Hepatic ImpairmentPhase 1NCT04193436
A STUDY TO COMPARE THE PHARMACOKINETICS OF PF-06835919 IN PARTICIPANTS WITH AND WITHOUT HEPATIC IMPAIRMENT
A Phase 1 study testing PF-06835919 25 mg in people with Hepatic Impairment and Healthy Participants, run by Pfizer at 3 sites in 3 countries.
Trial summary
The study is proposed to characterize the effect of varying degrees of hepatic impairment on the plasma PK of PF-06835919 Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Hepatic Impairment, Healthy Participants
- What is being tested?
- PF-06835919 25 mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- 3 sitesin 3 countries
- Study dates
- 21 Jan 2020to 9 Jul 2021
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Male and female participants between the ages of 18 (or the minimum country specific age of consent if >18) and 70 years, inclusive, at the Screening visit:
- Participants who are willing and able to comply with all scheduled visits, treatment plan, laboratory tests, lifestyle considerations, and other study procedures.
- Body mass index (BMI) of 17.5 to 35.4 kg/m2; and a total body weight >50 kg (110 lb).
- Capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in the informed consent document (ICD) and in this protocol.
Who cannot join
- Any condition possibly affecting drug absorption (eg, prior bariatric surgery, gastrectomy, ileal resection).
- (Participants who have undergone cholecystectomy and/or appendectomy are eligible for this study as long as the surgery occurred more than 6 months prior to Screening)..
- At Screening, participants with a positive result for human immunodeficiency virus (HIV) antibodies, as assessed by sponsor identified central laboratory, with a single repeat permitted to assess eligibility, if needed.
- Other acute or chronic medical or psychiatric condition including recent (within the past year) or active suicidal ideation or behaviour or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the participant inappropriate for entry into this study.
- Use of prior/concomitant therapies.
- Previous administration with an investigational drug within 30 days (or as determined by the local requirement) or 5 half lives preceding the first dose of investigational product used in this study (whichever is longer).
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- Participants with known prior participation (ie, randomized and received at least 1 dose of investigational product) in a study involving PF 06835919.
- A positive urine drug test, for illicit drugs, and/or a positive breath alcohol test at Screening. However, participants who have been medially prescribed opiates/opiods or benzodiazepines and report the use of these drugs to the investigator at the screening visit will be allowed to participate.
- Male participants with partners who are currently pregnant.
- Blood donation (excluding plasma donations) of approximately 1 pint (500 mL) or more within 60 days prior to dosing and until the follow-up contact.
- History of sensitivity to heparin or heparin induced thrombocytopenia, only if heparin is used to flush intravenous catheters used during serial blood collections.
- Unwilling or unable to comply with the criteria in the Lifestyle Considerations section of the protocol.
- Investigator site staff members directly involved in the conduct of the study and their family members, site staff members otherwise supervised by the investigator, or Pfizer employees, including their family members, directly involved in the conduct of the study.
Trial locations and contacts
3 sites in 3 countries.
3 sites in 3 countries
Belgium1 site
Pfizer Clinical Research Unit - Brussels
Brussels, Bruxelles-capitale, Région de, B-1070
About this study
Official title: A PHASE 1, NON-RANDOMIZED, OPEN-LABEL, SINGLE-DOSE, PARALLEL-COHORT STUDY TO COMPARE THE PHARMACOKINETICS OF PF-06835919 IN ADULT PARTICIPANTS WITH VARYING DEGREES OF HEPATIC IMPAIRMENT RELATIVE TO PARTICIPANTS WITHOUT HEPATIC IMPAIRMENT
The study is proposed to characterize the effect of varying degrees of hepatic impairment on the plasma PK of PF-06835919
- Conditions
- Hepatic Impairment, Healthy Participants
- Being tested
- PF-06835919 25 mg
- Keywords
- Non-alcoholic Fatty Liver Disease, Non-alcoholic steatohepatitis
- Medical subject headings
- Non-alcoholic Fatty Liver Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PF-06835919 25 mgDrug
PF-06835919 in 25 mg oral tablet will be administered on Day 1
| Study group | Role | What they receive |
|---|---|---|
| PF-06835919 with severe hepatic impairement | Experimental | This arm includes participants with severe hepatic impairment who will receive a 25mg oral dose of PF-06835919 Receives: Drug: PF-06835919 25 mg |
| PF-06835919 with moderate hepatic impairement | Experimental | This arm includes participants with moderate hepatic impairment who will receive a 25mg oral dose of PF-06835919 Receives: Drug: PF-06835919 25 mg |
| PF-06835919 with mild hepatic impairement | Experimental | This arm includes participants with mild hepatic impairment who will receive a 25mg oral dose of PF-06835919 Receives: Drug: PF-06835919 25 mg |
| PF-06835919 without hepatic impairment | Experimental | This arm includes participants without hepatic impairment who will receive a 25mg oral dose of PF-06835919 Receives: Drug: PF-06835919 25 mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area Under the Plasma Concentration-time Curve From Time 0 Extrapolated to Infinite Time (AUCinf) of PF-06835919
AUCinf was defined as area under the plasma concentration time curve from time 0 extrapolated to infinite time.
