CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 48 enrolled
Drug / intervention
TAK-058 (ENV8058) +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02153099
NCT02153099Phase 1Completed
CompareCT.gov

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

Takeda·interventional·Posted Jun 2, 2014·Updated Dec 17, 2015

In Brief

A Phase 1 clinical trial evaluating TAK-058 (ENV8058) and Placebo for Dose Finding Study. Completed, enrolled 48 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDose Finding Study
CountriesUnited States
Collaborators--

Timeline

Phase 1CompletedFinished
201520162017201820192020202120222023202420252026
First PostedJun 2, 2014
Enrollment StartJun 1, 2014
Primary CompletionNov 1, 2014
TodayJul 2, 2026
Enrollment to primary: 5 monthsPosted 12.1 years ago

Interventions

TAK-058 (ENV8058)drug

TAK-058 (ENV8058) oral solution

Placebodrug

TAK-058 (ENV8058) placebo-matching oral solution