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NCT03411122 · ClinicalTrials.gov registry record · Phase 1
A Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Drug Interaction Potential of Napabucasin in Healthy Volunteers
A Phase 1 study, sponsored by Sumitomo Pharma America.
- Completed
- Registry status
- Phase 1
- Development phase
- 30
- Enrollment target
NCT03411122: Completed Phase 1 study, sponsored by Sumitomo Pharma America.
NCT03411122 is a Phase 1 study that has completed, run by Sumitomo Pharma America. The registered enrollment target is 30 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (50% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03411122, a Phase 1 study, has completed, sponsored by Sumitomo Pharma America.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 30 participants
- Enrollment target
Study Summary
This is a phase I, single-center, open-label, single-sequence, 3-period, PK drug interaction study evaluating the effect of napabucasin in healthy volunteers on the single-dose PK of several cytochrome P450 (CYP450) probe drugs as well as a BCRP substrate.
Interventions
- DRUG napabucasin
- DRUG cytochrome P450 (CYP450) probe drugs or BCRP transporter substrate
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 30 participants |
| Start Date | 2017-06-30 |
| Est. Completion | 2018-01-23 |
| Phase | Phase 1 |
What the finished NCT03411122 record still lists
NCT03411122 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 30 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (50% lower).
The record links to 0 conditions, and to 2 interventions - of which napabucasin is the first listed.
NCT03411122 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03411122 about?
NCT03411122 is a clinical study titled "A Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Drug Interaction Potential of Napabucasin in Healthy Volunteers". This is a phase I, single-center, open-label, single-sequence, 3-period, PK drug interaction study evaluating the effect of napabucasin in healthy volunteers on the single-dose PK of several cytochrome P450 (CYP450) probe drugs as well as a BCRP substrate.
What is the current status of trial NCT03411122?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 30 participants. The study started on 2017-06-30. Estimated completion is 2018-01-23.
What interventions are being tested in trial NCT03411122?
The interventions under investigation include: napabucasin (DRUG), cytochrome P450 (CYP450) probe drugs or BCRP transporter substrate (DRUG).
Who is sponsoring clinical trial NCT03411122?
This trial is sponsored by Sumitomo Pharma America, which has 168 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03411122's enrollment target sits among peer trials
30 1332nd of 2000 higher than 561 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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