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NCT02795637 · ClinicalTrials.gov registry record · Phase 1

Study of the What the Body Does to the Drug in Subjects With Mild, Moderate, and Severe Liver Dysfunction

A Phase 1 study, sponsored by Sumitomo Pharma America.

Completed
Registry status
Phase 1
Development phase
44
Enrollment target

NCT02795637: Completed Phase 1 study, sponsored by Sumitomo Pharma America.

NCT02795637 is a Phase 1 study that has completed, run by Sumitomo Pharma America. The registered enrollment target is 44 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (27% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT02795637, a Phase 1 study, has completed, sponsored by Sumitomo Pharma America.

COMPLETED
Registry status
Phase 1
Development phase
44 participants
Enrollment target

Study Summary

Study of the what the body does to the drug in subjects with mild, moderate, and sever liver dysfunction (not working properly)

Primary Outcome

Plasma PK parameters: Area under the plasma/serum concentration-time curve from time zero to infinity (AUC0 inf)

Interventions

  • DRUG dasotraline

Trial Details

FieldValue
Enrollment Target 44 participants
Start Date 2016-05
Est. Completion 2016-11
Phase Phase 1
Sumitomo Pharma America

168 total trials

What the finished NCT02795637 record still lists

NCT02795637 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 44 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (27% lower).

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

NCT02795637 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT02795637 about?

NCT02795637 is a clinical study titled "Study of the What the Body Does to the Drug in Subjects With Mild, Moderate, and Severe Liver Dysfunction". Study of the what the body does to the drug in subjects with mild, moderate, and sever liver dysfunction (not working properly)

What is the current status of trial NCT02795637?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 44 participants. The study started on 2016-05. Estimated completion is 2016-11.

What interventions are being tested in trial NCT02795637?

The interventions under investigation include: dasotraline (DRUG).

Who is sponsoring clinical trial NCT02795637?

This trial is sponsored by Sumitomo Pharma America, which has 168 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT02795637's enrollment target sits among peer trials

44 1086th of 2000 higher than 901 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 NCT02795637, the US trial registry maintained by the National Library of Medicine. NCT02795637 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.