Ignite Creation Date:
2025-12-26 @ 4:00 PM
Ignite Modification Date:
2025-12-31 @ 12:27 PM
Study NCT ID:
NCT02209506
Status:
TERMINATED
Last Update Posted:
2016-07-25
First Post:
2014-08-04
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of MLN3126 in Healthy Japanese and Non-Japanese Participants
Sponsor:
Takeda
Organization:
Study Overview
Official Title:
A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Sequential-Cohort, Ascending Multiple Oral Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of MLN3126 in Healthy Non-Japanese and Japanese Subjects
Status:
TERMINATED
Status Verified Date:
2016-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Long-term animal toxicology findings (see detailed description).
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 evaluate the safety and tolerability of single and multiple oral dosing of MLN3126 in ascending doses in healthy non-Japanese and Japanese participants.
Detailed Description:
MLN3126 is being tested to find a safe and well-tolerated dose in healthy people and to assess how MLN3126 is processed by the body. In total, approximately 64 participants will be enrolled in the study.
This study is composed of 2 parts: Part A healthy non-Japanese participants and Part B healthy Japanese participants. Each part will consist of 4 Cohorts with 8 participants in each Cohort. In each Cohort, 6 participants will receive MLN3126 and 2 participants will receive matched placebo within 30 minutes after the start of a standard breakfast. The starting dose will be 100 mg followed by doses of 300 mg, 800 mg, and a dose to be determined during the study. Progression to the next dose level will only occur if the previous dose level was considered to be safe and well tolerated.
This single-center trial will be conducted in the United States. The overall time to participate in this study is up to 20 days. All participants will be contacted by telephone 7 days after the last dose of study drug for a follow-up assessment.
Due to toxicology findings from a long-term animal study, Takeda made the decision to terminate this study. No clinically significant safety and/or tolerability issues have been observed or reported in participants exposed to MLN3126.
This study is composed of 2 parts: Part A healthy non-Japanese participants and Part B healthy Japanese participants. Each part will consist of 4 Cohorts with 8 participants in each Cohort. In each Cohort, 6 participants will receive MLN3126 and 2 participants will receive matched placebo within 30 minutes after the start of a standard breakfast. The starting dose will be 100 mg followed by doses of 300 mg, 800 mg, and a dose to be determined during the study. Progression to the next dose level will only occur if the previous dose level was considered to be safe and well tolerated.
This single-center trial will be conducted in the United States. The overall time to participate in this study is up to 20 days. All participants will be contacted by telephone 7 days after the last dose of study drug for a follow-up assessment.
Due to toxicology findings from a long-term animal study, Takeda made the decision to terminate this study. No clinically significant safety and/or tolerability issues have been observed or reported in participants exposed to MLN3126.
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 |
|---|---|---|---|---|
| U1111-1156-8528 | OTHER | World Health Organziation | View |