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labeled RO7269162

Phase 1

Undisclosed | Small molecule | Other |Roche Holding AG|Trials Updated: Feb 25, 2025

labeled RO7269162 target and mechanism

ModalitySmall molecule

Also known as [ 14C]-labeled RO7269162

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLED
Total Trials1
Total Enrollment8

FDA Designations

No designations recorded

labeled RO7269162 clinical trials

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
Healthy VolunteersUnlock trial analytics

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?

RO7269162 is an investigational small molecule developed by Roche Holding AG. It is in Phase 1 clinical development, and its intended therapeutic indication has not been disclosed. A carbon-14 labeled version, [14C]-labeled RO7269162, has been studied in healthy male volunteers to characterize how the body handles the drug.

Who makes RO7269162?

RO7269162 is being developed by Roche Holding AG, which trades on the OTC market under the ticker RHHBY. Roche is the sponsor of the clinical program for this investigational small molecule.

What phase is RO7269162 in?

RO7269162 is in Phase 1 clinical development. It is investigational and has not been approved by the FDA. One Phase 1 trial has been completed, and no active trials are currently listed for this asset.

What clinical trials is RO7269162 in?

RO7269162 has been evaluated in one completed Phase 1 trial, NCT06733298, titled A Study Investigating [14C]-Labeled RO7269162 in Healthy Male Participants. The trial enrolled 8 healthy male volunteers aged 35 years and older in the Netherlands. It was an uncontrolled study without randomization or double blinding.

Is RO7269162 the same as [14C]-labeled RO7269162?

[14C]-labeled RO7269162 is the carbon-14 radiolabeled form of RO7269162, used as a tracer in clinical research. The two names refer to the same investigational molecule. The labeled version was administered in the completed Phase 1 study NCT06733298 to track the drug's absorption, distribution, metabolism, and excretion in healthy volunteers.