Moderate Hepatic ImpairmentPhase 1NCT05116826
Nitazoxanide Pharmacokinetic Parameters in Hepatic Impaired Patients
A Phase 1 study testing Nitazoxanide in people with Moderate Hepatic Impairment and Severe Hepatic Impairment, run by Genfit at 2 sites in United States.
Trial summary
This study is being conducted to evaluate the major Nitazoxanide (NTZ) active metabolite in adult participants with hepatic impairment and healthy adults. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Moderate Hepatic Impairment, Severe Hepatic Impairment, Liver Diseases
- What is being tested?
- Nitazoxanide
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 2 sitesUnited States
- Study dates
- 5 Nov 2021to 13 Apr 2022
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Males or females, between 18 and 75 years of age, inclusive;
- With a minimum body weight of 50 kg and within a BMI range of 18.0 to 40.0 kg/m^2, inclusive;
- Females participating in this study must be of non-childbearing potential or must be using highly effective contraception for the full duration of the study;
- Negative human immunodeficiency virus antibody screens at Screening;
- Matched to participants with moderate and/or severe hepatic impairment in age (± 10 years), BMI (± 20 percentage) and sex;
- Participants who have chronic (≥ 6 months) moderate or severe hepatic insufficiency (of any etiology) that has been clinically stable (no acute episodes of illness due to deterioration in hepatic function) for at least 1 month prior to Screening and must also remain stable throughout the Screening period.
- Other protocol-defined inclusion criteria may apply
Who cannot join
- A positive alcohol test result at Check-In Visit;
- A history of alcohol abuse in the prior 2 years;
- Positive urine screen for drugs of abuse at Screening or Check-In;
- Strenuous exercise within 72 hours prior to Check-In Visit;
- Blood donation or loss of blood (excluding volume drawn at screening or menses) of 50 mL to 499 mL of blood within 30 days, or more than 499 mL within 56 days prior to the dosing;
- History of a major surgical procedure within 30 days prior to Screening;
Show all 22Show fewer
- History of stomach or intestinal surgery or resection that would potentially alter absorption and/or excretion of orally administered drugs except that appendectomy and hernia repair will be allowed. Bariatric surgery will not be allowed;
- Presence or history of malignancy within the prior 3 years, with the exception of treated basal cell or squamous cell carcinoma;
- Poor peripheral venous access;
- Receipt of blood products within 2 months prior to Check-In Visit;
- Significant history or clinical manifestation of any metabolic (including thyroid), allergic, dermatological, hepatic, renal, hematological, pulmonary, cardiovascular (including any prior history of cardiomyopathy or cardiac failure), gastrointestinal (GI), neurological, or psychiatric disorder;
- Positive serologic test for hepatitis B surface antigen or for hepatitis C virus antibody at Screening;
- Frequent headaches (> twice a month) and/or migraines, recurrent nausea and/or vomiting, diarrhea;
- Participants with symptomatic hypotension at Screening, whatever the decrease of blood pressure, or asymptomatic postural hypotension;
- History of unstable diabetes mellitus;
- Participants who have a transjugular intrahepatic portosystemic shunt and/or have undergone portacaval shunting;
- Participant has shown evidence of hepatorenal syndrome or has creatinine clearance ≤ 60 mL/min;
- Participants has required treatment for GI bleeding within the 6 months prior to Check-In Visit;
- Recent history of paracentesis (< 1 months prior to Check-In Visit);
- Participants with Wilson's disease, alpha-1 antitrypsin deficiency, glycogen storage diseases, or galactosemia;
- Participants with anemia secondary to hepatic disease, unless hemoglobin is ≥ 8.5 g/dL and anemia symptoms are not clinically significant. Participants must have ≥ 30,000 platelets at screening and at Check-In Visit.
- Other protocol-defined exclusion criteria may apply
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Panax Clinical Research
Miami Lakes, Florida, 33014
Orlando Clinical Research Center
Orlando, Florida, 32802
About this study
Official title: An Open-label, Phase 1, Multiple-dose Study to Evaluate the Pharmacokinetics of Nitazoxanide 500 mg Twice Daily for 7 Days in Adult Subjects With Moderate and Severe Hepatic Impairment and Adult Healthy Control Subjects
This study is being conducted to evaluate the major Nitazoxanide (NTZ) active metabolite in adult participants with hepatic impairment and healthy adults.
