Multiple Dose Ethnobridging PK Study in Healthy Subjects
NCT ID: NCT03750565
Last Updated: 2021-01-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
60 participants
INTERVENTIONAL
2018-11-27
2019-02-13
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
SEQUENTIAL
TREATMENT
QUADRUPLE
Study Groups
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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.
TD-1473 - Dose A
oral capsule/tablet, QD
Placebo
oral capsule/tablet, QD
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.
TD-1473 - Dose B
oral capsule/tablet, QD
Placebo
oral capsule/tablet, QD
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.
TD-1473 - Dose B
oral capsule/tablet, QD
Placebo
oral capsule/tablet, QD
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.
TD-1473 - Dose C
oral capsule/tablet, QD
Placebo
oral capsule/tablet, QD
Interventions
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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
Eligibility Criteria
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Inclusion Criteria
* 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.
Exclusion Criteria
* 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)
18 Years
55 Years
ALL
Yes
Sponsors
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Theravance Biopharma
INDUSTRY
Responsible Party
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Principal Investigators
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Medical Monitor
Role: STUDY_DIRECTOR
Theravance Biopharma
Locations
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Theravance Biopharma Investigational Site
Cypress, California, United States
Countries
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Other Identifiers
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0176
Identifier Type: -
Identifier Source: org_study_id
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