Status:
COMPLETED
TAK-114 Single- and Multiple-Dose Phase 1 Study
Lead Sponsor:
Takeda
Conditions:
Clinical Pharmacology
Eligibility:
MALE
20-45 years
Phase:
PHASE1
Brief Summary
The purpose of this study is to evaluate the safety and tolerability of TAK-114 following single and multiple ascending oral doses in healthy Japanese male participants.
Detailed Description
This is a phase 1, randomized, double-blind, placebo-controlled, single and multiple oral dose study in healthy Caucasian and Japanese male participants. The study is composed of three parts, Single-...
Eligibility Criteria
Inclusion
- Healthy Japanese participants:
- Must be willing to provide written informed consent and in the investigator's opinion able to comply with the study protocol.
- Is aged 20 to 45 years, inclusive.
- Weighs at least 50 kilogram (kg) and have a body mass index (BMI) between 18.5 and 25.0 kilogram per square meter (kg/m\^2).
- Healthy Caucasian participants:
- Must be willing to provide written informed consent and in the investigator's opinion able to comply with the study protocol.
- Is aged 20 to 45 years, inclusive; are of Caucasian descent (born to Caucasian parents and grandparents and has lived outside original country for less than 5 years) and maintains their original diet and lifestyle.
- Weighs at least 50 kg and have a body mass index between 18.5 and 30.0 kg/m2.
Exclusion
- • Participants have a known hypersensitivity to any component of the formulation of TAK-114 or any herb medicine or supplement related to Indigo naturalis.
Key Trial Info
Start Date :
November 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2015
Estimated Enrollment :
82 Patients enrolled
Trial Details
Trial ID
NCT02286518
Start Date
November 1 2014
End Date
April 1 2015
Last Update
July 25 2016
Active Locations (1)
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1
Sumida-ku, Tokyo, Japan