Healthy VolunteersPhase 1NCT04729309
Mass Balance and Absolute Bioavailability Study of RO7049389 in Healthy Volunteers
A Phase 1 study testing [12C] RO7049389, [13C] RO7049389 and [14C] RO7049389 in people with Healthy Volunteers, run by Hoffmann-La Roche at 1 site in United Kingdom.
Trial summary
The objective of this study is to characterize the mass balance, absolute bioavailability, route and rates of elimination of RO7049839. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- [12C] RO7049389, [13C] RO7049389 and [14C] RO7049389
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 31 Mar 2021to 14 Jun 2021
- 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 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Caucasian (must have Caucasian parents and grandparents) or East Asian (must have Chinese, Korean, or Japanese parents and grandparents)
- Body mass index between 18 to 30 kg/m^2 (inclusive) and a weight range of 50 kg to 100 kg (inclusive) at screening
- For women of childbearing potential: agree to use two methods of contraception, with at least one method considered as highly effective during the study and for at least 90 days after the last dose of study drug
- For men: agree to remain abstinent (refrain from heterosexual intercourse) or agree to use contraceptive measures, and agree to refrain from donating sperm during the treatment period and for at least 90 days after the last dose of study drug
Who cannot join
- Pregnant or lactating women, and male participants with partners who are pregnant or lactating
- History or symptoms of any clinically significant cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematological, oncologic, or neurological disorders capable of significantly altering the absorption, metabolism, or elimination of drugs; of constituting a risk when taking the study treatment; or of interfering with the interpretation of data
- Personal history or family history of congenital long QT interval (QT) syndrome and/or cardiac sudden death
- History of Gilbert syndrome
- Participants who have had significant acute infection, e.g. influenza, local infection, acute gastrointestinal (GI) symptoms, or any other clinically significant illness within two weeks of dose administration
- Any confirmed significant reactions (urticaria or anaphylaxis) against any drug, or multiple drug allergies
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- Any clinically significant concomitant diseases or conditions that could interfere with the conduct of the study, or in the opinion of the Investigator, would pose an unacceptable risk to the participant in this study
- Taking any herbal medications or substances, supplements (including vitamins), traditional Chinese medicines, prescription medicine, or over-the-counter medications within 14 days of first dosing or within 5 times the elimination half-life of the medication prior to first dosing, whichever is longer
- History of having received any systemic anti-neoplastic (including radiation) or immune-modulatory treatment (including systemic oral or inhaled corticosteroids) 6 months prior to the first dose of study drug or the expectation that such treatment will be needed at any time during the study
- Are currently enrolled in or have participated in any other clinical study involving an investigational product or in any other type of medical research within the last 90 days (or within 5 half-lives of the investigational product, whichever is longer)
- Donation or loss of blood or blood products in excess of 500 mL within 3 months of screening
- Evidence of current severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection
- Hepatitis A, B, C, D, or E or HIV infection
- History of drug or alcohol abuse in the past 2 years
- Regular alcohol consumption in males > 21 units per week and in females > 14 units per week (1 unit = 1/2 pint of beer, or a 25 mL shot of 40% spirit, 1.5 to 2 units = 125 mL glass of wine, depending on type)
- Use of > 5 cigarettes or equivalent nicotine-containing product per day prior to screening
- Regular work with ionizing radiation or radioactive material
- Radiation exposure, including that from the present study, excluding background radiation but including diagnostic X-rays and other medical exposures, exceeding 5 mSv in the last 12 months or 10 mSv in the last 5 years. No occupationally exposed worker, as defined in the Ionising Radiation Regulations 2017, shall participate in the study
- Exposure to radiation for diagnostic reasons (except dental X-rays and plain X-rays of thorax and bony skeleton [excluding spinal column]), during work, or during participation in a medical trial in the previous year
- History of gastrointestinal (GI) surgery
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Open-Label Study to Investigate the Mass Balance and Absolute Bioavailability of a Single Oral Dose of [14C]-Labeled RO7049389 or RO7049389 and an Intravenous Micro-Dose of [13C]-Labeled RO7049389 in Healthy Volunteers
The objective of this study is to characterize the mass balance, absolute bioavailability, route and rates of elimination of RO7049839.
- Conditions
- Healthy Volunteers
- Being tested
- [12C] RO7049389, [13C] RO7049389, [14C] RO7049389
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
[12C] RO7049389Drug
Participants will receive oral [12C] RO7049389.
