Clinical trial NCT06733298: A Study Investigating [14C]-Labeled RO7269162 in Healthy Male Participants
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Volunteers
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2024-12-13
Enrollment: 8
Sex: MALE
Minimum age (years): 35
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: [14C] recovery in urine
timeFrame: Up to Day 22 or Day 37
measure: [14C] recovery in feces
timeFrame: Up to Day 22 or Day 37
measure: Concentration of [14C] in whole blood
timeFrame: Up to Day 22 or Day 37
measure: Plasma concentration of [14C]
timeFrame: Up to Day 22 or Day 37
measure: Plasma concentration of RO7269162
timeFrame: Up to Day 22 or Day 37
measure: Amount of RO7269162 excreted in urine
timeFrame: Up to Day 22 or Day 37
Secondary outcomes:
measure: Amount of RO7269162 metabolites in plasma
timeFrame: Up to Day 22 or Day 37
measure: Amount of RO7269162 metabolites in blood
timeFrame: Up to Day 22 or Day 37
measure: Amount of RO7269162 metabolites excreted in urine
timeFrame: Up to Day 22 or Day 37
measure: Amount of RO7269162 metabolites excreted in feces
timeFrame: Up to Day 22 or Day 37
measure: Incidence and severity of adverse events
timeFrame: Up to Day 22 or Day 37
Other outcomes:
Locations:
city: Groningen
country: Netherlands
facility: ICON Health sciences research center
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References: