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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: Completed Phase 1 study, sponsored by Astellas Pharma Global Development.
NCT04096157 is a Phase 1 study that has completed, run by Astellas Pharma Global Development. The registered enrollment target is 17 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (72% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
AUCinf will be recorded from the PK plasma samples collected.
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 |
What the finished NCT04096157 record still lists
NCT04096157 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 17 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (72% lower).
The record links to 0 conditions, and to 2 interventions - of which Isavuconazonium sulfate IV is the first listed.
NCT04096157 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04096157's enrollment target sits among peer trials
17 1785th of 2000 higher than 215 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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