[13C] RO7049389Drug
Participants will receive IV [13C] RO7049389.
[14C] RO7049389Drug
Participants will receive an oral suspension of [14C] RO7049389.
| Study group | Role | What they receive |
|---|---|---|
| Mass Balance (MB) Cohort | Experimental | Participants will receive oral [14C] RO7049389 under fasted conditions, followed by intravenous IV [13C] after a two-hour period. Receives: Drug: [13C] RO7049389; Drug: [14C] RO7049389 |
| Absolute Bioavailability (BA) Cohort | Experimental | In Periods 1 and 2, participants will receive oral [12C] RO7049389 under fasted conditions, followed by IV [13C] RO7049389. There is a minimum 7-day washout between periods. Receives: Drug: [12C] RO7049389; Drug: [13C] RO7049389 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Dose Excreted in Urine - MB Cohort
Measured: Up to Day 17
Percentage of Dose Excreted in Feces - MB Cohort
Measured: Up to Day 17
Percent Total Recovery (Urine + Feces) - MB Cohort
Measured: Up to Day 17
Absolute Oral BA for RO7049389 - BA Cohort
Measured: Up to Day 4 of Periods 1 and 2
Secondary outcomes (17)
Clearance (CL) of RO7049389 - MB Cohort
Measured: Up to Day 17
Clearance (CL) of RO7049389 - BA Cohort
Measured: Up to Day 4 of Periods 1 and 2
Half-Life (T1/2) of RO7049389 - MB Cohort
Measured: Up to Day 17
Half-Life (T1/2) of RO7049389 - BA Cohort
Measured: Up to Day 4 of Periods 1 and 2
Maximum Plasma Concentration (Cmax) of RO7049389 - MB Cohort
Measured: Up to Day 17
Maximum Plasma Concentration (Cmax) of RO7049389 - BA Cohort
Measured: Up to Day 4 of Periods 1 and 2
Time to Maximum Plasma Concentration (Tmax) of RO7049389 - MB Cohort
Measured: Up to Day 17
Time to Maximum Plasma Concentration (Tmax) of RO7049389 - BA Cohort
Measured: Up to Day 4 of Periods 1 and 2
Area Under Concentration-Time Curve From Time Zero to Infinity (AUC0-inf) of RO7049389 - MB Cohort
Measured: Up to Day 4
Area Under Concentration-Time Curve From Time Zero to Infinity (AUC0-inf) of RO7049389 - BA Cohort
Measured: Up to Day 4 of Periods 1 and 2
Area Under the Concentration-Time Curve From Time Zero to Last Measurable Concentration (AUClast) of RO7049389 - MB Cohort
Measured: Up to Day 17
Area Under the Concentration-Time Curve From Time Zero to Last Measurable Concentration (AUClast) of RO7049389 - BA Cohort
Measured: Up to Day 4 of Periods 1 and 2
Apparent Clearance (CL/F) of RO7049389 - MB Cohort
Measured: Up to Day 4
Apparent Clearance (CL/F) of RO7049389 - BA Cohort
Measured: Up to Day 4
Renal Clearance (CLr) of RO7049389 - BA Cohort
Measured: Up to Day 4 of Periods 1 and 2
Amount Excreted in Urine (Ae) of RO7049389 - BA Cohort
Measured: Up to Day 4 of Periods 1 and 2
Percentage of Participants With Adverse Events (AEs)
Measured: Up to Day 29 (MB Cohort) or up to Day 29 of Period 2 (AB Cohort)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2021
- Study start31 Mar 2021
- Primary completion14 Jun 2021
- Study completion14 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 22 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
- NCT04729309
- Sponsor's protocol ID
- BP41811
- Status last verified
- Jan 2024
- First submitted
- 26 Jan 2021
- Last updated
- 15 Jul 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Qualified researchers may request access to individual patient level data through the clinical study data request platform (www.vivli.org). Further details on Roche's criteria for eligible studies are available here (https://vivli.org/ourmember/roche/). For further details on Roche's Global Policy on the Sharing of Clinical Information and how to request access to related clinical study documents, see here (https://www.roche.com/research\_and\_development/who\_we\_are\_how\_we\_work/clinical\_trials/our\_commitment\_to\_data\_sharing.htm).