Healthy Volunteer StudyPhase 1TIOBLOCKNCT03945344
Effect of Charcoal on Gastrointestinal Absorption of Tiotropium
A Phase 1 study testing Tiotropium in people with Healthy Volunteer Study, run by Orion Corporation, Orion Pharma at 1 site in Finland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteer Study
- What is being tested?
- Tiotropium
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteFinland
- Study dates
- 27 May 2019to 19 Jun 2019
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Written informed consent (IC) obtained.
- Healthy males and females, aged 18-60
- Normal weight at least 50 kg.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Charcoal on Gastrointestinal Absorption of Tiotropium; A Randomised, Open, Single Centre, Single Dose, Crossover Study in Healthy Subjects
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
- Being tested
- Tiotropium
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TiotropiumDrug
Oral capsule 20 μg
TiotropiumDrug
Oral capsule 20 μg
| Study group | Role | What they receive |
|---|---|---|
| Treatment A | Experimental | Tiotropium with concomitant charcoal Receives: Drug: Tiotropium |
| Treatment B | Experimental | Tiotropium without concomitant charcoal. Receives: Drug: Tiotropium |
What is being measured
The primary outcome is the main question the study is designed to answer.
The pharmacokinetic parameter Area Under Curve (AUC)
Measured: 24 hours
Secondary outcomes (1)
Peak concentration in plasma (Cmax) and time to reach peak concentration in plasma (tmax)
Measured: (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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 May 2019
- Study start27 May 2019
- Primary completion19 Jun 2019
- Study completion19 Jun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy Volunteer StudyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Orion Corporation, Orion Pharma
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Maria Annunen, MSc, Study director, Orion Corporation, Orion Pharma
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03945344
- Sponsor's protocol ID
- 3122003
- Acronym
- TIOBLOCK
- Status last verified
- Sep 2019
- First submitted
- 8 May 2019
- Last updated
- 23 Sep 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Charcoal on Gastrointestinal Absorption of Tiotropium; A Randomised, Open, Single Centre, Single Dose, Crossover Study in Healthy Subjects
- ClinicalTrials.gov ID
- NCT03945344
- Acronym / sponsor ID
- TIOBLOCK / 3122003
- Conditions
- Healthy Volunteer Study
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Orion Corporation, Orion PharmaIndustry (pharma, biotech, devices)
- Study start
- 27 May 2019 (actual)
- Primary completion
- 19 Jun 2019 (actual)
- Study completion
- 19 Jun 2019 (actual)
- First posted
- 10 May 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment A | Experimental | Drug: TiotropiumTiotropium with concomitant charcoal |
| Treatment B | Experimental | Drug: TiotropiumTiotropium without concomitant charcoal. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Written informed consent (IC) obtained.
- Healthy males and females, aged 18-60
- Normal weight at least 50 kg.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TiotropiumOral capsule 20 μg | Drug | Treatment A |
| TiotropiumOral capsule 20 μg | Drug | Treatment B |
Primary outcome
The pharmacokinetic parameter Area Under Curve (AUC)
Time frame: 24 hours
1 secondary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Maria Annunen, MSc study director
Orion Corporation, Orion Pharma
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Tiotropium in people with Healthy Volunteer Study, run by Orion Corporation, Orion Pharma at 1 site in Finland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Finland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The pharmacokinetic parameter Area Under Curve (AUC) (time frame: 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Sep 2019.