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NCT01082146 · ClinicalTrials.gov registry record · Phase 1

RI-AME Study OF [ISOTHIAZOLYL-3-14C]-LURASIDONE

A Phase 1 study of Pharmacokinetics and Metabolism, sponsored by Sumitomo Pharma America.

Completed
Registry status
Phase 1
Development phase
6
Enrollment target
1
Study location

NCT01082146 is a Phase 1 study of Pharmacokinetics and Metabolism that has completed, run by Sumitomo Pharma America. The registered enrollment target is 6 participants, below the 62-participant average among 37 other Pharmacokinetics trials with a reported enrollment target (90% lower). The trial reports 1 study location across 1 state.

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The verdict

NCT01082146, a Phase 1 study of Pharmacokinetics and Metabolism, has completed, sponsored by Sumitomo Pharma America.

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

Study Summary

This will be an open-label, non-randomized, absorption, metabolism, and excretion study of Lurasidone administered in a suspension at 40 mg to 6 normal healthy male subjects in a postprandial state

Interventions

  • DRUG Lurasidone

Study Locations (1)

Wisconsin

  • Covance Global Clinical Research Unit Inc. - Madison

Trial Details

FieldValue
Enrollment Target 6 participants
Start Date 2008-08
Est. Completion 2008-08
Phase Phase 1

Sponsor

Sumitomo Pharma America

168 total trials

What the Registry Record Tells You About NCT01082146

The ClinicalTrials.gov registry entry for NCT01082146 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 6 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 62-participant average among 37 other Pharmacokinetics trials with a reported enrollment target (90% lower). The listed sponsor is Sumitomo Pharma America, which has 168 total studies on file at ClinicalTrials.gov.

The record links to 2 conditions, with Pharmacokinetics appearing as the primary indexed condition, and to 1 intervention - of which Lurasidone is the first listed.

NCT01082146 reports 1 study location spanning 1 distinct geographic area - top geographies include Wisconsin.

Frequently Asked Questions

What is clinical trial NCT01082146 about?

NCT01082146 is a clinical study titled "RI-AME Study OF [ISOTHIAZOLYL-3-14C]-LURASIDONE". This will be an open-label, non-randomized, absorption, metabolism, and excretion study of Lurasidone administered in a suspension at 40 mg to 6 normal healthy male subjects in a postprandial state

What is the current status of trial NCT01082146?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 6 participants. The study started on 2008-08. Estimated completion is 2008-08.

What conditions does trial NCT01082146 study?

This clinical trial studies the following conditions: Pharmacokinetics, Metabolism.

What interventions are being tested in trial NCT01082146?

The interventions under investigation include: Lurasidone (DRUG).

Who is sponsoring clinical trial NCT01082146?

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

Where is trial NCT01082146 being conducted?

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

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

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