Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-25 @ 12:00 AM
Ignite Modification Date:
2025-12-25 @ 12:00 AM
NCT ID:
NCT02447458
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.
Study:
NCT02447458
Study Brief:
Protocol Section:
NCT02447458