drugset / Trial / NCT04745767

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

NCT04745767 ↗

Phase 1 Completed 54 enrolled Takeda
RandomizedCrossoverOpen-labelOther

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.

Timeline

Start
2021-02-16
Primary completion
2021-03-25
Completion
2021-04-05

Drugs

EvaluationDrugModalityDoseRoute
Subject TAK-994 Unknown — —

Indications

No indication recorded.