Healthy VolunteersPhase 1NCT06444191
Pharmacokinetics (PK) of Rilzabrutinib (PRN1008) in Healthy Japanese and Caucasian Subjects
A Phase 1 study testing Rilzabrutinib in people with Healthy Volunteers, run by Principia Biopharma, a Sanofi Company at 1 site in United States.
Trial summary
This is a single-dose and multiple doses study to assess the Pharmacokinetics (PK) of rilzabrutinib as well as to evaluate the tolerability of rilzabrutinib in Japanese and Caucasian Healthy Male and Female subjects. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- Rilzabrutinib
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Jan 2021to 12 Apr 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 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Japanese subjects must have both biological parents and all four grandparents of Japanese ancestry and born in a Japanese country of origin.
- Caucasian subjects must have four Caucasian grandparents (Hispanics of white race can be considered Caucasian).
- Healthy adult male or non-pregnant non-lactating females, 18 to 75 years of age (inclusive) at the time of screening.
- Body mass index (BMI) ≥18 and ≤35 (kg/m2), inclusive, and a minimum body weight of 45 kg.
- Additional inclusion criteria might apply.
Who cannot join
- Symptoms consistent with COVID-19 such as fever, cough, and shortness of breath within 14 days before Day 1.
- Positive test for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) at screening or check-in (Day -1).
- Known previous COVID-19 infection.
- Use of any prescription or over-the-counter (OTC) medication, herbal products, or dietary supplements within the 7 days or 5 half-lives, whichever is longer, prior to the first study drug administration. Use of hormonal contraception is allowed prior to and during the study.
- Additional exclusion criteria might apply.
Trial locations and contacts
1 site in 1 country.
United States1 site
Investigational Site Number: 0001
Glendale, California, 91206
About this study
Official title: A Phase 1, Single-Center, Open-Label Study to Evaluate the Pharmacokinetics and Tolerability of Rilzabrutinib (PRN1008) in Japanese and Caucasian Healthy Male and Female Subjects
This is a single-dose and multiple doses study to assess the Pharmacokinetics (PK) of rilzabrutinib as well as to evaluate the tolerability of rilzabrutinib in Japanese and Caucasian Healthy Male and Female subjects.
- Conditions
- Healthy Volunteers
- Being tested
- Rilzabrutinib
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RilzabrutinibDrug
Rilzabrutinib tablet(s) administered orally
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1: Rilzabrutinib | Experimental | Not described Receives: Drug: Rilzabrutinib |
| Cohort 2: Rilzabrutinib | Experimental | Not described Receives: Drug: Rilzabrutinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum measured concentration of total rilzabrutinib in plasma (Cmax)
Measured: Up to 48 hours after the last rilzabrutinib dose
Time from dosing to maximum measured concentration of total rilzabrutinib in plasma (tmax)
Measured: Up to 48 hours after the last rilzabrutinib dose
Area under the concentration-time curve of total rilzabrutinib in plasma from 0 to the last measurable concentration (AUC0-last)
Measured: Up to 48 hours after the last rilzabrutinib dose
Area under the concentration-time curve of total rilzabrutinib in plasma over the time interval from 0 extrapolated to infinity (AUC0-inf)
Measured: Up to 48 hours after the last rilzabrutinib dose
Area under the plasma concentration-time curve of total rilzabrutinib from zero during the dosage interval (AUC0-tau)
Measured: Up to 48 hours after the last rilzabrutinib dose
Terminal Half-Life of total rilzabrutinib in Plasma (t1/2)
Measured: Up to 48 hours after the last rilzabrutinib dose
Apparent Total Clearance of rilzabrutinib in the plasma after oral administration (CL/F)
Measured: Up to 48 hours after the last rilzabrutinib dose
Apparent volume of distribution after oral administration (Vd/F)
Measured: Up to 48 hours after the last rilzabrutinib dose
