Hepatic ImpairmentPhase 1NCT04604496

STUDY OF PF-06882961 IN PARTICIPANTS WITH AND WITHOUT VARYING DEGREES OF HEPATIC IMPAIREMENT

A Phase 1 study testing PF-06882961 20MG in people with Hepatic Impairment and Healthy Volunteers, run by Pfizer at 2 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The current study is proposed to evaluate whether there is any clinically meaningful effect of hepatic impairment on the plasma Pharmacokinetic (PK) of PF-06882961 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 Volunteers
What is being tested?: PF-06882961 20MG
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 24 participants
Where: 2 sitesUnited States
Study dates: 30 Dec 2020to 10 Jan 2022
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 38.0 kg/m2, inclusive; and a total body weight >50 kg (110 lb), at the screening visit; with a single repeat assessment of total body weight (and hence BMI), on a separate day permitted to assess eligibility, if needed.

Who cannot join

Any condition possibly affecting drug absorption (eg, prior bariatric surgery, gastrectomy, ileal resection); NOTE: 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;
A positive COVID-19 test at screening;
A diagnosis of type 2 diabetes mellitus (T2DM) that is documented by medical history;
Personal or family history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia syndrome type 2 (MEN2), or participants with suspected MTC per the investigator's judgement;
Other medical or psychiatric condition including recent (within the past year) or active suicidal ideation/behavior or laboratory abnormality that may increase the risk of study participation or, in the investigator's judgment, make the participant inappropriate for the study;

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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);
Participants with known prior participation (ie, randomized and received at least 1 dose of investigational product) in a study involving PF-06882961;
Participants with ANY of the following abnormalities in clinical laboratory tests at Visit 1, as assessed by the study specific laboratory and confirmed by a single repeat test, if deemed necessary:
HbA1c ≥6.5%; FPG ≥126 mg/Dl; eGFR<60 mL/min/1.73m2;
A positive urine drug test, for illicit drugs at screening, as assessed by sponsor-identified central laboratory. However, participants in Cohorts 2-4, only, who have been medically prescribed opiates/opioids or benzodiazepines and report the use of these drugs to the investigator at the Screening visit will be allowed to participate; NOTE: repeat urine drug testing is not permitted in this study;
At screening or Day -1, a positive breath alcohol test, as assessed using kits provided by sponsor-identified central laboratory, with a single repeat on a separate day permitted to assess eligibility, if needed;
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; 13. 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 this protocol;
Investigator site staff or Pfizer employees directly involved in the conduct of the study, site staff otherwise supervised by the investigator, and their respective family members.

Trial locations and contacts

2 sites in 1 country.

United States2 sites

University of Miami Division of Clinical Pharmacology
Miami, Florida, 33136
Orlando Clinical Research Center
Orlando, Florida, 32809

Other trials in United States

About this study

Official title: A Phase 1, Non-randomized, Open-label, Single-dose, Parallel Cohort Study to Compare the Pharmacokinetics of PF-06882961 in Adult Participants With Varying Degrees of Hepatic Impairment Relative to Participants Without Hepatic Impairment.

The current study is proposed to evaluate whether there is any clinically meaningful effect of hepatic impairment on the plasma Pharmacokinetic (PK) of PF-06882961

Conditions: Hepatic Impairment, Healthy Volunteers
Being tested: PF-06882961 20MG

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

PF-06882961 20MGDrug
PF-06882961 in 20 mg oral tablet will be administered on Day 1

Study groups in NCT04604496
Study group	Role	What they receive
PF-06882961 participants without Hepatic Impairment	Experimental	This arm includes participants who will receive an oral dose of PF-06882961 20 milligrams (mg) on Day 1 Receives: Drug: PF-06882961 20MG
PF-06882961 participants with mild Hepatic Impairment	Experimental	This arm includes participants who will receive an oral dose of PF-06882961 20 mg on Day 1 Receives: Drug: PF-06882961 20MG
PF-06882961 participants with moderate Hepatic Impairment	Experimental	This arm includes participants who will receive an oral dose of PF-06882961 20 mg on Day 1 Receives: Drug: PF-06882961 20MG
PF-06882961 participants with severe Hepatic Impairment	Experimental	This arm includes participants who will receive an oral dose of PF-06882961 20 mg on Day 1 Receives: Drug: PF-06882961 20MG

What is being measured

The primary outcome is the main question the study is designed to answer.

