Last updated: 03/06/2025 11:30:10

A Study to Evaluate the Effect of Itraconazole on the Concentration of GSK3923868 in the Blood in Healthy Participants

GSK study ID
218376
Clinicaltrials.gov ID
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

Trial overview

Official title: A Single-Centre, Open-Label, Single Sequence Study to Evaluate the Effect of Itraconazole on the Pharmacokinetics of Single Inhaled Doses of GSK3923868 in Healthy Participants
Trial description: The purpose of this study is to evaluate how itraconazole affects the blood concentration of GSK3923868 in healthy adults.
Primary purpose:
Treatment
Trial design:
Sequential
Masking:
None (Open Label)
Allocation:
Non-randomized
Primary outcomes:

Treatment Period 1: Area under plasma concentration versus time curve (AUC) from time zero to last quantifiable concentration [AUC(0-t)] for GSK3923868 without itraconazole co-administration

Timeframe: Up to Day 3

Treatment Period 2: AUC(0-t) for GSK3923868 with itraconazole co-administration

Timeframe: Up to Day 11

Treatment Period 1: AUC from time zero to infinity [AUC(0-∞)] for GSK3923868 without itraconazole co-administration

Timeframe: Up to Day 3

Treatment Period 2: AUC(0-∞) for GSK3923868 with itraconazole co-administration

Timeframe: Up to Day 11

Treatment Period 1: Maximum observed plasma concentration (Cmax) for GSK3923868 without itraconazole co-administration

Timeframe: Up to Day 3

Treatment Period 2: Cmax for GSK3923868 with itraconazole co-administration

Timeframe: Up to Day 11

Treatment Period 1: Time to Cmax (Tmax) for GSK3923868 without itraconazole co-administration

Timeframe: Up to Day 3

Treatment Period 2: Tmax for GSK3923868 with itraconazole co-administration

Timeframe: Up to Day 11

Secondary outcomes:

Number of participants with adverse events (AEs)

Timeframe: Up to Day 30

Number of participants with serious adverse events (SAEs)

Timeframe: Up to Day 30

Number of participants with clinically significant changes in laboratory values

Timeframe: Up to Day 30

Number of participants with clinically significant changes in vital signs

Timeframe: Up to Day 30

Number of participants with clinically significant changes in 12-lead electrocardiogram (ECG) measurements

Timeframe: Up to Day 30

Treatment Period 2: AUC(0-t) for itraconazole and hydroxy-itraconazole

Timeframe: On Days 1 and 5

Treatment Period 2: AUC(0-∞) for itraconazole and hydroxy-itraconazole

Timeframe: On Days 1 and 5

Treatment Period 2: Cmax for itraconazole and hydroxy-itraconazole

Timeframe: On Days 1 and 5

Treatment Period 2: Tmax for itraconazole and hydroxy-itraconazole

Timeframe: On Days 1 and 5

Interventions:
  • Drug: GSK3923868
  • Drug: Itraconazole
  • Enrollment:
    20
    Primary completion date:
    2024-16-12
    Observational study model:
    Not applicable
    Time perspective:
    Not applicable
    Clinical publications:
    Not applicable
    Medical condition
    Pulmonary Disease, Chronic Obstructive
    Product
    Not applicable
    Collaborators
    Not applicable
    Study date(s)
    September 2024 to December 2024
    Type
    Interventional
    Phase
    1

    Participation criteria

    Sex
    Female & Male
    Age
    18 - 65 Years
    Accepts healthy volunteers
    Yes
    • Participants who are overtly healthy as determined by medical evaluation based on screening medical history, physical examination, vital signs, electrocardiogram (ECG) assessment, pulmonary function testing and laboratory tests.
    • Body weight at least 50 kilograms (kg) and body-mass index (BMI) within the range 18.5 to 32.0 kilogram per meter squared (kg/m^2) (inclusive).
    • History or presence of cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematological, or neurological disorders capable of significantly altering the absorption, metabolism, or elimination of drugs; constituting a risk when taking the study intervention or interfering with the interpretation of data.
    • Alanine transaminase (ALT) and aspartate aminotransferase (AST) greater than (>) upper limit of normal (ULN).

    Trial location(s)

    Location
    Status
    Contact us
    Contact us
    Location
    GSK Investigational Site
    Cambridge, United Kingdom, CB2 0GG
    Status
    Study Complete

    Study documents

    No study documents available.

    Results overview

    Study Results yet to be posted

    Recruitment status
    Study complete
    Actual primary completion date
    2024-16-12
    Actual study completion date
    2024-23-12

    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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