Read the detailed description
This study is being conducted to assess the effect of hepatic impairment on the pharmacokinetics of the major Nitazoxanide active metabolite in hepatic impaired (moderate and severe according to Child-Pugh categories) and healthy control adults following repeated oral dose administration of NTZ 500 mg twice a day for 7 days.
- Being tested
- Nitazoxanide
- Keywords
- Pharmacokinetics, Healthy Volunteer, Liver Disease, Hepatic Impairment, Antiparasitic, Antiprotozoal
- Medical subject headings
- Liver Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NitazoxanideDrug
Also called NTZ
500 mg Twice Daily for 7 days
| Study group | Role | What they receive |
|---|---|---|
| Healthy Control Match (Normal hepatic function) | Experimental | NTZ 500 mg twice a day for 7 days Receives: Drug: Nitazoxanide |
| Moderate Child-Pugh B (Moderate hepatic impairment) | Experimental | NTZ 500 mg twice a day for 7 days Receives: Drug: Nitazoxanide |
| Severe Child-Pugh C (Severe hepatic impairment) | Experimental | NTZ 500 mg twice a day for 7 days Receives: Drug: Nitazoxanide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area under the plasma concentration time curve (AUC) from time zero to 12h (AUC0-12)
In participants with moderate and severe hepatic impairment compared to healthy volunteers
Measured: Day 1: pre-dose; 1; 2; 3; 4; 5; 6; 7; 8; 10 and 12 hours post dose Day 7: pre-dose; 1; 2; 3; 4; 5; 6; 7; 8; 10; 12; 14; 16; 18; 24; and 48 hours post dose
AUC from time zero to the time of the last quantifiable concentration (AUC0-t)
In participants with moderate and severe hepatic impairment compared to healthy volunteers
Measured: Day 1: pre-dose; 1; 2; 3; 4; 5; 6; 7; 8; 10 and 12 hours post dose Day 7: pre-dose; 1; 2; 3; 4; 5; 6; 7; 8; 10; 12; 14; 16; 18; 24; and 48 hours post dose
Maximum observed plasma concentration (Cmax),
In participants with moderate and severe hepatic impairment compared to healthy volunteers
Measured: Day 1: pre-dose; 1; 2; 3; 4; 5; 6; 7; 8; 10 and 12 hours post dose Day 7: pre-dose; 1; 2; 3; 4; 5; 6; 7; 8; 10; 12; 14; 16; 18; 24; and 48 hours post dose
Secondary outcomes (4)
Plasma pharmacokinetics: time of the maximum observed plasma concentration (Tmax), apparent plasma terminal elimination half life (t1/2), AUC from time zero to infinity (AUC0-∞), trough concentration (Ctrough) and percentage of extrapolated (%AUCextrap)
For NTZ and its major active metabolite
Measured: Day 1: pre-dose; 1; 2; 3; 4; 5; 6; 7; 8; 10 and 12 hours post dose Day 7: pre-dose; 1; 2; 3; 4; 5; 6; 7; 8; 10; 12; 14; 16; 18; 24; and 48 hours post dose
Plasma pharmacokinetics: Tmax, AUC0-12, AUC0-t, AUC0-∞, Cmax, t1/2, %AUCextrap and Ctrough.
For the NTZ major active metabolite
Measured: Day 1: pre-dose; 1; 2; 3; 4; 5; 6; 7; 8; 10 and 12 hours post dose Day 7: pre-dose; 1; 2; 3; 4; 5; 6; 7; 8; 10; 12; 14; 16; 18; 24; and 48 hours post dose
Urine pharmacokinetics: amount of drug excreted (Ae), cumulative amount of drug excreted (Ae0-t), and renal clearance (CLR)
For the NTZ major active metabolites
Measured: Day-1: pre-dose, Day 1: 0-4 h, 4-8 h, 8-12, 12-24 h post-dose; Day 7: 0-4 h, 4-8 h, 8-12 h, 12-24 h, 24-48 h post-dose
Plasma and urine pharmacokinetics: After the single oral administration of NTZ 500 mg: Cmax, AUC0-12, AUC0-t, AUC0-∞ , Tmax, t1/2, %AUCextrap, Ae0-∞, Ae0-t and CLR.
