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NCT01093508 · ClinicalTrials.gov registry record · Phase 1

Single-dose Safety Study of APD916 in Healthy Volunteers

A Phase 1 study of Narcolepsy With or Without Cataplexy, sponsored by Arena Pharmaceuticals.

Completed
Registry status
Phase 1
Development phase
72
Enrollment target
1
Study location

NCT01093508: Completed Phase 1 study of Narcolepsy With or Without Cataplexy, sponsored by Arena Pharmaceuticals.

NCT01093508 is a Phase 1 study of Narcolepsy With or Without Cataplexy that has completed, run by Arena Pharmaceuticals. The registered enrollment target is 72 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (20% higher). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01093508, a Phase 1 study of Narcolepsy With or Without Cataplexy, has completed, sponsored by Arena Pharmaceuticals.

COMPLETED
Registry status
Phase 1
Development phase
72 participants
Enrollment target
1
Study location

Study Summary

The APD916-001 study is designed primarily to evaluate the safety and tolerability of APD916 when administered as a single dose

Primary Outcome

Safety measures to include adverse events, vital signs, 12-lead ECGs, physical examinations, and clinical lab parameters.

Interventions

  • DRUG APD916

Study Locations (1)

Ohio

  • Community Research - Cincinnati

Trial Details

FieldValue
Enrollment Target 72 participants
Start Date 2010-03
Est. Completion 2010-07
Phase Phase 1
Arena Pharmaceuticals

15 total trials

What the finished NCT01093508 record still lists

NCT01093508 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 72 participants, a relatively small participant target, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (20% higher).

The record links to 1 condition, with Narcolepsy With or Without Cataplexy appearing as the primary indexed condition, and to 1 intervention - of which APD916 is the first listed.

NCT01093508 reports a single indexed study location in Ohio.

Frequently Asked Questions

What is clinical trial NCT01093508 about?

NCT01093508 is a clinical study titled "Single-dose Safety Study of APD916 in Healthy Volunteers". The APD916-001 study is designed primarily to evaluate the safety and tolerability of APD916 when administered as a single dose

What is the current status of trial NCT01093508?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 72 participants. The study started on 2010-03. Estimated completion is 2010-07.

What conditions does trial NCT01093508 study?

This clinical trial studies the following conditions: Narcolepsy With or Without Cataplexy.

What interventions are being tested in trial NCT01093508?

The interventions under investigation include: APD916 (DRUG).

Who is sponsoring clinical trial NCT01093508?

This trial is sponsored by Arena Pharmaceuticals, which has 15 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT01093508 being conducted?

This trial has 1 study location across Ohio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

How this trial's enrollment target compares

Where NCT01093508's enrollment target sits among peer trials

72 736th of 2000 higher than 1,254 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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Source: ClinicalTrials.gov NCT01093508, the US trial registry maintained by the National Library of Medicine. NCT01093508 (small enrollment · single site footprint · completed) retrieved and formatted by PlainTrial, see methodology.