Liver DiseasesPhase 1NCT06340347
A Study to Learn How the Body Processes the Study Medicine Called Osivelotor (PF-07940367) in People With Loss of Liver Function
A Phase 1 study testing Osivelotor in people with Liver Diseases, run by Pfizer at 3 sites in United States.
Trial summary
The purpose of this study is to understand how Osivelotor is processed in people with loss of liver function. This study is seeking participants that are: stable loss of liver function with mild or moderate severity none of underlying conditions possibly affecting the study medicine being absorbed by the body All… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Liver Diseases
- What is being tested?
- Osivelotor
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 3 sitesUnited States
- Study dates
- 30 Apr 2024to 18 Sep 2024
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Body mass index (BMI) of 16 to 40 kg/m2, inclusive; and a total body weight greater than 50 kg (greater than 110 lb)
- Stable hepatic impairment that meets the criteria for Class A or B of the Child Pugh classification with no clinically significant change in disease status within the 28 days prior to the screening visit
- Stable concomitant medications for the management of individual participants' medical history
Who cannot join
- Any condition possibly affecting drug absorption (eg, prior bariatric surgery, gastrectomy, ileal resection, prior status portacaval shunt surgery);
- Hepatic carcinoma or hepatorenal syndrome or limited predicted life expectancy;
- A diagnosis of hepatic dysfunction secondary to any acute ongoing hepatocellular process that is documented by medical history, physical examination, liver biopsy, hepatic ultrasound, computerized tomography scan, or MRI;
- Presence of clinically active Stage 3 or 4 hepatic encephalopathy. Clinically active Stage 2 encephalopathy is allowed if, in the opinion of the investigator, the participant is able to provide informed consent.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Orange County Research Center
Lake Forest, California, 92630
Thomas Jefferson University-Pharmacology, Physiology and Cancer Biology
Philadelphia, Pennsylvania, 19107
Genesis Clinical Research, LLC
Tampa, Florida, 33603
About this study
Official title: A PHASE 1, OPEN-LABEL, SINGLE-DOSE, NON-RANDOMIZED PARALLEL GROUP STUDY TO COMPARE THE PHARMACOKINETICS, SAFETY, AND TOLERABILITY OF OSIVELOTOR (PF-07940367) IN ADULT PARTICIPANTS WITH MILD AND MODERATE HEPATIC IMPAIRMENT
The purpose of this study is to understand how Osivelotor is processed in people with loss of liver function.
This study is seeking participants that are:
Read more
- stable loss of liver function with mild or moderate severity
- none of underlying conditions possibly affecting the study medicine being absorbed by the body
All participants will receive one amount of Osivelotor by mouth before breakfast on the first day at the study clinic. A number of blood samples will be collected to understand how Osivelotor is changed and removed from the body. Participants will also have to undergo physical examination and other tests. This will help to understand if Osivelotor is safe.
Participants will take part in the study for a maximum of 112 days. During this time, participants will have to stay onsite for 5 days. There will be 5 study visits at the study clinic.
- Conditions
- Liver Diseases
- Being tested
- Osivelotor
- Medical subject headings
- Liver Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OsivelotorDrug
a single dose of osivelotor administered by mouth under fasted conditions
Other Names:
PF-07940367
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Experimental | Participants with moderate hepatic impairment will receive a single dose of osivelotor, administered orally under fasted conditions. Receives: Drug: Osivelotor |
| Group 2 | Experimental | Participants with mild hepatic impairment will receive a single dose of osivelotor, administered orally under fasted conditions. Receives: Drug: Osivelotor |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area under the whole blood and plasma concentration versus time curve (AUC) from time zero (pre-dose) to the last quantifiable concentration (AUClast) of osivelotor
Measured: 0 hours (pre-dose) to 84 days post-osivelotor dose
Area under the whole blood and plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (AUCinf) of osivelotor
Measured: 0 hours (pre-dose) to 84 days post-osivelotor dose
Maximum observed whole blood and plasma concentration (Cmax) of osivelotor
Measured: 0 hours (pre-dose) to 84 days post-osivelotor dose
Secondary outcomes (4)
Number of Participants With Treatment-Emergent Adverse Events (AEs)
Measured: From baseline up to 56 days after osivelotor dose
Number of Participants With Clinically Significant Laboratory Abnormalities
Measured: From baseline up to 84 days after osivelotor dose
Number of Participants With Clinically Significant Electrocardiogram (ECG) Findings
Measured: From baseline up to 84 days after osivelotor dose
Number of Participants With Clinically Significant With Clinically Significant Vital Signs
Measured: From baseline up to 84 days after osivelotor dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2024
- Study start30 Apr 2024
- Primary completion18 Sep 2024
- Study completion18 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Liver DiseasesStudies of the same condition, open and under way.
