Conditions: Dose Finding Study
Keywords: Drug therapy
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 48
Healthy volunteers: yes

Brief 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.

Arms:
arm 1: TAK-058 15 mg, 100 mL oral solution, once on Day 1. arm 2: TAK-058 30 mg, 100 mL oral solution, once on Day 1. arm 3: TAK-058 45 mg, 100 mL oral solution, once on Day 1. arm 4: TAK-058 5 mg, 100 mL oral solution, once on Day 1. arm 5: TAK-058 75 mg, 100 mL oral solution, once on Day 1. arm 6: TAK-058 150 mg, 100 mL oral solution, once on Day 1. arm 7: TAK-058 placebo-matching, 100 mL oral solution, once on Day 1.

Interventions: intervention 1: TAK-058 (ENV8058) intervention 2: Placebo
Intervention descriptions: intervention 1: TAK-058 (ENV8058) oral solution intervention 2: TAK-058 (ENV8058) placebo-matching oral solution

Protocol document: