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NCT01934205 · ClinicalTrials.gov registry record · Phase 1
To Evaluate Plasma and Pulmonary Pharmacokinetics of GSK2140944
A Phase 1 study, sponsored by GlaxoSmithKline.
- Completed
- Registry status
- Phase 1
- Development phase
- 22
- Enrollment target
NCT01934205 is a Phase 1 study that has completed, run by GlaxoSmithKline. The registered enrollment target is 22 participants.
The verdict
NCT01934205, a Phase 1 study, has completed, sponsored by GlaxoSmithKline.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 22 participants
- Enrollment target
Study Summary
Antimicrobial penetration can be assessed through evaluation of antimicrobial concentrations in various lung compartments, including bronchial mucosal tissue, epithelial lining fluid (ELF), and alveolar macrophages (AM). Antimicrobial concentrations determined in ELF and alveolar macrophages represent an ideal estimate of concentrations at the site of infection and can be accessed via bronchoalveolar lavage (BAL). However sampling of antimicrobial concentrations via BAL is not routine in clinical practice due to its complex methodology and poor patient tolerability. This study will evaluate intrapulmonary and plasma pharmacokinetics of GSK2140944 after single IV dose in adult healthy volunteers. This is a Phase I, open-label study to evaluate plasma and pulmonary pharmacokinetics following intravenous administration of GSK2140944 in healthy adult participants. Part A will evaluate the single dose PK profiles. Part B is optional and will only be conducted if necessary. Each part will consist of a maximum of 6 cohorts. In Part A, only 4 of the 6 cohorts will be dosed initially; cohorts 5 and 6 are optional and will only be dosed if additional time-points are necessary to adequately model the pulmonary pharmacokinetic profile.
Interventions
- DRUG GSK2140944 (Single dose)
- DRUG GSK2140944 (Multiple dose)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 22 participants |
| Start Date | 2013-09-25 |
| Est. Completion | 2013-12-21 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01934205
The ClinicalTrials.gov registry entry for NCT01934205 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 22 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is GlaxoSmithKline, which has 1,345 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which GSK2140944 (Single dose) is the first listed.
NCT01934205 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01934205 about?
NCT01934205 is a clinical study titled "To Evaluate Plasma and Pulmonary Pharmacokinetics of GSK2140944". Antimicrobial penetration can be assessed through evaluation of antimicrobial concentrations in various lung compartments, including bronchial mucosal tissue, epithelial lining fluid (ELF), and alveolar macrophages (AM). Antimicrobial concentrations determined in ELF and alveolar macrophages represe...
What is the current status of trial NCT01934205?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 22 participants. The study started on 2013-09-25. Estimated completion is 2013-12-21.
What interventions are being tested in trial NCT01934205?
The interventions under investigation include: GSK2140944 (Single dose) (DRUG), GSK2140944 (Multiple dose) (DRUG).
Who is sponsoring clinical trial NCT01934205?
This trial is sponsored by GlaxoSmithKline, which has 1,345 total clinical trials registered on ClinicalTrials.gov.
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