Measured: Predose, 0.5, 1, 2, 4, 6, 8, 10, 12, 24, 36, 48 ,72, 96 ,120 hours post dose on Day 1.
Maximum Plasma Concentration (Cmax) of PF-06835919
Cmax was defined as maximum plasma concentration of PF-06835919 and observed directly from data.
Measured: Predose, 0.5, 1, 2, 4, 6, 8, 10, 12, 24, 36, 48 ,72, 96 ,120 hours post dose on Day 1.
Unbound Area Under The Plasma Concentration-Time Curve From Time 0 Extrapolated To Infinite Time (AUCinf,u) of PF-06835919
AUCinf,u was defined as unbound area under the plasma concentration time curve from time 0 extrapolated to infinite time.
Measured: Predose, 0.5, 1, 2, 4, 6, 8, 10, 12, 24, 36, 48 ,72, 96 ,120 hours post dose on Day 1.
Unbound Maximum Plasma Concentration (Cmax,u) of PF-06835919
Cmax,u was defined as unbound maximum plasma concentration.
Measured: Predose, 0.5, 1, 2, 4, 6, 8, 10, 12, 24, 36, 48 ,72, 96 ,120 hours post dose on Day 1.
Fraction of Drug Unbound (fu) of PF-06835919
The fraction of PF-06835919 unbound in plasma (fu) was determined at approximately the expected Tmax in each participant.
Measured: Predose, 0.5, 1, 2, 4, 6, 8, 10, 12, 24, 36, 48 ,72, 96 ,120 hours post dose on Day 1.
Secondary outcomes (3)
Number of Participants Reporting Treatment-emergent Adverse Events (AEs)
An AE was any untoward medical occurrence in a participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An serious adverse event (SAE) was defined as an AE: 1. resulting in death, 2. was life-threatening, 3. required inpatient hospitalization or prolongation of existing hospitalization, 4. resulted in persistent disability, 5. was a congenital anomaly/birth defect, or considered to be an important medical event. Treatment-related AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. Treatment-emergent AE (TEAE) was defined as an AE with onset date occurring during the on-treatment period. AEs included all SAEs and non-SAEs.
Measured: Baseline (Day 1) up to follow-up (Day 31)
Number of Participants With Clinically Significant Change (Chg) From Baseline in Laboratory Tests
To determine if there were any clinically significant laboratory abnormalities, hematology (hemoglobin, hematocrit, erythrocytes, mean corpuscular hemoglobin, mean corpuscular volume, platelet count, lymphocytes, neutrophils, activated partial thromboplastin time, prothrombin time, prothrombin intl. normalized ratio), clinical chemistry (bilirubin, direct and indirect bilirubin, gamma glutamyl transferase, albumin, urea nitrogen, glucose) and urinalysis (glucose, protein, hemoglobin, urobilinogen, nitrite) tests were assessed. Each parameter was evaluated against commonly used and widely accepted criteria.
Measured: Baseline (Day 1) up to Day 6
Number of Participants With Clinically Significant Change From Baseline in 12-Lead Electrocardiograms (ECGs)
ECG endpoints (PR interval, QRS interval, QT interval and QTcF) meeting the criteria of potential clinical concern were summarized by treatment using categories as defined: 1. PR max. ≥300ms, %Chg ≥25/50%; 3. QRS max. ≥140ms，%Chg ≥50%; 3.maximum post-dose QTcF 450 - ≤480msec, 480 - ≤500msec and >500msec, 30<Chg≤60 and Chg>60.
Measured: Baseline (Day 1) up to Day 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2019
- Study start21 Jan 2020
- Primary completion9 Jul 2021
- Study completion9 Jul 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Hepatic ImpairmentStudies 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
- Masking
- None (open label)
- Enrolment
- 23 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
- NCT04193436
- Sponsor's protocol ID
- C1061013
- Other IDs
- HEPATIC IMPAIRMENT, 2019-003480-21, 2019
- Status last verified
- Jun 2023
- First submitted
- 11 Nov 2019
- Last updated
- 16 Feb 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- 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 16 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A PHASE 1, NON-RANDOMIZED, OPEN-LABEL, SINGLE-DOSE, PARALLEL-COHORT STUDY TO COMPARE THE PHARMACOKINETICS OF PF-06835919 IN ADULT PARTICIPANTS WITH VARYING DEGREES OF HEPATIC IMPAIRMENT RELATIVE TO PARTICIPANTS WITHOUT HEPATIC IMPAIRMENT
- ClinicalTrials.gov ID
- NCT04193436
- Acronym / sponsor ID
- C1061013
- Conditions
- Hepatic Impairment, Healthy Participants
- Keywords
- Non-alcoholic Fatty Liver Disease, Non-alcoholic steatohepatitis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- 21 Jan 2020 (actual)
- Primary completion
- 9 Jul 2021 (actual)
- Study completion
- 9 Jul 2021 (actual)
- First posted
- 10 Dec 2019 (actual)
- Results
- Posted 16 Feb 2024
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 proposed to characterize the effect of varying degrees of hepatic impairment on the plasma PK of PF-06835919
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| PF-06835919 with severe hepatic impairement | Experimental | Drug: PF-06835919 25 mgThis arm includes participants with severe hepatic impairment who will receive a 25mg oral dose of PF-06835919 |
| PF-06835919 with moderate hepatic impairement | Experimental | Drug: PF-06835919 25 mgThis arm includes participants with moderate hepatic impairment who will receive a 25mg oral dose of PF-06835919 |
| PF-06835919 with mild hepatic impairement | Experimental | Drug: PF-06835919 25 mgThis arm includes participants with mild hepatic impairment who will receive a 25mg oral dose of PF-06835919 |
| PF-06835919 without hepatic impairment | Experimental | Drug: PF-06835919 25 mgThis arm includes participants without hepatic impairment who will receive a 25mg oral dose of PF-06835919 |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Male and female participants between the ages of 18 (or the minimum country specific age of consent if >18) and 70 years, inclusive, at the Screening visit:
- Participants who are willing and able to comply with all scheduled visits, treatment plan, laboratory tests, lifestyle considerations, and other study procedures.
