Status:
WITHDRAWN
Bioavailability and Food Effect Study of Two Formulations of TAK-906
Lead Sponsor:
Takeda
Conditions:
Healthy Volunteers
Eligibility:
All Genders
18-55 years
Phase:
PHASE1
Brief Summary
The aim of this study is to understand how TAK-906 tablets and capsules are processed by the body in healthy adults under fasting conditions and also how TAK-906 tablets are processed by the body when...
Detailed Description
The drug being tested in this study is called TAK-906. This study will compare the pharmacokinetics (PK) of single oral dose of 50 mg tablet (test \[Treatment B\]) relative to single oral dose of 50 m...
Eligibility Criteria
Inclusion
- Continuous nonsmoker who has not used nicotine-containing products for at least 3 months prior to the first dosing and throughout the study, based on participant self-reporting and urine cotinine test.
- Body mass index (BMI) greater than or equal to (\>=) 18.0 and less than (\<) 30.0 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) performed at the screening visit and before administration of the initial dose of trial drug, as deemed by the investigator or designee.
Exclusion
- Presence of infectious diseases (example, Coronavirus disease-19 \[COVID-19\] and flu) at the time of screening or check-in.
- Any history of major surgery that may affect absorption, metabolism or excretion of study drug (example, intestinal resections, hepatectomy, nephrectomy, cholecystectomy), and/or digestive organ resection (except appendectomy).
- History of any illness that, in the opinion of the investigator or designee, might confound the results of the study or poses an additional risk to the participant by their participation in the study.
- History or presence of alcoholism or drug abuse within the past 2 years prior to the first dosing.
- Positive urine drug or alcohol results at screening or check-in.
- Positive urine cotinine at screening.
- Positive results at screening for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg) or hepatitis C virus (HCV).
- QT interval corrected for heart rate using Frederica's equation (QTcF) is greater than (\>) 450 milliseconds (msec) or ECG findings are deemed abnormal with clinical significance by the Investigator or designee at screening.
- Estimated creatinine clearance \<90 milliliter per minute (mL/min) at screening.
- Unable to refrain from or anticipates the use of:
- o Any drug, including prescription and non-prescription medications, herbal remedies, or vitamin supplements within 14 days prior to the first dosing and throughout the study. After first dosing, acetaminophen (up to 2 grams \[g\] per 24 hours) may be administered at the discretion of the investigator or designee; sponsor must be consulted prior to administering acetaminophen to a participants.
- Has been on a diet incompatible with the on-study diet, in the opinion of the investigator or designee, within 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 (whichever is longer) 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 :
April 2 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 2 2022
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT04831502
Start Date
April 2 2021
End Date
February 2 2022
Last Update
March 24 2022
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Celerion
Tempe, Arizona, United States, 85283