Back to resultsMultiple Dose Ethnobridging PK Study in Healthy Subjects
Primary Purpose
Inflammatory Bowel Diseases, IBD
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
TD-1473 - Dose A
TD-1473 - Dose B
TD-1473 - Dose C
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Inflammatory Bowel Diseases focused on measuring Healthy Japanese Subjects, Healthy Caucasian Subjects, Ethnobridging
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
Sites / Locations
- Theravance Biopharma Investigational Site
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Experimental
Experimental
Experimental
Arm Label
Cohort 1
Cohort 2
Cohort 3
Cohort 4
Arm Description
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.
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.
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.
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.
Outcomes
Primary Outcome Measures
Area under the concentration-time curve (AUC0 t)
Area under the concentration-time curve (AUC0 24)
Area under the concentration-time curve (AUCtau)
Maximum observed concentration (Cmax)
Maximum observed concentration at steady state (Cmax_ss)
Secondary Outcome Measures
Full Information
NCT ID
NCT03750565
First Posted
November 20, 2018
Last Updated
January 12, 2021
Sponsor
Theravance Biopharma
1. Study Identification
Unique Protocol Identification Number
NCT03750565
Brief Title
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
2. Study Status
Record Verification Date
January 2021
Overall Recruitment Status
Completed
Study Start Date
November 27, 2018 (Actual)
Primary Completion Date
February 13, 2019 (Actual)
Study Completion Date
February 13, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Theravance Biopharma
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
A Phase 1, double blind, placebo controlled, 4 cohort, multiple dose study in healthy adult Japanese and Caucasian subjects.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Inflammatory Bowel Diseases, IBD
Keywords
Healthy Japanese Subjects, Healthy Caucasian Subjects, Ethnobridging
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Sequential Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Cohort 1
Arm Type
Experimental
Arm Description
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.
Arm Title
Cohort 2
Arm Type
Experimental
Arm Description
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.
Arm Title
Cohort 3
Arm Type
Experimental
Arm Description
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.
Arm Title
Cohort 4
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
TD-1473 - Dose A
Intervention Description
oral capsule/tablet, QD
Intervention Type
Drug
Intervention Name(s)
TD-1473 - Dose B
Intervention Description
oral capsule/tablet, QD
Intervention Type
Drug
Intervention Name(s)
TD-1473 - Dose C
Intervention Description
oral capsule/tablet, QD
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
oral capsule/tablet, QD
Primary Outcome Measure Information:
Title
Area under the concentration-time curve (AUC0 t)
Time Frame
Day 1 & Day 14
Title
Area under the concentration-time curve (AUC0 24)
Time Frame
Day 1 & Day 14
Title
Area under the concentration-time curve (AUCtau)
Time Frame
Day 1 & Day 14
Title
Maximum observed concentration (Cmax)
Time Frame
Day 1 & Day 14
Title
Maximum observed concentration at steady state (Cmax_ss)
Time Frame
Day 1 & Day 14
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Monitor
Organizational Affiliation
Theravance Biopharma
Official's Role
Study Director
Facility Information:
Facility Name
Theravance Biopharma Investigational Site
City
Cypress
State/Province
California
ZIP/Postal Code
90630
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
Theravance Biopharma, Inc. will not be sharing individual de-identified participant data or other relevant study documents.
Learn more about this trial
Multiple Dose Ethnobridging PK Study in Healthy Subjects
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