Multiple Dose Ethnobridging PK Study in Healthy Subjects

Study Overview
=================
Brief Summary
-----------------
A Phase 1, double blind, placebo controlled, 4 cohort, multiple dose study in healthy adult Japanese and Caucasian subjects.

Official Title
-----------------
A Multiple Dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of TD-1473 in Healthy Adult Japanese Subjects

Conditions
-----------------
Inflammatory Bowel Diseases, IBD

Intervention / Treatment
-----------------
* Drug: TD-1473 - Dose A
* Drug: TD-1473 - Dose B
* Drug: TD-1473 - Dose C
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: For All subjects: Male or female between 18 to 55 years old Female subjects must have documentation of a negative serum pregnancy test, Female subjects must be either of non-childbearing potential or if of childbearing potential use a highly efficient birth control method Male subjects must be vasectomized with documented medical assessment of the surgical success, or use acceptable contraception All male subjects must agree to refrain from sperm donation during the study and for at least 7 days after the last dose of study drug. Body Mass Index (BMI) 18 to 32 kg/m2, inclusive, and weighs at least 50 kg and less than 90 kg Willing and able to give informed consent Additional inclusion criteria apply For Japanese subjects only: Subject must have been born in Japan, with 2 Japanese biological parents and 4 Japanese grandparents as confirmed by interview. Subject has lived no longer than 10 years outside of Japan. Subject had no significant change in lifestyle, including diet, since leaving Japan. For Caucasian subjects only: Subject has 2 Caucasian biological parents and 4 Caucasian grandparents as confirmed by interview. Subject has lived no longer than 10 years outside of Europe and/or North America. Exclusion Criteria: For all subjects: Subject is a female who is pregnant, lactating, breastfeeding, or planning to become pregnant during the study or within 7 days after the last dose of study drug. Subject is a male who is planning to father a child during the study or within 7 days after the last dose of study drug. Is positive for hepatitis A, B or C, and/or HIV Has clinically significant abnormalities in baseline laboratory evaluations Subject has a clinically significant abnormal electrocardiogram (ECG) Participated in another clinical trial of an investigational drug (or medical device) within 30 days prior to screening or is currently participating in another trial of an investigational drug (or medical device) Additional exclusion criteria apply

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cohort 1<br>Japanese subjects will receive oral doses of either TD-1473 - Dose A or placebo (15 healthy Japanese subjects randomized 3:1 to 12 active and 3 placebo) once daily (QD) for 14 consecutive days. | Drug: TD-1473 - Dose A<br>* oral capsule/tablet, QD<br>Drug: Placebo<br>* oral capsule/tablet, QD<br>|
| Experimental: Cohort 2<br>Japanese subjects will receive oral doses of either TD-1473 - Dose B or placebo (15 healthy Japanese subjects randomized 3:1 to 12 active and 3 placebo) once daily (QD) for 14 consecutive days. | Drug: TD-1473 - Dose B<br>* oral capsule/tablet, QD<br>Drug: Placebo<br>* oral capsule/tablet, QD<br>|
| Experimental: Cohort 3<br>Caucasian subjects will receive oral doses of either TD-1473 - Dose B or placebo (15 healthy Caucasian subjects randomized 3:1 to 12 active and 3 placebo) once daily (QD) for 14 consecutive days. | Drug: TD-1473 - Dose B<br>* oral capsule/tablet, QD<br>Drug: Placebo<br>* oral capsule/tablet, QD<br>|
| Experimental: Cohort 4<br>Japanese subjects will receive oral doses of either TD-1473 - Dose C or placebo (15 healthy Japanese subjects randomized 3:1 to 12 active and 3 placebo) once daily (QD) for 14 consecutive days. | Drug: TD-1473 - Dose C<br>* oral capsule/tablet, QD<br>Drug: Placebo<br>* oral capsule/tablet, QD<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Area under the concentration-time curve (AUC0 t) |  | Day 1 & Day 14 | 
| Area under the concentration-time curve (AUC0 24) |  | Day 1 & Day 14 | 
| Area under the concentration-time curve (AUCtau) |  | Day 1 & Day 14 | 
| Maximum observed concentration (Cmax) |  | Day 1 & Day 14 | 
| Maximum observed concentration at steady state (Cmax_ss) |  | Day 1 & Day 14 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Healthy Japanese Subjects, Healthy Caucasian Subjects, Ethnobridging