RecruitingPhase 1

Hepatic Impairment With Cirrhosis Due to Cholestatic Liver Disease

United States30 participantsStarted 2021-10-21

Plain-language summary

A Phase 1, Open-label Extension Groups Study in Subjects having Hepatic Impairment with Cirrhosis due to Cholestatic Liver Disease

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 ICF 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.
✓. Participants having documented history of hepatic impairment with cirrhosis due to cholestatic liver disease in Groups 8 and 9 will be classified in sub groups 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.
✓. Laboratory test values for hepatic impairment subjects Groups 8 (8A, 8B, 8C) and 9 (9A, 9B, 9C) must be clinically acceptable to the Investigator and meet all the following parameters at Screening:

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

To evaluate the plasma PK of Saroglitazar (parent compound)

Timeframe: Serial PK blood samples will be collected on Day1 and Day 28 (1 pre-dose sample and serial post dose sampling till 24 hours post dose on both days)

To assess the safety and tolerability of Saroglitazar

Timeframe: Through study completion, an average of 9 weeks

To evaluate plasma PK of Saroglitazar metabolite (Saroglitazar sulfoxide)

Timeframe: Serial PK blood samples will be collected on Day 1 and Day 28 (1 pre-dose sample and serial post dose sampling till 24 hours post dose on both days)

To evaluate the impact of hepatic impairment with cirrhosis due to cholestatic liver disease on the unbound concentration of Saroglitazar in systemic circulation in

Timeframe: The blood samples will be collected on Day 1 and Day 28 at pre-dose, 2.0 h and 24.0 h post dose.

To evaluate the trough plasma concentration of Saroglitazar (parent compound)

Timeframe: Trough plasma sample will be collected at pre-dose on Visit 3 (on day 8), Visit-4 (On day 15) and at Visit 5 (on day 22). Additional PK sample will be collected at 168.0 hours post dose of day 28 (i.e. on Day 35 ±3D)

To determine the plasma PK of Saroglitazar (parent compound)

Timeframe: Serial PK blood samples will be collected on Day1 and Day 28 (1 pre-dose sample and serial post dose sampling till 24 hours post dose on both days)

Trial details

NCT IDNCT05045482

SponsorZydus Therapeutics Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2026-03-31

Contact for this trial

Farheen Shaikh

+1 6094534751 fshaikh@zydustherapeutics.com

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 ICF 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.
✓. Participants having documented history of hepatic impairment with cirrhosis due to cholestatic liver disease in Groups 8 and 9 will be classified in sub groups 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.
✓. Laboratory test values for hepatic impairment subjects Groups 8 (8A, 8B, 8C) and 9 (9A, 9B, 9C) must be clinically acceptable to the Investigator and meet all the following parameters at Screening:

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

To evaluate the plasma PK of Saroglitazar (parent compound)

Timeframe: Serial PK blood samples will be collected on Day1 and Day 28 (1 pre-dose sample and serial post dose sampling till 24 hours post dose on both days)

To assess the safety and tolerability of Saroglitazar

Timeframe: Through study completion, an average of 9 weeks

To evaluate plasma PK of Saroglitazar metabolite (Saroglitazar sulfoxide)

Timeframe: Serial PK blood samples will be collected on Day 1 and Day 28 (1 pre-dose sample and serial post dose sampling till 24 hours post dose on both days)

To evaluate the impact of hepatic impairment with cirrhosis due to cholestatic liver disease on the unbound concentration of Saroglitazar in systemic circulation in

Timeframe: The blood samples will be collected on Day 1 and Day 28 at pre-dose, 2.0 h and 24.0 h post dose.

To evaluate the trough plasma concentration of Saroglitazar (parent compound)

To determine the plasma PK of Saroglitazar (parent compound)

Timeframe: Serial PK blood samples will be collected on Day1 and Day 28 (1 pre-dose sample and serial post dose sampling till 24 hours post dose on both days)