Hepatic ImpairmentPhase 1NCT04091061

Effect Of Hepatic Impairment on the Pharmacokinetics, Safety and Tolerability of PF-06865571 In Subjects With Hepatic Impairment and in Healthy Subjects

A Phase 1 study testing PF-06865571 100 mg 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

Search all trials

Trial summary

The current study is proposed to evaluate whether there is any clinically meaningful effect of hepatic impairment on the plasma PK of PF-06865571. 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-06865571 100 mg
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: 3 Oct 2019to 7 Apr 2020
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

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, 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.
Capable of giving signed informed consent.

Who cannot join

Any condition possibly affecting drug absorption (eg, prior bariatric surgery,gastrectomy, ileal resection).
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 behavior 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.
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-06865571.
A positive urine drug test, for illicit drugs on Day -1,

Show all 11Show fewer

At Screening or Day -1, a positive breath alcohol test.
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.
Unwilling or unable to comply with the criteria in the Lifestyle Considerations.
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

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 06865571 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 PK of PF-06865571.

Conditions: Hepatic Impairment, Healthy Volunteers
Being tested: PF-06865571 100 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-06865571 100 mgDrug
PF-06865571 in 100 mg oral tablet will be administered on Day 1

Study groups in NCT04091061
Study group	Role	What they receive
PF-06865571 Moderate Hepatic Impairment	Experimental	This arm includes participants with moderate hepatic impairment who will receive an oral dose of PF-06865571 100 mg on Day 1 Receives: Drug: PF-06865571 100 mg
PF-06865571 Severe Hepatic Impairment	Experimental	This arm includes participants with severe hepatic impairment who will receive an oral dose of PF-06865571 100 mg on Day 1 Receives: Drug: PF-06865571 100 mg
PF-06865571 Mild Hepatic Impairment	Experimental	This arm includes participants with mild hepatic impairment who will receive an oral dose of PF-06865571 100 mg on Day 1 Receives: Drug: PF-06865571 100 mg
PF-06865571 Healthy Participants	Experimental	This arm includes healthy participants who will receive an oral dose of PF-06865571 100 mg on Day 1 Receives: Drug: PF-06865571 100 mg

What is being measured

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

Maximum Observed Plasma Concentration (Cmax)
Cmax of PF-06865571 was observed directly from data.
Measured: For Cohort 1, pre-dose, 0.5, 1, 2, 4, 6, 8, 10, 12, 16, 24, 36, 48 hours post dose. For Cohorts 2-4, pre-dose, 0.5, 1, 2, 4, 6, 8, 10, 12, 16, 24, 36, 48, 72 hours post dose.
Area Under the Curve From Time 0 to Last Quantifiable Concentration (AUClast)
AUClast of PF-06865571 was determined by linear/log trapezoidal method.
Measured: For Cohort 1, pre-dose, 0.5, 1, 2, 4, 6, 8, 10, 12, 16, 24, 36, 48 hours post dose. For Cohorts 2-4, pre-dose, 0.5, 1, 2, 4, 6, 8, 10, 12, 16, 24, 36, 48, 72 hours post dose.
Area Under the Curve From Time 0 to Extrapolated Infinite Time (AUCinf)
AUCinf = Area under the plasma concentration versus time curve (AUC) from time 0 (pre-dose) to extrapolated infinite time (0-inf).
Measured: For Cohort 1, pre-dose, 0.5, 1, 2, 4, 6, 8, 10, 12, 16, 24, 36, 48 hours post dose. For Cohorts 2-4, pre-dose, 0.5, 1, 2, 4, 6, 8, 10, 12, 16, 24, 36, 48, 72 hours post dose.

