Primary Biliary CholangitisPhase 1NCT04950764
An Open-Label Study Following Oral Dosing of Seladelpar to Participants With Primary Biliary Cholangitis (PBC) and Hepatic Impairment (HI)
A Phase 1 study testing Seladelpar in people with Primary Biliary Cholangitis and Compensated Cirrhosis, run by Gilead Sciences at 20 sites in 4 countries.
Trial summary
The Effect of Hepatic Impairment on The Pharmacokinetics of Seladelpar: An Open-Label Study Following Oral Dosing of Seladelpar to Participants with Primary Biliary Cholangitis (PBC) and Hepatic Impairment (HI) Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Primary Biliary Cholangitis, Compensated Cirrhosis, Hepatic Impairment
- What is being tested?
- Seladelpar
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 20 sitesin 4 countries
- Study dates
- 16 Nov 2021to 27 Feb 2025
- Phase
- Phase 1
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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Males and females between 18 and 80 years of age (inclusive) who are able to comprehend instructions and follow the study procedures and are willing to sign an Informed Consent Form (ICF)
- Females of childbearing potential who are sexually active with a non-sterile male partner (sterile male partners are defined as men vasectomized since at least 6 months) must be willing to use the contraceptive methods throughout the study and for 30 days after study drug administration.
- For at least 90 days after study drug administration, non-vasectomized males must not donate sperm, be willing to use contraception with childbearing potential partners and any male participant with a pregnant partner must use a condom.
- Willing to abstain from consuming grapefruit, pomelo, star fruit, or Seville orange containing products from 7 days prior to dose of study medication through day of discharge.
- Confirmed diagnosis of PBC with evidence of cirrhosis and Child-Pugh classification of CP-A, CP-A + PHT, CP-B or CP-C
- Screening laboratory parameters:
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- Alkaline phosphatase (ALP), alanine aminotransferase (ALT) and aspartate aminotransferase (AST) < 10 × upper Limit of normal (ULN)
- Total bilirubin ≤ 5 × ULN
- Ursodeoxycholic acid (UDCA) for a minimum of 12 weeks of treatment prior to Day 1
- At screening confirmed diagnosis of PBC
- Model for end-stage liver disease (MELD)-Na scores of 6 to 24
Who cannot join
- Clinically significant or history of acute or chronic liver disease of an etiology other than PBC
- Patients with a diagnosis of overlapping PBC and autoimmune hepatitis
- History, evidence, or high suspicion of hepatobiliary malignancy based on imaging, screening laboratory values, and/or clinical symptoms.
- Presumptive or diagnosed infection that requires systemic therapy within 12 weeks of Screening and through Day 1
- Female participants who are pregnant or nursing
- Screening electrocardiogram (ECG) that demonstrates a QT interval ≥ 500 msec, or any other significant ECG finding with clinically significant abnormalities as determined by the Investigator
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- Positive for hepatitis B surface antigen (HBsAg), hepatitis C virus - ribonucleic acid (HCV RNA), or anti human immunodeficiency virus (HIV) antibody
- Any non-hepatic acute or chronic condition that, in the opinion of the Investigator, would limit the patient's ability to complete and/or participate in the study or compromise the integrity of the data
- Has experienced an illness that is considered by the Investigator to be clinically significant within 2 weeks before administration of investigational product
- Clinically relevant drug or alcohol abuse within 6 months of Screening. A positive drug screen will exclude participants unless it can be explained by a prescribed medication
- Use of obeticholic acid (OCA), any drug of the same class, or fibrates (e.g., bezafibrate, fenofibrate, elafibranor, lanifibranor, pemafibrate, saroglitizar) within 30 days of Baseline
- Use of an experimental or unapproved treatment for PBC within 30 days of Baseline
- Clinically evident complication(s) of cirrhosis and portal hypertension that required either emergency room visit, hospital admission or both during the 12 week period prior to investigational product administration
- Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Trial locations and contacts
20 sites in 4 countries.
