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NCT04745767 · ClinicalTrials.gov registry record · Phase 1

A Study of Different Forms of TAK-994 in Healthy Adults

A Phase 1 study of Healthy Participants, sponsored by Takeda.

Completed
Registry status
Phase 1
Development phase
54
Enrollment target
2
Study locations

NCT04745767 is a Phase 1 study of Healthy Participants that has completed, run by Takeda. The registered enrollment target is 54 participants, below the 65-participant average among 119 other Healthy Participants trials with a reported enrollment target (17% lower). The trial reports 2 study locations across 2 states.

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The verdict

NCT04745767, a Phase 1 study of Healthy Participants, has completed, sponsored by Takeda.

COMPLETED
Registry status
Phase 1
Development phase
54 participants
Enrollment target
2
Study locations

Study Summary

It is hoped that TAK-994 will eventually help people with a sleep condition called narcolepsy. Narcolepsy is a condition that causes extreme sleepiness during the day, including falling asleep suddenly. Before then, the sponsor needs to understand how the body processes TAK-994. The main aims of the study are to learn how the body processes 4 different new forms of TAK-994, when taken with food and without food, compared to a standard form of TAK-994. At the first visit, the study doctor will check who can take part. Then the participants will be picked for 1 of 3 groups by chance. These groups of participants will take different new forms of TAK-994 and the standard form. They will take these with and without food. This will happen again 3 or 4 times but will take TAK-994 in a different order each time. After each treatment with TAK-994, the study doctors will check the amount of TAK-994 in the blood of the participants, over time. The study doctors will also check if the participants have any side effects from TAK-994. Participants will wait 5 or more days between each dose to allow time for TAK-994 to completely leave their bodies. Participants will stay in the clinic during their treatment with TAK-994. They will stay in the clinic for 15 days or longer. Participants who have 4 treatments with TAK-994 will stay in the clinic for 20 days or longer. Then, the clinic will telephone the participants 12 days after their final treatment of TAK-994 to check if they have any health problems.

Conditions Studied

Healthy Participants

Interventions

  • DRUG TAK-994

Study Locations (2)

Arizona

  • Celerion Tempe, AZ site - Tempe

Nebraska

  • Celerion Lincoln, NE site - Lincoln

Trial Details

FieldValue
Enrollment Target 54 participants
Start Date 2021-02-16
Est. Completion 2021-04-05
Phase Phase 1

Sponsor

Takeda

408 total trials

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What the Registry Record Tells You About NCT04745767

The ClinicalTrials.gov registry entry for NCT04745767 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 54 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 65-participant average among 119 other Healthy Participants trials with a reported enrollment target (17% lower). The listed sponsor is Takeda, which has 408 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Healthy Participants appearing as the primary indexed condition, and to 1 intervention - of which TAK-994 is the first listed.

NCT04745767 reports 2 study locations spanning 2 distinct geographic areas - top geographies include Arizona, Nebraska.

Frequently Asked Questions

What is clinical trial NCT04745767 about?

NCT04745767 is a clinical study titled "A Study of Different Forms of TAK-994 in Healthy Adults". It is hoped that TAK-994 will eventually help people with a sleep condition called narcolepsy. Narcolepsy is a condition that causes extreme sleepiness during the day, including falling asleep suddenly. Before then, the sponsor needs to understand how the body processes TAK-994. The main aims of th...

What is the current status of trial NCT04745767?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 54 participants. The study started on 2021-02-16. Estimated completion is 2021-04-05.

What conditions does trial NCT04745767 study?

This clinical trial studies the following conditions: Healthy Participants.

What interventions are being tested in trial NCT04745767?

The interventions under investigation include: TAK-994 (DRUG).

Who is sponsoring clinical trial NCT04745767?

This trial is sponsored by Takeda, which has 408 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT04745767 being conducted?

This trial has 2 study locations across Arizona, Nebraska. 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.