Maximum Plasma Concentration (Cmax)
Maximum observed plasma PF-06882961 concentration.
Measured: Predose (0 hours), 1, 2, 3, 4, 5, 6, 8, 10, 12, 14, 24, 36 and 48 hours post dose on Day 1.
Area Under the Plasma Concentration-Time Profile From Time Zero Extrapolated to Infinite Time (AUCinf)
Area under the plasma PF-06882961 concentration-time profile from time 0 extrapolated to infinite time.
Measured: Predose (0 hours), 1, 2, 3, 4, 5, 6, 8, 10, 12, 14, 24, 36 and 48 hours post dose on Day 1.
Area Under the Plasma Concentration-Time Profile From Time Zero to the Time of the Last Quantifiable Concentration (AUClast)
Area under the plasma PF-06882961 concentration-time profile from time 0 extrapolated to the time of the last quantifiable concentration.
Measured: Predose (0 hours), 1, 2, 3, 4, 5, 6, 8, 10, 12, 14, 24, 36 and 48 hours post dose on Day 1.
Fraction of Unbound Drug in Plasma (fu)
fu = Cu/C (where Cu represents unbound concentration and C represents total concentration).
Measured: Predose (0 hours), and 4 hours post dose on Day 1.

Secondary outcomes (4)

Number of Participants Reporting Treatment-emergent Adverse Events (AEs)
Adverse events (AEs): any untoward medical occurrence in a clinical investigation participant administered a product or medical device, without regard to causality. Treatment-emergent AEs (TEAEs): AEs which occurred for the first time during the effective duration of treatment or AEs that increased in severity during treatment. AEs included SAEs and non-serious AEs. Serious AEs (SAEs) were any untoward medical occurrence at any dose that resulted in death; was life-threatening; required inpatient hospitalization or caused prolongation of existing hospitalization; resulted in persistent or significant disability/incapacity (substantial disruption of the ability to conduction normal life functions). Treatment-related TEAEs were any untoward medical occurrence attributed to study treatment. Relatedness to study treatment was determined by the investigator.
Measured: Baseline to Day 30
Number of Participants With Clinical Laboratory Abnormalities
Protocol-required safety laboratory assessments included: hemoglobin <0.8 x lower limit of normal (LLN), hematocrit <0.8 x LLN, erythrocytes <0.8 x LLN, ery. mean corpuscular volume >1.1 x upper limit of normal (ULN), ery. mean corpuscular hemoglobin >1.1 x ULN, platelets <0.5 x LLN, eosinophils >1.2 x ULN, activated partial thromboplastin time >1.1 x ULN, prothrombin time >1.1 x ULN, prothrombin intl. normalized ratio >1.1 x ULN; bilirubin/direct bilirubin/indirect bilirubin >1.5 x ULN, aspartate aminotransferase/alanine aminotransferase/gamma glutamyl transferase >3.0 x ULN, albumin <0.8 x LLN, urate >1.2 x ULN, bicarbonate >1.1 x ULN, triacylglycerol lipase >1.5 x ULN; urine hemoglobin/urine urobilinogen/urine nitrite/urine leukocyte esterase ≥1.
Measured: Baseline to Day 3
Number of Participants With Categorical Vital Signs Data
Vital signs categorical criteria: 1) supine systolic blood pressure (SBP) <90 millimeters of mercury (mmHg); 2) supine diastolic blood pressure (DBP) <50 mmHg; 3) supine pulse rate <40 or >120 beats per minute (bpm); 4) change from baseline (increase or decrease) in supine SBP greater than or equal to (≥) 30 mmHg; 5) change from baseline (increase or decrease) in supine DBP ≥ 20 mmHg.
Measured: Baseline to Day 3
Number of Participants With Categorical Electrocardiogram (ECG) Data
ECG categorical criteria: 1. PR interval (the interval between the start of the P wave and the start of the QRS complex, corresponding to the time between the onset of the atrial depolarization and onset of ventricular depolarization): a) greater than or equal to (≥) 300 millisecond (msec), b) ≥25% increase when baseline is > 200 msec or ≥50% increase when baseline is less than or equal to (≤) 200 msec.
1. QRS interval (time from ECG Q wave to the end of the S wave corresponding to ventricle depolarization): a) ≥140 msec, b) ≥50% increase from baseline.
2. QTcF interval (QT corrected using the Fridericia formula): a) >450 msec and ≤480 msec, b) >480 msec and ≤500 msec, c) >500 msec, d) >30 msec and ≤60 msec increase from baseline, e) >60 msec increase from baseline
Measured: Baseline to Day 3

