Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT02023125 · ClinicalTrials.gov registry record · Phase 1
A Study Investigating the Effect of Food and Esomeprazole on the Single Oral Dose Pharmacokinetics of Alectinib (RO5424802) in Healthy Volunteers.
A Phase 1 study, sponsored by Hoffmann-La Roche.
- Completed
- Registry status
- Phase 1
- Development phase
- 42
- Enrollment target
NCT02023125 is a Phase 1 study that has completed, run by Hoffmann-La Roche. The registered enrollment target is 42 participants.
The verdict
NCT02023125, a Phase 1 study, has completed, sponsored by Hoffmann-La Roche.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 42 participants
- Enrollment target
Study Summary
This two-group study will investigate the effect of food (Group 1) and esomeprazole (Group 2) on the single oral dose pharmacokinetics of alectinib in healthy volunteers. Participants in Group 1 will be randomly assigned to a two period treatment sequence (AB or BA) in which they will receive a single, oral dose of alectinib per period separated by at least 10 days. Each participant will receive single, oral doses alectinib given under fasted conditions (Treatment A) or following the ingestion of a high fat, high calorie meal (Treatment B) as determined by their assigned sequence. Participants in Group 2 will be given a single, oral dose of alectinib following a standard meal. After a washout period of at least 10 days, they will receive an oral dose of esomeprazole (40 mg) once daily for 6 days. On the 6th day of esomeprazole administration, a single, oral dose alectinib will be given after ingestion of a standard meal. In all groups, pharmacokinetics will be assessed in the 4 days following alectinib administration.
Interventions
- DRUG Alectinib
- DRUG Esomeprazole
- OTHER High Fat and Calorie Meal
- OTHER Standard Meal
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 42 participants |
| Start Date | 2013-12 |
| Est. Completion | 2014-03 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02023125
The ClinicalTrials.gov registry entry for NCT02023125 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 42 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 Alectinib is the first listed.
NCT02023125 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02023125 about?
NCT02023125 is a clinical study titled "A Study Investigating the Effect of Food and Esomeprazole on the Single Oral Dose Pharmacokinetics of Alectinib (RO5424802) in Healthy Volunteers.". This two-group study will investigate the effect of food (Group 1) and esomeprazole (Group 2) on the single oral dose pharmacokinetics of alectinib in healthy volunteers. Participants in Group 1 will be randomly assigned to a two period treatment sequence (AB or BA) in which they will receive a sin...
What is the current status of trial NCT02023125?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 42 participants. The study started on 2013-12. Estimated completion is 2014-03.
What interventions are being tested in trial NCT02023125?
The interventions under investigation include: Alectinib (DRUG), Esomeprazole (DRUG), High Fat and Calorie Meal (OTHER), Standard Meal (OTHER).
Who is sponsoring clinical trial NCT02023125?
This trial is sponsored by Hoffmann-La Roche, which has 909 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
Explore more on PlainTrial
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.