Hepatic Function AbnormalPhase 1NCT06444204
A Study to Evaluate the Effect of Mild and Moderate Hepatic Impairment on the Single-Dose Pharmacokinetics of Rilzabrutinib (PRN1008)
A Phase 1 study testing Rilzabrutinib in people with Hepatic Function Abnormal and Healthy Volunteers, run by Principia Biopharma, a Sanofi Company at 2 sites in United States.
Trial summary
This is a single-dose study to assess the effect of mild or moderate Hepatic Impairment (HI) on the Pharmacokinetics (PK) of rilzabrutinib as well as to evaluate the safety and tolerability of rilzabrutinib in subjects with HI. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Hepatic Function Abnormal, 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
- 29 participants
- Where
- 2 sitesUnited States
- Study dates
- 2 Nov 2020to 23 Mar 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
- Hepatic Impaired Subjects:
- Non-smoking or light smoker (not exceeding 5 cigarettes per day), adult male or non-pregnant, non-lactating female, 18-75 years of age, inclusive, at screening.
- Weight ≥ 50 kg, at screening.
- Healthy Subjects:
- Non-smoking or light smoker (not exceeding 5 cigarettes per day), healthy, adult males and non-pregnant, non-lactating females, 18-75 years of age, inclusive, at screening.
- Subject must be matched for age (within ± 10 years), and sex of the matched subject with hepatic impairment.
- --Weight ≥ 50 kg at screening.
- Additional inclusion criteria might apply.
Who cannot join
- Hepatic Impaired Subjects:
- Pregnant or lactating female.
- Uncontrolled treated/untreated hypertension (systolic blood pressure ≥ 160 millimeters of mercury [mmHg] and/or diastolic blood pressure ≥ 105 mmHg), or resting pulse rate < 45 or > 100 beats per minute (bpm). Measurements may be repeated once in order to determine eligibility.
- Healthy Subjects
- Pregnant or lactating female.
- Uncontrolled treated/untreated hypertension (systolic blood pressure ≥ 160 mmHg and/or diastolic blood pressure ≥ 105 mmHg), or resting pulse rate < 45 or > 100 bpm. Measurements may be repeated once in order to determine eligibility.
- Additional exclusion criteria might apply.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Investigational Site Number: 0002
Miami, Florida, 33014
Investigational Site Number: 0001
Orlando, Florida, 32809
About this study
Official title: An Open-Label, Phase 1 Study to Evaluate the Effect of Mild and Moderate Hepatic Impairment on the Single-Dose Pharmacokinetics of Rilzabrutinib (PRN1008)
This is a single-dose study to assess the effect of mild or moderate Hepatic Impairment (HI) on the Pharmacokinetics (PK) of rilzabrutinib as well as to evaluate the safety and tolerability of rilzabrutinib in subjects with HI.
- Conditions
- Hepatic Function Abnormal, Healthy Volunteers
- Being tested
- Rilzabrutinib
- Medical subject headings
- Liver Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RilzabrutinibDrug
Rilzabrutinib tablet administered orally
| Study group | Role | What they receive |
|---|---|---|
| Rilzabrutinib: Mild Hepatic Impairment | Experimental | Subjects with mild Hepatic Impairment (HI) Receives: Drug: Rilzabrutinib |
| Rilzabrutinib: Moderate Hepatic Impairment | Experimental | Subjects with moderate Hepatic Impairment (HI) Receives: Drug: Rilzabrutinib |
| Rilzabrutinib: Healthy-Matched Control | Experimental | Subjects with normal hepatic function Receives: Drug: Rilzabrutinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area under the concentration-time curve of total rilzabrutinib in plasma from 0 to t (AUC0-t)
Measured: Up to 30 hours after rilzabrutinib dosing
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 30 hours after rilzabrutinib dosing
Percent of AUC0-inf extrapolated total rilzabrutinib in plasma (%AUCextrap )
Measured: Up to 30 hours after rilzabrutinib dosing
Maximum measured concentration of total rilzabrutinib in plasma (Cmax)
Measured: Up to 30 hours after rilzabrutinib dosing
Time from dosing to maximum measured concentration of total rilzabrutinib in plasma (tmax)
Measured: Up to 30 hours after rilzabrutinib dosing
Terminal Half-Life of total rilzabrutinib in Plasma (t1/2)
