Ignite Creation Date:
2025-12-25 @ 12:00 AM
Ignite Modification Date:
2026-03-13 @ 5:35 AM
Study NCT ID:
NCT02447458
Status:
TERMINATED
Last Update Posted:
2015-08-05
First Post:
2015-05-14
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
MLN3126 Single Rising Dose Study
Sponsor:
Takeda
Organization:
Study Overview
Official Title:
A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Safety, Tolerability, and Pharmacokinetics Study of Escalating Single Doses of MLN3126 in Healthy Subjects
Status:
TERMINATED
Status Verified Date:
2015-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Site non-compliance to GCP (No safety concerns. 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 was to evaluate the safety, tolerability, and pharmacokinetics of MLN3126 when administered as a single dose of tablets at escalating dose levels in healthy participants.
Detailed Description:
The drug tested in this study is called MLN3126. The study evaluated the safety, tolerability, pharmacokinetics (PK), pharmacodynamics and the potential effect of food on the PK of MLN3126 and its M-I metabolite following single oral dose administrations.
This study planned to enroll approximately 48 healthy participants, who were to be enrolled in 1 of the 6 dose cohorts or matching placebo in an ascending fashion. Participants were randomly assigned to MLN3126 or placebo within each cohort- which remained undisclosed to the participant and study doctor during the study (unless there was an urgent medical need):
* Cohort 1 - MLN3126 300 mg or matching placebo
* Cohort 2 - MLN3126 600 mg or matching placebo
* Cohort 3 - MLN3126 1000 mg or matching placebo
* Cohort 3 - MLN3126 1000 mg or matching placebo (fed regimen)
* Cohort 4 - MLN3126 1500 mg or matching placebo
* Cohort 5 - MLN3126 2000 mg or matching placebo
* Cohort 6 - Did not taken place due to termination of the study
All participants were asked to take the required tablets at the same time throughout the study.
This single-centre trial was conducted in The United States. Participants were confined to the clinic for 5 days, and were contacted by telephone on day 14 (±2days) for a follow-up assessment.
This study was terminated after completion of Cohort 5 due to findings of study site non-compliance to Good Clinical Practice (GCP) regarding study documentation. There were no safety concerns.
This study planned to enroll approximately 48 healthy participants, who were to be enrolled in 1 of the 6 dose cohorts or matching placebo in an ascending fashion. Participants were randomly assigned to MLN3126 or placebo within each cohort- which remained undisclosed to the participant and study doctor during the study (unless there was an urgent medical need):
* Cohort 1 - MLN3126 300 mg or matching placebo
* Cohort 2 - MLN3126 600 mg or matching placebo
* Cohort 3 - MLN3126 1000 mg or matching placebo
* Cohort 3 - MLN3126 1000 mg or matching placebo (fed regimen)
* Cohort 4 - MLN3126 1500 mg or matching placebo
* Cohort 5 - MLN3126 2000 mg or matching placebo
* Cohort 6 - Did not taken place due to termination of the study
All participants were asked to take the required tablets at the same time throughout the study.
This single-centre trial was conducted in The United States. Participants were confined to the clinic for 5 days, and were contacted by telephone on day 14 (±2days) for a follow-up assessment.
This study was terminated after completion of Cohort 5 due to findings of study site non-compliance to Good Clinical Practice (GCP) regarding study documentation. There were no safety concerns.
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 |
|---|---|---|---|---|
| U1111-1163-1717 | OTHER | Universal Trial Number (WHO) | View |