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

Takeda

Status and phase: Completed; Phase 1

Conditions: Healthy Volunteers

Treatments: Drug: Placebo; Drug: TAK-935

Study type: Interventional

Funder types: Industry

Identifiers

NCT02201056

TAK-935_101

U111-1155-6022 (Registry Identifier)

Details and patient eligibility

About

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.

Full 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 and lab results in people who take TAK-935 and is designed as a randomized dose-rising study.

The study will consist of 6 Cohorts with 8 participants in each Cohort. In each Cohort, 6 participants will receive a single dose of TAK-935 and 2 participants will receive placebo after a 10-hour fast. The starting dose will be 15 mg followed by planned doses of 50, 200, 600, 900 and not to exceed 1350 mg in subsequent cohorts.

This single-center trial will be conducted in the United States. The overall time to participate in this study is up to 51 days. Participants will make 2 visits to the clinic, including one 7-day period of confinement to the clinic. All participants will be contacted by telephone 14 days after the dose of study drug for a follow-up assessment.

Enrollment: 48 patients

Sex: All

Ages: 19 to 55 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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48 participants in 7 patient groups, including a placebo group

Cohort 1: TAK-935 15 mg

Experimental group

Description:

TAK-935 15 mg solution, orally, once, on Day 1.

Treatment:

Drug: TAK-935

Cohort 2: TAK-935 50 mg

Experimental group

Description:

TAK-935 50 mg solution, orally, once, on Day 1.

Treatment:

Drug: TAK-935

Cohort 3: TAK-935 200 mg

Experimental group

Description:

TAK-935 200 mg solution, orally, once, on Day 1.

Treatment:

Drug: TAK-935

Cohort 4: TAK-935 600 mg

Experimental group

Description:

TAK-935 600 mg solution, orally, once, on Day 1.

Treatment:

Drug: TAK-935

Cohort 5: TAK-935 900 mg

Experimental group

Description:

TAK-935 900 mg solution, orally, once, on Day 1.

Treatment:

Drug: TAK-935

Cohort 6: TAK-935 1350 mg

Experimental group

Description:

TAK-935 1350 mg solution, orally, once, on Day 1.

Treatment:

Drug: TAK-935

Cohorts 1-6: Placebo

Placebo Comparator group

Description:

TAK-935 placebo-matching solution, orally, once, on Day 1.

Treatment:

Drug: Placebo