For the NTZ major active metabolites
Measured: Plasma:Day 1: pre-dose; 1; 2; 3; 4; 5; 6; 7; 8; 10, 12 h post dose Day 7: pre-dose; 1; 2; 3; 4; 5; 6; 7; 8; 10; 12; 14; 16; 18; 24; and 48 h post dose Urine:Day-1: pre-dose, Day 1: 24 hours urine collection post-dose; Day 7: 48 hours urine collection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Nov 2021
- Study start5 Nov 2021
- Primary completion8 Apr 2022
- Study completion13 Apr 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Moderate Hepatic ImpairmentStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Genfit
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Carol Addy, MD, Study director, Genfit
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05116826
- Sponsor's protocol ID
- NTZ-121-1
- Status last verified
- Oct 2022
- First submitted
- 1 Nov 2021
- Last updated
- 14 Oct 2022
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, Phase 1, Multiple-dose Study to Evaluate the Pharmacokinetics of Nitazoxanide 500 mg Twice Daily for 7 Days in Adult Subjects With Moderate and Severe Hepatic Impairment and Adult Healthy Control Subjects
- ClinicalTrials.gov ID
- NCT05116826
- Acronym / sponsor ID
- NTZ-121-1
- Keywords
- Pharmacokinetics, Healthy Volunteer, Liver Disease, Hepatic Impairment, Antiparasitic, Antiprotozoal
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- GenfitIndustry (pharma, biotech, devices)
- Study start
- 5 Nov 2021 (actual)
- Primary completion
- 8 Apr 2022 (actual)
- Study completion
- 13 Apr 2022 (actual)
- First posted
- 11 Nov 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is being conducted to evaluate the major Nitazoxanide (NTZ) active metabolite in adult participants with hepatic impairment and healthy adults.
Detailed description
This study is being conducted to assess the effect of hepatic impairment on the pharmacokinetics of the major Nitazoxanide active metabolite in hepatic impaired (moderate and severe according to Child-Pugh categories) and healthy control adults following repeated oral dose administration of NTZ 500 mg twice a day for 7 days.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Healthy Control Match (Normal hepatic function) | Experimental | Drug: NitazoxanideNTZ 500 mg twice a day for 7 days |
| Moderate Child-Pugh B (Moderate hepatic impairment) | Experimental | Drug: NitazoxanideNTZ 500 mg twice a day for 7 days |
| Severe Child-Pugh C (Severe hepatic impairment) | Experimental | Drug: NitazoxanideNTZ 500 mg twice a day for 7 days |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Males or females, between 18 and 75 years of age, inclusive;
- With a minimum body weight of 50 kg and within a BMI range of 18.0 to 40.0 kg/m^2, inclusive;
- Females participating in this study must be of non-childbearing potential or must be using highly effective contraception for the full duration of the study;
- Negative human immunodeficiency virus antibody screens at Screening;
- Matched to participants with moderate and/or severe hepatic impairment in age (± 10 years), BMI (± 20 percentage) and sex;
Key exclusion criteria (22 listed)
- A positive alcohol test result at Check-In Visit;
- A history of alcohol abuse in the prior 2 years;
- Positive urine screen for drugs of abuse at Screening or Check-In;
- Strenuous exercise within 72 hours prior to Check-In Visit;
- Blood donation or loss of blood (excluding volume drawn at screening or menses) of 50 mL to 499 mL of blood within 30 days, or more than 499 mL within 56 days prior to the dosing;
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 |
