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NCT03109756 · ClinicalTrials.gov registry record · Phase 1
Single Dose Pharmacokinetic (PK) Study
A Phase 1 study, sponsored by Healx AI.
- Completed
- Registry status
- Phase 1
- Development phase
- 12
- Enrollment target
NCT03109756: Completed Phase 1 study, sponsored by Healx AI.
NCT03109756 is a Phase 1 study that has completed, run by Healx AI. The registered enrollment target is 12 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (80% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03109756, a Phase 1 study, has completed, sponsored by Healx AI.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 12 participants
- Enrollment target
Study Summary
The trial is a Phase 1 Single Dose PK Study in Adolescent Subjects with Fragile X syndrome (FXS) or Angelman syndrome (AS). * The primary objective of the study is to evaluate the pharmacokinetics (PK) of OV101 following a single 5 mg dose of OV101 in adolescents with FXS or AS. * Secondary objectives are to determine the safety and tolerability of a single 5 mg dose of OV101 in adolescents with FXS or AS.
Primary Outcome
Maximum plasma concentration (Cmax)
Interventions
- DRUG OV101
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 12 participants |
| Start Date | 2017-04-03 |
| Est. Completion | 2017-11-28 |
| Phase | Phase 1 |
What the finished NCT03109756 record still lists
NCT03109756 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 12 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (80% lower).
The record links to 0 conditions, and to 1 intervention - of which OV101 is the first listed.
NCT03109756 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03109756 about?
NCT03109756 is a clinical study titled "Single Dose Pharmacokinetic (PK) Study". The trial is a Phase 1 Single Dose PK Study in Adolescent Subjects with Fragile X syndrome (FXS) or Angelman syndrome (AS). * The primary objective of the study is to evaluate the pharmacokinetics (PK) of OV101 following a single 5 mg dose of OV101 in adolescents with FXS or AS. * Secondary objecti...
What is the current status of trial NCT03109756?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 12 participants. The study started on 2017-04-03. Estimated completion is 2017-11-28.
What interventions are being tested in trial NCT03109756?
The interventions under investigation include: OV101 (DRUG).
Who is sponsoring clinical trial NCT03109756?
This trial is sponsored by Healx AI, which has 5 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03109756's enrollment target sits among peer trials
12 1852nd of 2000 higher than 90 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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