Healthy VolunteersPhase 1NCT04748926
Food Effect and Relative Bioavailability Study of Rilzabrutinib in Healthy Participants
A Phase 1 study testing rilzabrutinib SAR444671 in people with Healthy Volunteers, run by Principia Biopharma, a Sanofi Company at 1 site in Australia.
Trial summary
Primary Objective: To evaluate the impact of food on the pharmacokinetics (PK) of rilzabrutinib following single oral doses to healthy subjects. To evaluate the impact of formulation on the PK of rilzabrutinib following single oral doses to healthy subjects Secondary Objective: To assess the safety and tolerability of… 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?
- rilzabrutinib SAR444671
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteAustralia
- Study dates
- 7 Apr 2021to 21 May 2021
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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
- Participants who are overtly healthy as determined by medical evaluation
- Body mass index (BMI) within the range ≥18 and ≤31 kg/m2 (inclusive) and a minimum body weight of 45 kg.
- Female participant is eligible to participate if she is not pregnant or breastfeeding
- Male participants are eligible to participate if they agree to refrain from donating sperm and use contraception/barrier or be abstinent from intercourse
Who cannot join
- COVID-19 infection, positive test result for human immunodeficiency virus (HIV), hepatitis B virus or hepatitis C virus antibody
- Use of any prescription or over-the-counter (OTC) medication, herbal products, or dietary supplements within 7 days
- Participation in another clinical trial of a drug or device whereby the last investigational drug/device administration is within 30 days or 5 half-lives, whichever is longer, prior to the first dose of study drug.
- Clinically significant abnormal in vital signs. - Any specific situation during study implementation/course that may rise ethics considerations.
- The above information is not intended to contain all considerations relevant to a subject's potential participation in a clinical trial.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Open-label, Phase I Study to Assess the Effects of Food and Formulation on the Pharmacokinetics of a Single Dose of Rilzabrutinib (SAR444671 [Formerly PRN1008]) in Healthy Male and Female Participants
Primary Objective:
- To evaluate the impact of food on the pharmacokinetics (PK) of rilzabrutinib following single oral doses to healthy subjects.
- To evaluate the impact of formulation on the PK of rilzabrutinib following single oral doses to healthy subjects
Secondary Objective:
- To assess the safety and tolerability of single oral doses of rilzabrutinib administered under fasted and fed conditions
Read the detailed description
The total study duration is approximately 43 days for each participant, including a screening period of 2 to 28 days, treatment period of 12 days, and follow-up of 3 days
- Conditions
- Healthy Volunteers
- Being tested
- rilzabrutinib SAR444671
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
rilzabrutinib SAR444671Drug
Pharmaceutical form: caplet Route of administration: oral
rilzabrutinib SAR444671Drug
Pharmaceutical form: Oral Formulation 1 tablets Route of administration: oral
rilzabrutinib SAR444671Drug
Pharmaceutical form: Oral Formulation 2 tablets Route of administration: oral
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Experimental | Participants will receive caplets after fast (treatment A) on Day 1 and caplets after meal (treatment B) on day 6, and then receive either oral formulation 1 tablets after fast (treatment C) or oral formulation 2 tablets after fast (treatment D) on day 11. Receives: Drug: rilzabrutinib SAR444671 |
| Group 2 | Experimental | Participants will receive caplets after meal (treatment B) on Day 1 and caplets after fast (treatment A) on day 6, and then receive either oral formulation 1 tablets after fast (treatment C) or oral formulation 2 tablets after fast (treatment D) on day 11. Receives: Drug: rilzabrutinib SAR444671 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rilzabrutinib plasma PK parameters following administration of the reference formulation in the fed and fasted states: Cmax
maximun plasma concentration
Measured: From Day 1 to Day 7
Rilzabrutinib plasma PK parameters following administration of the reference formulation in the fed and fasted states: Tmax
time to maximum plasma concentration
Measured: From Day 1 to Day 7
Rilzabrutinib plasma PK parameters following administration of the reference formulation in the fed and fasted states: AUC0-last
