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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: Completed Phase 1 study, sponsored by Hoffmann-La Roche.
NCT02074553 is a Phase 1 study that has completed, run by Hoffmann-La Roche. The registered enrollment target is 97 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (62% higher). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
AUC(0-inf) is the area under the alectinib plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0-inf). AUC is a measure of the plasma concentration of a drug over time. AUC(0-inf) is presented in nanogram times (\*) hour per milliliter (ng\*hour/mL).
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 |
What the finished NCT02074553 record still lists
NCT02074553 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 97 participants, a relatively small participant target, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (62% higher).
The record links to 0 conditions, and to 4 interventions - of which Ro542-4802/F03 (Reference) is the first listed.
NCT02074553 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02074553's enrollment target sits among peer trials
97 597th of 2000 higher than 1,401 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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
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