Last updated: 12/10/2025 05:30:12

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
Completed
Completed
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
Observational study model:
Not applicable
Primary completion date:
2024-16-12
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
Completed
Actual primary completion date
2024-16-12
Actual study completion date
2024-23-12

Plain language summaries

Summary of results in plain language
Available language(s): English

To view plain language summaries on trialsummaries.com click here.

Additional information about the trial

Additional information
Not applicable
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