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NCT03795519 · ClinicalTrials.gov registry record · Phase 1

A Trial to Study the Absorption, Metabolism, and Excretion of [14C]-Olinciguat in Healthy Male Volunteers

A Phase 1 study of Healthy Volunteers, sponsored by Cyclerion Therapeutics.

Completed
Registry status
Phase 1
Development phase
8
Enrollment target
1
Study location

NCT03795519 is a Phase 1 study of Healthy Volunteers that has completed, run by Cyclerion Therapeutics. The registered enrollment target is 8 participants, below the 482-participant average among 283 other Healthy Volunteers trials with a reported enrollment target (98% lower). The trial reports 1 study location across 1 state.

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The verdict

NCT03795519, a Phase 1 study of Healthy Volunteers, has completed, sponsored by Cyclerion Therapeutics.

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

Study Summary

The primary objective is to characterize the pharmacokinetics (PK) of olinciguat and total radioactivity and to assess the elimination of total radioactivity from a single oral dose of \[14C\]-olinciguat.

Conditions Studied

Interventions

  • DRUG [14C]-olinciguat

Study Locations (1)

Wisconsin

  • Covance Clinical Research Unit Inc. - Madison

Trial Details

FieldValue
Enrollment Target 8 participants
Start Date 2019-01-17
Est. Completion 2019-02-27
Phase Phase 1

Sponsor

Cyclerion Therapeutics

11 total trials

What the Registry Record Tells You About NCT03795519

The ClinicalTrials.gov registry entry for NCT03795519 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 8 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 482-participant average among 283 other Healthy Volunteers trials with a reported enrollment target (98% lower). The listed sponsor is Cyclerion Therapeutics, which has 11 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Healthy Volunteers appearing as the primary indexed condition, and to 1 intervention - of which [14C]-olinciguat is the first listed.

NCT03795519 reports 1 study location spanning 1 distinct geographic area - top geographies include Wisconsin.

Frequently Asked Questions

What is clinical trial NCT03795519 about?

NCT03795519 is a clinical study titled "A Trial to Study the Absorption, Metabolism, and Excretion of [14C]-Olinciguat in Healthy Male Volunteers". The primary objective is to characterize the pharmacokinetics (PK) of olinciguat and total radioactivity and to assess the elimination of total radioactivity from a single oral dose of \[14C\]-olinciguat.

What is the current status of trial NCT03795519?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 8 participants. The study started on 2019-01-17. Estimated completion is 2019-02-27.

What conditions does trial NCT03795519 study?

This clinical trial studies the following conditions: Healthy Volunteers.

What interventions are being tested in trial NCT03795519?

The interventions under investigation include: [14C]-olinciguat (DRUG).

Who is sponsoring clinical trial NCT03795519?

This trial is sponsored by Cyclerion Therapeutics, which has 11 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT03795519 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

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.