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NCT03432793 · ClinicalTrials.gov registry record · Phase 1
Drug-Drug Interaction (DDI) Study for TD-9855
A Phase 1 study of Drug-Drug Interaction (DDI), sponsored by Theravance Biopharma.
- Completed
- Registry status
- Phase 1
- Development phase
- 41
- Enrollment target
- 1
- Study location
NCT03432793: Completed Phase 1 study of Drug-Drug Interaction (DDI), sponsored by Theravance Biopharma.
NCT03432793 is a Phase 1 study of Drug-Drug Interaction (DDI) that has completed, run by Theravance Biopharma. The registered enrollment target is 41 participants, roughly in line with the 43-participant average among 3 other Drug-Drug Interaction (DDI) trials with a reported enrollment target. The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03432793, a Phase 1 study of Drug-Drug Interaction (DDI), has completed, sponsored by Theravance Biopharma.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 41 participants
- Enrollment target
- 1
- Study location
Study Summary
This study is designed to assess the effect of fluvoxamine, itraconazole and smoking on the PK disposition of multiple doses TD-9855 in healthy male subjects. The study will also assess the relationship between caffeine PK and TD-9855 PK disposition in healthy male smokers and non-smokers.
Conditions Studied
Interventions
- DRUG Itraconazole
- DRUG Caffeine
- DRUG Fluvoxamine
- DRUG TD-9855
Study Locations (1)
Nebraska
- Celerion - Lincoln
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 41 participants |
| Start Date | 2018-02-28 |
| Est. Completion | 2018-04-21 |
| Phase | Phase 1 |
What the finished NCT03432793 record still lists
NCT03432793 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 41 participants, a relatively small participant target, roughly in line with the 43-participant average among 3 other Drug-Drug Interaction (DDI) trials with a reported enrollment target.
The record links to 1 condition, with Drug-Drug Interaction (DDI) appearing as the primary indexed condition, and to 4 interventions - of which Itraconazole is the first listed.
NCT03432793 reports a single indexed study location in Nebraska.
Frequently Asked Questions
What is clinical trial NCT03432793 about?
NCT03432793 is a clinical study titled "Drug-Drug Interaction (DDI) Study for TD-9855". This study is designed to assess the effect of fluvoxamine, itraconazole and smoking on the PK disposition of multiple doses TD-9855 in healthy male subjects. The study will also assess the relationship between caffeine PK and TD-9855 PK disposition in healthy male smokers and non-smokers.
What is the current status of trial NCT03432793?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 41 participants. The study started on 2018-02-28. Estimated completion is 2018-04-21.
What conditions does trial NCT03432793 study?
This clinical trial studies the following conditions: Drug-Drug Interaction (DDI).
What interventions are being tested in trial NCT03432793?
The interventions under investigation include: Itraconazole (DRUG), Caffeine (DRUG), Fluvoxamine (DRUG), TD-9855 (DRUG).
Who is sponsoring clinical trial NCT03432793?
This trial is sponsored by Theravance Biopharma, which has 38 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03432793 being conducted?
This trial has 1 study location across Nebraska. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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