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

30 Dec 202010 Jan 2022

First posted27 Oct 2020
Study start30 Dec 2020
Primary completion10 Jan 2022
Study completion10 Jan 2022

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: Single blind
Who is masked: Participant
Enrolment: 24 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04604496
Sponsor's protocol ID: C3421014
Status last verified: Sep 2023
First submitted: 21 Oct 2020
Last updated: 21 Mar 2024
Results posted: Yes, on ClinicalTrials.gov
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.

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 21 Mar 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-06882961 in Adult Participants With Varying Degrees of Hepatic Impairment Relative to Participants Without Hepatic Impairment.
ClinicalTrials.gov ID: NCT04604496
Acronym / sponsor ID: C3421014
Conditions: Hepatic Impairment, Healthy Volunteers
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 24 participants (actual)
Lead sponsor: PfizerIndustry (pharma, biotech, devices)
Study start: 30 Dec 2020 (actual)
Primary completion: 10 Jan 2022 (actual)
Study completion: 10 Jan 2022 (actual)
First posted: 27 Oct 2020 (actual)
Results: Posted 21 Mar 2024

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

The current study is proposed to evaluate whether there is any clinically meaningful effect of hepatic impairment on the plasma Pharmacokinetic (PK) of PF-06882961

Study design

Primary purpose: Basic science
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: Single blind (participant)
Number of arms: 4

Arm	Type	Receives
PF-06882961 participants without Hepatic Impairment	Experimental	Drug: PF-06882961 20MGThis arm includes participants who will receive an oral dose of PF-06882961 20 milligrams (mg) on Day 1
PF-06882961 participants with mild Hepatic Impairment	Experimental	Drug: PF-06882961 20MGThis arm includes participants who will receive an oral dose of PF-06882961 20 mg on Day 1
PF-06882961 participants with moderate Hepatic Impairment	Experimental	Drug: PF-06882961 20MGThis arm includes participants who will receive an oral dose of PF-06882961 20 mg on Day 1
PF-06882961 participants with severe Hepatic Impairment	Experimental	Drug: PF-06882961 20MGThis arm includes participants who will receive an oral dose of PF-06882961 20 mg on Day 1

Who may qualify

Ages: 18 to 70 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 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 38.0 kg/m2, inclusive; and a total body weight >50 kg (110 lb), at the screening visit; with a single repeat assessment of total body weight (and hence BMI), on a separate day permitted to assess eligibility, if needed.

