Status:
COMPLETED
A Study of TAK-510 in Healthy Adults
Lead Sponsor:
Takeda
Conditions:
Healthy Participants
Eligibility:
All Genders
18-55 years
Phase:
PHASE1
Brief Summary
This is a study of TAK-510 for people with symptoms of feeling sick (nausea) or being sick (vomiting). The main aims of the study are to check if healthy adults have side effects from TAK-510 and to ...
Detailed Description
The drug being tested in this study is called TAK-510. The study will look at the safety, tolerability, and PK of TAK-510 in healthy participants. The study will enroll up to approximately 224 health...
Eligibility Criteria
Inclusion
- Continuous nonsmoker who has not used nicotine- and tobacco-containing products for at least 3 months prior to dosing and throughout the study.
- Body mass index (BMI) greater than or equal to (\>=) 18.0 and less than or equal to (\<=) 30.0 kilogram per square meter (kg/m\^2) at the screening visit.
Exclusion
- Has a positive test result for hepatitis B surface antigen, hepatitis C virus antibody, or human immunodeficiency antibody/antigen, at the screening visit.
- Had major surgery or donated or lost 1 unit of blood (approximately 500 milliliter \[mL\]) within 4 weeks before the screening visit.
- Unable to refrain from or anticipates using all medications including herbal medicines beginning approximately 7 days before administration of the first dose of study drug, throughout the study until 2 days after discharge.
- Unable to refrain from or anticipates using marijuana or cannabis-containing products beginning approximately 7 days before administration of the first dose of study drug, throughout the study until after the last PK dose.
- Has had a previous major psychotic disorder.
- Has an average semirecumbent blood pressure (BP) less than 90/60 millimeter of mercury (mmHg) or greater than 140/90 mmHg from screening to predose, inclusive. Any assessments on Day -1, where 2 consecutive time point values do not meet this criterion must be discussed with the medical monitor for approval.
- Has orthostatic hypotension defined as a decrease in systolic BP \>=20 mmHg or a decrease in diastolic BP \>=10 mmHg at approximately 3 minutes of standing when compared with BP from the semirecumbent position, at screening to predose assessments, inclusive. In asymptomatic participants, any assessments after screening that do not meet this criterion may be repeated after the participant has remained in the semirecumbent or supine position for 15 minutes. If the repeat assessment is exclusionary based on the above criterion, the participant will not be eligible. If the repeat assessment is not exclusionary, the participant will be eligible.
- Has postural orthostatic tachycardia, defined as an increase of greater than (\>) 30 beats per minute (bpm) or heart rate (HR) \>120 bpm at approximately 3 minutes, of standing, at screening to predose assessments, inclusive. Any assessments after screening that do not meet this criterion may be repeated with the participant remaining standing for up to a total of 5 minutes, provided that the participant remains asymptomatic. If the repeat assessment occurring within 5 minutes is exclusionary based on the above criterion, the participant will not be eligible. A confirmed orthostatic increase of \>30 bpm, but less than (\<) 40 bpm, on 1 or more Day -1 assessments may not be considered exclusionary if not considered clinically significant by the investigator and the medical monitor. Such assessments must be discussed with the medical monitor prior to determination that the participant is eligible to proceed.
- Has a known or suspected current coronavirus disease 2019 (COVID-19) infection or is at risk of COVID-19 infection as assessed by the investigator.
Key Trial Info
Start Date :
February 3 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 24 2022
Estimated Enrollment :
124 Patients enrolled
Trial Details
Trial ID
NCT04731922
Start Date
February 3 2021
End Date
July 24 2022
Last Update
March 4 2024
Active Locations (2)
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1
PPD Development, LP
Las Vegas, Nevada, United States, 89113
2
PPD Development, LP
Austin, Texas, United States, 78744