TIOBLOCK: Effect of Charcoal on Gastrointestinal Absorption of Tiotropium

• Sponsor: Orion Corporation, Orion Pharma (Industry)
• Overall Status: Completed
• CT.gov ID: NCT03945344
• Collaborator: (none)
• Enrollment: 20
• Location: 1
• Arms: 2
• Actual Duration (Days): 23
• Patients Per Site Per Month: 26.5

Study Details

Study Description

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; Drug: Tiotropium	Phase 1

Study Design

• Study Type: Interventional
• 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: Jun 19, 2019
• Actual Study Completion Date: Jun 19, 2019

Arms and Interventions

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

Primary Outcome Measures

1. The pharmacokinetic parameter Area Under Curve (AUC) [24 hours]

Secondary Outcome Measures

1. Peak concentration in plasma (Cmax) and time to reach peak concentration in plasma (tmax) [(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

Criteria

• Ages Eligible for Study: 18 Years to 60 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Locations

	Site	City	State	Country	Postal Code
1	Clinical Pharmacology Unit	Espoo		Finland

Sponsors and Collaborators

• Orion Corporation, Orion Pharma

Investigators

• Study Director: Maria Annunen, MSc, Orion Corporation, Orion Pharma

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Orion Corporation, Orion Pharma
• ClinicalTrials.gov Identifier: NCT03945344
• Other Study ID Numbers: 3122003
• First Posted: May 10, 2019
• Last Update Posted: Sep 23, 2019
• Last Verified: Sep 1, 2019

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Tiotropium Bromide

Study Results

No Results Posted as of Sep 23, 2019