Status:
COMPLETED
A Study to Evaluate Safety, Tolerability and Pharmacokinetics of Ascending Oral Single Dose of TAK-418 in Healthy Participants
Lead Sponsor:
Takeda
Conditions:
Healthy Participants
Eligibility:
All Genders
18-55 years
Phase:
PHASE1
Brief Summary
The purpose of this study is to evaluate the safety and tolerability of TAK-418 following single oral doses in healthy participants.
Detailed Description
The drug being tested in this study is called TAK-418. TAK-418 is being tested in healthy participants in order to evaluate the safety, tolerability, and pharmacokinetics (PK) of single oral doses. T...
Eligibility Criteria
Inclusion
- Is a male or female participants with a body mass index (BMI) within the range of 18.5 -30.0 kilogram per square meter (kg/m\^2) at the Screening Visit.
- Is a nonsmoker who has not used tobacco or nicotine-containing products (example, nicotine patch) for at least 6 months before trial drug administration of the initial dose of trial drug or invasive procedure.
- Must be judged to be in good health by the investigator, based on clinical evaluations including laboratory safety tests, medical history, physical examination, 12-lead ECG, and vital sign measurements performed at the Screening Visit and before administration of the initial dose of trial drug or invasive procedure as per principal investigator's judgment.
- Female subjects with no childbearing potential, defined by at least 1 of the following criteria:
- Postmenopausal (defined as 12 months of spontaneous amenorrhea in women aged greater than \[\>\]45 years, 6 months of spontaneous amenorrhea in women aged \>45 years with serum follicle-stimulating hormone \[FSH\] levels \>40 milli-international units per milliliter \[mIU/mL\]). Appropriate documentation of FSH levels is required.
- Surgically sterile by hysterectomy and/or bilateral oophorectomy with appropriate documentation of surgical procedure.
- Had a tubal ligation with appropriate documentation of surgical procedure.
- Has a congenital condition resulting in no uterus.
Exclusion
- Has had major surgery, donated or lost 1 unit of blood (approximately 500 milliliter \[mL\]) within 4 weeks before the Screening Visit.
- Has a risk of suicide according to the investigator's clinical judgment per the Columbia-Suicide Severity Rating Scale at Screening or has made a suicide attempt in the 6 months before Screening.
Key Trial Info
Start Date :
July 21 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 12 2018
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT03228433
Start Date
July 21 2017
End Date
May 12 2018
Last Update
September 9 2019
Active Locations (1)
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1
PAREXEL International
Glendale, California, United States, 91206