area under the plasma concentration-time curve from zero to the last measurable concentration
Measured: From Day 1 to Day 7
Rilzabrutinib plasma PK parameters following administration of the reference formulation in the fed and fasted states: AUC0-inf
area under the plasma concentration-time curve from zero to infinity
Measured: From Day 1 to Day 7
Rilzabrutinib plasma PK parameters following administration of the reference formulation in the fed and fasted states: half-life
terminal elimination phase half-life
Measured: From Day 1 to Day 7
Rilzabrutinib plasma PK parameters following administration of two test formulations in the fasted state: Cmax
maximun plasma concentration
Measured: From Day 11 to Day 12
Rilzabrutinib plasma PK parameters following administration of two test formulations in the fasted state: Tmax
time to maximum plasma concentration
Measured: From Day 11 to Day 12
Rilzabrutinib plasma PK parameters following administration of two test formulations in the fasted state: AUC0-last
area under the plasma concentration-time curve from zero to the last measurable concentration
Measured: From Day 11 to Day 12
Rilzabrutinib plasma PK parameters following administration of two test formulations in the fasted state: AUC0-inf
area under the plasma concentration-time curve from zero to infinity
Measured: From Day 11 to Day 12
Rilzabrutinib plasma PK parameters following administration of two test formulations in the fasted state: half-life
terminal elimination phase half-life
Measured: From Day 11 to Day 12
Secondary outcomes (1)
Treatment-emergent AE and treatment-emergent SAE
Measured: Until Day 15
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2021
- Study start7 Apr 2021
- Primary completion21 May 2021
- Study completion21 May 2021
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.
- 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
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Principia Biopharma, a Sanofi Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Sciences & Operations, Study director, Sanofi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04748926
- Sponsor's protocol ID
- PKM17098
- Other IDs
- U1111-1260-4526, PRN1008-25
- Status last verified
- Sep 2025
- First submitted
- 3 Feb 2021
- Last updated
- 23 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- 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 23 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Open-label, Phase I Study to Assess the Effects of Food and Formulation on the Pharmacokinetics of a Single Dose of Rilzabrutinib (SAR444671 [Formerly PRN1008]) in Healthy Male and Female Participants
- ClinicalTrials.gov ID
- NCT04748926
- Acronym / sponsor ID
- PKM17098
- Conditions
- Healthy Volunteers
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Principia Biopharma, a Sanofi CompanyIndustry (pharma, biotech, devices)
- Study start
- 7 Apr 2021 (actual)
- Primary completion
- 21 May 2021 (actual)
- Study completion
- 21 May 2021 (actual)
- First posted
- 10 Feb 2021 (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.
Primary Objective:
- To evaluate the impact of food on the pharmacokinetics (PK) of rilzabrutinib following single oral doses to healthy subjects.
- To evaluate the impact of formulation on the PK of rilzabrutinib following single oral doses to healthy subjects
Secondary Objective:
- To assess the safety and tolerability of single oral doses of rilzabrutinib administered under fasted and fed conditions
Detailed description
The total study duration is approximately 43 days for each participant, including a screening period of 2 to 28 days, treatment period of 12 days, and follow-up of 3 days
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Experimental | Drug: rilzabrutinib SAR444671Participants will receive caplets after fast (treatment A) on Day 1 and caplets after meal (treatment B) on day 6, and then receive either oral formulation 1 tablets after fast (treatment C) or oral formulation 2 tablets after fast (treatment D) on day 11. |
| Group 2 | Experimental | Drug: rilzabrutinib SAR444671Participants will receive caplets after meal (treatment B) on Day 1 and caplets after fast (treatment A) on day 6, and then receive either oral formulation 1 tablets after fast (treatment C) or oral formulation 2 tablets after fast (treatment D) on day 11. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Participants who are overtly healthy as determined by medical evaluation
- Body mass index (BMI) within the range ≥18 and ≤31 kg/m2 (inclusive) and a minimum body weight of 45 kg.
