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NCT04096157 · ClinicalTrials.gov registry record · Phase 1
A Study to Assess Isavuconazole Following a Single Dose of Isavuconazonium Sulfate Intravenous Solution Via Nasogastric (NG) Tube Compared to a Single Dose of Oral Capsules Under Fasting Conditions in Healthy Participants
A Phase 1 study, sponsored by Astellas Pharma Global Development.
- Completed
- Registry status
- Phase 1
- Development phase
- 17
- Enrollment target
NCT04096157 is a Phase 1 study that has completed, run by Astellas Pharma Global Development. The registered enrollment target is 17 participants.
The verdict
NCT04096157, a Phase 1 study, has completed, sponsored by Astellas Pharma Global Development.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 17 participants
- Enrollment target
Study Summary
The purpose of this study is to evaluate the bioequivalence of isavuconazole following a single dose of isavuconazonium sulfate intravenous (IV) solution via nasogastric (NG) tube (test formulation) compared to a single dose of isavuconazonium sulfate capsules for oral administration (i.e., oral capsules administered to nonintubated participants)(reference formulation). In addition, this study will evaluate the safety and tolerability of isavuconazole and the general pharmacokinetic (PK) parameters of isavuconazole when administered as a single dose of isavuconazonium sulfate IV solution via NG tube (test formulation) and a single dose of isavuconazonium sulfate capsules for oral administration (i.e., oral capsules administered to nonintubated participants) (reference formulation) under fasting conditions in healthy male and female participants.
Interventions
- DRUG Isavuconazonium sulfate IV
- DRUG Isavuconazonium sulfate capsules
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 17 participants |
| Start Date | 2019-09-24 |
| Est. Completion | 2020-01-16 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04096157
The ClinicalTrials.gov registry entry for NCT04096157 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 17 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Astellas Pharma Global Development, which has 168 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Isavuconazonium sulfate IV is the first listed.
NCT04096157 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT04096157 about?
NCT04096157 is a clinical study titled "A Study to Assess Isavuconazole Following a Single Dose of Isavuconazonium Sulfate Intravenous Solution Via Nasogastric (NG) Tube Compared to a Single Dose of Oral Capsules Under Fasting Conditions in Healthy Participants". The purpose of this study is to evaluate the bioequivalence of isavuconazole following a single dose of isavuconazonium sulfate intravenous (IV) solution via nasogastric (NG) tube (test formulation) compared to a single dose of isavuconazonium sulfate capsules for oral administration (i.e., oral cap...
What is the current status of trial NCT04096157?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 17 participants. The study started on 2019-09-24. Estimated completion is 2020-01-16.
What interventions are being tested in trial NCT04096157?
The interventions under investigation include: Isavuconazonium sulfate IV (DRUG), Isavuconazonium sulfate capsules (DRUG).
Who is sponsoring clinical trial NCT04096157?
This trial is sponsored by Astellas Pharma Global Development, which has 168 total clinical trials registered on ClinicalTrials.gov.
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