Ignite Creation Date:
2025-12-25 @ 2:29 AM
Ignite Modification Date:
2026-01-08 @ 6:45 PM
Study NCT ID:
NCT02539134
Status:
COMPLETED
Last Update Posted:
2017-07-12
First Post:
2015-08-31
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
TAK-935 Multiple Rising Dose Study in Healthy Participants
Sponsor:
Takeda
Organization:
Study Overview
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:
COMPLETED
Status Verified Date:
2017-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
Detailed 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 QD
* Part 1, Cohort 2: TAK-935 300 mg QD
* Part 1, Cohort 3: TAK-935 300 mg BID
* Part 1, Cohort 4: TAK-935 600 mg QD
* Part 1, Cohort 5: TAK-935 400 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.
* Part 1, Cohort 1: TAK-935 100 mg QD
* Part 1, Cohort 2: TAK-935 300 mg QD
* Part 1, Cohort 3: TAK-935 300 mg BID
* Part 1, Cohort 4: TAK-935 600 mg QD
* Part 1, Cohort 5: TAK-935 400 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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| U1111-1168-6634 | REGISTRY | WHO | View |