Healthy VolunteerPhase 1NCT07855250
An Open-label DDI Study to Investigate the Effect of Rilzabrutinib on P-gp, BCRP, OATP1B1 and OATP1B3 Inhibition
A Phase 1 study testing Rilzabrutinib, Rosuvastatin and Digoxin in people with Healthy Volunteer, run by Sanofi at 1 site in Canada.
Trial summary
The study is a single-center, Phase-1, open-label, one-sequence, two-treatment period, cross-over, DDI study designed to investigate the effects of rilzabrutinib on the PK of digoxin (as P-gp substrate) and of rosuvastatin (as substrate of BCRP, OATP1B1, and OATP1B3) in healthy male and female participants. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteer
- What is being tested?
- Rilzabrutinib, Rosuvastatin and Digoxin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteCanada
- Study dates
- 1 Oct 2026to 3 Nov 2026
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Participant must be 18 to 55 years of age inclusive.
- Body weight between 50.0 and 100.0 kg for males, 40.0 and 90.0 kg for females.
- Contraceptive use by male and female participants should be consistent with local regulations
Who cannot join
- History of serious infections requiring intravenous therapy.
- Frequent headaches, migraine, nausea or vomiting.
- Blood donation within 1 month before inclusion.
- History of drug hypersensitivity or allergic disease.
- History of drug or alcohol abuse.
- Smoking regularly more than 5 cigarettes or equivalent in nicotine per week
Show all 10Show fewer
- Excessive consumption of beverages containing xanthine bases.
- Pregnancy or breastfeeding.
- Recent vaccinations.
- The above information is not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase-1, Open-label, One-sequence, Two-treatment Period, Cross-over, Drug-drug Interaction Study to Evaluate the Effect of Oral Rilzabrutinib on P-gp, BCRP, OATP1B1 and OATP1B3 Substrates in Healthy Participants
The study is a single-center, Phase-1, open-label, one-sequence, two-treatment period, cross-over, DDI study designed to investigate the effects of rilzabrutinib on the PK of digoxin (as P-gp substrate) and of rosuvastatin (as substrate of BCRP, OATP1B1, and OATP1B3) in healthy male and female participants. For this study a cocktail of digoxin and rosuvastatin will be used.
- Conditions
- Healthy Volunteer
- Being tested
- Rilzabrutinib, Rosuvastatin, Digoxin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RilzabrutinibDrug
Also called SAR444671
From Day 1 to Day 12 of Period 2
RosuvastatinDrug
Also called Crestor
Single dose on Day 1 of Period 1 and on Day 8 of Period 2
DigoxinDrug
Also called Lanicor
Single dose on Day 1 of Period 1 and on Day 8 of Period 2
| Study group | Role | What they receive |
|---|---|---|
| Treatment A then Treatment B | Experimental | Treatment A in Period 1: digoxin + rosuvastatin cocktail alone on Day 1 of Period 1 Treatment B in Period 2: rilzabrutinib (SAR444671) BID from Day 1 to Day 12 of Period 2, plus digoxin + rosuvastatin cocktail on Day 8 of Period 2 Receives: Drug: Rilzabrutinib; Drug: Rosuvastatin; Drug: Digoxin |
What is being measured
The primary outcome is the main question the study is designed to answer.
AUC for digoxin and rosuvastatin
area under curve
Measured: Up to Day 13 in Period 2
AUClast for digoxin and rosuvastatin
area under the curve from time zero to the last measurable concentration
Measured: Up to Day 13 in Period 2
Cmax for digoxin and rosuvastatin
maximum (peak) plasma concentration
Measured: Up to Day 13 in Period 2
Secondary outcomes (5)
tmax for digoxin and for rosuvastatin
time to reach maximum plasma concentration
Measured: Up to Day 13 in Period 2
tmax for rilzabrutinib
time to reach maximum plasma concentration
Measured: Up to Day 11 in Period 2
Cmax for rilzabrutinib
maximum (peak) plasma concentration
Measured: Up to Day 11 in Period 2
AUC0-tau for rilzabrutinib
area under the plasma concentration-time curve from time 0 to tau
Measured: Up to Day 11 in Period 2
Assessment of AEs and TEAEs
including clinical laboratory evaluation, vital signs, and electrocardiogram (ECG).
