PruritusPhase 1NCT05435170
Food Effect Study of Linerixibat Tablets in Healthy Adult Participants
A Phase 1 study testing linerixibat in people with Pruritus, run by GlaxoSmithKline at 1 site in United Kingdom.
Trial summary
This study will evaluate the effect of food on the Pharmacokinetic (PK) and Pharmacodynamic (PD) parameters of linerixibat administered in fed and fasted states in heathy adult participants Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Pruritus
- What is being tested?
- linerixibat
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 11 Aug 2022to 10 Oct 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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Overtly healthy male or female participants 18 to 55 years of age inclusive, at the time of signing the informed consent.
- Participants' age greater than (>) 50 years old, must have had at least 3 weeks elapsed after the completion of an approved primary SARS-CoV-2 vaccination course.
- Body weight >50 kg and body mass index (BMI) within the range 18.5 - 32 kilogram per meter square (kg/m2) (inclusive).
- Female Participants:
- A female participant is eligible to participate if she is not pregnant or breastfeeding, and one of the following conditions applies:
- Is a woman of non-childbearing potential (WONCBP). OR
- Is a woman of childbearing potential (WOCBP) and using a contraceptive method that is highly effective (with a failure rate of <1% per year).
- Capable of giving signed informed consent.
Who cannot join
- History of cholecystectomy.
- Current symptomatic cholelithiasis or inflammatory gall bladder disease.
- Significant history of or current disorders capable of significantly altering the absorption, metabolism, or elimination of drugs.
- Current clinically significant diarrhea.
- 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.
Show all 18Show fewer
- Administration of any other Ileal Bile Acid Transport (IBAT) inhibitor (including linerixibat) 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 Medical Monitor.
- Current enrollment in a clinical trial or recent participation in a clinical trial and has received an investigational product within the following time period prior to study drug administration: 30 days, 5 half-lives, or twice the duration of the biological effect of the investigational product (whichever is longer).
- 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 >1.5x ULN (isolated bilirubin >1.5x ULN is acceptable if bilirubin is fractionated and direct bilirubin <35%).
- Positive hepatitis B surface antigen (HBsAg), hepatitis C antibody test or hepatitis C Ribonucleic acid (RNA) test at screening or within 3 months prior to first dose of study intervention.
- Positive human immunodeficiency virus (HIV) antibody test
- Fridericia's QT correction formula (QTcF) >450 msec on ECG performed at screening.
- Regular use of known drugs of abuse or history of drug abuse or dependence within 6 months of the study.
- Regular alcohol consumption within 6 months prior to signing the informed consent.
- Regular use of tobacco- or nicotine-containing products in the 3 months prior to screening.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase I, Randomized, Open-label, Single Dose, 2 Period, Crossover Study to Evaluate the Effect of Food on the Pharmacokinetics of Linerixibat Tablets in Healthy Adult Participants
This study will evaluate the effect of food on the Pharmacokinetic (PK) and Pharmacodynamic (PD) parameters of linerixibat administered in fed and fasted states in heathy adult participants
- Conditions
- Pruritus
- Being tested
- linerixibat
- Keywords
- Pharmacokinetic, Pharmacodynamic, Food effect, Ileal bile acid transporter (IBAT) inhibitor, Linerixibat
- Medical subject headings
- Pruritus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
linerixibatDrug
linerixibat will be administered per the treatment sequence
| Study group | Role | What they receive |
|---|---|---|
| Treatment sequence AB | Experimental | Participants will receive linerixibat in fed state (Treatment A) in period 1 followed by linerixibat in fasted state (Treatment B) in period 2. The washout period will be of at least 7 days. Receives: Drug: linerixibat |
| Treatment sequence BA | Experimental | Participants will receive linerixibat in fasted state (Treatment B) in period 1 followed by linerixibat in fed state (Treatment A) in period 2. The washout period will be of at least 7 days. Receives: Drug: linerixibat |
What is being measured
The primary outcome is the main question the study is designed to answer.
Plasma linerixibat area under the concentration-time curve from time zero (pre-dose) to the time of the last quantifiable concentration [AUC(0-t)]
Measured: Up to 36 hours post dose
Maximum observed plasma concentration (Cmax) of linerixibat
Measured: Up to 36 hours post dose
Secondary outcomes (10)
Plasma linerixibat area under the concentration-time curve from time zero (pre-dose) to infinite time [AUC (0-∞)]
Measured: Up to 36 hours post dose
Plasma linerixibat area under the concentration-time curve from time zero (pre-dose) to 24 hour [AUC (0-24)]
Measured: Up to 24 hours post dose
Time of occurrence of Cmax (Tmax) of linerixibat
Measured: Up to 36 hours post dose
Delay in achieving Tmax (Tlag) of linerixibat
Measured: Up to 36 hours post dose
Apparent terminal phase half-life (t1/2) of linerixibat
Measured: Up to 36 hours post dose
Apparent clearance (CL/F) of linerixibat
Measured: Up to 36 hours post dose
Apparent terminal phase volume of distribution (Vz/F) of linerixibat
Measured: Up to 36 hours post dose
Serum C4 area under the concentration-time curve from time zero (pre-dose) to the time of the last quantifiable concentration [AUC(0-t)]
Measured: Up to 36 hours post dose
Serum C4 area under the concentration-time curve from time zero (pre-dose) to 24 hour [AUC (0-24)]
Measured: Up to 24 hours post dose
Incidence of adverse events (AEs) and of serious adverse events (SAEs)
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 posted28 Jun 2022
- Study start11 Aug 2022
- Primary completion10 Oct 2022
- Study completion10 Oct 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
- Crossover
- Model description
- Participants will be randomized to one of the 2 sequences. In sequence AB, participants will receive linerixibat under fed state (Treatment A) in Period 1, then linerixibat under fasted state (Treatment B) in Period 2. In Sequence BA, the 2 treatments will be reversed. The washout period will be of at least 7 days.
