MedTrace Logo

Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of MLN3126 in Healthy Japanese and Non-Japanese Participants

NCT02209506 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 23

Last updated 2016-07-25

Study results available
· View outcomes & findings →

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.

Conditions

  • Safety
  • Tolerability
  • Pharmacokinetics
  • Pharmacodynamics

Interventions

DRUG

MLN3126

MLN3126 tablets

DRUG

MLN3126 Matched Placebo

MLN3126 placebo-matching tablets

Sponsors & Collaborators

Principal Investigators

  • Medical Director Clinical Science · Takeda

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2014-07-31
Primary Completion
2014-09-30
Completion
2014-12-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02209506 on ClinicalTrials.gov