20 sites in 4 countries
United States11 sites
University of Colorado Anschutz
Aurora, Colorado, 80045
Mercy Medical Center
Baltimore, Maryland, 21202
Massachusetts General Hospital
Boston, Massachusetts, 02114
Arizona Liver Health
Chandler, Arizona, 85224
The Liver Institute at Methodist Dallas Medical Center
Dallas, Texas, 75203
Southern Therapy and Advanced Research LLC
Jackson, Mississippi, 39216
Weill Medical College of Cornell University
New York, New York, 10021
Henry Ford Health System
Novi, Michigan, 48377
University of California Davis
Sacramento, California, 95817
American Research Corporation
San Antonio, Texas, 78215
Pinnacle Clinical Research- SA
San Antonio, Texas, 78229
South Korea5 sites
Pusan National University Hospital
Busan, 49241
Inje University Busan Paik Hospital
Busan
Kyungpook National University Hospital
Daegu, 41944
Seoul National University Hospital
Seoul, 3080
Severance Hospital Yonsei University Health System
Seoul, 3722
United Kingdom3 sites
NIHR BRC Centre for Liver and Gastrointestinal Research Birmingham
Birmingham, B15 2GW
The Royal Free London NHS Foundation Trust
London, NW2 2QG
Kings College Hospital
London, SE5 9RS
About this study
Official title: The Effect of Hepatic Impairment on The Pharmacokinetics of Seladelpar: An Open-Label Study Following Oral Dosing of Seladelpar to Subjects With Primary Biliary Cholangitis (PBC) and Hepatic Impairment
The Effect of Hepatic Impairment on The Pharmacokinetics of Seladelpar: An Open-Label Study Following Oral Dosing of Seladelpar to Participants with Primary Biliary Cholangitis (PBC) and Hepatic Impairment (HI)
- Being tested
- Seladelpar
- Keywords
- PBC, Primary Biliary Cholangitis (PBC)
- Medical subject headings
- Liver Cirrhosis, Biliary
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SeladelparDrug
Also called Livdelzi®
Tablets Administered Orally
| Study group | Role | What they receive |
|---|---|---|
| Part A: Cohort 1 - CP-A Without PHT (Seladelpar 10 mg) | Experimental | Participants with primary biliary cholangitis (PBC) and a Child-Pugh (CP) classification of CP-A (score 5 to 6) without portal hypertension (PHT) will receive a single dose of seladelpar 10 mg, orally, on Day 1. Receives: Drug: Seladelpar |
| Part A: Cohort 2 - CP-A With PHT (Seladelpar 10 mg) | Experimental | Participants with PBC and a CP classification of CP-A (score 5 to 6) with PHT will receive a single dose of seladelpar 10 mg, orally, on Day 1. Receives: Drug: Seladelpar |
| Part A: Cohort 3 - CP-B (Seladelpar 10 mg) | Experimental | Participants with PBC and a CP classification of CP-B (score 7 to 9) will receive a single dose of seladelpar 10 mg, orally, on Day 1. Receives: Drug: Seladelpar |
| Part A: Cohort 4 - CP-C (Seladelpar 10 mg) | Experimental | Participants with PBC and a CP classification of CP-C (score 10 to 12) will receive a single dose of seladelpar 10 mg, orally, on Day 1. Receives: Drug: Seladelpar |
| Experimental: Part B: Cohort 2 - CP-A With PHT (Seladelpar 5 mg or 10 mg) | Experimental | Participants with PBC and a CP classification of CP-A (score 5 to 6) with PHT, who complete Part A, will receive seladelpar 10 mg or 5 mg, orally, once daily, for 28 days. Doses for Part B will be chosen based on exposure from a single dose in Part A for individual participants. Receives: Drug: Seladelpar |
| Experimental: Part B: Cohort 3 - CP-B (Seladelpar 5 mg or 10 mg) | Experimental | Participants with PBC and a CP classification of CP-B (score 7 to 9), who complete Part A, will receive seladelpar 10 mg or 5 mg, orally, once daily, for 28 days. Doses for Part B will be chosen based on exposure from a single dose in Part A for individual participants. Receives: Drug: Seladelpar |
What is being measured
The primary outcome is the main question the study is designed to answer.
Part A: Pharmacokinetic (PK) Parameter: Cmax of Seladelpar and Its Metabolites (M1, M2, and M3)
Cmax is defined as the maximum observed plasma concentration of the study drug.
Measured: Day 1: Predose; 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 24, 48 and 72 hours postdose
Part A: PK Parameter: Tmax of Seladelpar and Its Metabolites (M1, M2, and M3)
Tmax is defined as the time to reach the maximum observed plasma concentration of the study drug.
Measured: Day 1: Predose; 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 24, 48 and 72 hours postdose
Part A: PK Parameter: AUC0-t of Seladelpar and Its Metabolites (M1, M2, and M3)
AUC0-t is defined as area under the concentration--time curve from time zero to the last measurable concentration.
