Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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: Completed Phase 1 study of Pulmonary Disease, Chronic Obstructive, sponsored by GlaxoSmithKline.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Blood samples were collected from participants at indicated time points after the administration of study treatment to investigate pharmacokinetic parameters of nemiralisib in both treatment period 1 and 2. Pharmacokinetic analysis was conducted using standard non-compartmental methods. Pharmacokinetic population comprised of all participants enrolled in the study who took at least 1 dose of nemiralisib and for whom a nemiralisib pharmacokinetic sample was obtained and analyzed.
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 |
What the finished NCT03398421 record still lists
NCT03398421 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 20 participants, a relatively small participant target, below the 1,044-participant average among 74 other Pulmonary Disease, Chronic Obstructive trials with a reported enrollment target (98% lower).
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 a single indexed study location in 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.
Learn More About Clinical Trials
Similar trials for Pulmonary Disease, Chronic Obstructive
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT03398421's enrollment target sits among peer trials
20 69th of 74 higher than 5 of 74 other Pulmonary Disease, Chronic Obstructive trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Pulmonary Disease, Chronic Obstructive trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
-
A Study for GSK3862995B in Healthy Participants and Participants With Chronic Obstructive Pulmonary Disease
RECRUITING · Phase 1
-
Transforming Psychotherapy for Chronically Ill Patients
COMPLETED · Phase 1
-
Study to Evaluate the Safety, Tolerability and Pharmacokinetics of GSK2269557 Administered Via the ELLIPTA Dry Powder Inhaler to Healthy Subjects
COMPLETED · Phase 1
-
Real-Time Support for Exercise Persistence in COPD
COMPLETED · Phase 1
-
A Study to Investigate the Safety and Pharmacokinetics of a Single Dose of GSK2256294 in Healthy Young Males and Elderly Subjects
COMPLETED · Phase 1
-
Pharmacokinetic Study in Healthy Volunteers to Characterise the Exposure of Fluticasone Furoate (FF), Vilanterol (VI) and Umeclidinium (UMEC) at Two Different Doses
COMPLETED · Phase 1
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT00573339 · 20 participants
Cardiac Magnetic Resonance Imaging (MRI) Normal Reference Control Group Testing
- NCT00692939 · 20 participants · Phase 1
Autologous Stem Cell Transplantation for Crohn's Disease
- NCT00967785 · 20 participants · Phase 1
A Phase I Study of Mozobil in the Treatment of Patients With WHIMS
- NCT01406691 · 20 participants · Phase 4
Light Flashes to Treat Delayed Sleep Phase Disorder (DSPD)
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI