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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 is a Phase 1 study that has completed, run by Sumitomo Pharma America. The registered enrollment target is 30 participants.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03411122
The ClinicalTrials.gov registry entry for NCT03411122 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 30 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Sumitomo Pharma America, which has 168 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which napabucasin is the first listed.
NCT03411122 reports 0 study locations.
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.
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