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NCT01072175 · ClinicalTrials.gov registry record · Phase 2
Investigate Safety, Pharmacokinetics and Pharmacodynamics of GSK2118436 & GSK1120212
A Phase 2 study, sponsored by Novartis Pharmaceuticals.
- Completed
- Registry status
- Phase 2
- Development phase
- 430
- Enrollment target
NCT01072175 is a Phase 2 study that has completed, run by Novartis Pharmaceuticals. The registered enrollment target is 430 participants.
The verdict
NCT01072175, a Phase 2 study, has completed, sponsored by Novartis Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 430 participants
- Enrollment target
Study Summary
This was an open-label, dose escalation study to investigate the safety, pharmacokinetics, pharmacodynamics and clinical activity of GSK2118436 and GSK1120212 in combination. This study was designed in four parts. In Part A, the effect of repeat doses of GSK1120212 on the pharmacokinetics of single dose GSK2118436 was investigated prior to evaluating combination regimens. In Part B, the range of tolerated dose combinations was identified using a dose-escalation procedure. In Part C, different dose combinations of GSK2118436 and GSK1120212 were evaluated, based on results from the dose escalation cohorts. In Part D, the pharmacokinetics and safety of GSK2118436 administered as HPMC capsules alone and in combination with GSK1120212 was evaluated.
Interventions
- DRUG GSK2118436
- DRUG GSK1120212
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 430 participants |
| Start Date | 2010-03-26 |
| Est. Completion | 2018-02-27 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01072175
The ClinicalTrials.gov registry entry for NCT01072175 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 430 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Novartis Pharmaceuticals, which has 1,375 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which GSK2118436 is the first listed.
NCT01072175 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01072175 about?
NCT01072175 is a clinical study titled "Investigate Safety, Pharmacokinetics and Pharmacodynamics of GSK2118436 & GSK1120212". This was an open-label, dose escalation study to investigate the safety, pharmacokinetics, pharmacodynamics and clinical activity of GSK2118436 and GSK1120212 in combination. This study was designed in four parts. In Part A, the effect of repeat doses of GSK1120212 on the pharmacokinetics of single ...
What is the current status of trial NCT01072175?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 430 participants. The study started on 2010-03-26. Estimated completion is 2018-02-27.
What interventions are being tested in trial NCT01072175?
The interventions under investigation include: GSK2118436 (DRUG), GSK1120212 (DRUG).
Who is sponsoring clinical trial NCT01072175?
This trial is sponsored by Novartis Pharmaceuticals, which has 1,375 total clinical trials registered on ClinicalTrials.gov.
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