Inflammatory Bowel DiseasesPhase 1NCT03750565
Multiple Dose Ethnobridging PK Study in Healthy Subjects
A Phase 1 study testing TD-1473 - Dose A, TD-1473 - Dose B and TD-1473 - Dose C in people with Inflammatory Bowel Diseases and IBD, run by Theravance Biopharma at 1 site in United States.
Trial summary
A Phase 1, double blind, placebo controlled, 4 cohort, multiple dose study in healthy adult Japanese and Caucasian subjects. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Inflammatory Bowel Diseases, IBD
- What is being tested?
- TD-1473 - Dose A, TD-1473 - Dose B and TD-1473 - Dose C
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 27 Nov 2018to 13 Feb 2019
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Theravance Biopharma Investigational Site
Cypress, California, 90630
About this study
Official title: A Multiple Dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of TD-1473 in Healthy Adult Japanese Subjects
A Phase 1, double blind, placebo controlled, 4 cohort, multiple dose study in healthy adult Japanese and Caucasian subjects.
- Conditions
- Inflammatory Bowel Diseases, IBD
- Being tested
- TD-1473 - Dose A, TD-1473 - Dose B, TD-1473 - Dose C, Placebo
- Keywords
- Healthy Japanese Subjects, Healthy Caucasian Subjects, Ethnobridging
- Medical subject headings
- Inflammatory Bowel Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TD-1473 - Dose ADrug
oral capsule/tablet, QD
TD-1473 - Dose BDrug
oral capsule/tablet, QD
TD-1473 - Dose CDrug
oral capsule/tablet, QD
PlaceboDrug
oral capsule/tablet, QD
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: 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. Receives: Drug: TD-1473 - Dose C; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area under the concentration-time curve (AUC0 t)
Measured: Day 1 & Day 14
Area under the concentration-time curve (AUC0 24)
Measured: Day 1 & Day 14
Area under the concentration-time curve (AUCtau)
Measured: Day 1 & Day 14
Maximum observed concentration (Cmax)
Measured: Day 1 & Day 14
Maximum observed concentration at steady state (Cmax_ss)
Measured: Day 1 & Day 14
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Nov 2018
- Study start27 Nov 2018
- Primary completion13 Feb 2019
- Study completion13 Feb 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Inflammatory Bowel DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Theravance Biopharma
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Monitor, Study director, Theravance Biopharma
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03750565
- Sponsor's protocol ID
- 0176
- Status last verified
- Jan 2021
- First submitted
- 20 Nov 2018
- Last updated
- 14 Jan 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: Theravance Biopharma, Inc. will not be sharing individual de-identified participant data or other relevant study documents.
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multiple Dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of TD-1473 in Healthy Adult Japanese Subjects
- ClinicalTrials.gov ID
- NCT03750565
- Acronym / sponsor ID
- 0176
- Conditions
- Inflammatory Bowel Diseases, IBD
- Keywords
- Healthy Japanese Subjects, Healthy Caucasian Subjects, Ethnobridging
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Theravance BiopharmaIndustry (pharma, biotech, devices)
- Study start
- 27 Nov 2018 (actual)
- Primary completion
- 13 Feb 2019 (actual)
- Study completion
- 13 Feb 2019 (actual)
- First posted
- 23 Nov 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A Phase 1, double blind, placebo controlled, 4 cohort, multiple dose study in healthy adult Japanese and Caucasian subjects.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 | Experimental | Drug: TD-1473 - Dose A, Drug: PlaceboJapanese 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. |
| Cohort 2 | Experimental | Drug: TD-1473 - Dose B, Drug: PlaceboJapanese 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. |
| Cohort 3 | Experimental | Drug: TD-1473 - Dose B, Drug: PlaceboCaucasian 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. |
| Cohort 4 | Experimental | Drug: TD-1473 - Dose C, Drug: PlaceboJapanese 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. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (16 listed)
- 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.
Key exclusion criteria (7 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TD-1473 - Dose Aoral capsule/tablet, QD | Drug | Cohort 1 |
| TD-1473 - Dose Boral capsule/tablet, QD | Drug | Cohort 2, Cohort 3 |
| TD-1473 - Dose Coral capsule/tablet, QD | Drug | Cohort 4 |
| Placebooral capsule/tablet, QD | Drug | Cohort 1, Cohort 2, Cohort 3, Cohort 4 |
Primary outcome
Area under the concentration-time curve (AUC0 t)
Time frame: Day 1 & Day 14
Area under the concentration-time curve (AUC0 24)
Time frame: Day 1 & Day 14
Area under the concentration-time curve (AUCtau)
Time frame: Day 1 & Day 14
Maximum observed concentration (Cmax)
Time frame: Day 1 & Day 14
Maximum observed concentration at steady state (Cmax_ss)
Time frame: Day 1 & Day 14
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jan 2021.
- Individual participant dataSharing planned: No. Theravance Biopharma, Inc. will not be sharing individual de-identified participant data or other relevant study documents.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Medical Monitor study director
Theravance Biopharma
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing TD-1473 - Dose A, TD-1473 - Dose B and TD-1473 - Dose C in people with Inflammatory Bowel Diseases and IBD, run by Theravance Biopharma at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 16 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Area under the concentration-time curve (AUC0 t) (time frame: Day 1 & Day 14). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jan 2021; AzTrials last refreshed its copy on 2 Nov 2026.