Trials Sponsors Conditions Drugs Pricing

Conditions

Health Volunteers

Keywords

mass balancephase 1

Outcome Measures

Primary Outcomes (4)

Mass balance recovery of total radioactivity in all excreta: CumAe
Day 1 to Day 8
Mass balance recovery of total radioactivity in all excreta: Cum%Ae
Day 1 to Day 8
Number of OD-001 metabolites at ≥10% of total exposure of [14C]-radiolabel in blood
Day 1 to Day 8
Identity of OD-001 metabolites at ≥10% of total exposure of [14C]-radiolabel in blood by LC-MS and NMR
Day 1 to Day 8

Secondary Outcomes (12)

Rate of elimination of [14C]OD-001 in excreta by Ae
Day 1 to Day 8
Rate of elimination of [14C]OD-001 in excreta by %Ae
Day 1 to Day 8
Secondary Rate of elimination of [14C]OD-001 in excreta by CumAe
Day 1 to Day 8
Rate of elimination of [14C]OD-001 in excreta by Cum%Ae by interval
Day 1 to Day 8
Incidence of treatment-emergent adverse events
Day 1 to Day 8
+7 more secondary outcomes

Study Arms (1)

[14C]OD-001

EXPERIMENTAL

oral solution

Drug: [14C]OD-001

Interventions

[14C]OD-001Drug

\[14C\]OD-001

[14C]OD-001

Eligibility Criteria

Age30 Years - 65 Years

Sexmale

Healthy VolunteersYes

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Aged 30 to 65 years inclusive at the time of signing informed consent
Must agree to adhere to the contraception requirements. In addition, vasectomised male participants with partners of childbearing potential must have received medical assessment of the surgical success of the procedure Healthy male participants according to the assessment of the Investigator, as based on a complete medical history including a physical examination, vital signs, single 12-lead ECGs, and laboratory safety tests without any clinically significant abnormalities as measured at screening. ECGs and vital signs to be re-checked at pre-dose.

Sponsors & Collaborators

Odyssey Therapeutics, Inc.
Industrylead

Study Sites (1)

Quotient Sciences

Ruddington, United Kingdom

Study CoordinatorCONTACT+44 (0)115 974 9000 clinicaltrials@odysseytx.com

Study Officials

Anthony Opipari
Odyssey Therapeutics, Inc.
STUDY DIRECTOR
Sharan Sidhu, MBChB, BAO, MRCS, MFPM
Quotient Sciences
PRINCIPAL INVESTIGATOR

Central Study Contacts

Kelly Bourdon

CONTACT

857-393-6160 clinicaltrials@odysseytx.com

Study Design

Study Type: interventional
Phase: phase 1
Allocation: NA
Masking: NONE
Purpose: OTHER
Intervention Model: SINGLE GROUP
Sponsor Type: INDUSTRY
Responsible Party: SPONSOR

Study Record Dates

First Submitted

October 5, 2026

First Posted

October 28, 2026

Study Start

October 2026

Estimated

Planned date reported by the registry; this milestone is not confirmed as achieved.

Primary Completion

December 2026

Estimated

The Mass Balance Recovery, Metabolite Profile and Metabolite Identification of [14C]OD-001 in Healthy Male Participants

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (4)

Secondary Outcomes (12)

Study Arms (1)

[14C]OD-001

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

Study Officials

Central Study Contacts

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (4)

Secondary Outcomes (12)

Study Arms (1)

[14C]OD-001

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

Study Officials

Central Study Contacts

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations