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NCT01813448 · ClinicalTrials.gov registry record · Phase 1
A Study to Assess the Safety, Tolerability and Pharmacokinetics of Single and Multiple Ascending Doses of Fidaxomicin in Healthy Male Japanese and Caucasian Subjects
A Phase 1 study, sponsored by Astellas Pharma Global Development.
- Completed
- Registry status
- Phase 1
- Development phase
- 36
- Enrollment target
NCT01813448 is a Phase 1 study that has completed, run by Astellas Pharma Global Development. The registered enrollment target is 36 participants.
The verdict
NCT01813448, a Phase 1 study, has completed, sponsored by Astellas Pharma Global Development.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 36 participants
- Enrollment target
Study Summary
The purpose of this study is to evaluate the safety, tolerability and pharmacokinetics (PK) of single and multiple ascending doses of fidaxomicin in healthy subjects. This study will also compare the safety, tolerability and PK of single and multiple doses of fidaxomicin in healthy Japanese and Caucasian subjects.
Interventions
- DRUG Placebo
- DRUG Fidaxomicin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 36 participants |
| Start Date | 2013-02 |
| Est. Completion | 2013-04 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01813448
The ClinicalTrials.gov registry entry for NCT01813448 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 36 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 Placebo is the first listed.
NCT01813448 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01813448 about?
NCT01813448 is a clinical study titled "A Study to Assess the Safety, Tolerability and Pharmacokinetics of Single and Multiple Ascending Doses of Fidaxomicin in Healthy Male Japanese and Caucasian Subjects". The purpose of this study is to evaluate the safety, tolerability and pharmacokinetics (PK) of single and multiple ascending doses of fidaxomicin in healthy subjects. This study will also compare the safety, tolerability and PK of single and multiple doses of fidaxomicin in healthy Japanese and Cauc...
What is the current status of trial NCT01813448?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 36 participants. The study started on 2013-02. Estimated completion is 2013-04.
What interventions are being tested in trial NCT01813448?
The interventions under investigation include: Placebo (DRUG), Fidaxomicin (DRUG).
Who is sponsoring clinical trial NCT01813448?
This trial is sponsored by Astellas Pharma Global Development, which has 168 total clinical trials registered on ClinicalTrials.gov.
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