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labeled RO7269162

Phase 1

Healthy Volunteers | Small molecule | Other |Roche Holding AG|Last Updated: Feb 25, 2025

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLED
Total Trials1
Total Enrollment8

FDA Designations

No designations recorded

Clinical trial landscape

labeled RO7269162 · 1 trial · 1 indication

Phase 1 1
NCT06733298A Study Investigating [14C]-Labeled RO7269162 in Healthy Male ParticipantsHealthy Volunteers
COMPLETED8 Analytics
PHASE1COMPLETED
A Study Investigating [14C]-Labeled RO7269162 in Healthy Male Participants
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Study Endpoints

Primary Endpoints

[14C] recovery in urine
Up to Day 22 or Day 37
[14C] recovery in feces
Up to Day 22 or Day 37
Concentration of [14C] in whole blood
Up to Day 22 or Day 37
Plasma concentration of [14C]
Up to Day 22 or Day 37
Plasma concentration of RO7269162
Up to Day 22 or Day 37
Amount of RO7269162 excreted in urine
Up to Day 22 or Day 37

Secondary Endpoints

Amount of RO7269162 metabolites in plasma
Up to Day 22 or Day 37
Amount of RO7269162 metabolites in blood
Up to Day 22 or Day 37
Amount of RO7269162 metabolites excreted in urine
Up to Day 22 or Day 37
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Study Design & Arms

AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Arm 1EXPERIMENTALParticipants will receive one oral dose of \[14C\]-labeled RO7269162 on Day 1.

Interventions

NameTypeDescription
[ 14C]-labeled RO7269162DRUGParticipants will receive one oral dose of \[14C\]-labeled RO7269162.
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Eligibility Criteria

Age Range35 Years to 64 Years
SexMALE
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Male participants aged 35 to 64 years of age (inclusive), at screening * Body weight ≥ 50 kg and body mass index within the range 18 to 30 kg/m2 (inclusive), at screening * Male participants who, for 3 months after dosing of \[14C\]-RO7269162, agree to: remain abstinent (refra...

Countries:Netherlands
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Frequently asked questions about labeled RO7269162

What is RO7269162 used for?

RO7269162 is an investigational small molecule being studied in healthy volunteers. It is currently in Phase 1 clinical development, with a completed trial that enrolled healthy male participants. The drug is not approved for any indication and remains under investigation.

Who makes RO7269162?

RO7269162 is being developed by Roche Holding AG, which trades under the ticker RHHBY. The company is conducting clinical research on this investigational small molecule, which is currently in Phase 1 development.

What phase is RO7269162 in?

RO7269162 is in Phase 1 clinical development. A single Phase 1 trial has been completed, involving 8 healthy male participants. The drug is investigational and has not been approved for any use.

What clinical trials is RO7269162 in?

RO7269162 has one completed clinical trial, NCT06733298, titled "A Study Investigating [14C]-Labeled RO7269162 in Healthy Male Participants." This Phase 1 study enrolled 8 healthy male volunteers in the Netherlands, with participants aged 35 years and older.

Is RO7269162 FDA approved?

RO7269162 is not FDA approved. It is an investigational drug currently in Phase 1 clinical development. The only completed trial was a small study in healthy volunteers, and the drug has not progressed to later-stage trials or regulatory approval.