Multiple Dose Ethnobridging PK Study in Healthy Subjects

NCT03750565 | Completed Phase 1 FDA Drug

• 1 other identifier: 0176
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Inflammatory Bowel Diseases; IBD

Keywords

Healthy Japanese Subjects; Healthy Caucasian Subjects; Ethnobridging

Outcome Measures

Primary Outcomes (5)

• 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

Study Arms (4)

Cohort 1

EXPERIMENTAL

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; Drug: Placebo

Cohort 2

EXPERIMENTAL

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; Drug: Placebo

Cohort 3

EXPERIMENTAL

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; Drug: Placebo

Cohort 4

EXPERIMENTAL

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; Drug: Placebo

Interventions

TD-1473 - Dose A DRUG

oral capsule/tablet, QD

Cohort 1

TD-1473 - Dose B DRUG

oral capsule/tablet, QD

Cohort 2; Cohort 3

TD-1473 - Dose C DRUG

oral capsule/tablet, QD

Cohort 4

Placebo DRUG

oral capsule/tablet, QD

Cohort 1; Cohort 2; Cohort 3; Cohort 4

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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
• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• Theravance Biopharma: lead

Study Sites (1)

Theravance Biopharma Investigational Site

Cypress, California, 90630, United States

Location

MeSH Terms

Conditions

Inflammatory Bowel Diseases

Condition Hierarchy (Ancestors)

Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases

Study Officials

• Medical Monitor

  Theravance Biopharma

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 20, 2018
• First Posted: November 23, 2018
• Study Start: November 27, 2018
• Primary Completion: February 13, 2019
• Study Completion: February 13, 2019
• Last Updated: January 14, 2021

Record last verified: 2021-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)