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

Phase 1

Completed

• Conditions: Healthy Volunteers
• Interventions: Drug: TAK-935; Drug: Placebo

• Registration Number: NCT02201056
• Lead Sponsor: Takeda

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 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.

Study Timeline

• Study Start: 2014-07
• Study First Submitted: 2014-07-23
• Study First Submitted QC: 2014-07-23
• Study First Posted: 2014-07-25
• Primary Completion: 2015-07
• Study Completion: 2015-07
• Status Verified: 2016-06
• Results First Submitted: 2016-06-01
• Results First Submitted QC: 2016-06-01
• Last Update Submitted: 2016-06-01
• Results First Posted: 2016-07-12
• Last Update Posted: 2016-07-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 48

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Cohort 1: TAK-935 15 mg	TAK-935	TAK-935 15 mg solution, orally, once, on Day 1.
Cohort 2: TAK-935 50 mg	TAK-935	TAK-935 50 mg solution, orally, once, on Day 1.
Cohort 3: TAK-935 200 mg	TAK-935	TAK-935 200 mg solution, orally, once, on Day 1.
Cohort 4: TAK-935 600 mg	TAK-935	TAK-935 600 mg solution, orally, once, on Day 1.
Cohorts 1-6: Placebo	Placebo	TAK-935 placebo-matching solution, orally, once, on Day 1.
Cohort 6: TAK-935 1350 mg	TAK-935	TAK-935 1350 mg solution, orally, once, on Day 1.
Cohort 5: TAK-935 900 mg	TAK-935	TAK-935 900 mg solution, orally, once, on Day 1.

Primary Outcome Measures

Name	Time	Method
Percentage of Participants Who Experience at Least One Treatment-emergent Adverse Event (TEAE)	Day 1 to Day 30	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.
Percentage of Participants Who Meet the Markedly Abnormal Criteria, for Safety Laboratory Tests at Least Once Post-dose	Day 1 to Day 14	The percentage of participants with any markedly abnormal standard safety laboratory values (hematology, serum chemistries, and urinalysis) collected during the treatment period.
Percentage of Participants Who Meet Markedly Abnormal Criteria, for Vital Sign Measurements at Least Once Post-dose	Day 1 to Day 14	The percentage of participants with any markedly abnormal vital signs (oral temperature, respiration rate, pulse, and blood pressure) collected during the treatment period.
Percentage of Participants Who Meet the Markedly Abnormal Criteria, for Electrocardiogram (ECG) Measurements at Least Once Post-dose	Day 1 to Day 14	The percentage of participants with any markedly abnormal criteria for standard 12-lead ECG measured collected during the treatment period.

Secondary Outcome Measures

Name	Time	Method
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