Status:
COMPLETED
A Study of Different Forms of TAK-994 in Healthy Adults
Lead Sponsor:
Takeda
Conditions:
Healthy Participants
Eligibility:
All Genders
18-55 years
Phase:
PHASE1
Brief 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 suddenl...
Detailed Description
The drug being tested in this study is called TAK-994. TAK-994 is being tested in healthy participants. This study will look at the relative BA of different TAK-994 test formulations relative to the c...
Eligibility Criteria
Inclusion
- Body mass index (BMI) greater than or equal to (\>=) 18.0 and less than or equal to (\<=) 32.0 kilogram per square meter (kg/m\^2) at the screening.
- Medically healthy with no clinically significant medical history, physical examination, laboratory profiles, vital signs or electrocardiograms (ECGs), as deemed by the Investigator or designee.
Exclusion
- Mentally or legally incapacitated or has significant emotional problems at the time of the screening visit or expected during the conduct of the study.
- Current or past history of epilepsy, seizure, or convulsion, tremor, or related symptoms.
- Positive urine drug or alcohol results at screening or check-in.
- Positive results at screening for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg) or hepatitis C virus (HCV).
- Consumes excessive amounts, defined as greater than 4 servings (1 serving is approximately equivalent to 120 mg of caffeine), of coffee, tea, cola, energy drinks, or other caffeinated beverages per day.
- Has been on a diet incompatible with the on-study diet, in the opinion of the Investigator or designee, within the 30 days prior to the first dosing and throughout the study.
- Is lactose intolerant or unable/unwilling to eat the high-fat/high-calorie breakfast.
- Donation of blood or significant blood loss within 56 days prior to the first dosing.
- Plasma donation within 7 days prior to the first dosing.
- Participation in another clinical study within 30 days or 5 half-lives (whichever is longer) prior to the first dosing. The 30-day window or 5 half-lives will be derived from the date of the last blood collection or dosing, whichever is later, in the previous study to Day 1 of Period 1 of the current study.
Key Trial Info
Start Date :
February 16 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 5 2021
Estimated Enrollment :
54 Patients enrolled
Trial Details
Trial ID
NCT04745767
Start Date
February 16 2021
End Date
April 5 2021
Last Update
April 22 2021
Active Locations (2)
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1
Celerion Tempe, AZ site
Tempe, Arizona, United States, 85283
2
Celerion Lincoln, NE site
Lincoln, Nebraska, United States, 68502