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

An Open Label, Single-Dose, Single-Period Study Designed to Assess the Mass Balance Recovery, Metabolite Profile and Metabolite Identification of [14C]OD-001 in Healthy Male Participants

This study looks at how the body handles an investigational drug called OD-001. Researchers want to learn how the medicine is absorbed, how it is broken down, and how it leaves the body.

About 8 healthy men will join the study, so that at least 6 people complete it. Each participant will drink a single dose of OD-001 as a liquid. This will be done on an empty stomach, so each participant will be asked not to eat for a period of time beforehand.

The medicine contains a small amount of a radioactive "tracer" (carbon-14). The tracer lets researchers follow the medicine and its breakdown products through your body. The amount of radioactivity is small and carefully limited. After the dose, researchers will collect samples such as blood, urine and stool. These will show how much of the medicine is recovered and what it turns into in the body.

Study Overview

• Status: Recruiting
• Conditions: Health Volunteers
• Intervention / Treatment: Drug: [14C]OD-001

• Study Type: Interventional
• Enrollment (Estimated): 8
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Kelly Bourdon; Phone Number: 857-393-6160; Email: clinicaltrials@odysseytx.com

Study Locations

• United Kingdom
  • Ruddington, United Kingdom
    • Recruiting
    • Quotient Sciences
    • Contact: Study Coordinator; Phone Number: +44 (0)115 974 9000; Email: clinicaltrials@odysseytx.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Male

Description

Inclusion Criteria:

• 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.
• Body mass index (BMI) of 18.0 to 35.0 kg/m2 as measured at screening.
• Must have regular bowel movements (i.e. average stool production of ≥1 and ≤3 stools per day).

Exclusion Criteria:

• Presence or history of clinically significant allergy requiring treatment, as judged by the Investigator. Hay fever is allowed unless it is active.
• History of clinically significant cardiovascular, renal, hepatic, dermatological, respiratory, particularly GI disease, especially peptic ulceration, clinically significant GI bleeding, UC, CD, Irritable Bowel Syndrome or malabsorption syndrome that may impair bioavailability, and neurological or psychiatric disorder
• Participants who are unable to take oral medication.
• Acute diarrhea, constipation or vomiting in the 7 days before the predicted Day 1. If screening occurs >7 days before Day 1his criterion will be determined on Day 1. Diarrhoea will be defined as the passage of liquid faeces and/or a stool frequency of greater than three times per day. Constipation will be defined as a failure to open the bowels more frequently than every other day

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: [14C]OD-001; oral solution	Drug: [14C]OD-001; [14C]OD-001

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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 Outcome Measures

Outcome Measure	Time Frame
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
Percentage of [14C] total radioactivity OD-001 metabolites in excreta	Day 1 to Day 8
Tmax of OD-001 in blood, total radioactivity in blood and plasma	Day 1 to Day 8
Cmax of OD-001 in blood, total radioactivity in blood and plasma	Day 1 to Day 8
AUC0-last of OD-001 in blood, total radioactivity in blood and plasma	Day 1 to Day 8
T1/2 of OD-001 in blood, total radioactivity in blood and plasma	Day 1 to Day 8
Incidence of abnormal clinical laboratory test results	Day 1 to Day 8
Incidence of abnormal electrocardiograms (ECGs)	Day 1 to Day 8

Collaborators and Investigators

• Sponsor: Odyssey Therapeutics, Inc.
• Investigators: Principal Investigator: Sharan Sidhu, MBChB, BAO, MRCS, MFPM, Quotient Sciences; Study Director: Anthony Opipari, Odyssey Therapeutics, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): October 31, 2026
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): January 1, 2027

Study Registration Dates

• First Submitted: October 5, 2026
• First Submitted That Met QC Criteria: October 21, 2026
• First Posted (Actual): October 28, 2026

Study Record Updates

• Last Update Posted (Actual): November 5, 2026
• Last Update Submitted That Met QC Criteria: November 2, 2026
• Last Verified: November 1, 2026

More Information

Terms related to this study

• Keywords: phase 1; mass balance
• Other Study ID Numbers: OD-001-100

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No