Measured: Day 1: Predose; 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 24, 48 and 72 hours postdose
Part A: PK Parameter: AUC0-inf of Seladelpar and Its Metabolites (M1, M2, and M3)
AUC0-inf is defined as area under the concentration--time curve from time zero extrapolated to infinity, calculated as AUC0-t+Ct/Kel, where: Ct = the last measurable concentration and Kel = elimination rate constant.
Measured: Day 1: Predose; 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 24, 48 and 72 hours postdose
Part B: PK Parameter: Cmax of Seladelpar and Its Metabolites (M1, M2, and M3)
Cmax is defined as the maximum observed plasma concentration of the study drug.
Measured: Day 1: Predose; 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, and 24 hours postdose
Part B: PK Parameter: Cmax,ss of Seladelpar and Its Metabolites (M1, M2, and M3)
Cmax,ss is defined as the steady-state maximum observed plasma concentration of the study drug at Day 28.
Measured: Day 28: Predose; 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 24, 48, and 72 hours postdose
Part B: PK Parameter: Tmax of Seladelpar and Its Metabolites (M1, M2, and M3)
Tmax is defined as the time to reach the maximum observed plasma concentration of the study drug.
Measured: Day 1: Predose; 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, and 24 hours postdose
Part B: PK Parameter: Tmax,ss of Seladelpar and Its Metabolites (M1, M2, and M3)
Tmax,ss is defined as the steady-state time to reach maximum observed plasma concentration of the study drug at Day 28.
Measured: Day 28: Predose; 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 24, 48, and 72 hours postdose
Part B: PK Parameter: AUC0-24 of Seladelpar and Its Metabolites (M1, M2, and M3)
AUC0-24 is defined as area under the concentration-time curve from time zero to 24 hours.
Measured: Day 1: Predose; 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, and 24 hours postdose
Part B: PK Parameter: AUC0-tau of Seladelpar and Its Metabolites (M1, M2, and M3)
AUCtau is defined as the area under the drug concentration versus time curve over the dosing interval.
Measured: Day 28: Predose; 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 24, 48, and 72 hours postdose
Part B: PK Parameter: RCmax of Seladelpar and Its Metabolites (M1, M2, and M3)
RCmax is defined as the accumulation ratio based on Cmax, calculated as Cmax on Day 28/ Day 1.
Measured: Day 28: Predose; 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 24, 48, and 72 hours postdose
Part B: PK Parameter: RAUC0-t of Seladelpar and Its Metabolites (M1, M2, and M3)
RAUC0-t is defined as the accumulation ratio based on AUC0-t, calculated as AUC0-tau on Day 28/ AUC0-24 on Day 1 for participants with dose once a day.
Measured: Day 28: Predose; 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 24, 48, and 72 hours postdose
Percentage of Participants Who Experienced Treatment-Emergent Adverse Events (TEAEs) and Study Drug-Related TEAEs
An adverse event (AE) was defined as any medical occurrence in a participant administered to a pharmaceutical product in a clinical study, regardless of a causal relationship with this treatment. TEAEs were defined as AEs that commenced or worsened on or after the time of study drug administration in Part A until up to 30 days after study drug administration in Part A or before the first study drug administration in Part B (whichever is earlier). For Part B, TEAEs are defined as AEs that commence or worsen on or after the time of first study drug administration in Part B until up to 30 days after the last study drug administration in Part B. A drug-related TEAE was defined as TEAE which was related (reported as 'possible', 'probable', or 'definite') to study drug. Percentages were rounded off.
Measured: Part A: Up to Week 5; Part B: Up to Week 8
Percentage of Participants Who Experienced Any Grade and Grade 3 or 4 TEAEs
TEAEs severity was graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 5.0. Grade 1: Mild; Grade 2: Moderate; Grade 3: Severe; Grade 4: Life-threatening; Grade 5: Fatal. Participants were counted at the highest AE grade experienced. The percentage of participants with any severity grade and severity grade of 3 or 4 were reported. Percentages were rounded off.
Measured: Part A: Up to Week 5; Part B: Up to Week 8
Percentage of Participants Who Experienced TEAEs of Special Interest
TEAEs of special interest for this study were defined as AEs that met CTCAE version 5.0 or the most recent version Grade 2 criteria or higher for AEs of elevated alanine transaminase (ALT), aspartate aminotransferase (AST), bilirubin, creatinine kinase, lipase, or serum creatinine. Hepatic decompensation clinical events including ascites, jaundice, esophageal variceal bleeding, and hepatic encephalopathy, were also defined as TEAEs of special interest for this study. Percentages were rounded off.
