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NCT03978143 · ClinicalTrials.gov registry record · Phase 1
Evaluate Taste and Relative Bioavailability of Two Microsphere Formulations of Crizotinib in Healthy Participants
A Phase 1 study, sponsored by Pfizer.
- Completed
- Registry status
- Phase 1
- Development phase
- 25
- Enrollment target
NCT03978143 is a Phase 1 study that has completed, run by Pfizer. The registered enrollment target is 25 participants.
The verdict
NCT03978143, a Phase 1 study, has completed, sponsored by Pfizer.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 25 participants
- Enrollment target
Study Summary
The primary purpose of the study is to estimate the relative bioavailability and palatability of 2 new crizotinib formulations to the commercially available crizotinib formulated capsule at a 250 mg dose administered under fasted conditions in adult healthy participants. Additionally, this study aims to assess the safety and tolerability of crizotinib 250 mg single dose in 4 formulations when given fasted, with high fat meal, or with a proton pump inhibitor in healthy participants. Finally, this study will explore the effect of food or proton pump inhibitor on the pharmacokinetics of the 2 new crizotinib formulations. We hypothesize 1 of the 2 new crizotinib formulations will have improved relative bioavailability and palatability than the formulated capsule under fasted or fed conditions with or without a proton pump inhibitor.
Interventions
- DRUG Treatment A
- DRUG Treatment B
- DRUG Treatment C
- DRUG Treatment D
- DRUG Treatment E
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 25 participants |
| Start Date | 2019-06-12 |
| Est. Completion | 2019-10-17 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03978143
The ClinicalTrials.gov registry entry for NCT03978143 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 25 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Pfizer, which has 1,845 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 5 interventions - of which Treatment A is the first listed.
NCT03978143 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03978143 about?
NCT03978143 is a clinical study titled "Evaluate Taste and Relative Bioavailability of Two Microsphere Formulations of Crizotinib in Healthy Participants". The primary purpose of the study is to estimate the relative bioavailability and palatability of 2 new crizotinib formulations to the commercially available crizotinib formulated capsule at a 250 mg dose administered under fasted conditions in adult healthy participants. Additionally, this study aim...
What is the current status of trial NCT03978143?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 25 participants. The study started on 2019-06-12. Estimated completion is 2019-10-17.
What interventions are being tested in trial NCT03978143?
The interventions under investigation include: Treatment A (DRUG), Treatment B (DRUG), Treatment C (DRUG), Treatment D (DRUG), Treatment E (DRUG).
Who is sponsoring clinical trial NCT03978143?
This trial is sponsored by Pfizer, which has 1,845 total clinical trials registered on ClinicalTrials.gov.
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