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

Study Overview
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Brief Summary
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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
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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.

Official Title
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A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Safety, Tolerability and Pharmacokinetic Study of Escalating Single Doses of TAK-935 in Healthy Subjects

Conditions
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Healthy Volunteers

Intervention / Treatment
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* Drug: TAK-935
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Criteria: 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.

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cohort 1: TAK-935 15 mg<br>TAK-935 15 mg solution, orally, once, on Day 1. | Drug: TAK-935<br>* TAK-935 oral solution<br>|
| Experimental: Cohort 2: TAK-935 50 mg<br>TAK-935 50 mg solution, orally, once, on Day 1. | Drug: TAK-935<br>* TAK-935 oral solution<br>|
| Experimental: Cohort 3: TAK-935 200 mg<br>TAK-935 200 mg solution, orally, once, on Day 1. | Drug: TAK-935<br>* TAK-935 oral solution<br>|
| Experimental: Cohort 4: TAK-935 600 mg<br>TAK-935 600 mg solution, orally, once, on Day 1. | Drug: TAK-935<br>* TAK-935 oral solution<br>|
| Experimental: Cohort 5: TAK-935 900 mg<br>TAK-935 900 mg solution, orally, once, on Day 1. | Drug: TAK-935<br>* TAK-935 oral solution<br>|
| Experimental: Cohort 6: TAK-935 1350 mg<br>TAK-935 1350 mg solution, orally, once, on Day 1. | Drug: TAK-935<br>* TAK-935 oral solution<br>|
| Placebo Comparator: Cohorts 1-6: Placebo<br>TAK-935 placebo-matching solution, orally, once, on Day 1. | Drug: Placebo<br>* TAK-935 placebo-matching oral solution<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants Who Experience at Least One Treatment-emergent Adverse Event (TEAE) | An adverse event (AE) is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (eg, a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug, whether or not it is considered related to the drug. A treatment-emergent adverse event (TEAE) is defined as an adverse event with an onset that occurs after receiving study drug and within 30 days after the last dose of study drug. | Day 1 to Day 30 | 
| Percentage of Participants Who Meet the Markedly Abnormal Criteria, for Safety Laboratory Tests at Least Once Post-dose | The percentage of participants with any markedly abnormal standard safety laboratory values (hematology, serum chemistries, and urinalysis) collected during the treatment period. | Day 1 to Day 14 | 
| Percentage of Participants Who Meet Markedly Abnormal Criteria, for Vital Sign Measurements at Least Once Post-dose | The percentage of participants with any markedly abnormal vital signs (oral temperature, respiration rate, pulse, and blood pressure) collected during the treatment period. | Day 1 to Day 14 | 
| Percentage of Participants Who Meet the Markedly Abnormal Criteria, for Electrocardiogram (ECG) Measurements at Least Once Post-dose | The percentage of participants with any markedly abnormal criteria for standard 12-lead ECG measured collected during the treatment period. | Day 1 to Day 14 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cmax: Maximum Observed Plasma Concentration for TAK-935 |  | Multiple time-points (Up to 96 hours) post-dose | 
| AUClast: Area Under the Plasma Concentration-Time Curve From Time 0 to the Time of the Last Quantifiable Concentration for TAK-935 |  | Multiple time-points (Up to 96 hours) post-dose | 
| AUC∞: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity of TAK-935 |  | Multiple time-points (Up to 96 hours) post-dose | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Drug Therapy