomitant treatment during the study.
  3. Any clinically significant abnormal laboratory value or physical finding that may interfere the interpretation of study result or constitute a health risk for the subject if he/she participates in the study.
  4. Known hypersensitivity to tiotropium bromide, atropine or its derivatives or to the excipients of the drug.
  5. Pregnant or lactating females.
  6. Females of childbearing potential not using proper contraception.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03945344


Locations
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Finland
Clinical Pharmacology Unit
Espoo, Finland
Sponsors and Collaborators
Orion Corporation, Orion Pharma
Investigators
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Study Director: Maria Annunen, MSc Orion Corporation, Orion Pharma
More Information
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Responsible Party: Orion Corporation, Orion Pharma
ClinicalTrials.gov Identifier: NCT03945344    
Other Study ID Numbers: 3122003
First Posted: May 10, 2019    Key Record Dates
Last Update Posted: September 23, 2019
Last Verified: September 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Tiotropium Bromide
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
 Respiratory System Agents
Parasympatholytics
Cholinergic Antagonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action