Phase 1, TAK-648, Single-Rising Dose Study

Healthy Volunteers Clinical Trial

Official title: A Phase 1, Randomized, Double-Blind, Placebo- Controlled, Safety, Tolerability, and Pharmacokinetic Study of Escalating Single Oral TAK-648 Doses in Healthy Subjects

Status Completed

Clinical Trial Summary

The purpose of this study is to determine the safety, tolerability and pharmacokinetics of TAK-648 when administered as a single oral dose of TAK-648 solution at escalating dose levels in healthy participants.

Clinical Trial Description

This is a phase 1, randomized, double-blind, placebo-controlled, single-center, single-dose study in healthy subjects The study is the first TAK-648 study in humans and is designed to evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of a single dose of TAK-648 to healthy subjects.

The compound being tested in this study is TAK-648. TAK-648 is being tested to find a safe and well-tolerated dose and to assess how TAK-648 is eliminated by the body. This study evaluates side effects and lab results in people who take TAK-648 and is a randomized dose-rising study.

Approximately 40 healthy male and female subjects were planned for enrollment with 8 subjects planned (6 randomized to TAK-648 and 2 randomized to placebo) for each cohort. The study consisted of 5 cohorts.

• TAK-648 will be dosed in 5 sequential cohorts with escalating dose from the lowest dose given in Cohort 1 to higher doses given in the subsequent cohorts)

• Placebo(dummy inactive solution) - this is a solution that looks like the study drug but has no active ingredient This single-center trial will be conducted in the United States. The overall time to participate in this study is up to 45 days. Participants will make multiple visits to the clinic, including one 5-day period of confinement to the clinic. All participants will be contacted by telephone 14 days after the last dose of study drug and on Day 84 (+/-2 days) for a follow-up assessment . ;

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Healthy Volunteers

• NCT number: NCT02684396
• Study type: Interventional
• Source: Takeda
• Status: Completed
• Phase: Phase 1
• Start date: September 2014
• Completion date: July 2015