- More trials run by PfizerThe 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
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- An open label, single dose, parallel cohort study
- Masking
- None (open label)
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06340347
- Sponsor's protocol ID
- C5351010
- Other IDs
- GBT601
- Status last verified
- Jan 2025
- First submitted
- 25 Mar 2024
- Last updated
- 10 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.
Study at a glance
From the registry record, last updated by the sponsor on 10 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A PHASE 1, OPEN-LABEL, SINGLE-DOSE, NON-RANDOMIZED PARALLEL GROUP STUDY TO COMPARE THE PHARMACOKINETICS, SAFETY, AND TOLERABILITY OF OSIVELOTOR (PF-07940367) IN ADULT PARTICIPANTS WITH MILD AND MODERATE HEPATIC IMPAIRMENT
- ClinicalTrials.gov ID
- NCT06340347
- Acronym / sponsor ID
- C5351010
- Conditions
- Liver Diseases
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- 30 Apr 2024 (actual)
- Primary completion
- 18 Sep 2024 (actual)
- Study completion
- 18 Sep 2024 (actual)
- First posted
- 1 Apr 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.
The purpose of this study is to understand how Osivelotor is processed in people with loss of liver function.
This study is seeking participants that are:
- stable loss of liver function with mild or moderate severity
- none of underlying conditions possibly affecting the study medicine being absorbed by the body
All participants will receive one amount of Osivelotor by mouth before breakfast on the first day at the study clinic. A number of blood samples will be collected to understand how Osivelotor is changed and removed from the body. Participants will also have to undergo physical examination and other tests. This will help to understand if Osivelotor is safe.
Participants will take part in the study for a maximum of 112 days. During this time, participants will have to stay onsite for 5 days. There will be 5 study visits at the study clinic.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- An open label, single dose, parallel cohort study
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Experimental | Drug: OsivelotorParticipants with moderate hepatic impairment will receive a single dose of osivelotor, administered orally under fasted conditions. |
| Group 2 | Experimental | Drug: OsivelotorParticipants with mild hepatic impairment will receive a single dose of osivelotor, administered orally under fasted conditions. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Body mass index (BMI) of 16 to 40 kg/m2, inclusive; and a total body weight greater than 50 kg (greater than 110 lb)
- Stable hepatic impairment that meets the criteria for Class A or B of the Child Pugh classification with no clinically significant change in disease status within the 28 days prior to the screening visit
- Stable concomitant medications for the management of individual participants' medical history
Key exclusion criteria (4 listed)
- Any condition possibly affecting drug absorption (eg, prior bariatric surgery, gastrectomy, ileal resection, prior status portacaval shunt surgery);
- Hepatic carcinoma or hepatorenal syndrome or limited predicted life expectancy;
- A diagnosis of hepatic dysfunction secondary to any acute ongoing hepatocellular process that is documented by medical history, physical examination, liver biopsy, hepatic ultrasound, computerized tomography scan, or MRI;
- Presence of clinically active Stage 3 or 4 hepatic encephalopathy. Clinically active Stage 2 encephalopathy is allowed if, in the opinion of the investigator, the participant is able to provide informed consent.
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 |
|---|---|---|
| Osivelotora single dose of osivelotor administered by mouth under fasted conditions Other Names: PF-07940367 | Drug | Group 1, Group 2 |
Primary outcome
Area under the whole blood and plasma concentration versus time curve (AUC) from time zero (pre-dose) to the last quantifiable concentration (AUClast) of osivelotor
Time frame: 0 hours (pre-dose) to 84 days post-osivelotor dose
Area under the whole blood and plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (AUCinf) of osivelotor
Time frame: 0 hours (pre-dose) to 84 days post-osivelotor dose
Maximum observed whole blood and plasma concentration (Cmax) of osivelotor
Time frame: 0 hours (pre-dose) to 84 days post-osivelotor dose
4 secondary outcomes
Number of Participants With Treatment-Emergent Adverse Events (AEs)
Time frame: From baseline up to 56 days after osivelotor dose
Number of Participants With Clinically Significant Laboratory Abnormalities
Time frame: From baseline up to 84 days after osivelotor dose
Number of Participants With Clinically Significant Electrocardiogram (ECG) Findings
Time frame: From baseline up to 84 days after osivelotor dose
Number of Participants With Clinically Significant With Clinically Significant Vital Signs
Time frame: From baseline up to 84 days after osivelotor 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 10 Jan 2025.
- To obtain contact information for a study center near you, click here.Link provided by the sponsor.
- Individual participant dataSharing planned: No. Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.
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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.
Pfizer CT.gov Call Center study director
Pfizer
3 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 Osivelotor in people with Liver Diseases, run by Pfizer at 3 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 3 inclusion and 4 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 10 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 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 whole blood and plasma concentration versus time curve (AUC) from time zero (pre-dose) to the last quantifiable concentration (AUClast) of osivelotor (time frame: 0 hours (pre-dose) to 84 days post-osivelotor dose). 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 10 Jan 2025.