Multiple Dose Ethnobridging PK Study in Healthy Subjects

Inflammatory Bowel Diseases Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03750565
• Other study ID #: 0176
• Status: Completed
• Phase: Phase 1
• Start date: November 27, 2018
• Est. completion date: February 13, 2019

Study information

• Verified date: January 2021
• Source: Theravance Biopharma
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: February 13, 2019
• Est. primary completion date: February 13, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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

Related Conditions & MeSH terms

• IBD
• Inflammatory Bowel Diseases

Intervention

Drug:
• TD-1473 - Dose A
oral capsule/tablet, QD
• TD-1473 - Dose B
oral capsule/tablet, QD
• TD-1473 - Dose C
oral capsule/tablet, QD
• Placebo
oral capsule/tablet, QD

Locations

Country	Name	City	State
United States	Theravance Biopharma Investigational Site	Cypress	California

Sponsors (1)

Lead Sponsor	Collaborator
Theravance Biopharma

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Area under the concentration-time curve (AUC0 t)		Day 1 & Day 14
Primary	Area under the concentration-time curve (AUC0 24)		Day 1 & Day 14
Primary	Area under the concentration-time curve (AUCtau)		Day 1 & Day 14
Primary	Maximum observed concentration (Cmax)		Day 1 & Day 14
Primary	Maximum observed concentration at steady state (Cmax_ss)		Day 1 & Day 14