Dose proportionality of rilzabrutinib
Measured: Up to 48 hours after the last rilzabrutinib dose
Accumulation ratio (Rac)
Measured: Up to 48 hours after the last rilzabrutinib dose
Secondary outcomes (9)
Incidence of potentially clinically significant laboratory test, vital signs, and electrocardiogram (ECGs) abnormalities
Measured: Up to 14 days after rilzabrutinib dosing
Number of Adverse Events (AE) / Serious Adverse Events (SAE)
Measured: From date of signed ICF, up to 47 days
Bruton's Tyrosine Kinase (BTK) Occupancy characterization
Measured: Up to 48 hours after the last rilzabrutinib dose
Maximum measured concentration of rilzabrutinib metabolites in plasma (Cmax)
Measured: Up to 48 hours after the last rilzabrutinib dose
Time from dosing to maximum measured concentration of rilzabrutinib metabolites in plasma (tmax)
Measured: Up to 48 hours after the last rilzabrutinib dose
Area under the concentration-time curve of rilzabrutinib metabolites in plasma from 0 to the last measurable concentration (AUC0-last)
Measured: Up to 48 hours after the last rilzabrutinib dose
Area under the concentration-time curve of rilzabrutinib metabolites in plasma over the time interval from 0 extrapolated to infinity (AUC0-inf)
Measured: Up to 48 hours after the last rilzabrutinib dose
Area under the plasma concentration-time curve of rilzabrutinib metabolites from zero during the dosage interval (AUC0-tau)
Measured: Up to 48 hours after the last rilzabrutinib dose
Terminal Half-Life of rilzabrutinib metabolites in Plasma (t1/2)
Measured: Up to 48 hours after the last rilzabrutinib dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2024
- Study start4 Jan 2021
- Primary completion12 Apr 2021
- Study completion12 Apr 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
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 23 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
- NCT06444191
- Sponsor's protocol ID
- PKM17089
- Other IDs
- U1111-1260-4452, PRN1008-023, PKM17089
- Status last verified
- May 2024
- First submitted
- 30 May 2024
- Last updated
- 5 Jun 2024
- Results posted
- 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 5 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Single-Center, Open-Label Study to Evaluate the Pharmacokinetics and Tolerability of Rilzabrutinib (PRN1008) in Japanese and Caucasian Healthy Male and Female Subjects
- ClinicalTrials.gov ID
- NCT06444191
- Acronym / sponsor ID
- PKM17089
- Conditions
- Healthy Volunteers
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- Principia Biopharma, a Sanofi CompanyIndustry (pharma, biotech, devices)
- Study start
- 4 Jan 2021 (actual)
- Primary completion
- 12 Apr 2021 (actual)
- Study completion
- 12 Apr 2021 (actual)
- First posted
- 5 Jun 2024 (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.
This is a single-dose and multiple doses study to assess the Pharmacokinetics (PK) of rilzabrutinib as well as to evaluate the tolerability of rilzabrutinib in Japanese and Caucasian Healthy Male and Female subjects.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cohort 1: Rilzabrutinib | Experimental | Drug: Rilzabrutinib |
| Cohort 2: Rilzabrutinib | Experimental | Drug: Rilzabrutinib |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Japanese subjects must have both biological parents and all four grandparents of Japanese ancestry and born in a Japanese country of origin.
- Caucasian subjects must have four Caucasian grandparents (Hispanics of white race can be considered Caucasian).
- Healthy adult male or non-pregnant non-lactating females, 18 to 75 years of age (inclusive) at the time of screening.
- Body mass index (BMI) ≥18 and ≤35 (kg/m2), inclusive, and a minimum body weight of 45 kg.
- Additional inclusion criteria might apply.
Key exclusion criteria (5 listed)
- Symptoms consistent with COVID-19 such as fever, cough, and shortness of breath within 14 days before Day 1.
- Positive test for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) at screening or check-in (Day -1).
- Known previous COVID-19 infection.