- Masking
- None (open label)
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- GlaxoSmithKline
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- GSK Clinincal Trials, Study director, GlaxoSmithKline
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05435170
- Sponsor's protocol ID
- 214656
- Status last verified
- Nov 2022
- First submitted
- 22 Jun 2022
- Last updated
- 29 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 29 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I, Randomized, Open-label, Single Dose, 2 Period, Crossover Study to Evaluate the Effect of Food on the Pharmacokinetics of Linerixibat Tablets in Healthy Adult Participants
- ClinicalTrials.gov ID
- NCT05435170
- Acronym / sponsor ID
- 214656
- Conditions
- Pruritus
- Keywords
- Pharmacokinetic, Pharmacodynamic, Food effect, Ileal bile acid transporter (IBAT) inhibitor, Linerixibat
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- 11 Aug 2022 (actual)
- Primary completion
- 10 Oct 2022 (actual)
- Study completion
- 10 Oct 2022 (actual)
- First posted
- 28 Jun 2022 (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 will evaluate the effect of food on the Pharmacokinetic (PK) and Pharmacodynamic (PD) parameters of linerixibat administered in fed and fasted states in heathy adult participants
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants will be randomized to one of the 2 sequences. In sequence AB, participants will receive linerixibat under fed state (Treatment A) in Period 1, then linerixibat under fasted state (Treatment B) in Period 2. In Sequence BA, the 2 treatments will be reversed. The washout period will be of at least 7 days.
| Arm | Type | Receives |
|---|---|---|
| Treatment sequence AB | Experimental | Drug: linerixibatParticipants will receive linerixibat in fed state (Treatment A) in period 1 followed by linerixibat in fasted state (Treatment B) in period 2. The washout period will be of at least 7 days. |
| Treatment sequence BA | Experimental | Drug: linerixibatParticipants will receive linerixibat in fasted state (Treatment B) in period 1 followed by linerixibat in fed state (Treatment A) in period 2. The washout period will be of at least 7 days. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Overtly healthy male or female participants 18 to 55 years of age inclusive, at the time of signing the informed consent.
- Participants' age greater than (>) 50 years old, must have had at least 3 weeks elapsed after the completion of an approved primary SARS-CoV-2 vaccination course.
- Body weight >50 kg and body mass index (BMI) within the range 18.5 - 32 kilogram per meter square (kg/m2) (inclusive).
- Female Participants:
- Capable of giving signed informed consent.
Key exclusion criteria (18 listed)
- History of cholecystectomy.
- Current symptomatic cholelithiasis or inflammatory gall bladder disease.
- Significant history of or current disorders capable of significantly altering the absorption, metabolism, or elimination of drugs.
- Current clinically significant diarrhea.
- History of gastrointestinal surgery with ileal resection or ileal bypass at any time.
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 |
|---|---|---|
| linerixibatlinerixibat will be administered per the treatment sequence | Drug | Treatment sequence AB, Treatment sequence BA |
Primary outcome
Plasma linerixibat area under the concentration-time curve from time zero (pre-dose) to the time of the last quantifiable concentration [AUC(0-t)]
Time frame: Up to 36 hours post dose
Maximum observed plasma concentration (Cmax) of linerixibat
Time frame: Up to 36 hours post dose
10 secondary outcomes
Plasma linerixibat area under the concentration-time curve from time zero (pre-dose) to infinite time [AUC (0-∞)]
Time frame: Up to 36 hours post dose
Plasma linerixibat area under the concentration-time curve from time zero (pre-dose) to 24 hour [AUC (0-24)]
Time frame: Up to 24 hours post dose
Time of occurrence of Cmax (Tmax) of linerixibat
Time frame: Up to 36 hours post dose
Delay in achieving Tmax (Tlag) of linerixibat
Time frame: Up to 36 hours post dose
Apparent terminal phase half-life (t1/2) of linerixibat
Time frame: Up to 36 hours post dose
Apparent clearance (CL/F) of linerixibat
Time frame: Up to 36 hours post dose
Apparent terminal phase volume of distribution (Vz/F) of linerixibat
Time frame: Up to 36 hours post dose
Serum C4 area under the concentration-time curve from time zero (pre-dose) to the time of the last quantifiable concentration [AUC(0-t)]
Time frame: Up to 36 hours post dose
Serum C4 area under the concentration-time curve from time zero (pre-dose) to 24 hour [AUC (0-24)]
Time frame: Up to 24 hours post dose
Incidence of adverse events (AEs) and of serious adverse events (SAEs)
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 29 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 Clinincal 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 linerixibat in people with Pruritus, run by GlaxoSmithKline at 1 site in United Kingdom.
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 8 inclusion and 18 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 29 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 Kingdom. 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?
Plasma linerixibat area under the concentration-time curve from time zero (pre-dose) to the time of the last quantifiable concentration [AUC(0-t)] (time frame: Up to 36 hours post dose). The study lists 2 primary outcomes in all. 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 29 Nov 2022.