Secondary outcomes (4)

Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
An adverse event (AE) was any untoward medical occurrence attributed to study drug in a participant who receives study drug. A serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. TEAEs were events following start of treatment.
Measured: Up to Day 32 (31 days after investigational product administration)
Number of Participants With Clinical Laboratory Abnormalities
The following parameters were analyzed for laboratory examination: hematology, clinical chemistry, and urinalysis. The abnormalities with at least 1 participant are presented here.
Measured: Up to Day 4 (3 days after investigational product administration)
Number of Participants With Categorical Vital Signs Data
Vital signs (systolic and diastolic blood pressure, and pulse rate) were obtained with participants after having sat calmly for at least 5 minutes.
Measured: Up to Day 4 (3 days after investigational product administration)
Number of Participants With Categorical Electrocardiogram (ECG)
QT interval corrected using Fridericia's formula (QTcF) was obtained with participants. All scheduled ECGs were performed after the participant had rested quietly for at least 10 minutes in a supine position.
Measured: Up to Day 4 (3 days after investigational product administration)

Timeline

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

3 Oct 20197 Apr 2020

First posted16 Sep 2019
Study start3 Oct 2019
Primary completion7 Apr 2020
Study completion7 Apr 2020

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: 24 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04091061
Sponsor's protocol ID: C2541009
Status last verified: Mar 2021
First submitted: 13 Sep 2019
Last updated: 13 Apr 2021
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?

See locations

Not yet recruitingPhase 1
A Study to Assess the Pharmacokinetics and Safety of Revumenib in Participants With Advanced Cancer and Hepatic or Renal Impairment
Relapsed/Refractory (R/R) Hematologic Malignancies, Acute Leukemia
RecruitingPhase 1
A Study of Efimosfermin Alfa in Adults With Hepatic Impairment
Non-alcoholic Fatty Liver Disease
Not yet recruitingPhase 1
A Study of Zovaglutide (ZT002 Injection) in Participants With Hepatic Impairment and Healthy Participants
Overweight, Obesity
Not yet recruitingPhase 1
A Study to Investigate Safety, Tolerability, and Pharmacokinetics of Tacabrutideg (BGB-16673) in Participants With Moderate and Severe Hepatic Impairment
Hepatic Impairment, Healthy Adult Participants
RecruitingPhase 1
Investigation of Pharmacokinetics, Safety of HSK31858 in Subjects With Hepatic Impairment
Non-cystic Fibrosis Bronchiectasis (NCFBE)

All Hepatic Impairment trials

Study at a glance

From the registry record, last updated by the sponsor on 13 Apr 2021. 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 06865571 IN ADULT PARTICIPANTS WITH VARYING DEGREES OF HEPATIC IMPAIRMENT RELATIVE TO PARTICIPANTS WITHOUT HEPATIC IMPAIRMENT
ClinicalTrials.gov ID: NCT04091061
Acronym / sponsor ID: C2541009
Conditions: Hepatic Impairment, Healthy Volunteers
Keywords: Non-alcoholic Fatty Liver Disease, Non-alcoholic steatohepatitis
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 24 participants (actual)
Lead sponsor: PfizerIndustry (pharma, biotech, devices)
Study start: 3 Oct 2019 (actual)
Primary completion: 7 Apr 2020 (actual)
Study completion: 7 Apr 2020 (actual)
First posted: 16 Sep 2019 (actual)
Results: Posted 13 Apr 2021

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 PK of PF-06865571.

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-06865571 Moderate Hepatic Impairment	Experimental	Drug: PF-06865571 100 mgThis arm includes participants with moderate hepatic impairment who will receive an oral dose of PF-06865571 100 mg on Day 1
PF-06865571 Severe Hepatic Impairment	Experimental	Drug: PF-06865571 100 mgThis arm includes participants with severe hepatic impairment who will receive an oral dose of PF-06865571 100 mg on Day 1
PF-06865571 Mild Hepatic Impairment	Experimental	Drug: PF-06865571 100 mgThis arm includes participants with mild hepatic impairment who will receive an oral dose of PF-06865571 100 mg on Day 1
PF-06865571 Healthy Participants	Experimental	Drug: PF-06865571 100 mgThis arm includes healthy participants who will receive an oral dose of PF-06865571 100 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)

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, 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.
Capable of giving signed informed consent.

Key exclusion criteria (11 listed)

Any condition possibly affecting drug absorption (eg, prior bariatric surgery,gastrectomy, ileal resection).
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 behavior 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.
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-06865571.