Key exclusion criteria (16 listed)

Any condition possibly affecting drug absorption (eg, prior bariatric surgery, gastrectomy, ileal resection); NOTE: 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;
A positive COVID-19 test at screening;
A diagnosis of type 2 diabetes mellitus (T2DM) that is documented by medical history;
Personal or family history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia syndrome type 2 (MEN2), or participants with suspected MTC per the investigator's judgement;

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-06882961 20MGPF-06882961 in 20 mg oral tablet will be administered on Day 1	Drug	PF-06882961 participants with mild Hepatic Impairment, PF-06882961 participants with moderate Hepatic Impairment, PF-06882961 participants with severe Hepatic Impairment, PF-06882961 participants without Hepatic Impairment

Primary outcome

Maximum Plasma Concentration (Cmax)
Time frame: Predose (0 hours), 1, 2, 3, 4, 5, 6, 8, 10, 12, 14, 24, 36 and 48 hours post dose on Day 1.
Maximum observed plasma PF-06882961 concentration.
Area Under the Plasma Concentration-Time Profile From Time Zero Extrapolated to Infinite Time (AUCinf)
Time frame: Predose (0 hours), 1, 2, 3, 4, 5, 6, 8, 10, 12, 14, 24, 36 and 48 hours post dose on Day 1.
Area under the plasma PF-06882961 concentration-time profile from time 0 extrapolated to infinite time.
Area Under the Plasma Concentration-Time Profile From Time Zero to the Time of the Last Quantifiable Concentration (AUClast)
Time frame: Predose (0 hours), 1, 2, 3, 4, 5, 6, 8, 10, 12, 14, 24, 36 and 48 hours post dose on Day 1.
Area under the plasma PF-06882961 concentration-time profile from time 0 extrapolated to the time of the last quantifiable concentration.
Fraction of Unbound Drug in Plasma (fu)
Time frame: Predose (0 hours), and 4 hours post dose on Day 1.
fu = Cu/C (where Cu represents unbound concentration and C represents total concentration).

4 secondary outcomes

Number of Participants Reporting Treatment-emergent Adverse Events (AEs)
Time frame: Baseline to Day 30
Number of Participants With Clinical Laboratory Abnormalities
Time frame: Baseline to Day 3
Number of Participants With Categorical Vital Signs Data
Time frame: Baseline to Day 3
Number of Participants With Categorical Electrocardiogram (ECG) Data
Time frame: Baseline to Day 3

Results and safety

Results posted to the registry on 21 Mar 2024, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Without Hepatic Impairment	6	6
Mild Hepatic Impairment	6	6
Moderate Hepatic Impairment	6	6
Severe Hepatic Impairment	6	6

Primary outcome: Maximum Plasma Concentration (Cmax)

Time frame: Predose (0 hours), 1, 2, 3, 4, 5, 6, 8, 10, 12, 14, 24, 36 and 48 hours post dose on Day 1.. Geometric mean (Geometric Coefficient of Variation). Unit: nanogram per milliliter (ng/mL)

Measure	Without Hepatic Impairment n = 6	Mild Hepatic Impairment n = 6	Moderate Hepatic Impairment n = 6	Severe Hepatic Impairment n = 6
Value	23.56 (50)	31.37 (33)	51.82 (83)	78.73 (33)

Without Hepatic Impairment vs Mild Hepatic Impairment: Ratio of adjusted geometric means: 133.17 (90% CI 81.97 to 216.37)
Without Hepatic Impairment vs Moderate Hepatic Impairment: Ratio of adjusted geometric means: 219.98 (90% CI 135.39 to 357.41)
Without Hepatic Impairment vs Severe Hepatic Impairment: Ratio of adjusted geometric means: 334.21 (90% CI 205.70 to 543.00)

Population analysed: The analysis population refers to all participants who received at least 1 dose of PF-06882961 and had at least 1 of the pharmacokinetic (PK) parameters of interest calculated.

