PruritusPhase 1NCT05133830
Linerixibat and Obeticholic Acid Drug Interaction Study in Healthy Adult Participants
A Phase 1 study testing Obeticholic acid and Linerixibat in people with Pruritus, run by GlaxoSmithKline at 1 site in United States.
Trial summary
This study aims to investigate the effect of linerixibat on plasma concentrations of obeticholic acid (OCA) and its conjugates in healthy adult participants to inform the potential for drug interaction with coadministration of linerixibat and OCA. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Pruritus
- What is being tested?
- Obeticholic acid and Linerixibat
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 1 siteUnited States
- Study dates
- 23 Nov 2021to 31 May 2022
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Overtly healthy male or female participants 18 to 50 years of age inclusive, at the time of signing the informed consent
- Body weight greater than (>) 50 kilogram (kg) and body mass index (BMI) within the range 18.5 - 32 kilogram per meter square (kg/m^2) (inclusive)
- Capable of giving signed informed consent as the protocol.
Who cannot join
- Any active dermatologic disorder leading to or with the potential to cause itching or a recent history of unexplained clinically significant itching locally or generally within the prior 3 months
- Current or chronic history of liver disease or known hepatic or biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones) and/or confirmed hepatocellular carcinoma or biliary cancer
- History of gall bladder removal
- Current symptomatic gallstones or inflammatory gall bladder disease
- Significant history of or current disorders that can significantly alter the absorption, metabolism, or elimination of drugs
- Current clinically significant diarrhea
Show all 24Show fewer
- History of gastrointestinal surgery with ileal resection or ileal bypass at any time
- Any malignancy within the past 5 years except for basal cell or squamous epithelial carcinomas of the skin that have been resected with no evidence of metastatic disease for 3 years
- Administration of any other ileal bile acid transport (IBAT) inhibitor (including linerixibat) or Ocaliva in the 3 months prior to screening
- Past or intended use of over-the-counter or prescription medication, including vitamins and dietary or herbal supplements) within 7 days (or 14 days if the drug is a potential enzyme inhibitor) or 5 half-lives (whichever is longer) prior to the first dose of study medication, unless approved by the Investigator in conjunction with GSK
- Current enrolment in a clinical trial or recent participation in a clinical trial and has received an investigational product within 30 days before the first dose in the current study
- Exposure to more than 4 new chemical entities within 12 months before the first dose in the current study
- Screening alanine aminotransferase (ALT) or aspartate aminotransferase (AST) >1.5x upper limit of normal (ULN)
- Bilirubin >1.5xULN (isolated bilirubin >1.5x ULN is acceptable if bilirubin is fractionated and direct bilirubin lesser than (<)35%
- Presence of hepatitis B surface antigen (HBsAg), positive hepatitis C antibody test or positive hepatitis C riboneucleic acid (RNA) test result at screening or within 3 months prior to first dose of study intervention
- Positive pregnancy test at screening or at Day -1
- Positive human immunodeficiency virus (HIV) antibody test
- QT interval corrected (QTc) >450 millisecond (msec)
- Regular use of known drugs of abuse or history of drug abuse or dependence within 6 months of the study
- Participants with moderate (or greater) alcohol consumption
- History of or regular use of tobacco- or nicotine-containing products in the 3 months prior to screening.
- Female participants unable or unwilling to comply with specific contraception restrictions as detailed in the protocol
- Where participation in the study would result in donation of blood or blood products in excess of 500 milliliter (mL) within a 56-day period
- Sensitivity to any of the study interventions, or components thereof, or drug or other allergy that, in the opinion of the investigator or GSK Medical Monitor, contraindicates participation in the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Two-part, Phase 1, Open-label, Randomized, Parallel-arm, Fixed Sequence, Drug-drug Interaction Study to Investigate the Effect of Linerixibat on Plasma Concentrations of Obeticholic Acid and Conjugates in Healthy Adult Participants
This study aims to investigate the effect of linerixibat on plasma concentrations of obeticholic acid (OCA) and its conjugates in healthy adult participants to inform the potential for drug interaction with coadministration of linerixibat and OCA.
