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NCT01998646 · ClinicalTrials.gov registry record · Phase 1
A Dose Escalation Study to Assess the Safety, Tolerability, and Pharmacokinetics of ASP4058 Following Single Oral Doses
A Phase 1 study, sponsored by Astellas Pharma Global Development.
- Completed
- Registry status
- Phase 1
- Development phase
- 130
- Enrollment target
NCT01998646: Completed Phase 1 study, sponsored by Astellas Pharma Global Development.
NCT01998646 is a Phase 1 study that has completed, run by Astellas Pharma Global Development. The registered enrollment target is 130 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (117% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01998646, a Phase 1 study, has completed, sponsored by Astellas Pharma Global Development.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 130 participants
- Enrollment target
Study Summary
The purpose of this study is to explore the safety, tolerability and pharmacokinetics (PK) of single ascending oral doses of ASP4058 in non-elderly, healthy male and female subjects. This study will also explore the effect of food on the PK of ASP4058.The food-effect crossover group was open-label treatment with no placebo control.
Primary Outcome
Maximum Concentration (Cmax)
Interventions
- DRUG Placebo
- DRUG ASP4058
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 130 participants |
| Start Date | 2010-08 |
| Est. Completion | 2012-07 |
| Phase | Phase 1 |
What the finished NCT01998646 record still lists
NCT01998646 is an interventional study that assigns participants to a tested intervention. The registered 130 participants enrollment target is mid-sized for trials with a published cap, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (117% higher).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT01998646 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01998646 about?
NCT01998646 is a clinical study titled "A Dose Escalation Study to Assess the Safety, Tolerability, and Pharmacokinetics of ASP4058 Following Single Oral Doses". The purpose of this study is to explore the safety, tolerability and pharmacokinetics (PK) of single ascending oral doses of ASP4058 in non-elderly, healthy male and female subjects. This study will also explore the effect of food on the PK of ASP4058.The food-effect crossover group was open-label t...
What is the current status of trial NCT01998646?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 130 participants. The study started on 2010-08. Estimated completion is 2012-07.
What interventions are being tested in trial NCT01998646?
The interventions under investigation include: Placebo (DRUG), ASP4058 (DRUG).
Who is sponsoring clinical trial NCT01998646?
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 NCT01998646's enrollment target sits among peer trials
130 439th of 2000 higher than 1,550 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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