Multiple Dose Ethnobridging PK Study in Healthy Subjects

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

A Phase 1, double blind, placebo controlled, 4 cohort, multiple dose study in healthy adult Japanese and Caucasian subjects.

Study Overview

• Status: Completed
• Conditions: Inflammatory Bowel Diseases; IBD
• Intervention / Treatment: Drug: TD-1473 - Dose A; Drug: Placebo; Drug: TD-1473 - Dose B; Drug: TD-1473 - Dose C

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • California
    • Cypress, California, United States, 90630
      • Theravance Biopharma Investigational Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Sequential Assignment
• Masking: Quadruple

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Cohort 1; 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; oral capsule/tablet, QD; Drug: Placebo; oral capsule/tablet, QD
Experimental: Cohort 2; 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: Placebo; oral capsule/tablet, QD; Drug: TD-1473 - Dose B; oral capsule/tablet, QD
Experimental: Cohort 3; 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: Placebo; oral capsule/tablet, QD; Drug: TD-1473 - Dose B; oral capsule/tablet, QD
Experimental: Cohort 4; 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: Placebo; oral capsule/tablet, QD; Drug: TD-1473 - Dose C; oral capsule/tablet, QD

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Theravance Biopharma

Study record dates

Study Major Dates

• Study Start (Actual): November 27, 2018
• Primary Completion (Actual): February 13, 2019
• Study Completion (Actual): February 13, 2019

Study Registration Dates

• First Submitted: November 20, 2018
• First Submitted That Met QC Criteria: November 20, 2018
• First Posted (Actual): November 23, 2018

Study Record Updates

• Last Update Posted (Actual): January 14, 2021
• Last Update Submitted That Met QC Criteria: January 12, 2021
• Last Verified: January 1, 2021

More Information

Terms related to this study

• Keywords: Healthy Japanese Subjects; Healthy Caucasian Subjects; Ethnobridging
• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Gastroenteritis; Intestinal Diseases; Inflammatory Bowel Diseases
• Other Study ID Numbers: 0176

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Theravance Biopharma, Inc. will not be sharing individual de-identified participant data or other relevant study documents.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No