Primary outcome: Area Under the Plasma Concentration-Time Profile From Time Zero Extrapolated to Infinite Time (AUCinf)

Time frame: Predose (0 hours), 1, 2, 3, 4, 5, 6, 8, 10, 12, 14, 24, 36 and 48 hours post dose on Day 1.. Geometric mean (Geometric Coefficient of Variation). Unit: nanogram*hour per milliliter (ng*hr/mL)

Measure	Without Hepatic Impairment n = 6	Mild Hepatic Impairment n = 6	Moderate Hepatic Impairment n = 6	Severe Hepatic Impairment n = 6
Value	193.4 (83)	237.3 (34)	546.7 (116)	1239 (75)

Without Hepatic Impairment vs Mild Hepatic Impairment: Ratio of adjusted geometric means: 122.70 (90% CI 61.33 to 245.49)
Without Hepatic Impairment vs Moderate Hepatic Impairment: Ratio of adjusted geometric means: 282.73 (90% CI 141.32 to 565.66)
Without Hepatic Impairment vs Severe Hepatic Impairment: Ratio of adjusted geometric means: 640.78 (90% CI 320.27 to 1282.00)

Population analysed: The analysis population refers to all participants who received at least 1 dose of PF-06882961 and had at least 1 of the PK parameters of interest calculated.

Primary outcome: Area Under the Plasma Concentration-Time Profile From Time Zero to the Time of the Last Quantifiable Concentration (AUClast)

Measure	Without Hepatic Impairment n = 6	Mild Hepatic Impairment n = 6	Moderate Hepatic Impairment n = 6	Severe Hepatic Impairment n = 6
Value	191.2 (84)	235.0 (34)	542.9 (117)	1217 (73)

Without Hepatic Impairment vs Mild Hepatic Impairment: Ratio of adjusted geometric means: 122.89 (90% CI 61.51 to 245.51)
Without Hepatic Impairment vs Moderate Hepatic Impairment: Ratio of adjusted geometric means: 283.88 (90% CI 142.10 to 567.13)
Without Hepatic Impairment vs Severe Hepatic Impairment: Ratio of adjusted geometric means: 636.32 (90% CI 318.51 to 1271.24)

Population analysed: The analysis population refers to all participants who received at least 1 dose of PF-06882961 and had at least 1 of the PK parameters of interest calculated.

Primary outcome: Fraction of Unbound Drug in Plasma (fu)

Time frame: Predose (0 hours), and 4 hours post dose on Day 1.. Geometric mean (Geometric Coefficient of Variation). Unit: Ratio

Measure	Without Hepatic Impairment n = 6	Mild Hepatic Impairment n = 6	Moderate Hepatic Impairment n = 6	Severe Hepatic Impairment n = 6
Value	0.02137 (18)	0.01820 (13)	0.02059 (21)	0.02889 (53)

Without Hepatic Impairment vs Mild Hepatic Impairment: Ratio of adjusted geometric means: 85.19 (90% CI 63.60 to 114.10)
Without Hepatic Impairment vs Moderate Hepatic Impairment: Ratio of adjusted geometric means: 96.37 (90% CI 71.95 to 129.07)
Without Hepatic Impairment vs Severe Hepatic Impairment: Ratio of adjusted geometric means: 135.20 (90% CI 100.94 to 181.10)

Population analysed: The analysis population refers to all participants who received at least 1 dose of PF-06882961 and had at least 1 of the PK parameters of interest calculated.

4 secondary outcomes are reported in the full results.

Adverse events

Time frame: Baseline to Day 30. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Without Hepatic Impairment	0 of 6 (0%)	0 of 6 (0%)	0 of 6
Mild Hepatic Impairment	0 of 6 (0%)	1 of 6 (16.7%)	0 of 6
Moderate Hepatic Impairment	0 of 6 (0%)	2 of 6 (33.3%)	0 of 6
Severe Hepatic Impairment	0 of 6 (0%)	1 of 6 (16.7%)	0 of 6

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 21 Mar 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

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 PF-06882961 20MG in people with Hepatic Impairment and Healthy Volunteers, run by Pfizer 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 3 inclusion and 16 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 21 Mar 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?

Yes. Results are posted in the registry (first posted 21 Mar 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?

Maximum Plasma Concentration (Cmax) (time frame: Predose (0 hours), 1, 2, 3, 4, 5, 6, 8, 10, 12, 14, 24, 36 and 48 hours post dose on Day 1.). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04604496.

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 21 Mar 2024.