Measured: Part A: Up to Week 5; Part B: Up to Week 8
Percentage of Participants With Clinically Significant Changes in Vital Signs
Vital signs (including oral temperature, respiratory rate, seated blood pressure [diastolic and systolic], and heart rate) were evaluated. Percentage of participants with clinically significant changes in vital signs evaluations was reported. The clinically significant changes were based on investigator's judgement.
Measured: Part A: Up to Day 4; Part B: Up to Day 31
Percentage of Participants With Abnormal Clinically Significant 12-Lead Electrocardiogram (ECG) Findings
ECG measurements included the parameters of heart rate, ventricular rate, PR interval, QRS duration, QT interval (uncorrected), and QT interval corrected for heart rate according to Fridericia's formula (QTcF). Per protocol, ECG findings were classified in 1 of 3 categories: normal, abnormal but not clinically significant, or abnormal and clinically significant. Any abnormality in ECG assessments which were deemed clinically significant by the investigator were reported.
Measured: Part A: Up to Day 4; Part B: Up to Day 28
Percentage of Participants Who Experienced Laboratory Abnormalities
Clinical laboratory parameters included biochemistry, hematology, coagulation, and urinalysis. Abnormal laboratory values were graded according to the NCI CTCAE version 5.0.Grade 1: Mild; Grade 2: Moderate; Grade 3: Severe; Grade 4: Life-threatening; Grade 5: Fatal. The percentage of participants with a shift of ≥ 2 NCI CTCAE grade from baseline was reported.
Measured: Part A: Up to Day 4; Part B: Up to Day 31
Secondary outcomes (26)
Part A: PK Parameter (Urine): Ae0-t of Seladelpar and Its Metabolites (M1, M2, and M3)
Ae0-t is defined as the cumulative urinary excretion from time zero to time t, calculated as the sum of the amounts excreted over each collection interval.
Measured: Day 1: Predose; 0-6 h, and 6-12 h postdose
Part A: PK Parameter (Urine): CLR of Seladelpar
CLR is defined as the renal clearance, calculated as Ae0-t / AUC0-12.
Measured: Day 1: Predose; 0-6 h, and 6-12 h postdose
Part A: Rsq Between Plasma Seladelpar Cmax and Baseline Albumin
Rsq is defined as the R-squared value for the regression between Cmax and Baseline Albumin.
Measured: Day 1: Predose; 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 24, 48 and 72 hours postdose
Part A: Rsq Between Plasma Seladelpar AUC0-inf and Baseline Albumin
Rsq is defined as the R-squared value for the regression between AUC0-inf and Baseline Albumin.
Measured: Day 1: Predose; 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 24, 48 and 72 hours postdose
Part A: Rsq Between Plasma Seladelpar AUC0-t and Baseline Albumin
Rsq is defined as the R-squared value for the regression between AUC0-t and Baseline Albumin.
Measured: Day 1: Predose; 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 24, 48 and 72 hours postdose
Part A: Rsq Between Plasma Seladelpar Cmax and Baseline Bilirubin
Rsq is defined as the R-squared value for the regression between Cmax and Baseline Bilirubin.
Measured: Day 1: Predose; 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 24, 48 and 72 hours postdose
Part A: Rsq Between Plasma Seladelpar AUC0-inf and Baseline Bilirubin
Rsq is defined as the R-squared value for the regression between AUC0-inf and Baseline Bilirubin.
Measured: Day 1: Predose; 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 24, 48 and 72 hours postdose
Part A: Rsq Between Plasma Seladelpar AUC0-t and Baseline Bilirubin
Rsq is defined as the R-squared value for the regression between AUC0-t and Baseline Bilirubin.
Measured: Day 1: Predose; 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 24, 48 and 72 hours postdose
Part A: Rsq Between Plasma Seladelpar Cmax and Baseline Prothrombin Time
Rsq is defined as the R-squared value for the regression between Cmax and Baseline Prothrombin Time.
Measured: Day 1: Predose; 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 24, 48 and 72 hours postdose
Part A: Rsq Between Plasma Seladelpar AUC0-inf and Baseline Prothrombin Time
Rsq is defined as the R-squared value for the regression between AUC0-inf and Baseline Prothrombin Time.
Measured: Day 1: Predose; 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 24, 48 and 72 hours postdose
Part A: Rsq Between Plasma Seladelpar AUC0-t and Baseline Prothrombin Time
Rsq is defined as the R-squared value for the regression between AUC0-t and Baseline Prothrombin Time.
Measured: Day 1: Predose; 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 24, 48 and 72 hours postdose
Part A: Rsq Between Plasma Seladelpar Cmax and CP Score
Rsq is defined as the R-squared value for the regression between Cmax and CP score of participants.
