Last updated: 11/06/2023 17:00:49
Food effect study of linerixibat tablets in healthy adult participants
GSK study ID
214656
Clinicaltrials.gov ID
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Completed
Completed
Trial overview
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
Trial description: 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
Primary purpose:
Treatment
Trial design:
Crossover Assignment
Masking:
None (Open Label)
Allocation:
Randomized
Primary outcomes:
Plasma linerixibat area under the concentration-time curve from time zero (pre-dose) to the time of the last quantifiable concentration [AUC(0-t)]
Timeframe: Up to 36 hours post dose
Maximum observed plasma concentration (Cmax) of linerixibat
Timeframe: Up to 36 hours post dose
Secondary outcomes:
Plasma linerixibat area under the concentration-time curve from time zero (pre-dose) to infinite time [AUC (0-∞)]
Timeframe: 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)]
Timeframe: Up to 24 hours post dose
Time of occurrence of Cmax (Tmax) of linerixibat
Timeframe: Up to 36 hours post dose
Delay in achieving Tmax (Tlag) of linerixibat
Timeframe: Up to 36 hours post dose
Apparent terminal phase half-life (t1/2) of linerixibat
Timeframe: Up to 36 hours post dose
Apparent clearance (CL/F) of linerixibat
Timeframe: Up to 36 hours post dose
Apparent terminal phase volume of distribution (Vz/F) of linerixibat
Timeframe: 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)]
Timeframe: 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)]
Timeframe: Up to 24 hours post dose
Incidence of adverse events (AEs) and of serious adverse events (SAEs)
Timeframe: Up to day 52
Interventions:
Drug: linerixibat
Enrollment:
23
Observational study model:
Not applicable
Primary completion date:
2022-10-10
Time perspective:
Not applicable
Clinical publications:
Not applicable
Medical condition
Pruritus
Product
Not applicable
Collaborators
Not applicable
Study date(s)
August 2022 to October 2022
Type
Interventional
Phase
1
Participation criteria
Sex
Female & Male
Age
18 - 55 Years
Accepts healthy volunteers
Yes
- 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.
- History of cholecystectomy.
- Current symptomatic cholelithiasis or inflammatory gall bladder disease.
Inclusion and exclusion criteria
Inclusion criteria:
- 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).
- 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.
Female Participants:
Exclusion criteria:
- 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.
- 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 location(s)
Study documents
No study documents available.
Results overview
Study Results yet to be posted
Recruitment status
Completed
Actual primary completion date
2022-10-10
Actual study completion date
2022-10-10
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.
Additional information about the trial
Additional information
Not applicable
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