- Body mass index (BMI) of 17.5 to 35.4 kg/m2; and a total body weight >50 kg (110 lb).
- Capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in the informed consent document (ICD) and in this protocol.
Key exclusion criteria (13 listed)
- Any condition possibly affecting drug absorption (eg, prior bariatric surgery, gastrectomy, ileal resection).
- (Participants who have undergone cholecystectomy and/or appendectomy are eligible for this study as long as the surgery occurred more than 6 months prior to Screening)..
- At Screening, participants with a positive result for human immunodeficiency virus (HIV) antibodies, as assessed by sponsor identified central laboratory, with a single repeat permitted to assess eligibility, if needed.
- Other acute or chronic medical or psychiatric condition including recent (within the past year) or active suicidal ideation or behaviour or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the participant inappropriate for entry into this study.
- Use of prior/concomitant therapies.
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 |
|---|---|---|
| PF-06835919 25 mgPF-06835919 in 25 mg oral tablet will be administered on Day 1 | Drug | PF-06835919 with mild hepatic impairement, PF-06835919 with moderate hepatic impairement, PF-06835919 with severe hepatic impairement, PF-06835919 without hepatic impairment |
Primary outcome
Area Under the Plasma Concentration-time Curve From Time 0 Extrapolated to Infinite Time (AUCinf) of PF-06835919
Time frame: Predose, 0.5, 1, 2, 4, 6, 8, 10, 12, 24, 36, 48 ,72, 96 ,120 hours post dose on Day 1.
AUCinf was defined as area under the plasma concentration time curve from time 0 extrapolated to infinite time.
Maximum Plasma Concentration (Cmax) of PF-06835919
Time frame: Predose, 0.5, 1, 2, 4, 6, 8, 10, 12, 24, 36, 48 ,72, 96 ,120 hours post dose on Day 1.
Cmax was defined as maximum plasma concentration of PF-06835919 and observed directly from data.
Unbound Area Under The Plasma Concentration-Time Curve From Time 0 Extrapolated To Infinite Time (AUCinf,u) of PF-06835919
Time frame: Predose, 0.5, 1, 2, 4, 6, 8, 10, 12, 24, 36, 48 ,72, 96 ,120 hours post dose on Day 1.
AUCinf,u was defined as unbound area under the plasma concentration time curve from time 0 extrapolated to infinite time.
Unbound Maximum Plasma Concentration (Cmax,u) of PF-06835919
Time frame: Predose, 0.5, 1, 2, 4, 6, 8, 10, 12, 24, 36, 48 ,72, 96 ,120 hours post dose on Day 1.
Cmax,u was defined as unbound maximum plasma concentration.
Fraction of Drug Unbound (fu) of PF-06835919
Time frame: Predose, 0.5, 1, 2, 4, 6, 8, 10, 12, 24, 36, 48 ,72, 96 ,120 hours post dose on Day 1.
The fraction of PF-06835919 unbound in plasma (fu) was determined at approximately the expected Tmax in each participant.
3 secondary outcomes
Number of Participants Reporting Treatment-emergent Adverse Events (AEs)
Time frame: Baseline (Day 1) up to follow-up (Day 31)
Number of Participants With Clinically Significant Change (Chg) From Baseline in Laboratory Tests
Time frame: Baseline (Day 1) up to Day 6
Number of Participants With Clinically Significant Change From Baseline in 12-Lead Electrocardiograms (ECGs)
Time frame: Baseline (Day 1) up to Day 6
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Feb 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing PF-06835919 25 mg in people with Hepatic Impairment and Healthy Participants, run by Pfizer at 3 sites in 3 countries.
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 13 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 16 Feb 2024. 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 Belgium, Czechia, Slovakia. 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?
Yes. Results are posted in the registry (first posted 16 Feb 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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 Plasma Concentration-time Curve From Time 0 Extrapolated to Infinite Time (AUCinf) of PF-06835919 (time frame: Predose, 0.5, 1, 2, 4, 6, 8, 10, 12, 24, 36, 48 ,72, 96 ,120 hours post dose on Day 1.). The study lists 5 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 16 Feb 2024.