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Orvepitant

Phase 1

Pharmacokinetic Study in Healthy Male Volunteers | Small molecule | Other |cbdMD, Inc.|Last Updated: Oct 11, 2018

Success Probability

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Market & Valuation

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Trial Design

CONTROLLEDBiomarker
Total Trials1
Total Enrollment16

FDA Designations

No designations recorded

Clinical trial landscape

Orvepitant · 1 trial · 1 indication

Phase 1 1
NCT03535662A Pharmacokinetic Study of the Effect of Itraconazole Exposure to Orvepitant in Healthy VolunteersPharmacokinetic Study in Healthy Male Volunteers
COMPLETED16 Analytics
PHASE1COMPLETED
A Pharmacokinetic Study of the Effect of Itraconazole Exposure to Orvepitant in Healthy Volunteers
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Study Endpoints

Primary Endpoints

Exposure to orvepitant
0 to 168 hours post dose

Area Under Curve (AUC)

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Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelSEQUENTIAL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
OrvepitantEXPERIMENTALOrvepitant single 20mg dose
Orvepitant and itraconazoleEXPERIMENTALOrvepitant single 20mg dose in combination with repeat dose itraconazole

Interventions

NameTypeDescription
OrvepitantDRUGSingle oral dose
ItraconazoleDRUGOnce daily dosing for 10 days
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Eligibility Criteria

Age Range18 Years to 45 Years
SexMALE
Healthy VolunteersYes
Study Sites1

Key Inclusion Criteria: * male volunteers * judged to be in good health, based on the results of medical history, physical examination, vital signs, 12 lead ECG, and clinical laboratory findings * body weight greater than 50 kg and body mass index (BMI) within the range 18 to 30 kg/m2 (inclusive) ...

Countries:United Kingdom
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Frequently asked questions about Orvepitant

What is Orvepitant?

Orvepitant is an investigational small molecule being developed by cbdMD, Inc. (YCBD). It is currently in Phase 1 clinical development. The drug has been studied in a pharmacokinetic trial involving healthy male volunteers to assess how it interacts with other substances in the body.

What is Orvepitant used for?

Orvepitant is being studied for its pharmacokinetic properties in healthy male volunteers. The completed Phase 1 trial focused on understanding how the drug is processed in the body when exposed to itraconazole. Its intended therapeutic use has not been specified in available clinical trial information.

Who makes Orvepitant?

Orvepitant is being developed by cbdMD, Inc., a company traded on the stock exchange under the ticker symbol YCBD. The company is conducting clinical research on this investigational small molecule drug candidate.

What phase is Orvepitant in?

Orvepitant is in Phase 1 clinical development. The drug is investigational and has not been approved by regulatory authorities. One Phase 1 study has been completed, and no active trials are currently listed for this drug candidate.

What clinical trials is Orvepitant in?

Orvepitant has one completed clinical trial registered as NCT03535662. This Phase 1 study, titled 'A Pharmacokinetic Study of the Effect of Itraconazole Exposure to Orvepitant in Healthy Volunteers,' enrolled 16 healthy male participants in the United Kingdom. The trial was controlled but not randomized or double-blinded.

Is Orvepitant the same as any other drug?

No alternative names for Orvepitant have been reported. The drug is identified by its single name in clinical trial registrations and development records. It is a distinct investigational compound being studied by cbdMD, Inc.