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Farnesoid X receptor (FXR) agonist

Seladelpar 10 mg for Primary Biliary Cirrhosis

Phase 1
Recruiting
Research Sponsored by CymaBay Therapeutics, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Confirmed diagnosis of PBC with evidence of cirrhosis and Child-Pugh classification of CP-A, CP-A + PHT, CP-B or CP-C
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 17 weeks
Awards & highlights

Study Summary

This trial found that Seladelpar is safe and well tolerated in patients with PBC and HI.

Who is the study for?
This trial is for adults aged 18-80 with Primary Biliary Cholangitis (PBC) and liver cirrhosis, classified as CP-A to CP-C. Participants must have been on Ursodeoxycholic acid for at least 12 weeks, not be pregnant or nursing, and agree to use contraception. Exclusions include other liver diseases, recent infections requiring systemic therapy, significant ECG abnormalities, substance abuse within the last six months, and certain medication use.Check my eligibility
What is being tested?
The study tests how different levels of liver impairment affect the body's handling of Seladelpar in PBC patients. It involves oral dosing with either a fixed dose of Seladelpar (10 mg) or a potentially lower amount based on individual tolerance.See study design
What are the potential side effects?
While specific side effects are not listed here, participants can generally expect potential risks associated with medications affecting the liver which may include gastrointestinal symptoms like nausea or diarrhea, fatigue, itching (pruritus), abdominal pain and possible changes in blood tests related to liver function.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I have PBC with cirrhosis and my liver function is classified as CP-A, CP-A + PHT, CP-B, or CP-C.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~17 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 17 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Brain Diseases, Metabolic
Evaluate maximum concentration (Cmax) of seladelpar and metabolites
Therapeutic procedure
+2 more

Trial Design

2Treatment groups
Experimental Treatment
Group I: Seladelpar 10 mg or lessExperimental Treatment1 Intervention
Part B: Multiple oral dose of 10 mg or less
Group II: Seladelpar 10 mgExperimental Treatment1 Intervention
Part A: Single oral dose 10 mg
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Seladelpar 10 mg
2021
Completed Phase 3
~200

Find a Location

Who is running the clinical trial?

CymaBay Therapeutics, Inc.Lead Sponsor
22 Previous Clinical Trials
3,232 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many medical institutions are participating in the research project?

"This investigation is currently carried out across 8 different sites, including San Antonio and Novi. Additionally, Jackson and other cities are included in the list of trial locations - participants should seek to join a nearby centre to minimize their commute."

Answered by AI

Has the FDA sanctioned Seladelpar 10 mg for public use?

"Our team at Power has assigned Seladelpar 10 mg a rating of 1 due to the limited amount of clinical data available regarding its efficacy and safety as this is only in Phase 1 trials."

Answered by AI

Could you point me to any prior research that has utilized Seladelpar 10 mg?

"Seladelpar 10 mg was initially tested in 2017 at Soon Chun Hyang University Hospital Bucheon. To date, there are 6 finished research projects and 3 ongoing clinical studies; many of these trials take place in San Antonio, Texas."

Answered by AI

Is it possible to enlist in this experiment at the present moment?

"Affirmative. Information on the clinicaltrials.gov website states that this medical experiment, which was initially advertised on September 17th 2021, is in search of participants. A total of 24 individuals need to be enrolled from 8 locations."

Answered by AI

How many individuals are currently participating in this research project?

"In order to successfully run the trial, a total of 24 compliant patients must be enrolled. CymaBay Therapeutics Inc., will execute the study from multiple sites, including American Research Corporation's Texas Liver Institute in San Antonio as well as Henry Ford Columbus Center in Novi, Michigan."

Answered by AI

Does this research protocol permit participants who are over 35 years of age?

"In order to be a part of this research, participants must range in age from 18 to 80. For those under the legal age and seniors over 65 years old respectively, there are 31 and 274 separate clinical trials available."

Answered by AI

Does this trial open to my participation?

"This clinical trial is recruiting 24 adults between the ages of 18 and 80 who have compensated liver disease. Participants must meet several requirements, such as being able to comprehend instructions and sign an informed consent form (ICF), using contraception if sexually active with a non-sterile male partner for 30 days after study medication, abstaining from grapefruit products 7 days prior to dosing throughout discharge day, having confirmed diagnosis of PBC with cirrhosis and Child-Pugh classification within CP A through C, ALP/ALT/AST all under 10×ULN, total bilirubin no higher than 5x ULN, 12 weeks"

Answered by AI

Are there any precedents for this experimental trial?

"CymaBay Therapeutics, Inc. sponsored the initiation of Seladelpar 10 mg's clinical trials in 2017 with a sample size of 500 participants. After successful completion and Phase 3 drug approval, active trials for this medication are now held across 26 countries and 98 cities worldwide."

Answered by AI

Who else is applying?

What portion of applicants met pre-screening criteria?
Met criteria
Recent research and studies
clinicaltrials.govStudy
An Open-Label Study Following Oral Dosing of Seladelpar to Subjects With Primary Biliary Cholangitis (PBC) and Hepatic Impairment (HI)
2021. "An Open-Label Study Following Oral Dosing of Seladelpar to Subjects With Primary Biliary Cholangitis (PBC) and Hepatic Impairment (HI)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04950764.
All > Liver Cirrhosis > Primary Biliary Cirrhosis
~1 spots leftby Jun 2024
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