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tiotropium

Phase 1

Healthy | Small molecule | Other |Solventum Corporation|Last Updated: Dec 2, 2024

Success Probability

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Market & Valuation

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Trial Design

RandomizedACTIVE_CONTROLLEDDMC
Total Trials3
Total Enrollment95

FDA Designations

No designations recorded

Clinical trial landscape

tiotropium · 3 trials · 1 indication

Phase 1 3
NCT03302065Comparison of the Pharmacokinetics of Tiotropium Delivered From Test Inhaler Products With ReferenceHealthy
COMPLETED38 Analytics
NCT02676297Cross-over Study in Volunteers to Compare the Pharmacokinetics of Tiotropium Delivered From Test and Reference ProductsHealthy
COMPLETED26 Analytics
NCT02627625Comparison of the Pharmacokinetics of Tiotropium Delivered From Test Inhaler Products With Two Reference ProductsHealthy
COMPLETED31 Analytics
PHASE1COMPLETED
Comparison of the Pharmacokinetics of Tiotropium Delivered From Test Inhaler Products With Reference
HealthyUnlock trial analytics
PHASE1COMPLETED
Cross-over Study in Volunteers to Compare the Pharmacokinetics of Tiotropium Delivered From Test and Reference Products
HealthyUnlock trial analytics
PHASE1COMPLETED
Comparison of the Pharmacokinetics of Tiotropium Delivered From Test Inhaler Products With Two Reference Products
HealthyUnlock trial analytics

Study Endpoints

Primary Endpoints

Cmax
48 hours

maximum plasma concentration

peak plasma concentration
8 hours

measured by noncompartmental analysis

Peak Plasma Concentration (Cmax)
8 hours

noncompartmental analysis

Secondary Endpoints

adverse events
8 hours
Area Under the Plasma Concentration vs Time Curve (AUC)
8 hours
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelCROSSOVER
PurposeBASIC_SCIENCE

Treatment Arms

ArmTypeDescription
Test Product 1 TiotropiumEXPERIMENTAL4 inhalations
Test Product 2 TiotropiumEXPERIMENTAL4 inhalations
Test Product 3 TiotropiumEXPERIMENTAL4 inhalations
Reference TiotropiumACTIVE_COMPARATOR2 inhalations
Test product AEXPERIMENTALtiotropium
Test product BEXPERIMENTALtiotropium
reference productACTIVE_COMPARATORtiotropium
test product CEXPERIMENTALtiotropium
Commercial product DACTIVE_COMPARATORtiotropium
commercial product EACTIVE_COMPARATORtiotropium

Interventions

NameTypeDescription
TiotropiumDRUG -
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Eligibility Criteria

Age Range18 Years to 55 Years
SexALL
Healthy VolunteersYes

Inclusion Criteria: * 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 ...

Countries:United Kingdom
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Frequently asked questions about tiotropium

What is tiotropium used for?

Tiotropium is a small molecule being studied in healthy volunteers. It is delivered via inhaler products, and the clinical trials focus on comparing the pharmacokinetics of tiotropium from test inhaler products with reference products. The drug is currently in Phase 1 clinical development.

Who is developing tiotropium?

Tiotropium is being developed by Solventum Corporation, which trades under the ticker SOLV. The company is conducting Phase 1 clinical trials to evaluate the pharmacokinetics of tiotropium delivered from different inhaler products in healthy volunteers.

What phase is tiotropium in?

Tiotropium is in Phase 1 clinical development. All three completed trials are Phase 1 studies involving healthy volunteers. These trials are designed to compare the pharmacokinetics of tiotropium delivered from test inhaler products with reference products.

What clinical trials is tiotropium in?

Tiotropium has been studied in three completed Phase 1 clinical trials: NCT02627625, NCT02676297, and NCT03302065. Each trial enrolled healthy volunteers aged 18 years and older, with enrollment numbers of 31, 26, and 38 participants, respectively. The trials were conducted in the United Kingdom.

Is tiotropium FDA approved?

Tiotropium is an investigational drug currently in Phase 1 clinical development. It has not been approved by the FDA, as it is still being studied in clinical trials. The completed trials focused on pharmacokinetic comparisons in healthy volunteers, which are early-stage studies.

How is tiotropium administered?

Tiotropium is delivered via inhaler products. The clinical trials compare the pharmacokinetics of tiotropium from test inhaler products with reference products. These studies are conducted in healthy volunteers to assess how the drug is absorbed and processed by the body.