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The purpose of this study is to evaluate how itraconazole affects the blood concentration of GSK3923868 in healthy adults.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment Period 1: GSK3923868 | Experimental | Participants will receive GSK3923868 on Day 1. |
|
| Treatment Period 2: GSK3923868 + Itraconazole | Experimental | Participants will receive itraconazole from Days 1 to 10 and GSK3923868 on Day 5. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GSK3923868 | Drug | GSK3923868 will be administered. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Up to Day 3 | |
| Treatment Period 2: AUC(0-t) for GSK3923868 with itraconazole co-administration | Up to Day 11 | |
| Treatment Period 1: AUC from time zero to infinity [AUC(0-∞)] for GSK3923868 without itraconazole co-administration | Up to Day 3 | |
| Treatment Period 2: AUC(0-∞) for GSK3923868 with itraconazole co-administration | Up to Day 11 | |
| Treatment Period 1: Maximum observed plasma concentration (Cmax) for GSK3923868 without itraconazole co-administration | Up to Day 3 | |
| Treatment Period 2: Cmax for GSK3923868 with itraconazole co-administration | Up to Day 11 | |
| Treatment Period 1: Time to Cmax (Tmax) for GSK3923868 without itraconazole co-administration | Up to Day 3 | |
| Treatment Period 2: Tmax for GSK3923868 with itraconazole co-administration | Up to Day 11 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with adverse events (AEs) | An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention. | Up to Day 30 |
| Number of participants with serious adverse events (SAEs) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| GSK Clinical Trials | GlaxoSmithKline | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GSK Investigational Site | Cambridge | CB2 0GG | United Kingdom |
Qualified researchers may request access to anonymized individual patient-level data (IPD) and related study documents of the eligible studies via the Data Sharing Portal. Details on GSK's data sharing criteria can be found at: https://www.gsk.com/en-gb/innovation/trials/data-transparency/
Anonymized IPD will be made available within 6 months of publication of primary, key secondary and safety results for studies in product with approved indication(s) or terminated asset(s) across all indications.
Anonymized IPD is shared with researchers whose proposals are approved by an Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension may be granted, when justified, for up to 6 months.
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| ID | Term |
|---|---|
| D029424 | Pulmonary Disease, Chronic Obstructive |
| ID | Term |
|---|---|
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D002908 | Chronic Disease |
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| ID | Term |
|---|---|
| D017964 | Itraconazole |
| ID | Term |
|---|---|
| D014230 | Triazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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| Itraconazole | Drug | Itraconazole will be administered. |
|
An SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect in the offspring of a study participant, is an abnormal pregnancy outcome, or is a suspected transmission of any infectious agent via an authorized medicinal product. |
| Up to Day 30 |
| Number of participants with clinically significant changes in laboratory values | Up to Day 30 |
| Number of participants with clinically significant changes in vital signs | Up to Day 30 |
| Number of participants with clinically significant changes in 12-lead electrocardiogram (ECG) measurements | Up to Day 30 |
| Treatment Period 2: AUC(0-t) for itraconazole and hydroxy-itraconazole | On Days 1 and 5 |
| Treatment Period 2: AUC(0-∞) for itraconazole and hydroxy-itraconazole | On Days 1 and 5 |
| Treatment Period 2: Cmax for itraconazole and hydroxy-itraconazole | On Days 1 and 5 |
| Treatment Period 2: Tmax for itraconazole and hydroxy-itraconazole | On Days 1 and 5 |
| D020969 |
| Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010879 |
| Piperazines |