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NCT01454076 · ClinicalTrials.gov registry record · Phase 1
Pharmacokinetics Study of Oral IXAZOMIB in Participants With Advanced Nonhematologic Malignancies or Lymphoma
A Phase 1 study, sponsored by Millennium Pharmaceuticals.
- Completed
- Registry status
- Phase 1
- Development phase
- 112
- Enrollment target
NCT01454076 is a Phase 1 study that has completed, run by Millennium Pharmaceuticals. The registered enrollment target is 112 participants.
The verdict
NCT01454076, a Phase 1 study, has completed, sponsored by Millennium Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 112 participants
- Enrollment target
Study Summary
This is an open-label, multicenter, sequential, 5-arm, phase 1 study of oral IXAZOMIB designed to assess drug-drug interaction with ketoconazole (Arm 1), the relative bioavailability of 2 capsule formulations of IXAZOMIB (Arm 2), food effect (Arm 3), drug-drug interaction with rifampin (Arm 4), and drug-drug interaction with clarithromycin (Arm 5) in participants with advanced nonhematologic malignancies or lymphoma.
Interventions
- DRUG Rifampin
- DRUG Ketoconazole
- DRUG Ixazomib 2.5 mg
- DRUG Ixazomib 4 mg Capsule A
- DRUG Ixazomib 4 mg Capsule B
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 112 participants |
| Start Date | 2011-11-10 |
| Est. Completion | 2016-06-16 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01454076
The ClinicalTrials.gov registry entry for NCT01454076 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 112 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Millennium Pharmaceuticals, which has 135 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 5 interventions - of which Rifampin is the first listed.
NCT01454076 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01454076 about?
NCT01454076 is a clinical study titled "Pharmacokinetics Study of Oral IXAZOMIB in Participants With Advanced Nonhematologic Malignancies or Lymphoma". This is an open-label, multicenter, sequential, 5-arm, phase 1 study of oral IXAZOMIB designed to assess drug-drug interaction with ketoconazole (Arm 1), the relative bioavailability of 2 capsule formulations of IXAZOMIB (Arm 2), food effect (Arm 3), drug-drug interaction with rifampin (Arm 4), and ...
What is the current status of trial NCT01454076?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 112 participants. The study started on 2011-11-10. Estimated completion is 2016-06-16.
What interventions are being tested in trial NCT01454076?
The interventions under investigation include: Rifampin (DRUG), Ketoconazole (DRUG), Ixazomib 2.5 mg (DRUG), Ixazomib 4 mg Capsule A (DRUG), Ixazomib 4 mg Capsule B (DRUG).
Who is sponsoring clinical trial NCT01454076?
This trial is sponsored by Millennium Pharmaceuticals, which has 135 total clinical trials registered on ClinicalTrials.gov.
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