TAK-935 Multiple Rising Dose Study in Healthy Participants

Epilepsy Clinical Trial

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

Status Recruiting

Clinical Trial Summary

The purpose of this study is to assess the safety, tolerability and pharmacokinetics (PK) of multiple rising doses of TAK-935 in healthy participants.

Clinical Trial Description

The drug being tested in this study is called TAK-935. This study will look at the pharmacokinetics, safety and tolerability of TAK-935 in healthy participants. The study will enroll approximately 56 participants. Participants will be randomly assigned (by chance, like flipping a coin) to 1 of the 5 cohorts in Part 1, which will remain undisclosed to the participant and study doctor during the study (unless there is an urgent medical need): • Part 1, Cohort 1: TAK-935 100 mg once daily (QD) • Part 1, Cohort 2: TAK-935 300 mg QD• Part 1, Cohort 3: TAK-935 300 mg twice daily (BID) • Part 1, Cohort 4: TAK-935 600 mg QD • Part 1, Cohort 5: TAK-935 900 to 1350 mg QD.

Participants will be asked to take the oral solution once or twice a day at the same time for 14 days. An optional Part 2 may be conducted for collecting data to assess the engagement by TAK-935 of the central molecular target cholesterol 24S-hydroxylase (CH24H) by measuring the changes of levels of the metabolite 24S-hydroxycholesterol (24HC). In Part 2, participants will be assigned to up to 2 treatment groups at doses based on the data from other ongoing TAK-935 trials, combined with the safety and tolerability data from Cohorts 1-4 of Part 1.

This single center trial will be conducted in the United States. The overall time to participate in this study will be approximately 30 days. Participants will be admitted in the clinic for the first 14 days, and will be contacted by telephone on Day 28 for a follow-up assessment. ;

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)

Related Conditions & MeSH terms

• Epilepsy

• NCT number: NCT02539134
• Study type: Interventional
• Source: Takeda
• Contact: Takeda Study Registration Call Center
• Phone: +1-877-825-3327
• Email: medicalinformation@tpna.com
• Status: Recruiting
• Phase: Phase 1
• Start date: September 2015
• Completion date: February 2016