NCT02153099

Safety, Tolerability and Pharmacokinetics of Escalating Single Doses of ENV8058 (TAK-058) in Healthy Participants

A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Safety, Tolerability and Pharmacokinetic Study of Escalating Single Doses of ENV8058 in Healthy Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 48 (actual)
• Sponsor: Takeda · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to characterize the safety and tolerability profile of escalating dose levels of ENV8058 (TAK-058) solution when administered as a single oral dose in healthy adults.

Detailed description

The drug being tested in this study is called ENV8058 (also known as TAK-058). ENV8058 is being tested to find a safe and well-tolerated dose and to assess how ENV8058 moves throughout the body. This study will look at side effects and lab results in people who took ENV8058. This study was designed as a randomized, sequential-panel, single rising dose study. The study population will consist of 6 Cohorts with 8 participants in each Cohort; with 6 participants randomized to receive a single dose of ENV8058, and 2 participants to receive placebo. Participants in each Cohort will receive a single dose of study drug after a 10-hour fast. The starting dose is 15 mg followed by administrations of 30, 45, 15, 75 and 150 mg. * ENV8058 (Tak-058): 5, 15, 30, 45, 75 or 150 mg oral solution * Placebo (dummy inactive) - this oral solution looks like the study drug but has no active ingredient This single-centre trial will be conducted in the United States. The overall time to participate in this study is up to 14 days. Participants will make 2 visits to the clinic, including one 5-day period of confinement to the clinic. All participants will be contacted by telephone 14 days after last dose of study drug for a follow-up assessment.

Conditions

• Dose Finding Study

Interventions

Type	Name	Description
DRUG	TAK-058 (ENV8058)	TAK-058 (ENV8058) oral solution
DRUG	Placebo	TAK-058 (ENV8058) placebo-matching oral solution

Timeline

• Start date: 2014-06-01
• Primary completion: 2014-11-01
• Completion: 2014-11-01
• First posted: 2014-06-02
• Last updated: 2015-12-17
• Results posted: 2015-12-17

Locations

1 site across 1 country: United States