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

NCT06733298 | Completed Phase 1

• 1 other identifier: BP45325
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (6)

• [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 Outcomes (5)

• 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

Study Arms (1)

Arm 1

EXPERIMENTAL

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

Drug: [ 14C]-labeled RO7269162

Interventions

[ 14C]-labeled RO7269162 DRUG

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

Arm 1

Eligibility Criteria

• Age: 35 Years - 64 Years
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hoffmann-La Roche: lead

Study Sites (1)

ICON Health sciences research center

Groningen, 9728 NZ, Netherlands

Location

Study Officials

• Clinical Trials

  Hoffmann-La Roche

  STUDY DIRECTOR

Study Design

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

Study Record Dates

• First Submitted: December 10, 2024
• First Posted: December 13, 2024
• Study Start: January 8, 2025
• Primary Completion: January 29, 2025
• Study Completion: January 29, 2025
• Last Updated: February 25, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)