Effect of Charcoal on Gastrointestinal Absorption of Tiotropium

NCT03945344 | Completed Phase 1

• 1 other identifier: 3122003
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy Volunteer Study

Outcome Measures

Primary Outcomes (1)

• The pharmacokinetic parameter Area Under Curve (AUC)

  24 hours

Secondary Outcomes (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

Study Arms (2)

Treatment A

EXPERIMENTAL

Tiotropium with concomitant charcoal

Drug: Tiotropium

Treatment B

EXPERIMENTAL

Tiotropium without concomitant charcoal.

Drug: Tiotropium

Interventions

Tiotropium DRUG

Oral capsule 20 μg

Treatment A

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• Evidence of a clinically significant cardiovascular, renal, hepatic, haematological, gastrointestinal, pulmonary, metabolic-endocrine, neurological or psychiatric disease.
• Any condition requiring regular concomitant treatment (including vitamins and herbal products) or likely to need any concomitant treatment during the study.
• 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.
• Known hypersensitivity to tiotropium bromide, atropine or its derivatives or to the excipients of the drug.
• Pregnant or lactating females.
• Females of childbearing potential not using proper contraception.

Sponsors & Collaborators

• Orion Corporation, Orion Pharma: lead

Study Sites (1)

Clinical Pharmacology Unit

Espoo, Finland

Location

MeSH Terms

Interventions

Tiotropium Bromide

Intervention Hierarchy (Ancestors)

Scopolamine Derivatives; Tropanes; Azabicyclo Compounds; Aza Compounds; Organic Chemicals; Alkaloids; Heterocyclic Compounds; Bridged Bicyclo Compounds, Heterocyclic; Heterocyclic Compounds, Bridged-Ring

Study Officials

• Maria Annunen, MSc

  Orion Corporation, Orion Pharma

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 8, 2019
• First Posted: May 10, 2019
• Study Start: May 27, 2019
• Primary Completion: June 19, 2019
• Study Completion: June 19, 2019
• Last Updated: September 23, 2019

Record last verified: 2019-09

Locations

FI (1)