Measured: Up to 30 hours after rilzabrutinib dosing
Elimination Rate Constant of total rilzabrutinib (Kel)
Measured: Up to 30 hours after rilzabrutinib dosing
Apparent Total Clearance of rilzabrutinib in the plasma after extra-vascular administration (CL/F)
Measured: Up to 30 hours after rilzabrutinib dosing
Apparent Volume of Distribution during the Terminal elimination phase after extravascular administration (Vz/F)
Measured: Up to 30 hours after rilzabrutinib dosing
Fraction of unbound drug ( rilzabrutinib) expressed as percent (%fu)
Measured: Up to 24 hours after rilzabrutinib dosing
Number of Adverse Events (AE) / Serious Adverse Events (SAE)
Measured: From date of signed ICF, up to 9 days after rilzabrutinib dosing
Incidence of potentially clinically significant laboratory test, vital signs, and electrocardiogram (ECGs) abnormalities
Measured: Up to 30 hours after rilzabrutinib dosing
Secondary outcomes (9)
Area under the concentration-time curve of rilzabrutinib metabolites in plasma from 0 to t (AUC0-t)
Measured: Up to 24 hours after rilzabrutinib dosing
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 24 hours after rilzabrutinib dosing
Percent of AUC0-inf extrapolated rilzabrutinib metabolites in plasma (%AUCextrap)
Measured: Up to 24 hours after rilzabrutinib dosing
Maximum measured concentration of rilzabrutinib metabolites in plasma (Cmax)
Measured: Up to 24 hours after rilzabrutinib dosing
Time from dosing to maximum measured concentration of rilzabrutinib metabolites in plasma (tmax)
Measured: Up to 24 hours after rilzabrutinib dosing
Terminal Half-Life of rilzabrutinib metabolites in Plasma (t1/2)
Measured: Up to 24 hours after rilzabrutinib dosing
Elimination Rate Constant of rilzabrutinib metabolites (Kel)
Measured: Up to 24 hours after rilzabrutinib dosing
Metabolite-to-parent ratio (MRAUC)
MRAUC is Based on AUC0-t, corrected for Molecular weights (MW). MRAUC = (AUC0-t,M/AUC0-t,P) x (MW,P/MW,M) where M was metabolite and P was parent.
Measured: Up to 24 hours after rilzabrutinib dosing
Metabolite-to-parent ratio (MRCmax)
MRCmax is based on Cmax, corrected for MW. MRCmax = (Cmax,M/ Cmax,P) x (MW,P/MW,M) where M was metabolite and P was parent.
Measured: Up to 24 hours after rilzabrutinib dosing
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 start2 Nov 2020
- Primary completion23 Mar 2021
- Study completion23 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatic Function AbnormalStudies 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
- 29 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
- NCT06444204
- Sponsor's protocol ID
- POP17091
- Other IDs
- U1111-1260-4098, PRN1008-020, POP17091
- 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
- An Open-Label, Phase 1 Study to Evaluate the Effect of Mild and Moderate Hepatic Impairment on the Single-Dose Pharmacokinetics of Rilzabrutinib (PRN1008)
- ClinicalTrials.gov ID
- NCT06444204
- Acronym / sponsor ID
- POP17091
- Conditions
- Hepatic Function Abnormal, Healthy Volunteers
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 29 participants (actual)
- Lead sponsor
- Principia Biopharma, a Sanofi CompanyIndustry (pharma, biotech, devices)
- Study start
- 2 Nov 2020 (actual)
- Primary completion
- 23 Mar 2021 (actual)
- Study completion
- 23 Mar 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 study to assess the effect of mild or moderate Hepatic Impairment (HI) on the Pharmacokinetics (PK) of rilzabrutinib as well as to evaluate the safety and tolerability of rilzabrutinib in subjects with HI.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Rilzabrutinib: Mild Hepatic Impairment | Experimental | Drug: RilzabrutinibSubjects with mild Hepatic Impairment (HI) |
| Rilzabrutinib: Moderate Hepatic Impairment | Experimental | Drug: RilzabrutinibSubjects with moderate Hepatic Impairment (HI) |
| Rilzabrutinib: Healthy-Matched Control | Experimental | Drug: RilzabrutinibSubjects with normal hepatic function |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Hepatic Impaired Subjects:
- Healthy Subjects:
- Subject must be matched for age (within ± 10 years), and sex of the matched subject with hepatic impairment.
