A Study Investigating [14C]-Labeled RO7269162 in Healthy Male Participants

Open-Label, Non-Randomized Study Investigating the Excretion Balance, Pharmacokinetics, and Metabolism of a Single Oral Dose of [14C]-Labeled RO7269162 in Healthy Male Participants

This study will investigate how RO7269162 labeled with a carbon tracer ([14C]) is absorbed, metabolized, and eliminated by the body after a single dose in healthy male volunteers.

Study Overview

• Status: Completed
• Conditions: Healthy Volunteers
• Intervention / Treatment: Drug: [ 14C]-labeled RO7269162

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

Contacts and Locations

Study Locations

• Netherlands
  • Groningen, Netherlands, 9728 NZ
    • ICON Health sciences research center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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 (refrain from heterosexual intercourse) or use contraception as defined by the protocol with a partner that is a woman of childbearing potential; remain abstinent or use contraception with a pregnant female partner; refrain from donating sperm

Exclusion Criteria:

• History or evidence of any clinically significant gastrointestinal, renal, hepatic, broncho-pulmonary, neurological, psychiatric, cardiovascular, endocrinological, hematological, or allergic disease, metabolic disorder, cancer, or cirrhosis
• Any disease or condition that could interfere with the conduct of the study or pose an unacceptable risk to the participant
• History or evidence of any medical condition that could potentially alter the absorption, metabolism, or elimination of drugs
• Surgical history of the gastrointestinal (GI) tract affecting gastric motility or altering the GI tract (with the exception of uncomplicated appendectomy and hernia repair)
• History of malignancy
• Use of any prescription drugs, herbal supplements, and/or over-the-counter medication (OTC), dietary supplements (vitamins included) within 2 weeks before Day 1. Use of any prohibited food before study start and during the study as defined by the protocol
• Likely to need medication during the study period except for those defined by the protocol
• Are currently enrolled in, have participated in, or plan to participate in any other clinical study involving an investigational medicinal product or medical device study from within the 30 days directly preceding screening or within 5 times the elimination half-life, if known (whichever is longer), until completion of the follow-up visit
• Evidence of human immunodeficiency virus (HIV), hepatitis B, or hepatitis C
• Donation of blood or blood products for transfusion over 100 mL or significant blood loss within 2 months prior to screening through study completion, clinic discharge or early termination, inclusive. Donation of blood or plasma is not allowed throughout the entire study. Receipt of blood products within 2 months prior to Day -1 is not allowed
• Clinically significant history of hypersensitivity or allergic reactions
• Regular work with ionizing radiation or radioactive material, or exposure to ionizing radiation within 1 year prior to study drug administration

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• 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: Arm 1; Participants will receive one oral dose of [14C]-labeled RO7269162 on Day 1.	Drug: [ 14C]-labeled RO7269162; Participants will receive one oral dose of [14C]-labeled RO7269162.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
[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 Outcome Measures

Outcome Measure	Time Frame
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
Amount of RO7269162 metabolites excreted in feces	Up to Day 22 or Day 37
Incidence and severity of adverse events	Up to Day 22 or Day 37

Collaborators and Investigators

• Sponsor: Hoffmann-La Roche
• Investigators: Study Director: Clinical Trials, Hoffmann-La Roche

Study record dates

Study Major Dates

• Study Start (Actual): January 8, 2025
• Primary Completion (Actual): January 29, 2025
• Study Completion (Actual): January 29, 2025

Study Registration Dates

• First Submitted: December 10, 2024
• First Submitted That Met QC Criteria: December 10, 2024
• First Posted (Actual): December 13, 2024

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 23, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Other Study ID Numbers: BP45325

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

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