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Radio-labeled rodatristat ethyl

Phase 1

Healthy | Small molecule | Other |Roivant Sciences Ltd.|Last Updated: Jul 13, 2022

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLEDBiomarker
Total Trials1
Total Enrollment5

FDA Designations

No designations recorded

Clinical trial landscape

Radio-labeled rodatristat ethyl · 1 trial · 1 indication

Phase 1 1
NCT05006118Pharmacokinetics and Excretion of Oral [14C]-Rodatristat EthylHealthy
COMPLETED5 Analytics
PHASE1COMPLETED
Pharmacokinetics and Excretion of Oral [14C]-Rodatristat Ethyl
Healthy
NCT050061185
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Study Endpoints

Primary Endpoints

Overall, urinary, and fecal recovery of total radioactivity as a percentage of administered dose.
15 days or until total recovery (urine and feces combined) of the administered radioactive dose is ≥90% and the total daily recovery of radioactive dose is ≤1% on 2 consecutive days in which a fecal sample is collected

Secondary Endpoints

Plasma AUC(0-t) of total radioactivity, rodatristat ethyl, rodatristat, M15, and other metabolites if appropriate.
15 days or until total recovery (urine and feces combined) of the administered radioactive dose is ≥90% and the total daily recovery of radioactive dose is ≤1% on 2 consecutive days in which a fecal sample is collected
Plasma AUC(0-∞) of total radioactivity, rodatristat ethyl, rodatristat, M15, and other metabolites if appropriate.
15 days or until total recovery (urine and feces combined) of the administered radioactive dose is ≥90% and the total daily recovery of radioactive dose is ≤1% on 2 consecutive days in which a fecal sample is collected
Plasma Cmax of total radioactivity, rodatristat ethyl, rodatristat, M15, and other metabolites if appropriate.
15 days or until total recovery (urine and feces combined) of the administered radioactive dose is ≥90% and the total daily recovery of radioactive dose is ≤1% on 2 consecutive days in which a fecal sample is collected
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Study Design & Arms

AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Radio-labeled rodatristat ethyl 600 mgEXPERIMENTALSingle dose of rodatristat ethyl 600 mg as an oral suspension containing a mixture of \[12C\]-rodatristat ethyl and \[14C\]-rodatristat ethyl to contain approximately 600 microcuries (uCi) of radioactivity

Interventions

NameTypeDescription
Radio-labeled rodatristat ethyl 600 mgDRUGSingle dose of rodatristat ethyl 600 mg as an oral suspension containing a mixture of \[12C\]-rodatristat ethyl and \[14C\]-rodatristat ethyl to contain approximately 600 microcuries (uCi) of radioactivity
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Eligibility Criteria

Age Range18 Years to 55 Years
SexMALE
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Healthy males aged 18 to 55 years, inclusive. * Healthy subjects are defined as individuals free from clinically significant illness or disease as determined by their medical history, physical examination, vital signs, cardiac monitoring, and clinical laboratory test results. ...

Countries:United States
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Frequently asked questions about Radio-labeled rodatristat ethyl

What is Radio-labeled rodatristat ethyl?

Radio-labeled rodatristat ethyl is an investigational small molecule being studied in healthy volunteers. It is a radiolabeled form of rodatristat ethyl, used in a Phase 1 clinical trial to assess its pharmacokinetics and excretion. The drug is not approved and remains in clinical development.

Who makes Radio-labeled rodatristat ethyl?

Radio-labeled rodatristat ethyl is being developed by Roivant Sciences Ltd., a biopharmaceutical company traded on NASDAQ under the ticker ROIV. The company is conducting clinical research on this investigational compound.

What phase is Radio-labeled rodatristat ethyl in?

Radio-labeled rodatristat ethyl is in Phase 1 clinical development. A single Phase 1 trial has been completed, involving 5 healthy male participants in the United States. The drug remains investigational and is not FDA approved.

What clinical trials is Radio-labeled rodatristat ethyl in?

Radio-labeled rodatristat ethyl has one completed clinical trial, NCT05006118, titled 'Pharmacokinetics and Excretion of Oral [14C]-Rodatristat Ethyl'. This Phase 1 study enrolled 5 healthy male volunteers aged 18 years and older in the United States.

Is Radio-labeled rodatristat ethyl the same as rodatristat ethyl?

Radio-labeled rodatristat ethyl is a radiolabeled version of rodatristat ethyl, meaning it contains a radioactive carbon isotope ([14C]) for tracking in the body. It is used in research to study the pharmacokinetics and excretion of the parent drug.