Measured: Up to Day 21 in Period 2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2026
- Study start1 Oct 2026
- Primary completion3 Nov 2026 (estimated)
- Study completion3 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteerStudies of the same condition, open and under way.
- More trials run by SanofiThe 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
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 14 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sanofi
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07855250
- Sponsor's protocol ID
- INT22851
- Other IDs
- U1111-1334-2206
- Status last verified
- Oct 2026
- First submitted
- 21 Sep 2026
- Last updated
- 21 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase-1, Open-label, One-sequence, Two-treatment Period, Cross-over, Drug-drug Interaction Study to Evaluate the Effect of Oral Rilzabrutinib on P-gp, BCRP, OATP1B1 and OATP1B3 Substrates in Healthy Participants
- ClinicalTrials.gov ID
- NCT07855250
- Acronym / sponsor ID
- INT22851
- Conditions
- Healthy Volunteer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 14 participants (estimated)
- Lead sponsor
- SanofiIndustry (pharma, biotech, devices)
- Study start
- 1 Oct 2026 (actual)
- Primary completion
- 3 Nov 2026 (estimated)
- Study completion
- 3 Nov 2026 (estimated)
- First posted
- 2 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study is a single-center, Phase-1, open-label, one-sequence, two-treatment period, cross-over, DDI study designed to investigate the effects of rilzabrutinib on the PK of digoxin (as P-gp substrate) and of rosuvastatin (as substrate of BCRP, OATP1B1, and OATP1B3) in healthy male and female participants. For this study a cocktail of digoxin and rosuvastatin will be used.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment A then Treatment B | Experimental | Drug: Rilzabrutinib, Drug: Rosuvastatin, Drug: DigoxinTreatment A in Period 1: digoxin + rosuvastatin cocktail alone on Day 1 of Period 1 Treatment B in Period 2: rilzabrutinib (SAR444671) BID from Day 1 to Day 12 of Period 2, plus digoxin + rosuvastatin cocktail on Day 8 of Period 2 |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Participant must be 18 to 55 years of age inclusive.
- Body weight between 50.0 and 100.0 kg for males, 40.0 and 90.0 kg for females.
- Contraceptive use by male and female participants should be consistent with local regulations
Key exclusion criteria (10 listed)
- History of serious infections requiring intravenous therapy.
- Frequent headaches, migraine, nausea or vomiting.
- Blood donation within 1 month before inclusion.
- History of drug hypersensitivity or allergic disease.
- History of drug or alcohol abuse.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RilzabrutinibAlso: SAR444671From Day 1 to Day 12 of Period 2 | Drug | Treatment A then Treatment B |
| RosuvastatinAlso: CrestorSingle dose on Day 1 of Period 1 and on Day 8 of Period 2 | Drug | Treatment A then Treatment B |
| DigoxinAlso: LanicorSingle dose on Day 1 of Period 1 and on Day 8 of Period 2 | Drug | Treatment A then Treatment B |
Primary outcome
AUC for digoxin and rosuvastatin
Time frame: Up to Day 13 in Period 2
area under curve
AUClast for digoxin and rosuvastatin
Time frame: Up to Day 13 in Period 2
area under the curve from time zero to the last measurable concentration
Cmax for digoxin and rosuvastatin
Time frame: Up to Day 13 in Period 2
maximum (peak) plasma concentration
5 secondary outcomes
tmax for digoxin and for rosuvastatin
Time frame: Up to Day 13 in Period 2
tmax for rilzabrutinib
Time frame: Up to Day 11 in Period 2
Cmax for rilzabrutinib
Time frame: Up to Day 11 in Period 2
AUC0-tau for rilzabrutinib
Time frame: Up to Day 11 in Period 2
Assessment of AEs and TEAEs
Time frame: Up to Day 21 in Period 2
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Oct 2026.
- Individual participant dataSharing planned: Yes. Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Rilzabrutinib, Rosuvastatin and Digoxin in people with Healthy Volunteer, run by Sanofi at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 21 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
AUC for digoxin and rosuvastatin (time frame: Up to Day 13 in Period 2). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Oct 2026.