- --Weight ≥ 50 kg at screening.
- Additional inclusion criteria might apply.
Key exclusion criteria (7 listed)
- Hepatic Impaired Subjects:
- Healthy Subjects
- 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 administered orally | Drug | Rilzabrutinib: Healthy-Matched Control, Rilzabrutinib: Mild Hepatic Impairment, Rilzabrutinib: Moderate Hepatic Impairment |
Primary outcome
Area under the concentration-time curve of total rilzabrutinib in plasma from 0 to t (AUC0-t)
Time frame: Up to 30 hours after rilzabrutinib dosing
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 30 hours after rilzabrutinib dosing
Percent of AUC0-inf extrapolated total rilzabrutinib in plasma (%AUCextrap )
Time frame: Up to 30 hours after rilzabrutinib dosing
Maximum measured concentration of total rilzabrutinib in plasma (Cmax)
Time frame: Up to 30 hours after rilzabrutinib dosing
Time from dosing to maximum measured concentration of total rilzabrutinib in plasma (tmax)
Time frame: Up to 30 hours after rilzabrutinib dosing
Terminal Half-Life of total rilzabrutinib in Plasma (t1/2)
Time frame: Up to 30 hours after rilzabrutinib dosing
Elimination Rate Constant of total rilzabrutinib (Kel)
Time frame: Up to 30 hours after rilzabrutinib dosing
Apparent Total Clearance of rilzabrutinib in the plasma after extra-vascular administration (CL/F)
Time frame: Up to 30 hours after rilzabrutinib dosing
Apparent Volume of Distribution during the Terminal elimination phase after extravascular administration (Vz/F)
Time frame: Up to 30 hours after rilzabrutinib dosing
Fraction of unbound drug ( rilzabrutinib) expressed as percent (%fu)
Time frame: Up to 24 hours after rilzabrutinib dosing
Number of Adverse Events (AE) / Serious Adverse Events (SAE)
Time frame: From date of signed ICF, up to 9 days after rilzabrutinib dosing
Incidence of potentially clinically significant laboratory test, vital signs, and electrocardiogram (ECGs) abnormalities
Time frame: Up to 30 hours after rilzabrutinib dosing
9 secondary outcomes
Area under the concentration-time curve of rilzabrutinib metabolites in plasma from 0 to t (AUC0-t)
Time frame: Up to 24 hours after rilzabrutinib dosing
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 24 hours after rilzabrutinib dosing
Percent of AUC0-inf extrapolated rilzabrutinib metabolites in plasma (%AUCextrap)
Time frame: Up to 24 hours after rilzabrutinib dosing
Maximum measured concentration of rilzabrutinib metabolites in plasma (Cmax)
Time frame: Up to 24 hours after rilzabrutinib dosing
Time from dosing to maximum measured concentration of rilzabrutinib metabolites in plasma (tmax)
Time frame: Up to 24 hours after rilzabrutinib dosing
Terminal Half-Life of rilzabrutinib metabolites in Plasma (t1/2)
Time frame: Up to 24 hours after rilzabrutinib dosing
Elimination Rate Constant of rilzabrutinib metabolites (Kel)
Time frame: Up to 24 hours after rilzabrutinib dosing
Metabolite-to-parent ratio (MRAUC)
Time frame: Up to 24 hours after rilzabrutinib dosing
Metabolite-to-parent ratio (MRCmax)
Time frame: Up to 24 hours after rilzabrutinib dosing
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
2 sites 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 Hepatic Function Abnormal and Healthy Volunteers, run by Principia Biopharma, a Sanofi Company at 2 sites 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 8 inclusion and 7 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 2 sites 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?
Area under the concentration-time curve of total rilzabrutinib in plasma from 0 to t (AUC0-t) (time frame: Up to 30 hours after rilzabrutinib dosing). The study lists 12 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; AzTrials last refreshed its copy on 3 Nov 2026.