CompletedPhase 1

Hepatic Impairment, Cholestatic Liver Disease, & NASH with Advanced Fibrosis & Normal Hepatic Function

United States98 participantsStarted 2020-07-16

Plain-language summary

This will be a Phase 1, Open-label Study of Participants with Hepatic Impairment, Cholestatic Liver Disease, and NASH with Advanced Fibrosis and Normal Hepatic Function

Who can participate

Age range18 Years – 80 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Ability to comprehend and willingness to sign a written informed consent for the study.
✓. Male or female aged 18 to 80 years (inclusive) at the time of signing the ICF.
✓. Body mass index within the range 18.0 to 48.0 kg/m2 (inclusive) at screening.
✓. Females must be non-pregnant, non-lactating and of non-childbearing potential or using highly efficient contraception for the full duration of the study.
✓. Females of child-bearing potential and Males must agree to use contraception for the full duration of the study.
✓. Ability to swallow and retain oral medication.
✓. Groups 1 through 6 subjects may have medical findings consistent with their degree of hepatic dysfunction, as determined by medical history, physical examination, vital signs, ECGs, and clinical laboratory examinations at screening and check-in. Participants with abnormal findings considered not clinically significant by the Investigator are eligible.
✓. Participants with hepatic impairment in Groups 1-4 will be classified at screening based on CPT score. If the hepatic impairment classification for the subject is not the same at screening and day -1, enrolment of the subject into a hepatic category group will be at the discretion of the hepatology Investigator.

Exclusion criteria

✕. Any significant, unstable medical condition or other instability that would prevent the subject from participating in the study as determined by the Investigator or designee.
✕. History of malignancy of any type in the last 3 years of screening, with the exception of the following: in situ cervical or breast cancer or surgically excised non-melanoma skin cancers (i.e. basal cell or squamous cell carcinoma).
✕. History of stomach or intestinal surgery or resection within the six months prior to screening that would potentially alter absorption and/or excretion of orally administered drugs (uncomplicated appendectomy, cholecystectomy, and hernia repair will be allowed).
✕. History of any significant drug allergy (such as anaphylaxis) deemed clinically relevant by the Investigator.
✕. Any major surgery within 3 months of screening.
✕. Donation of blood or blood products within 3 months prior to screening.
✕. Current active infectious disease requiring systemic antibiotic, antifungal, or antiviral treatment or symptoms of active infectious disease within the two weeks prior to screening.
✕. Use or intend to use any medications/products known to alter drug absorption, metabolism, or elimination processes, including St. John's Wort, within 21 days prior to screening, unless deemed acceptable by the Investigator.

What they're measuring

AUC from time zero to infinity (AUC0-∞)

Timeframe: Before dosing on Day 1 through Day 7

AUC from time zero to the last quantifiable concentration (AUC0-t)

Timeframe: Before dosing on Day 1 through Day 7

Cmax

Timeframe: Before dosing on Day 1 through Day 7

Tmax

Timeframe: Before dosing on Day 1 through Day 7

t1/2

Timeframe: Before dosing on Day 1 through Day 7

CL/F

Timeframe: Before dosing on Day 1 through Day 7

Vz/F

Timeframe: Before dosing on Day 1 through Day 7

Trial details

NCT IDNCT04469920

SponsorZydus Therapeutics Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2022-03-21

View on ClinicalTrials.gov More Hepatic Impairment trials

Who can participate

Age range18 Years – 80 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Ability to comprehend and willingness to sign a written informed consent for the study.
✓. Male or female aged 18 to 80 years (inclusive) at the time of signing the ICF.
✓. Body mass index within the range 18.0 to 48.0 kg/m2 (inclusive) at screening.
✓. Females must be non-pregnant, non-lactating and of non-childbearing potential or using highly efficient contraception for the full duration of the study.
✓. Females of child-bearing potential and Males must agree to use contraception for the full duration of the study.
✓. Ability to swallow and retain oral medication.
✓. Groups 1 through 6 subjects may have medical findings consistent with their degree of hepatic dysfunction, as determined by medical history, physical examination, vital signs, ECGs, and clinical laboratory examinations at screening and check-in. Participants with abnormal findings considered not clinically significant by the Investigator are eligible.
✓. Participants with hepatic impairment in Groups 1-4 will be classified at screening based on CPT score. If the hepatic impairment classification for the subject is not the same at screening and day -1, enrolment of the subject into a hepatic category group will be at the discretion of the hepatology Investigator.

Exclusion criteria

✕. Any significant, unstable medical condition or other instability that would prevent the subject from participating in the study as determined by the Investigator or designee.
✕. History of malignancy of any type in the last 3 years of screening, with the exception of the following: in situ cervical or breast cancer or surgically excised non-melanoma skin cancers (i.e. basal cell or squamous cell carcinoma).
✕. History of stomach or intestinal surgery or resection within the six months prior to screening that would potentially alter absorption and/or excretion of orally administered drugs (uncomplicated appendectomy, cholecystectomy, and hernia repair will be allowed).
✕. History of any significant drug allergy (such as anaphylaxis) deemed clinically relevant by the Investigator.
✕. Any major surgery within 3 months of screening.
✕. Donation of blood or blood products within 3 months prior to screening.
✕. Current active infectious disease requiring systemic antibiotic, antifungal, or antiviral treatment or symptoms of active infectious disease within the two weeks prior to screening.
✕. Use or intend to use any medications/products known to alter drug absorption, metabolism, or elimination processes, including St. John's Wort, within 21 days prior to screening, unless deemed acceptable by the Investigator.

What they're measuring

AUC from time zero to infinity (AUC0-∞)

Timeframe: Before dosing on Day 1 through Day 7

AUC from time zero to the last quantifiable concentration (AUC0-t)

Timeframe: Before dosing on Day 1 through Day 7

Cmax

Timeframe: Before dosing on Day 1 through Day 7

Tmax

Timeframe: Before dosing on Day 1 through Day 7

t1/2

Timeframe: Before dosing on Day 1 through Day 7

CL/F

Timeframe: Before dosing on Day 1 through Day 7

Vz/F

Timeframe: Before dosing on Day 1 through Day 7