Conditions: Healthy Volunteers
Keywords: Drug therapy
Allocation: RANDOMIZED | Intervention model: SINGLE_GROUP
Enrollment: 39
Healthy volunteers: yes

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.

Arms:
arm 1: MLN3126 300 mg tablets, orally, fasting, once on Day 1. arm 2: MLN3126 600 mg tablets, orally, fasting, once on Day 1. arm 3: MLN3126 1000 mg tablets, orally, fasting, once on Day 1. Participants returned to the clinic then received MLN3126 1000 mg tablets, orally, fed (30 minutes after the start of a high-fat breakfast), once on Day 1. arm 4: MLN3126 1500 mg administered orally as tablets, once on Day 1. arm 5: MLN3126 2000 mg tablets, orally, fasting, once on Day 1. arm 6: Did not take place due to termination of the study. arm 7: Placebo-matching MLN3126 tablets, orally, once on Day 1.

Interventions: intervention 1: MLN3126 intervention 2: MLN3126 Placebo
Intervention descriptions: intervention 1: MLN3126 tablets intervention 2: MLN3126 placebo-matching tablets

Protocol document: