Status:
COMPLETED
Safety, Tolerability, and Pharmacokinetics of Escalating Single Doses of TAK-935
Lead Sponsor:
Takeda
Conditions:
Healthy Volunteers
Eligibility:
All Genders
19-55 years
Phase:
PHASE1
Brief Summary
The purpose of this study is to characterize the safety and tolerability profile of TAK-935 in healthy participants when administered as a single dose of oral solution at escalating dose levels.
Detailed Description
The drug being tested in this study is TAK-935. TAK-935 is being tested to find a safe and well-tolerated dose and to assess how TAK-935 is processed by the body. This study will look at side effects ...
Eligibility Criteria
Inclusion
- Is a healthy male or female adult who is 19 to 55 years of age inclusive at the time of informed consent.
- Weighs at least 45 kg and has a body mass index (BMI) between 18.0 and 30.0 kg/m\^2, inclusive at the Screening Visit.
Exclusion
- Has uncontrolled, clinically significant neurological (including seizure disorders), cardiovascular, pulmonary, hepatic, renal, metabolic, gastrointestinal, urological, immunologic, endocrine disease, or psychiatric disorder, or other abnormality.
- Has a known hypersensitivity to any component of the formulation of TAK-935.
- There is any finding in the participant's medical history, significant results from physical examination, or safety laboratory tests.
Key Trial Info
Start Date :
July 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2015
Estimated Enrollment :
48 Patients enrolled
Trial Details
Trial ID
NCT02201056
Start Date
July 1 2014
End Date
July 1 2015
Last Update
July 12 2016
Active Locations (1)
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1
Lincoln, Nebraska, United States