- Female participant is eligible to participate if she is not pregnant or breastfeeding
- Male participants are eligible to participate if they agree to refrain from donating sperm and use contraception/barrier or be abstinent from intercourse
Key exclusion criteria (5 listed)
- COVID-19 infection, positive test result for human immunodeficiency virus (HIV), hepatitis B virus or hepatitis C virus antibody
- Use of any prescription or over-the-counter (OTC) medication, herbal products, or dietary supplements within 7 days
- Participation in another clinical trial of a drug or device whereby the last investigational drug/device administration is within 30 days or 5 half-lives, whichever is longer, prior to the first dose of study drug.
- Clinically significant abnormal in vital signs. - Any specific situation during study implementation/course that may rise ethics considerations.
- The above information is not intended to contain all considerations relevant to a subject's potential participation in a clinical trial.
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 |
|---|---|---|
| rilzabrutinib SAR444671Pharmaceutical form: caplet Route of administration: oral | Drug | Group 1, Group 2 |
| rilzabrutinib SAR444671Pharmaceutical form: Oral Formulation 1 tablets Route of administration: oral | Drug | Group 1, Group 2 |
| rilzabrutinib SAR444671Pharmaceutical form: Oral Formulation 2 tablets Route of administration: oral | Drug | Group 1, Group 2 |
Primary outcome
Rilzabrutinib plasma PK parameters following administration of the reference formulation in the fed and fasted states: Cmax
Time frame: From Day 1 to Day 7
maximun plasma concentration
Rilzabrutinib plasma PK parameters following administration of the reference formulation in the fed and fasted states: Tmax
Time frame: From Day 1 to Day 7
time to maximum plasma concentration
Rilzabrutinib plasma PK parameters following administration of the reference formulation in the fed and fasted states: AUC0-last
Time frame: From Day 1 to Day 7
area under the plasma concentration-time curve from zero to the last measurable concentration
Rilzabrutinib plasma PK parameters following administration of the reference formulation in the fed and fasted states: AUC0-inf
Time frame: From Day 1 to Day 7
area under the plasma concentration-time curve from zero to infinity
Rilzabrutinib plasma PK parameters following administration of the reference formulation in the fed and fasted states: half-life
Time frame: From Day 1 to Day 7
terminal elimination phase half-life
Rilzabrutinib plasma PK parameters following administration of two test formulations in the fasted state: Cmax
Time frame: From Day 11 to Day 12
maximun plasma concentration
Rilzabrutinib plasma PK parameters following administration of two test formulations in the fasted state: Tmax
Time frame: From Day 11 to Day 12
time to maximum plasma concentration
Rilzabrutinib plasma PK parameters following administration of two test formulations in the fasted state: AUC0-last
Time frame: From Day 11 to Day 12
area under the plasma concentration-time curve from zero to the last measurable concentration
Rilzabrutinib plasma PK parameters following administration of two test formulations in the fasted state: AUC0-inf
Time frame: From Day 11 to Day 12
area under the plasma concentration-time curve from zero to infinity
Rilzabrutinib plasma PK parameters following administration of two test formulations in the fasted state: half-life
Time frame: From Day 11 to Day 12
terminal elimination phase half-life
1 secondary outcome
Treatment-emergent AE and treatment-emergent SAE
Time frame: Until Day 15
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2025.
- PKM17098 Plain Language Results SummaryLink provided by the sponsor.
- 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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Screening Protocol
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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.
Clinical Sciences & Operations study director
Sanofi
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 SAR444671 in people with Healthy Volunteers, run by Principia Biopharma, a Sanofi Company at 1 site in Australia.
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 4 inclusion and 5 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: finished, as of the sponsor's last update on 23 Sep 2025. 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 Australia. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Rilzabrutinib plasma PK parameters following administration of the reference formulation in the fed and fasted states: Cmax (time frame: From Day 1 to Day 7). The study lists 10 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 23 Sep 2025.