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NCT02074553 · ClinicalTrials.gov registry record · Phase 1
A Cross-over Study Examining the Bioequivalence of 3 Test Formulations to a Reference Formulation of Alectinib (RO5424802) in Healthy Volunteers
A Phase 1 study, sponsored by Hoffmann-La Roche.
- Completed
- Registry status
- Phase 1
- Development phase
- 97
- Enrollment target
NCT02074553 is a Phase 1 study that has completed, run by Hoffmann-La Roche. The registered enrollment target is 97 participants.
The verdict
NCT02074553, a Phase 1 study, has completed, sponsored by Hoffmann-La Roche.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 97 participants
- Enrollment target
Study Summary
This 2-part, single center, open-label, randomized, single-dose, 4-sequence, 4-period cross-over study will compare the bioequivalence of three test RO5424802 capsule formulations with the reference capsule formulation in healthy adult volunteers. All participants in both fasted (Part 1) and fed (Part 2) conditions of the study will receive each of 4 treatments (Ro542-4802/F03 \[RO5424802 with 50 percentage (%) sodium lauryl sulfate (SLS) (reference)\], Ro542-4802/F07 \[RO5424802 with 25% SLS (test)\], Ro542-4802/F14 \[RO5424802 with 12.5% SLS (test)\] and Ro542-4802/F08 \[RO5424802 with 3% SLS (test)\] in a randomized sequence. Each treatment will be given as a single 600 milligrams (mg) oral administration in an upright position on Day 1 after an overnight fast, followed by a 10-day washout period. Total time on study is expected to last up to 75 days, for each enrolled participant.
Interventions
- DRUG Ro542-4802/F03 (Reference)
- DRUG Ro542-4802/F07 (Test)
- DRUG Ro542-4802/F08 (Test)
- DRUG Ro542-4802/F14 (Test)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 97 participants |
| Start Date | 2014-02 |
| Est. Completion | 2014-09 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02074553
The ClinicalTrials.gov registry entry for NCT02074553 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 97 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Hoffmann-La Roche, which has 909 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 4 interventions - of which Ro542-4802/F03 (Reference) is the first listed.
NCT02074553 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02074553 about?
NCT02074553 is a clinical study titled "A Cross-over Study Examining the Bioequivalence of 3 Test Formulations to a Reference Formulation of Alectinib (RO5424802) in Healthy Volunteers". This 2-part, single center, open-label, randomized, single-dose, 4-sequence, 4-period cross-over study will compare the bioequivalence of three test RO5424802 capsule formulations with the reference capsule formulation in healthy adult volunteers. All participants in both fasted (Part 1) and fed (Pa...
What is the current status of trial NCT02074553?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 97 participants. The study started on 2014-02. Estimated completion is 2014-09.
What interventions are being tested in trial NCT02074553?
The interventions under investigation include: Ro542-4802/F03 (Reference) (DRUG), Ro542-4802/F07 (Test) (DRUG), Ro542-4802/F08 (Test) (DRUG), Ro542-4802/F14 (Test) (DRUG).
Who is sponsoring clinical trial NCT02074553?
This trial is sponsored by Hoffmann-La Roche, which has 909 total clinical trials registered on ClinicalTrials.gov.
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