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Completed

NCT Number: NCT05435170

Food Effect Study 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

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Key information

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

GSK Investigational Site

Cambridge, CB2 0GG, United Kingdom

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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).
  • 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.

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.

Treatment and study plan

Linerixibat

Drug

linerixibat will be administered per the treatment sequence

Primary outcomes

  1. 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

  2. Maximum observed plasma concentration (Cmax) of linerixibat

    Time frame: Up to 36 hours post dose

Secondary outcomes

  1. 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

  2. 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

  3. Time of occurrence of Cmax (Tmax) of linerixibat

    Time frame: Up to 36 hours post dose

  4. Delay in achieving Tmax (Tlag) of linerixibat

    Time frame: Up to 36 hours post dose

  5. Apparent terminal phase half-life (t1/2) of linerixibat

    Time frame: Up to 36 hours post dose

  6. Apparent clearance (CL/F) of linerixibat

    Time frame: Up to 36 hours post dose

  7. Apparent terminal phase volume of distribution (Vz/F) of linerixibat

    Time frame: Up to 36 hours post dose

  8. 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

  9. 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

  10. Incidence of adverse events (AEs) and of serious adverse events (SAEs)

    Time frame: Up to day 52

Sponsors and collaborators

Lead sponsor

GlaxoSmithKline

Industry

Registry information

Official study 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

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Jun 28, 2022
Registry last updated
Nov 29, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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