Measured: Day 1: Predose; 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 24, 48 and 72 hours postdose
Part A: Rsq Between Plasma Seladelpar AUC0-inf and CP Score
Rsq is defined as the R-squared value for the regression between AUC0-inf and CP score of participants.
Measured: Day 1: Predose; 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 24, 48 and 72 hours postdose
Part A: Rsq Between Plasma Seladelpar AUC0-t and CP Score
Rsq is defined as the R-squared value for the regression between AUC0-t and CP score of participants.
Measured: Day 1: Predose; 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 24, 48 and 72 hours postdose
Part B: Rsq Between Plasma Seladelpar Cmax and Baseline Albumin
Rsq is defined as the R-squared value for the regression between Cmax and baseline Albumin.
Measured: Day 1: Predose; 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, and 24 hours postdose
Part B: Rsq Between Plasma Seladelpar AUC0-t and Baseline Albumin
Rsq is defined as the R-squared value for the regression between AUC0-t and baseline Albumin.
Measured: Day 1: Predose; 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, and 24 hours postdose; Day 28: Predose; 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 24, 48, and 72 hours postdose
Part B: Rsq Between Plasma Seladelpar AUC0-inf and Baseline Albumin
Rsq is defined as the R-squared value for the regression between AUC0-inf and baseline Albumin.
Measured: Day 1: Predose; 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, and 24 hours postdose
Part B: Rsq Between Plasma Seladelpar Cmax and Baseline Prothrombin Time
Rsq is defined as the R-squared value for the regression between Cmax and baseline prothrombin time.
Measured: Day 1: Predose; 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, and 24 hours postdose
Part B: Rsq Between Plasma Seladelpar AUC0-t and Baseline Prothrombin Time
Rsq is defined as the R-squared value for the regression between AUC0-t and baseline prothrombin time.
Measured: Day 1: Predose; 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, and 24 hours postdose; Day 28: Predose; 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 24, 48, and 72 hours postdose
Part B: Rsq Between Plasma Seladelpar AUC0-inf and Baseline Prothrombin Time
Rsq is defined as the R-squared value for the regression between AUC0-inf and baseline prothrombin time.
Measured: Day 1: Predose; 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, and 24 hours postdose
Part B: Rsq Between Plasma Seladelpar Cmax and Baseline Bilirubin
Rsq is defined as the R-squared value for the regression between Cmax and baseline bilirubin.
Measured: Day 1: Predose; 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, and 24 hours postdose
Part B: Rsq Between Plasma Seladelpar AUC0-t and Baseline Bilirubin
Rsq is defined as the R-squared value for the regression between AUC0-t and baseline bilirubin.
Measured: Day 1: Predose; 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, and 24 hours postdose; Day 28: Predose; 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 24, 48, and 72 hours postdose
Part B: Rsq Between Plasma Seladelpar AUC0-inf and Baseline Bilirubin
Rsq is defined as the R-squared value for the regression between AUC0-inf and baseline bilirubin.
Measured: Day 1: Predose; 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, and 24 hours postdose
Part B: Rsq Between Plasma Seladelpar Cmax and CP Score
Rsq is defined as the R-squared value for the regression between Cmax and CP score of participants.
Measured: Day 1: Predose; 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, and 24 hours postdose
Part B: Rsq Between Plasma Seladelpar AUC0-t and CP Score
Rsq is defined as the R-squared value for the regression between AUC0-t and and CP score of participants.
Measured: Day 1: Predose; 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, and 24 hours postdose; Day 28: Predose; 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 24, 48, and 72 hours postdose
Part B: Rsq Between Plasma Seladelpar AUC0-inf and CP Score
Rsq is defined as the R-squared value for the regression between AUC0-inf and and CP score of participants.
Measured: Day 1: Predose; 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, and 24 hours postdose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jul 2021
- Study start16 Nov 2021
- Primary completion24 Feb 2025
- Study completion27 Feb 2025
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 Primary Biliary CholangitisStudies of the same condition, open and under way.
- More trials run by Gilead SciencesThe 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
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gilead Sciences
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Gilead Study Director, Study director, Gilead Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04950764
- Sponsor's protocol ID
- CB8025-21838
- Other IDs
- 2020-005925-10
- Status last verified
- Apr 2026
- First submitted
- 14 Jun 2021
- Last updated
- 4 May 2026
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Qualified external researchers may request IPD for this study. For more information, please visit our website at https://www.gileadclinicaltrials.com/transparency-policy#Commitment