- Conditions
- Pruritus
- Being tested
- Obeticholic acid, Linerixibat
- Keywords
- Drug-drug interaction, Healthy Volunteers, Linerixibat, Obeticholic acid, Pharmacokinetics
- Medical subject headings
- Pruritus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Obeticholic acidDrug
OCA will be administered
LinerixibatDrug
Linerixibat will be administered
| Study group | Role | What they receive |
|---|---|---|
| Treatment Arm 1 | Experimental | Participants will receive OCA at dose level 1, 4 hours after the linerixibat administration Receives: Drug: Obeticholic acid; Drug: Linerixibat |
| Treatment Arm 2 | Experimental | Participants will receive OCA at dose level 2 along with linerixibat Receives: Drug: Obeticholic acid; Drug: Linerixibat |
| Treatment Arm 3 | Experimental | Participants will receive OCA at dose level 1 along with linerixibat Receives: Drug: Obeticholic acid; Drug: Linerixibat |
| Treatment Arm 4 | Experimental | Participants will receive OCA at dose level 2, 4 hours after the linerixibat administration Receives: Drug: Obeticholic acid; Drug: Linerixibat |
What is being measured
The primary outcome is the main question the study is designed to answer.
Average trough concentration (Ctrough) in plasma for total-OCA at steady state
Measured: Days 35 to 38
Secondary outcomes (7)
Area under the concentration curve from time 0 to t (AUC0-t) for OCA, tauro-OCA, glyco-OCA and total-OCA at steady state
Measured: At Day 18 and Day 37
AUC from time 0 to 24 hour (AUC0-24) for OCA, tauro-OCA, glyco-OCA and total-OCA at steady state
Measured: Up to 24 hours on Day 18 and Day 37
Maximum observed plasma concentration (Cmax) for OCA, tauro-OCA, glyco-OCA and total-OCA at steady state
Measured: At Day 18 and Day 37
Average trough concentration (Ctrough) in plasma for OCA, tauro-OCA, glyco-OCA and total-OCA at steady state
Measured: Days 17 to 19 and Days 35 to 38
Time to maximum concentration (Tmax) for OCA, tauro-OCA, glyco-OCA and total-OCA
Measured: At Day 18 and Day 37
Ctrough of total OCA over Days 17 to 19 and Days 35 to 38
Measured: Days 17 to 19 and Days 35 to 38
Number of participants with adverse events
Measured: Up to Day 52
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Nov 2021
- Study start23 Nov 2021
- Primary completion31 May 2022
- Study completion31 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PruritusStudies of the same condition, open and under way.
- More trials run by GlaxoSmithKlineThe 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- Two arms will be evaluated in parallel in Part A. After Part A, if Part B is conducted, one of the two remaining arms will be evaluated.
- Masking
- None (open label)
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- GlaxoSmithKline
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- GSK Clinical Trials, Study director, GlaxoSmithKline
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05133830
- Sponsor's protocol ID
- 213688
- Status last verified
- Nov 2022
- First submitted
- 12 Nov 2021
- Last updated
- 8 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: IPD for this study will be made available via the Clinical Study Data Request site.
- Expanded access
- Available
Study at a glance
From the registry record, last updated by the sponsor on 8 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Two-part, Phase 1, Open-label, Randomized, Parallel-arm, Fixed Sequence, Drug-drug Interaction Study to Investigate the Effect of Linerixibat on Plasma Concentrations of Obeticholic Acid and Conjugates in Healthy Adult Participants
- ClinicalTrials.gov ID
- NCT05133830
- Acronym / sponsor ID
- 213688
- Conditions
- Pruritus
- Keywords
- Drug-drug interaction, Healthy Volunteers, Linerixibat, Obeticholic acid, Pharmacokinetics
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- 23 Nov 2021 (actual)
- Primary completion
- 31 May 2022 (actual)
- Study completion
- 31 May 2022 (actual)
- First posted
- 24 Nov 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study aims to investigate the effect of linerixibat on plasma concentrations of obeticholic acid (OCA) and its conjugates in healthy adult participants to inform the potential for drug interaction with coadministration of linerixibat and OCA.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- Two arms will be evaluated in parallel in Part A. After Part A, if Part B is conducted, one of the two remaining arms will be evaluated.
