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Completed

NCT Number: NCT04971928

Phase 1 Study of GSK3228836 Pharmacokinetics in Participants With Hepatic Impairment

This is a Phase 1, open-label, parallel-group study to evaluate the pharmacokinetics of GSK3228836 in participants with Child-Pugh B (CP-B) cirrhosis (moderate hepatic impairment), Child-Pugh A (CP-A) cirrhosis (mild hepatic impairment) and participants with normal hepatic function as healthy control.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

GSK Investigational Site, Orlando, Florida, United States

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Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Body weight >50 Kilogram (kg) and body mass index (BMI) within the range 19 to 40 Kilogram per square meters (kg/m2) (inclusive)
  • Capable of giving signed informed consent.
  • Child-Pugh B cirrhosis (moderate hepatic impairment; Part 1) or Child-Pugh A cirrhosis (mild hepatic impairment; Part 2) or a healthy control participant based on a medical evaluation including medical history, physical examination (PE), laboratory tests.

Exclusion criteria

  • Diagnosed or suspected hepatocellular carcinoma.
  • History of malignancy within the past 5 years except for cancers that are cured by surgical resection (e.g., skin cancer).
  • History of vasculitis or presence of symptoms and signs of potential vasculitis or history/presence of other diseases that may be associated with vasculitis condition.
  • Unstable cardiac function or high blood pressure that is not controlled (based on the investigator's discretion).
  • Any other medical condition which, in the judgment of the investigator and Medical Monitor, could jeopardize the integrity of the data derived from that participant or the safety of the participant.
  • Participants who have taken or are currently taking any therapies not allowed by the protocol.
  • A positive test for human immunodeficiency virus (HIV) antibody.
  • History of sensitivity to GSK3228836 or components thereof or a history of drug or other allergy that, in the opinion of the investigator or Medical Monitor, contraindicates their participation.

Treatment and study plan

GSK3228836

Drug

GSK3228836 will be administered

Primary outcomes

  1. Area under the concentration-time curve (AUC) from time zero (pre-dose) extrapolated to infinite time [AUC(0-infinity)]

    Time frame: Up to Day 50 post-dose

  2. Maximum observed concentration (Cmax)

    Time frame: Up to Day 50 post-dose

Secondary outcomes

  1. AUC from time zero (pre-dose) to 24 hours [AUC(0-24)]

    Time frame: Up to 24 hours post-dose

  2. AUC from time zero (pre-dose) to 168 hours [AUC(0-168)]

    Time frame: Up to 168 hours post-dose

  3. Plasma concentration of GSK3228836 on Day 8

    Time frame: Day 8 post-dose

  4. Apparent terminal phase half-life (t1/2)

    Time frame: Up to Day 50 post-dose

  5. Apparent clearance (CL/F)

    Time frame: Up to Day 50 post-dose

  6. Time of occurrence of Cmax (Tmax)

    Time frame: Up to Day 50 post-dose

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

    Time frame: Up to Day 50 post-dose

Sponsors and collaborators

Lead sponsor

GlaxoSmithKline

Industry

Registry information

Official study title

A Phase 1, Open-label, Single-Dose Study to Evaluate the Pharmacokinetics of GSK3228836 in Adults With Hepatic Impairment and Healthy Matched Control Participants (B-Assured)

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Jul 22, 2021
Registry last updated
Sep 27, 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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