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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 is a Phase 1 study that has completed, run by Healx AI. The registered enrollment target is 12 participants.

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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.

Interventions

  • DRUG OV101

Trial Details

FieldValue
Enrollment Target 12 participants
Start Date 2017-04-03
Est. Completion 2017-11-28
Phase Phase 1

Sponsor

Healx AI

5 total trials

What the Registry Record Tells You About NCT03109756

The ClinicalTrials.gov registry entry for NCT03109756 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 12 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Healx AI, which has 5 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 1 intervention - of which OV101 is the first listed.

NCT03109756 reports 0 study locations.

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.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.