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Formulation 1 solabegron

Phase 1

Healthy Subjects, Overactive Bladder | Small molecule | Nephrology |cbdMD, Inc.|Last Updated: Apr 24, 2019

Success Probability

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Market & Valuation

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Trial Design

RandomizedCONTROLLEDBiomarker
Total Trials1
Total Enrollment24

FDA Designations

No designations recorded

Clinical trial landscape

Formulation 1 solabegron · 1 trial · 1 indication

Phase 1 1
NCT02938507Evaluate the Safety, Tolerability and PK of Different Formulations of Orally Administered Solabegron in Healthy Male SubjectsHealthy Subjects, Overactive Bladder
COMPLETED24 Analytics
PHASE1COMPLETED
Evaluate the Safety, Tolerability and PK of Different Formulations of Orally Administered Solabegron in Healthy Male Subjects
Healthy Subjects, Overactive BladderUnlock trial analytics

Study Endpoints

Primary Endpoints

Maximum observed plasma drug concentration (Cmax)
24 hours
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Study Design & Arms

AllocationRANDOMIZED
MaskingSINGLE
ModelCROSSOVER
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Formulation 1 solabegronEXPERIMENTALSubjects will receive formulation 1 solabegron doses in a single-blind, randomized, cross-over fashion in Periods 1 to 3.
Formulation 2 solabegronEXPERIMENTALSubjects will receive formulation 2 in a single-blind, randomized, cross-over fashion in Periods 1 to 3.

Interventions

NameTypeDescription
Formulation 1 solabegronDRUG -
Formulation 2 solabegronDRUG -
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Eligibility Criteria

Age Range18 Years to 65 Years
SexMALE
Healthy VolunteersYes

Inclusion Criteria: * Body weight greater than or equal to 50 kg, inclusive, and body mass index (BMI) 18.0 - 32.0 kg/m2, inclusive * In good general health as determined by a thorough medical history and physical examination, ECG, vital signs, and clinical laboratory evaluation. Results of clinica...

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Frequently asked questions about Formulation 1 solabegron

What is Formulation 1 solabegron used for?

Formulation 1 solabegron is an investigational small molecule being studied for use in healthy subjects and in patients with overactive bladder. It is currently in Phase 1 clinical development and has not been approved by regulatory authorities.

Who makes Formulation 1 solabegron?

Formulation 1 solabegron is being developed by cbdMD, Inc., a company traded on the NYSE American under the ticker symbol YCBD. The company is conducting clinical research to evaluate the safety and pharmacokinetics of this investigational drug.

What phase is Formulation 1 solabegron in?

Formulation 1 solabegron is in Phase 1 clinical development. It is an investigational drug, meaning it has not been approved for any use. The Phase 1 trial has been completed, and the drug remains under clinical investigation.

What clinical trials is Formulation 1 solabegron in?

Formulation 1 solabegron has one completed Phase 1 clinical trial registered as NCT02938507. This study evaluated the safety, tolerability, and pharmacokinetics of different orally administered formulations of solabegron in healthy male subjects, with a total enrollment of 24 participants.

Is Formulation 1 solabegron the same as solabegron?

Yes, Formulation 1 solabegron is a specific formulation of the drug solabegron. The clinical trial NCT02938507 was designed to compare different formulations of orally administered solabegron, with Formulation 1 being one of the versions tested in healthy subjects.