Safety, Tolerability, and Pharmacokinetics of Escalating Single Doses of TAK-935

Completed · Phase 1 · Has a placebo group

Conditions studied: Healthy Volunteers

In brief

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.

Key facts

Study ID

NCT02201056

Run by

Takeda

People needed

48

Starts

2014-07-01

Expected to finish

2015-07-01

Last updated by the study team

2016-07-12

Who can join

Age: 19 and older, up to 55. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Study site — Lincoln, Nebraska, United States

Full record on ClinicalTrials.gov

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