- Use of any prescription or over-the-counter (OTC) medication, herbal products, or dietary supplements within the 7 days or 5 half-lives, whichever is longer, prior to the first study drug administration. Use of hormonal contraception is allowed prior to and during the study.
- Additional exclusion criteria might apply.
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 |
|---|---|---|
| RilzabrutinibRilzabrutinib tablet(s) administered orally | Drug | Cohort 1: Rilzabrutinib, Cohort 2: Rilzabrutinib |
Primary outcome
Maximum measured concentration of total rilzabrutinib in plasma (Cmax)
Time frame: Up to 48 hours after the last rilzabrutinib dose
Time from dosing to maximum measured concentration of total rilzabrutinib in plasma (tmax)
Time frame: Up to 48 hours after the last rilzabrutinib dose
Area under the concentration-time curve of total rilzabrutinib in plasma from 0 to the last measurable concentration (AUC0-last)
Time frame: Up to 48 hours after the last rilzabrutinib dose
Area under the concentration-time curve of total rilzabrutinib in plasma over the time interval from 0 extrapolated to infinity (AUC0-inf)
Time frame: Up to 48 hours after the last rilzabrutinib dose
Area under the plasma concentration-time curve of total rilzabrutinib from zero during the dosage interval (AUC0-tau)
Time frame: Up to 48 hours after the last rilzabrutinib dose
Terminal Half-Life of total rilzabrutinib in Plasma (t1/2)
Time frame: Up to 48 hours after the last rilzabrutinib dose
Apparent Total Clearance of rilzabrutinib in the plasma after oral administration (CL/F)
Time frame: Up to 48 hours after the last rilzabrutinib dose
Apparent volume of distribution after oral administration (Vd/F)
Time frame: Up to 48 hours after the last rilzabrutinib dose
Dose proportionality of rilzabrutinib
Time frame: Up to 48 hours after the last rilzabrutinib dose
Accumulation ratio (Rac)
Time frame: Up to 48 hours after the last rilzabrutinib dose
9 secondary outcomes
Incidence of potentially clinically significant laboratory test, vital signs, and electrocardiogram (ECGs) abnormalities
Time frame: Up to 14 days after rilzabrutinib dosing
Number of Adverse Events (AE) / Serious Adverse Events (SAE)
Time frame: From date of signed ICF, up to 47 days
Bruton's Tyrosine Kinase (BTK) Occupancy characterization
Time frame: Up to 48 hours after the last rilzabrutinib dose
Maximum measured concentration of rilzabrutinib metabolites in plasma (Cmax)
Time frame: Up to 48 hours after the last rilzabrutinib dose
Time from dosing to maximum measured concentration of rilzabrutinib metabolites in plasma (tmax)
Time frame: Up to 48 hours after the last rilzabrutinib dose
Area under the concentration-time curve of rilzabrutinib metabolites in plasma from 0 to the last measurable concentration (AUC0-last)
Time frame: Up to 48 hours after the last rilzabrutinib dose
Area under the concentration-time curve of rilzabrutinib metabolites in plasma over the time interval from 0 extrapolated to infinity (AUC0-inf)
Time frame: Up to 48 hours after the last rilzabrutinib dose
Area under the plasma concentration-time curve of rilzabrutinib metabolites from zero during the dosage interval (AUC0-tau)
Time frame: Up to 48 hours after the last rilzabrutinib dose
Terminal Half-Life of rilzabrutinib metabolites in Plasma (t1/2)
Time frame: Up to 48 hours after the last rilzabrutinib dose
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 5 Jun 2024.
- 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.
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 in people with Healthy Volunteers, run by Principia Biopharma, a Sanofi Company at 1 site in United States.
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 5 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 5 Jun 2024. 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 United States. 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?
Maximum measured concentration of total rilzabrutinib in plasma (Cmax) (time frame: Up to 48 hours after the last rilzabrutinib dose). 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 5 Jun 2024.