Healthy VolunteersPhase 1NCT06733298
A Study Investigating [14C]-Labeled RO7269162 in Healthy Male Participants
A Phase 1 study testing [ 14C]-labeled RO7269162 in people with Healthy Volunteers, run by Hoffmann-La Roche at 1 site in Netherlands.
Trial 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. Read more about this study
- Who is it for?
- Ages 35 to 64 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- [ 14C]-labeled RO7269162
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteNetherlands
- Study dates
- 8 Jan 2025to 29 Jan 2025
- Phase
- Phase 1
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 to 64 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 12Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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
- Being tested
- [ 14C]-labeled RO7269162
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
[ 14C]-labeled RO7269162Drug
Participants will receive one oral dose of [14C]-labeled RO7269162.
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Experimental | Participants will receive one oral dose of [14C]-labeled RO7269162 on Day 1. Receives: Drug: [ 14C]-labeled RO7269162 |
What is being measured
The primary outcome is the main question the study is designed to answer.
[14C] recovery in urine
Measured: Up to Day 22 or Day 37
[14C] recovery in feces
Measured: Up to Day 22 or Day 37
Concentration of [14C] in whole blood
Measured: Up to Day 22 or Day 37
Plasma concentration of [14C]
Measured: Up to Day 22 or Day 37
Plasma concentration of RO7269162
Measured: Up to Day 22 or Day 37
Amount of RO7269162 excreted in urine
Measured: Up to Day 22 or Day 37
Secondary outcomes (5)
Amount of RO7269162 metabolites in plasma
Measured: Up to Day 22 or Day 37
Amount of RO7269162 metabolites in blood
Measured: Up to Day 22 or Day 37
Amount of RO7269162 metabolites excreted in urine
Measured: Up to Day 22 or Day 37
Amount of RO7269162 metabolites excreted in feces
Measured: Up to Day 22 or Day 37
Incidence and severity of adverse events
Measured: Up to Day 22 or Day 37
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2024
- Study start8 Jan 2025
- Primary completion29 Jan 2025
- Study completion29 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteersStudies of the same condition, open and under way.
- More trials run by Hoffmann-La RocheThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hoffmann-La Roche
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Trials, Study director, Hoffmann-La Roche
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06733298
- Sponsor's protocol ID
- BP45325
- Status last verified
- Feb 2025
- First submitted
- 10 Dec 2024
- Last updated
- 25 Feb 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No