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-06865571 100 mgPF-06865571 in 100 mg oral tablet will be administered on Day 1	Drug	PF-06865571 Healthy Participants, PF-06865571 Mild Hepatic Impairment, PF-06865571 Moderate Hepatic Impairment, PF-06865571 Severe Hepatic Impairment

Primary outcome

Maximum Observed Plasma Concentration (Cmax)
Time frame: For Cohort 1, pre-dose, 0.5, 1, 2, 4, 6, 8, 10, 12, 16, 24, 36, 48 hours post dose. For Cohorts 2-4, pre-dose, 0.5, 1, 2, 4, 6, 8, 10, 12, 16, 24, 36, 48, 72 hours post dose.
Cmax of PF-06865571 was observed directly from data.
Area Under the Curve From Time 0 to Last Quantifiable Concentration (AUClast)
Time frame: For Cohort 1, pre-dose, 0.5, 1, 2, 4, 6, 8, 10, 12, 16, 24, 36, 48 hours post dose. For Cohorts 2-4, pre-dose, 0.5, 1, 2, 4, 6, 8, 10, 12, 16, 24, 36, 48, 72 hours post dose.
AUClast of PF-06865571 was determined by linear/log trapezoidal method.
Area Under the Curve From Time 0 to Extrapolated Infinite Time (AUCinf)
Time frame: For Cohort 1, pre-dose, 0.5, 1, 2, 4, 6, 8, 10, 12, 16, 24, 36, 48 hours post dose. For Cohorts 2-4, pre-dose, 0.5, 1, 2, 4, 6, 8, 10, 12, 16, 24, 36, 48, 72 hours post dose.
AUCinf = Area under the plasma concentration versus time curve (AUC) from time 0 (pre-dose) to extrapolated infinite time (0-inf).

4 secondary outcomes

Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
Time frame: Up to Day 32 (31 days after investigational product administration)
Number of Participants With Clinical Laboratory Abnormalities
Time frame: Up to Day 4 (3 days after investigational product administration)
Number of Participants With Categorical Vital Signs Data
Time frame: Up to Day 4 (3 days after investigational product administration)
Number of Participants With Categorical Electrocardiogram (ECG)
Time frame: Up to Day 4 (3 days after investigational product administration)

Results and safety

Results posted to the registry on 13 Apr 2021, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Cohort 1 (Without Hepatic Impairment)	6	6
Cohort 2 (Mild Hepatic Impairment)	6	6
Cohort 3 (Moderate Hepatic Impairment)	6	6
Cohort 4 (Severe Hepatic Impairment)	6	6

Primary outcome: Maximum Observed Plasma Concentration (Cmax)

Time frame: For Cohort 1, pre-dose, 0.5, 1, 2, 4, 6, 8, 10, 12, 16, 24, 36, 48 hours post dose. For Cohorts 2-4, pre-dose, 0.5, 1, 2, 4, 6, 8, 10, 12, 16, 24, 36, 48, 72 hours post dose.. Geometric mean (Geometric Coefficient of Variation). Unit: nanogram per milliliter (ng/mL)

Measure	Cohort 1 (Without Hepatic Impairment) n = 6	Cohort 2 (Mild Hepatic Impairment) n = 6	Cohort 3 (Moderate Hepatic Impairment) n = 6	Cohort 4 (Severe Hepatic Impairment) n = 6
Value	532.2 (153)	835.5 (39)	668.3 (35)	658.6 (42)

Cohort 1 (Without Hepatic Impairment) vs Cohort 2 (Mild Hepatic Impairment): Ratio (%): 156.99 (90% CI 83.14 to 296.44)
Cohort 1 (Without Hepatic Impairment) vs Cohort 3 (Moderate Hepatic Impairment): Ratio (%): 125.58 (90% CI 66.51 to 237.13)
Cohort 1 (Without Hepatic Impairment) vs Cohort 4 (Severe Hepatic Impairment): Ratio (%): 123.75 (90% CI 65.54 to 233.68)

Population analysed: All participants who received PF-06865571 and in whom at least 1 plasma concentration value was reported.