| Arm | Type | Receives |
|---|---|---|
| Treatment Arm 1 | Experimental | Drug: Obeticholic acid, Drug: LinerixibatParticipants will receive OCA at dose level 1, 4 hours after the linerixibat administration |
| Treatment Arm 2 | Experimental | Drug: Obeticholic acid, Drug: LinerixibatParticipants will receive OCA at dose level 2 along with linerixibat |
| Treatment Arm 3 | Experimental | Drug: Obeticholic acid, Drug: LinerixibatParticipants will receive OCA at dose level 1 along with linerixibat |
| Treatment Arm 4 | Experimental | Drug: Obeticholic acid, Drug: LinerixibatParticipants will receive OCA at dose level 2, 4 hours after the linerixibat administration |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Overtly healthy male or female participants 18 to 50 years of age inclusive, at the time of signing the informed consent
- Body weight greater than (>) 50 kilogram (kg) and body mass index (BMI) within the range 18.5 - 32 kilogram per meter square (kg/m^2) (inclusive)
- Capable of giving signed informed consent as the protocol.
Key exclusion criteria (24 listed)
- Any active dermatologic disorder leading to or with the potential to cause itching or a recent history of unexplained clinically significant itching locally or generally within the prior 3 months
- Current or chronic history of liver disease or known hepatic or biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones) and/or confirmed hepatocellular carcinoma or biliary cancer
- History of gall bladder removal
- Current symptomatic gallstones or inflammatory gall bladder disease
- Significant history of or current disorders that can significantly alter the absorption, metabolism, or elimination of drugs
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Obeticholic acidOCA will be administered | Drug | Treatment Arm 1, Treatment Arm 2, Treatment Arm 3, Treatment Arm 4 |
| LinerixibatLinerixibat will be administered | Drug | Treatment Arm 1, Treatment Arm 2, Treatment Arm 3, Treatment Arm 4 |
Primary outcome
Average trough concentration (Ctrough) in plasma for total-OCA at steady state
Time frame: Days 35 to 38
7 secondary outcomes
Area under the concentration curve from time 0 to t (AUC0-t) for OCA, tauro-OCA, glyco-OCA and total-OCA at steady state
Time frame: At Day 18 and Day 37
AUC from time 0 to 24 hour (AUC0-24) for OCA, tauro-OCA, glyco-OCA and total-OCA at steady state
Time frame: Up to 24 hours on Day 18 and Day 37
Maximum observed plasma concentration (Cmax) for OCA, tauro-OCA, glyco-OCA and total-OCA at steady state
Time frame: At Day 18 and Day 37
Average trough concentration (Ctrough) in plasma for OCA, tauro-OCA, glyco-OCA and total-OCA at steady state
Time frame: Days 17 to 19 and Days 35 to 38
Time to maximum concentration (Tmax) for OCA, tauro-OCA, glyco-OCA and total-OCA
Time frame: At Day 18 and Day 37
Ctrough of total OCA over Days 17 to 19 and Days 35 to 38
Time frame: Days 17 to 19 and Days 35 to 38
Number of participants with adverse events
Time frame: Up to Day 52
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Nov 2022.
- Individual participant dataSharing planned: Yes. IPD for this study will be made available via the Clinical Study Data Request site.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
GSK Clinical Trials study director
GlaxoSmithKline
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Obeticholic acid and Linerixibat in people with Pruritus, run by GlaxoSmithKline at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Average trough concentration (Ctrough) in plasma for total-OCA at steady state (time frame: Days 35 to 38). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Nov 2022; AzTrials last refreshed its copy on 8 Nov 2026.