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

NCT ID: NCT06733298

Last Updated: 2025-02-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 8 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-01-08
• Study Completion Date: 2025-01-29

Brief Summary

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.

Conditions

Healthy Volunteers

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Arm 1

Participants will receive one oral dose of \[14C\]-labeled RO7269162 on Day 1.

Group Type: EXPERIMENTAL

[ 14C]-labeled RO7269162

Intervention Type: DRUG

Participants will receive one oral dose of \[14C\]-labeled RO7269162.

Interventions

[ 14C]-labeled RO7269162

Participants will receive one oral dose of \[14C\]-labeled RO7269162.

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 35 Years
• Maximum Eligible Age: 64 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Hoffmann-La Roche

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Clinical Trials

Role: STUDY_DIRECTOR

Hoffmann-La Roche

Locations

ICON Health sciences research center

Groningen, , Netherlands

Countries

Netherlands

Other Identifiers

BP45325

Identifier Type: -

Identifier Source: org_study_id