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NCT03398421 · ClinicalTrials.gov registry record · Phase 1
A Study to Evaluate the Effect of Itraconazole on the Pharmacokinetics (PK) of Nemiralisib
A Phase 1 study of Pulmonary Disease, Chronic Obstructive, sponsored by GlaxoSmithKline.
- Completed
- Registry status
- Phase 1
- Development phase
- 20
- Enrollment target
- 1
- Study location
NCT03398421 is a Phase 1 study of Pulmonary Disease, Chronic Obstructive that has completed, run by GlaxoSmithKline. The registered enrollment target is 20 participants, below the 1,044-participant average among 74 other Pulmonary Disease, Chronic Obstructive trials with a reported enrollment target (98% lower). The trial reports 1 study location across 1 state.
The verdict
NCT03398421, a Phase 1 study of Pulmonary Disease, Chronic Obstructive, has completed, sponsored by GlaxoSmithKline.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 20 participants
- Enrollment target
- 1
- Study location
Study Summary
Nemiralisib is a potent anti-inflammatory agent for the treatment of chronic obstructive pulmonary disease (COPD) and other inflammatory lung diseases. The Cytochrome P450 3A4 (CYP3A4) is a major route of clearance for nemiralisib. The co-administration of drug therapies, which modulate CYP3A4, may alter the exposure of nemiralisib. Hence, this clinical drug interaction study with itraconazole (a potent CYP3A4 inhibitor) is required. The study will evaluate the PK, safety and tolerability of nemiralisib when administered alone and when administered concomitantly with repeat doses of itraconazole in healthy males and females. Subjects will receive treatment with nemiralisib alone in Period 1 and itraconazole followed by nemiralisib in Period 2 in single sequence crossover manner. Approximately 20 subjects will be enrolled such that approximately 16 evaluable subjects complete the study. Each subject will participate in the study for approximately 7 weeks including screening visit, 2 treatment periods and a follow up visit.
Conditions Studied
Interventions
- DRUG Itraconazole
- DRUG Nemiralisib
Study Locations (1)
Kansas
- GSK Investigational Site - Overland Park
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 20 participants |
| Start Date | 2018-01-17 |
| Est. Completion | 2018-03-12 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03398421
The ClinicalTrials.gov registry entry for NCT03398421 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 20 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 1,044-participant average among 74 other Pulmonary Disease, Chronic Obstructive trials with a reported enrollment target (98% lower). The listed sponsor is GlaxoSmithKline, which has 1,345 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Pulmonary Disease, Chronic Obstructive appearing as the primary indexed condition, and to 2 interventions - of which Itraconazole is the first listed.
NCT03398421 reports 1 study location spanning 1 distinct geographic area - top geographies include Kansas.
Frequently Asked Questions
What is clinical trial NCT03398421 about?
NCT03398421 is a clinical study titled "A Study to Evaluate the Effect of Itraconazole on the Pharmacokinetics (PK) of Nemiralisib". Nemiralisib is a potent anti-inflammatory agent for the treatment of chronic obstructive pulmonary disease (COPD) and other inflammatory lung diseases. The Cytochrome P450 3A4 (CYP3A4) is a major route of clearance for nemiralisib. The co-administration of drug therapies, which modulate CYP3A4, may ...
What is the current status of trial NCT03398421?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 20 participants. The study started on 2018-01-17. Estimated completion is 2018-03-12.
What conditions does trial NCT03398421 study?
This clinical trial studies the following conditions: Pulmonary Disease, Chronic Obstructive.
What interventions are being tested in trial NCT03398421?
The interventions under investigation include: Itraconazole (DRUG), Nemiralisib (DRUG).
Who is sponsoring clinical trial NCT03398421?
This trial is sponsored by GlaxoSmithKline, which has 1,345 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03398421 being conducted?
This trial has 1 study location across Kansas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Related
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