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Completed
NCT02201056
Safety, Tolerability, and Pharmacokinetics of Escalating Single Doses of TAK-935
Conditions: Healthy Volunteers
Sex: All
Ages: 19 Years – 55 Years
Healthy volunteers: Yes
Phase: PHASE1
Enrollment: 48
Sponsor: Takeda
Location: Lincoln Nebraska
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.
Eligibility Criteria
Inclusion Criteria:
1. Is a healthy male or female adult who is 19 to 55 years of age inclusive at the time of informed consent.
2. 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 Criteria:
1. Has uncontrolled, clinically significant neurological (including seizure disorders), cardiovascular, pulmonary, hepatic, renal, metabolic, gastrointestinal, urological, immunologic, endocrine disease, or psychiatric disorder, or other abnormality.
2. Has a known hypersensitivity to any component of the formulation of TAK-935.
3. There is any finding in the participant's medical history, significant results from physical examination, or safety laboratory tests.
Source: ClinicalTrials.gov (NCT02201056). StuddyBuddy aggregates publicly available trial information.
