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NCT01287858 · ClinicalTrials.gov registry record · Phase 1
Study to Assess Safety, Tolerability, and Pharmacokinetics of Oral Doses for AC430 in Healthy Subjects
A Phase 1 study, sponsored by Daiichi Sankyo.
- Completed
- Registry status
- Phase 1
- Development phase
- 88
- Enrollment target
NCT01287858: Completed Phase 1 study, sponsored by Daiichi Sankyo.
NCT01287858 is a Phase 1 study that has completed, run by Daiichi Sankyo. The registered enrollment target is 88 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (47% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01287858, a Phase 1 study, has completed, sponsored by Daiichi Sankyo.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 88 participants
- Enrollment target
Study Summary
AC430 will be administered, orally under fasting conditions (fasting 4 hours before and 2 hours after dosing) with approximately 240 mL of water either once daily or twice daily. It is designed to assess the safety, tolerability, and pharmacokinetics of single and multiple oral doses of AC430.
Primary Outcome
* Number of participants with adverse events as measurement of safety and tolerability of AC430. \[Time frame: 1-28 days\] * Maximum concentration (Cmax) for AC430 in plasma (measured in ng/mL) \[Time frame: 1-28 days\] * Tmax = Time of maximum concentration of AC430 in plasma (hr) \[Time frame: 1-28 days\] * AUC = Area under the curve from the time of dosing extrapolated to infinity (ng.hr/mL) \[Time frame: 1-28 days\] * Urine: amount of AC430 excreted in urine (Ae0-48), renal clearance (CLr) a
Interventions
- DRUG AC430
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 88 participants |
| Start Date | 2010-11 |
| Est. Completion | 2011-06 |
| Phase | Phase 1 |
What the finished NCT01287858 record still lists
NCT01287858 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 88 participants, a relatively small participant target, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (47% higher).
The record links to 0 conditions, and to 1 intervention - of which AC430 is the first listed.
NCT01287858 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01287858 about?
NCT01287858 is a clinical study titled "Study to Assess Safety, Tolerability, and Pharmacokinetics of Oral Doses for AC430 in Healthy Subjects". AC430 will be administered, orally under fasting conditions (fasting 4 hours before and 2 hours after dosing) with approximately 240 mL of water either once daily or twice daily. It is designed to assess the safety, tolerability, and pharmacokinetics of single and multiple oral doses of AC430.
What is the current status of trial NCT01287858?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 88 participants. The study started on 2010-11. Estimated completion is 2011-06.
What interventions are being tested in trial NCT01287858?
The interventions under investigation include: AC430 (DRUG).
Who is sponsoring clinical trial NCT01287858?
This trial is sponsored by Daiichi Sankyo, which has 236 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01287858's enrollment target sits among peer trials
88 650th of 2000 higher than 1,350 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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