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NCT03571594 · ClinicalTrials.gov registry record · Phase 1
A Four-Part Study to Assess the Safety, Tolerability, PK and PD of ONO-5788 in Healthy Adult Volunteers
A Phase 1 study, sponsored by Ono Pharmaceutical Co..
- Terminated
- Registry status
- Phase 1
- Development phase
- 76
- Enrollment target
NCT03571594: Clinical Trial Phase 1 study, sponsored by Ono Pharmaceutical Co..
NCT03571594 is a Phase 1 study that was terminated before completion, run by Ono Pharmaceutical Co.. The registered enrollment target is 76 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (27% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03571594, a Phase 1 study, was terminated before completion, sponsored by Ono Pharmaceutical Co..
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 76 participants
- Enrollment target
Study Summary
This is a first in human study to determine the safety, tolerability, pharmacokinetics and pharmacodynamics of ONO-5788 in healthy adult volunteers. This study will be conducted in 4 parts: a single-ascending dose part, a multiple-ascending dose part, an elderly part and a proof of principle part.
Primary Outcome
An adverse event is any untoward medical occurrence in a participant who receive study drug without regard to possible causal relationship.
Interventions
- DRUG Octreotide
- DRUG ONO-5788
- DRUG ONO-5788 Placebo
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 76 participants |
| Start Date | 2018-06-07 |
| Est. Completion | 2019-05-16 |
| Phase | Phase 1 |
Why NCT03571594 stopped before completion
NCT03571594 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 76 participants, a relatively small participant target, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (27% higher).
The record links to 0 conditions, and to 3 interventions - of which Octreotide is the first listed.
NCT03571594 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03571594 about?
NCT03571594 is a clinical study titled "A Four-Part Study to Assess the Safety, Tolerability, PK and PD of ONO-5788 in Healthy Adult Volunteers". This is a first in human study to determine the safety, tolerability, pharmacokinetics and pharmacodynamics of ONO-5788 in healthy adult volunteers. This study will be conducted in 4 parts: a single-ascending dose part, a multiple-ascending dose part, an elderly part and a proof of principle part.
What is the current status of trial NCT03571594?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 76 participants. The study started on 2018-06-07. Estimated completion is 2019-05-16.
What interventions are being tested in trial NCT03571594?
The interventions under investigation include: Octreotide (DRUG), ONO-5788 (DRUG), ONO-5788 Placebo (DRUG).
Who is sponsoring clinical trial NCT03571594?
This trial is sponsored by Ono Pharmaceutical Co., which has 17 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03571594's enrollment target sits among peer trials
76 705th of 2000 higher than 1,290 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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