|---|---|---|
| NitazoxanideAlso: NTZ500 mg Twice Daily for 7 days | Drug | Healthy Control Match (Normal hepatic function), Moderate Child-Pugh B (Moderate hepatic impairment), Severe Child-Pugh C (Severe hepatic impairment) |
Primary outcome
Area under the plasma concentration time curve (AUC) from time zero to 12h (AUC0-12)
Time frame: Day 1: pre-dose; 1; 2; 3; 4; 5; 6; 7; 8; 10 and 12 hours post dose Day 7: pre-dose; 1; 2; 3; 4; 5; 6; 7; 8; 10; 12; 14; 16; 18; 24; and 48 hours post dose
In participants with moderate and severe hepatic impairment compared to healthy volunteers
AUC from time zero to the time of the last quantifiable concentration (AUC0-t)
Time frame: Day 1: pre-dose; 1; 2; 3; 4; 5; 6; 7; 8; 10 and 12 hours post dose Day 7: pre-dose; 1; 2; 3; 4; 5; 6; 7; 8; 10; 12; 14; 16; 18; 24; and 48 hours post dose
In participants with moderate and severe hepatic impairment compared to healthy volunteers
Maximum observed plasma concentration (Cmax),
Time frame: Day 1: pre-dose; 1; 2; 3; 4; 5; 6; 7; 8; 10 and 12 hours post dose Day 7: pre-dose; 1; 2; 3; 4; 5; 6; 7; 8; 10; 12; 14; 16; 18; 24; and 48 hours post dose
In participants with moderate and severe hepatic impairment compared to healthy volunteers
4 secondary outcomes
Plasma pharmacokinetics: time of the maximum observed plasma concentration (Tmax), apparent plasma terminal elimination half life (t1/2), AUC from time zero to infinity (AUC0-∞), trough concentration (Ctrough) and percentage of extrapolated (%AUCextrap)
Time frame: Day 1: pre-dose; 1; 2; 3; 4; 5; 6; 7; 8; 10 and 12 hours post dose Day 7: pre-dose; 1; 2; 3; 4; 5; 6; 7; 8; 10; 12; 14; 16; 18; 24; and 48 hours post dose
Plasma pharmacokinetics: Tmax, AUC0-12, AUC0-t, AUC0-∞, Cmax, t1/2, %AUCextrap and Ctrough.
Time frame: Day 1: pre-dose; 1; 2; 3; 4; 5; 6; 7; 8; 10 and 12 hours post dose Day 7: pre-dose; 1; 2; 3; 4; 5; 6; 7; 8; 10; 12; 14; 16; 18; 24; and 48 hours post dose
Urine pharmacokinetics: amount of drug excreted (Ae), cumulative amount of drug excreted (Ae0-t), and renal clearance (CLR)
Time frame: Day-1: pre-dose, Day 1: 0-4 h, 4-8 h, 8-12, 12-24 h post-dose; Day 7: 0-4 h, 4-8 h, 8-12 h, 12-24 h, 24-48 h post-dose
Plasma and urine pharmacokinetics: After the single oral administration of NTZ 500 mg: Cmax, AUC0-12, AUC0-t, AUC0-∞ , Tmax, t1/2, %AUCextrap, Ae0-∞, Ae0-t and CLR.
Time frame: Plasma:Day 1: pre-dose; 1; 2; 3; 4; 5; 6; 7; 8; 10, 12 h post dose Day 7: pre-dose; 1; 2; 3; 4; 5; 6; 7; 8; 10; 12; 14; 16; 18; 24; and 48 h post dose Urine:Day-1: pre-dose, Day 1: 24 hours urine collection post-dose; Day 7: 48 hours urine collection
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 14 Oct 2022.
- Individual participant dataSharing planned: No
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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.
Carol Addy, MD study director
Genfit
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 Nitazoxanide in people with Moderate Hepatic Impairment and Severe Hepatic Impairment, run by Genfit 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 7 inclusion and 22 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 14 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Area under the plasma concentration time curve (AUC) from time zero to 12h (AUC0-12) (time frame: Day 1: pre-dose; 1; 2; 3; 4; 5; 6; 7; 8; 10 and 12 hours post dose Day 7: pre-dose; 1; 2; 3; 4; 5; 6; 7; 8; 10; 12; 14; 16; 18; 24; and 48 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?
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 14 Oct 2022.