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NCT01910480 · ClinicalTrials.gov registry record · Phase 1
Study to Assess the Effect of Ketoconazole on the Pharmacokinetics of NBI-98854 in Healthy Subjects
A Phase 1 study, sponsored by Neurocrine Biosciences.
- Completed
- Registry status
- Phase 1
- Development phase
- 24
- Enrollment target
NCT01910480 is a Phase 1 study that has completed, run by Neurocrine Biosciences. The registered enrollment target is 24 participants.
The verdict
NCT01910480, a Phase 1 study, has completed, sponsored by Neurocrine Biosciences.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 24 participants
- Enrollment target
Study Summary
The purposes of this study are to: learn about the safety of the study drug (NBI-98854); learn how subjects tolerate the study drug; and evaluate and compare the pharmacokinetics (PK testing, the study of how the body absorbs, distributes, breaks down and eliminates a drug) of the investigational study drug after taking it alone and with ketoconazole. Ketoconazole is known to affect the PK of many drugs and is studied to more safely prescribe medications.
Interventions
- DRUG NBI-98854 50 mg capsule once daily
- DRUG Ketoconazole 400 mg (200 mg twice daily)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 24 participants |
| Start Date | 2013-07 |
| Est. Completion | 2013-08 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01910480
The ClinicalTrials.gov registry entry for NCT01910480 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 24 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Neurocrine Biosciences, which has 65 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which NBI-98854 50 mg capsule once daily is the first listed.
NCT01910480 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01910480 about?
NCT01910480 is a clinical study titled "Study to Assess the Effect of Ketoconazole on the Pharmacokinetics of NBI-98854 in Healthy Subjects". The purposes of this study are to: learn about the safety of the study drug (NBI-98854); learn how subjects tolerate the study drug; and evaluate and compare the pharmacokinetics (PK testing, the study of how the body absorbs, distributes, breaks down and eliminates a drug) of the investigational st...
What is the current status of trial NCT01910480?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 24 participants. The study started on 2013-07. Estimated completion is 2013-08.
What interventions are being tested in trial NCT01910480?
The interventions under investigation include: NBI-98854 50 mg capsule once daily (DRUG), Ketoconazole 400 mg (200 mg twice daily) (DRUG).
Who is sponsoring clinical trial NCT01910480?
This trial is sponsored by Neurocrine Biosciences, which has 65 total clinical trials registered on ClinicalTrials.gov.
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