A Single-center, Single- and Multiple-Dose Phase 1 Study to Evaluate the Safety and Pharmacokinetics of TAK-114 in Healthy Adult Japanese and Caucasian Male Subjects

Phase 1

• Conditions: Healthy adult male subject

• Registration Number: JPRN-jRCT2080222640
• Lead Sponsor: TAKEDA PHARMACEUTICAL COMPANY LTD.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2014-10-28
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Sex: Male
• Target Recruitment: 82

Inclusion Criteria

Healthy Japanese Subjects:
- All subjects must be willing to provide written informed consent and in the investigator's opinion able to comply with the study protocol.
- Male subjects aged 20 to 45 years, inclusive.
- All subjects should weigh at least 45 kg (99 lb) and have a body mass index between 18.5 and 25.0 kg/m2.
Healthy Caucasian Subjects:
- All subjects must be willing to provide written informed consent and in the investigator's opinion able to comply with the study protocol.
- Male subjects 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.
- All subjects should weigh at least 45 kg (99 lb) and have a body mass index between 18.5 and 30.0 kg/m2.

Exclusion Criteria

- Subjects have a known hypersensitivity to any component of the formulation of TAK-114 or any herb medicine or supplement related to Indigo naturalis.

Study & Design

• Study Type: Interventional
• Study Design: Not specified