Primary outcome: Area Under the Curve From Time 0 to Last Quantifiable Concentration (AUClast)

Measure	Cohort 1 (Without Hepatic Impairment) n = 6	Cohort 2 (Mild Hepatic Impairment) n = 6	Cohort 3 (Moderate Hepatic Impairment) n = 6	Cohort 4 (Severe Hepatic Impairment) n = 6
Value	2078 (155)	3247 (40)	3443 (42)	3163 (47)

Cohort 1 (Without Hepatic Impairment) vs Cohort 2 (Mild Hepatic Impairment): Ratio (%): 156.25 (90% CI 81.07 to 301.16)
Cohort 1 (Without Hepatic Impairment) vs Cohort 3 (Moderate Hepatic Impairment): Ratio (%): 165.66 (90% CI 85.95 to 319.29)
Cohort 1 (Without Hepatic Impairment) vs Cohort 4 (Severe Hepatic Impairment): Ratio (%): 152.18 (90% CI 78.96 to 293.32)

Population analysed: All participants dosed who had at least 1 of the PK parameters.

Primary outcome: Area Under the Curve From Time 0 to Extrapolated Infinite Time (AUCinf)

Measure	Cohort 1 (Without Hepatic Impairment) n = 6	Cohort 2 (Mild Hepatic Impairment) n = 6	Cohort 3 (Moderate Hepatic Impairment) n = 6	Cohort 4 (Severe Hepatic Impairment) n = 6
Value	2083 (155)	3250 (39)	3445 (42)	3171 (47)

Cohort 1 (Without Hepatic Impairment) vs Cohort 2 (Mild Hepatic Impairment): Ratio (%): 156.00 (90% CI 80.95 to 300.60)
Cohort 1 (Without Hepatic Impairment) vs Cohort 3 (Moderate Hepatic Impairment): Ratio (%): 165.38 (90% CI 85.82 to 318.67)
Cohort 1 (Without Hepatic Impairment) vs Cohort 4 (Severe Hepatic Impairment): Ratio (%): 152.20 (90% CI 78.99 to 293.29)

Population analysed: All participants dosed who had at least 1 of the PK parameters.

4 secondary outcomes are reported in the full results.

Adverse events

Time frame: Up to Day 32 (31 days after investigational product administration). Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Cohort 1 (Without Hepatic Impairment)	0 of 6 (0%)	0 of 6 (0%)	0 of 6
Cohort 2 (Mild Hepatic Impairment)	0 of 6 (0%)	0 of 6 (0%)	0 of 6
Cohort 3 (Moderate Hepatic Impairment)	0 of 6 (0%)	0 of 6 (0%)	0 of 6
Cohort 4 (Severe Hepatic Impairment)	0 of 6 (0%)	0 of 6 (0%)	0 of 6

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2021.
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.

Related trials for Hepatic Impairment

Not yet recruitingPhase 1
A Study to Assess the Pharmacokinetics and Safety of Revumenib in Participants With Advanced Cancer and Hepatic or Renal Impairment
Relapsed/Refractory (R/R) Hematologic Malignancies, Acute Leukemia
RecruitingPhase 1
A Study of Efimosfermin Alfa in Adults With Hepatic Impairment
Non-alcoholic Fatty Liver Disease
Not yet recruitingPhase 1
A Study of Zovaglutide (ZT002 Injection) in Participants With Hepatic Impairment and Healthy Participants
Overweight, Obesity
Not yet recruitingPhase 1
A Study to Investigate Safety, Tolerability, and Pharmacokinetics of Tacabrutideg (BGB-16673) in Participants With Moderate and Severe Hepatic Impairment
Hepatic Impairment, Healthy Adult Participants
RecruitingPhase 1
Investigation of Pharmacokinetics, Safety of HSK31858 in Subjects With Hepatic Impairment
Non-cystic Fibrosis Bronchiectasis (NCFBE)

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-06865571 100 mg 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 11 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 13 Apr 2021. 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 13 Apr 2021). 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 Observed Plasma Concentration (Cmax) (time frame: For Cohort 1, pre-dose, 0.5, 1, 2, 4, 6, 8, 10, 12, 16, 24, 36, 48 hours post dose. For Cohorts 2-4, pre-dose, 0.5, 1, 2, 4, 6, 8, 10, 12, 16, 24, 36, 48, 72 hours post 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?

On the ClinicalTrials.gov record for NCT04091061.

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 13 Apr 2021.