Clinical trial NCT03750565: Multiple Dose Ethnobridging PK Study in Healthy Subjects
Official title: A Multiple Dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of TD-1473 in Healthy Adult Japanese Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Inflammatory Bowel Diseases
IBD
Keywords: Healthy Japanese Subjects
Healthy Caucasian Subjects
Ethnobridging
Lead sponsor: Theravance Biopharma
Sponsor class: INDUSTRY
First posted: 2018-11-23
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

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


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

Primary outcomes:
measure: Area under the concentration-time curve (AUC0 t)
timeFrame: Day 1 & Day 14
measure: Area under the concentration-time curve (AUC0 24)
timeFrame: Day 1 & Day 14
measure: Area under the concentration-time curve (AUCtau)
timeFrame: Day 1 & Day 14
measure: Maximum observed concentration (Cmax)
timeFrame: Day 1 & Day 14
measure: Maximum observed concentration at steady state (Cmax_ss)
timeFrame: Day 1 & Day 14
Secondary outcomes:
Other outcomes:
Locations:
city: Cypress
country: United States
facility: Theravance Biopharma Investigational Site
state: California
Study officials:
affiliation: Theravance Biopharma
name: Medical Monitor
role: STUDY_DIRECTOR
References: