OD-001 mass balance and metabolism in healthy men

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This Phase 1 interventional study uses a single oral dose of [14C]OD-001 in healthy male volunteers to characterize pharmacokinetics. The primary aim is to determine how the drug is absorbed, metabolized, and eliminated, by collecting blood, urine, and stool samples over time. A radioactive tracer allows tracking of OD-001 and its metabolites while safety measures limit radiation exposure. Approximately 8 enrolled participants are planned to ensure at least 6 complete the study. Eligibility focuses on adults 30–65 with BMI 18–35 and adherence to contraception requirements; key exclusions include significant allergies or clinically meaningful medical abnormalities.

Why it matters

Who can join: the full rules

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

Where it's running

• Quotient Sciences
  Ruddington, United Kingdom Recruiting

Study contacts

• Principal investigator: Sharan Sidhu, MBChB, BAO, MRCS, MFPM — Quotient Sciences
• Study coordinator: Kelly Bourdon
• Email: clinicaltrials@odysseytx.com
• Phone: 857-393-6160

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.