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NCT02334501 · ClinicalTrials.gov registry record · Phase 1
Open-label PK Study to Evaluate Lansoprazole and Neratinib in Healthy Subjects
A Phase 1 study, sponsored by Puma Biotechnology.
- Completed
- Registry status
- Phase 1
- Development phase
- 15
- Enrollment target
NCT02334501: Completed Phase 1 study, sponsored by Puma Biotechnology.
NCT02334501 is a Phase 1 study that has completed, run by Puma Biotechnology. The registered enrollment target is 15 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (75% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02334501, a Phase 1 study, has completed, sponsored by Puma Biotechnology.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 15 participants
- Enrollment target
Study Summary
This is an open label, 2-period, fixed-sequence study in 15 healthy adult subjects under fed conditions. To evaluate the effect of multiple doses of lansoprazole on the absorption and pharmacokinetics (PK) of a single dose of neratinib in healthy subjects.
Primary Outcome
The area under the plasma concentration-time curve, from time 0 to the last measurable nonzero concentration, as calculated by the linear trapezoidal method.
Interventions
- DRUG Neratinib
- DRUG Lansoprazole
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 15 participants |
| Start Date | 2014-08 |
| Est. Completion | 2014-10 |
| Phase | Phase 1 |
What the finished NCT02334501 record still lists
NCT02334501 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 15 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (75% lower).
The record links to 0 conditions, and to 2 interventions - of which Neratinib is the first listed.
NCT02334501 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02334501 about?
NCT02334501 is a clinical study titled "Open-label PK Study to Evaluate Lansoprazole and Neratinib in Healthy Subjects". This is an open label, 2-period, fixed-sequence study in 15 healthy adult subjects under fed conditions. To evaluate the effect of multiple doses of lansoprazole on the absorption and pharmacokinetics (PK) of a single dose of neratinib in healthy subjects.
What is the current status of trial NCT02334501?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 15 participants. The study started on 2014-08. Estimated completion is 2014-10.
What interventions are being tested in trial NCT02334501?
The interventions under investigation include: Neratinib (DRUG), Lansoprazole (DRUG).
Who is sponsoring clinical trial NCT02334501?
This trial is sponsored by Puma Biotechnology, which has 28 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02334501's enrollment target sits among peer trials
15 1798th of 2000 higher than 157 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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