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NCT00386490 · ClinicalTrials.gov registry record · Phase 1

Safety of Larazotide Acetate in Healthy Volunteers

A Phase 1 study, sponsored by 9 Meters Biopharma.

Completed
Registry status
Phase 1
Development phase
24
Enrollment target

NCT00386490: Completed Phase 1 study, sponsored by 9 Meters Biopharma.

NCT00386490 is a Phase 1 study that has completed, run by 9 Meters Biopharma. The registered enrollment target is 24 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (60% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00386490, a Phase 1 study, has completed, sponsored by 9 Meters Biopharma.

COMPLETED
Registry status
Phase 1
Development phase
24 participants
Enrollment target

Study Summary

To demonstrate the safety, tolerance and pharmacokinetics of multiple, oral doses of larazotide acetate.

Primary Outcome

Safety evaluations included medical history, physical examination, vital signs, clinical laboratory testing, and 12-lead electrocardiograms

Interventions

  • DRUG larazotide acetate

Trial Details

FieldValue
Enrollment Target 24 participants
Start Date 2006-01-10
Est. Completion 2006-02-27
Phase Phase 1
9 Meters Biopharma

9 total trials

What the finished NCT00386490 record still lists

NCT00386490 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 24 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (60% lower).

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

NCT00386490 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00386490 about?

NCT00386490 is a clinical study titled "Safety of Larazotide Acetate in Healthy Volunteers". To demonstrate the safety, tolerance and pharmacokinetics of multiple, oral doses of larazotide acetate.

What is the current status of trial NCT00386490?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 24 participants. The study started on 2006-01-10. Estimated completion is 2006-02-27.

What interventions are being tested in trial NCT00386490?

The interventions under investigation include: larazotide acetate (DRUG).

Who is sponsoring clinical trial NCT00386490?

This trial is sponsored by 9 Meters Biopharma, which has 9 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT00386490's enrollment target sits among peer trials

24 1520th of 2000 higher than 405 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 NCT00386490, the US trial registry maintained by the National Library of Medicine. NCT00386490 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.