HealthyPhase 1NCT02676297
Cross-over Study in Volunteers to Compare the Pharmacokinetics of Tiotropium Delivered From Test and Reference Products
A Phase 1 study testing tiotropium in people with Healthy, run by Solventum US LLC at 1 site in United Kingdom.
Trial summary
The purpose of this study is to compare the absorption of two different inhalation products with the reference product in healthy volunteers. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- tiotropium
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Jan 2016to Jul 2016
- 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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy Volunteer
- Willing and able to give informed consent
- Willing to withhold all alcoholic beverages for 48 hours and all xanthine- containing foods and beverages for 24 hours prior to reporting to clinic
- Subjects must agree to use an adequate method of contraception from admission through 12 weeks after last administration
Who cannot join
- Evidence or history of clinically significant abnormalities or disease or chronic respiratory disorders
- Any presence or history of a clinically significant allergy including any adverse reaction to study drug
- History of drug or alcohol abuse within the past 2 years
- Smoked tobacco within the past 6 months or have a history of more than 10- pack years (number of packs smoked per day x number of years smoked)
- Donation or loss of greater than 400 mL of blood within the previous 3 months
- Have received any prescription medication within 4 weeks or investigational medication within 12 weeks of study (exception: contraceptives are permitted)
Show all 10Show fewer
- Have received any non-prescription medication within 14 days prior to dosing (exception: paracetamol use within 2 days)
- Upper respiratory tract infection (excluding otitis media) within 14 days of the first study day, or lower respiratory tract infection within the last 3 months
- If female, nursing, lactating or pregnant
- Regular alcohol consumption in males >21 units per week and females >14 units per week (1 unit = ½ pint beer, 25 mL of 40% spirit or a 125 mL glass of wine)
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Quotient Clinical Ltd
Ruddington, Nottingham, NG11 6JS
About this study
Official title: Phase I Randomised, Three-period Cross-over Study in Healthy Male and Female Volunteers to Compare the Pharmacokinetics of Tiotropium Delivered From Two Test Products With Spiriva Respimat Comparator Product
The purpose of this study is to compare the absorption of two different inhalation products with the reference product in healthy volunteers.
Read the detailed description
Healthy subjects will be enrolled and will receive single doses of 2 test inhalation products and one reference inhalation product according to a three-period cross-over design. Subjects will use the patient instruction leaflet to understand how each inhaler is administered. Plasma tiotropium levels will be measured pre-dose and over 8 hours post-dose.
- Conditions
- Healthy
- Being tested
- tiotropium
- Keywords
- inhalation, anticholinergic
- Medical subject headings
- Respiratory Aspiration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
tiotropiumDrug
Also called Spiriva Respimat
four inhalations
| Study group | Role | What they receive |
|---|---|---|
| Test product A | Experimental | tiotropium Receives: Drug: tiotropium |
| Test product B | Experimental | tiotropium Receives: Drug: tiotropium |
| reference product | Active comparator | tiotropium Receives: Drug: tiotropium |
What is being measured
The primary outcome is the main question the study is designed to answer.
peak plasma concentration
measured by noncompartmental analysis
Measured: 8 hours
Secondary outcomes (1)
adverse events
reported adverse events
Measured: 8 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2016 (estimated)
- Study startJan 2016
- Primary completionMay 2016
- Study completionJul 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Solventum US LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Quotient Clinical, 3M
- Responsible party
- Sponsor
- Investigators
- Pui Leung, MD, Principal investigator, Quotient Clinical
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02676297
- Sponsor's protocol ID
- CSP-07-000027
- Other IDs
- 2015-004145-10, 2015
- Status last verified
- Nov 2024
- First submitted
- 4 Feb 2016
- Last updated
- 2 Dec 2024
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes: will share summary data
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I Randomised, Three-period Cross-over Study in Healthy Male and Female Volunteers to Compare the Pharmacokinetics of Tiotropium Delivered From Two Test Products With Spiriva Respimat Comparator Product
- ClinicalTrials.gov ID
- NCT02676297
- Acronym / sponsor ID
- CSP-07-000027
- Conditions
- Healthy
- Keywords
- inhalation, anticholinergic
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Solventum US LLCIndustry (pharma, biotech, devices)
- Collaborators
- Quotient Clinical, 3M
- Study start
- Jan 2016
- Primary completion
- May 2016 (actual)
- Study completion
- Jul 2016 (actual)
- First posted
- 8 Feb 2016 (estimated)
- 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 purpose of this study is to compare the absorption of two different inhalation products with the reference product in healthy volunteers.
Detailed description
Healthy subjects will be enrolled and will receive single doses of 2 test inhalation products and one reference inhalation product according to a three-period cross-over design. Subjects will use the patient instruction leaflet to understand how each inhaler is administered. Plasma tiotropium levels will be measured pre-dose and over 8 hours post-dose.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Test product A | Experimental | Drug: tiotropiumtiotropium |
| Test product B | Experimental | Drug: tiotropiumtiotropium |
| reference product | Active comparator | Drug: tiotropiumtiotropium |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Healthy Volunteer
- Willing and able to give informed consent
- Willing to withhold all alcoholic beverages for 48 hours and all xanthine- containing foods and beverages for 24 hours prior to reporting to clinic
- Subjects must agree to use an adequate method of contraception from admission through 12 weeks after last administration
Key exclusion criteria (10 listed)
- Evidence or history of clinically significant abnormalities or disease or chronic respiratory disorders
- Any presence or history of a clinically significant allergy including any adverse reaction to study drug
- History of drug or alcohol abuse within the past 2 years
- Smoked tobacco within the past 6 months or have a history of more than 10- pack years (number of packs smoked per day x number of years smoked)
- Donation or loss of greater than 400 mL of blood within the previous 3 months
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 |
|---|---|---|
| tiotropiumAlso: Spiriva Respimatfour inhalations | Drug | Test product A, Test product B, reference product |
Primary outcome
peak plasma concentration
Time frame: 8 hours
measured by noncompartmental analysis
1 secondary outcome
adverse events
Time frame: 8 hours
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 2 Dec 2024.
- Individual participant dataSharing planned: Yes. will share summary data
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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.
Pui Leung, MD principal investigator
Quotient Clinical
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, run by Solventum US LLC at 1 site in United Kingdom.
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 4 inclusion and 10 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 2 Dec 2024. 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 United Kingdom. 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?
peak plasma concentration (time frame: 8 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 2 Dec 2024.