Trial results
AI generated results summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI
According to the results reported on ClinicalTrials.gov, this trial (NCT04053023) enrolled 19 participants in Part A, all of whom started the study. The trial was measuring how two medicines — obeticholic acid (OCA) and linerixibat — interact in the body when taken together, compared to OCA taken alone. Specifically, it tracked how much of the drug OCA was absorbed into the bloodstream and how high the drug levels peaked, using blood samples collected at set time points. The reported data shows that Part B of the trial had no participants enrolled, so only Part A results are available. The reported data shows that when participants took OCA 10 mg on its own, the total amount of OCA measured in the blood over time (a measure called "area under the curve," which is simply a way of capturing how much drug was in the body and for how long) was reported as approximately 2,330 and 2,350 units (hours × nanograms per millilitre) across two slightly different calculation methods. When OCA was taken together with linerixibat 90 mg, those same figures were reported as approximately 783 and 787 units — noticeably lower numbers. The peak blood level of OCA (the highest concentration reached) was reported as approximately 206 nanograms per millilitre when taking OCA alone, compared with approximately 83 nanograms per millilitre when taking OCA alongside linerixibat. No outcome data for Part B was reported in the submitted results. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View full results on ClinicalTrials.gov ↗
These are the results as reported to ClinicalTrials.gov, not medical advice. Verify independently with the trial site and discuss what they mean for you with your doctor.
Phase 1 Primary Biliary Cholangitis Trial, Completed
Who may be able to join
AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI
Who might be able to join this trial:
- People aged between 18 and 80 years old at the time of signing the consent form
- People considered generally healthy by the study doctor, based on a medical check-up including health history, physical examination, vital signs, blood tests, and a heart tracing (ECG)
- People with a body weight over 50 kg and a body mass index (BMI) between 18.5 and 32
- People who are able to give signed consent and agree to follow all study rules and requirements
- Female participants who are not pregnant, not breastfeeding, and either cannot become pregnant or agree to use appropriate contraception during the treatment period and for at least 4 weeks after the last dose of the study treatment
Who may not be able to join:
- People who have an active skin condition that causes or could cause itching, or who have had unexplained significant itching in the past 3 months
- People with a current or long-term history of liver disease, known liver or bile duct problems (except for a condition called Gilbert's syndrome or gallstones causing no symptoms), or confirmed liver or bile duct cancer
- People who have had their gallbladder removed
- People who currently have gallstones causing symptoms or an inflamed gallbladder
- People with a significant history of, or current, heart, lung, liver, kidney, digestive, hormonal, blood, or nervous system conditions that could affect how the body processes the study drug, pose a risk during the study, or make results difficult to interpret
- People with any clinically significant abnormality found during screening tests, physical examination, or heart tracing (ECG)
- People with a current episode, recent history (within 1 month of screening), or ongoing history of significant diarrhoea
- People who have had lymphoma, leukaemia, or any other cancer in the past 5 years, except for certain skin cancers that were fully removed with no signs of spread for at least 3 years
- People with any medical, psychiatric, or other condition that the study doctor believes would put them at unacceptable risk, affect their ability to follow the study, or prevent them from understanding what the study involves
- People who regularly use recreational drugs, or who have had a drug use or dependence problem in the past 6 months
- People who have regularly consumed more than 14 units of alcohol per week (for females) or more than 21 units per week (for males) in the 6 months before the study
- People who have used tobacco or nicotine products in the 3 months before screening, confirmed by a breath test
- People who have taken a specific type of drug called an IBAT inhibitor (including linerixibat) or OCA in the 3 months before screening
- People who have taken any prescription or over-the-counter medicines, vitamins, or herbal supplements within 7 to 14 days (or longer, depending on the medicine) before the first dose, unless approved by the study doctor and GSK medical monitor
- People currently enrolled in another clinical trial, or who have received an experimental treatment within the past 30 days (or longer, depending on the treatment) before the first dose in this study
- People who have taken part in studies involving more than 4 new experimental substances in the 12 months before the first dose
- People whose liver enzyme levels (ALT or AST) are more than 1.5 times the upper limit of normal on screening blood tests
- People whose bilirubin levels are more than 1.5 times the upper limit of normal on screening blood tests (confirm with trial site for specific exceptions)
- People who test positive for Hepatitis B or Hepatitis C at screening or within 3 months of the screening visit
- Female participants of childbearing potential who have a positive pregnancy test at screening or at admission to the study
- People who test positive for HIV antibodies
- People whose heart tracing (ECG) shows a QTc measurement greater than 450 milliseconds at screening
- People who test positive for drugs or alcohol before or during the study
- Female participants who are unable or unwilling to follow the specific contraception requirements of the study
- People whose participation would result in donating more than 500 mL of blood within any 56-day period
- People who are unwilling or unable to follow the study procedures for the full duration of the study
- People who have a known allergy or sensitivity to the study treatment or any of its ingredients, or any other allergy that the study doctor considers would make participation unsafe
Important: Always verify eligibility with the trial site directly before applying.
Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.
GP referral letter
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Trial details
Where this trial is recruiting
Primary endpoints
Part A- Area Under the Concentration-time Curve From Time 0 to Time of the Last Quantifiable Concentration (AUC[0-t]) for Total-OCA at Steady State: OCA Arm; Part A- AUC(0-t) for Total-OCA at Steady State: OCA + Linerixibat Arm; Part A- Area Under the Concentration-time Curve From Time 0 to 24 Hour (AUC[0-24]) for Total-OCA at Steady State: OCA Arm; Part A- AUC(0-24) for Total-OCA at Steady State: OCA + Linerixibat Arm; Part A- Maximum Observed Concentration (Cmax) for Total-OCA at Steady State: OCA Arm; Part A- Cmax for Total-OCA at Steady State: OCA + Linerixibat Arm; Part A- Average Trough...
Can't join this trial?
Data last synced from ClinicalTrials.gov: 28 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.