Intestinal DisorderPhase 1NCT04587713
Single Dose Bioavailability and Ethnobridging PK Study in Healthy Subjects
A Phase 1 study testing TD-1473 [Tablet A] and TD-1473 [Tablet B] in people with Intestinal Disorder and Bowel Diseases, Inflammatory, run by Theravance Biopharma at 2 sites in United States.
Trial summary
This is a Phase 1, 2-part, open-label study. Part A will be a formulation bridging and food effect study in healthy adult subjects. Part B will be an assessment of pharmacokinetics (PK) in healthy adult Chinese subjects. Read more about this study
- Who is it for?
- Ages 19 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Intestinal Disorder, Bowel Diseases, Inflammatory
- What is being tested?
- TD-1473 [Tablet A] and TD-1473 [Tablet B]
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 58 participants
- Where
- 2 sitesUnited States
- Study dates
- 16 Oct 2020to 27 Dec 2020
- 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 19 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Subject is a non-smoking male or female adult
- Subject (females) must be of non-childbearing potential or if of childbearing potential, subject must not be pregnant or breastfeeding, and must agree to use highly effective birth control and must not donate ova through 30 days after last dose of study drug.
- Subject (males) must agree to use contraception to prevent pregnancy/partner exposure and must not donate sperm through 30 days after last dose of study drug.
- Subject has a body mass index (BMI) 19 to 30 kg/m^2, inclusive and weighs at least 50 kg
- Subject is healthy as determined by the Principal Investigator or designee based on medical history and physical examinations performed at Screening and Day -1 of Period 1
- Subject must be willing and able to comply with the study diet, willing to abstain from strenuous physical activity which could cause muscle aches or injury, including contact sports for a period of 48 hours prior to study and through follow-up visit.
- Subject must be willing and able to give and understand written informed consent, communicate well with the PI, and comply with the study procedures, requirements and restrictions
- Part B: subject was born in China, with 2 Chinese biological parents and 4 Chinese grandparents as confirmed by interview, has lived no longer than 10 years outside of China, and has had no significant change in lifestyle, including diet, since leaving China
Who cannot join
- Subject is planning to conceive a child during the study or within 1 month after the last dose of TD 1473
- Subject has evidence or history of clinically significant allergic disease, hematological, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, or neurological disease
- Subject has history of venous thrombosis
- Subject has any clinically significant abnormalities in the results of laboratory evaluations, or liver function tests exceeding the upper limit of normal in the screening or pre-dose period
- Subject has creatinine clearance as calculated by Cockcroft-Gault formula <90mL/min at screening or pre-dose period.
- Subject has any medical condition possibly affecting drug absorption
Show all 30Show fewer
- Subject has history of lymphoma, leukemia, or other types of malignancy
- Subject previously participated in a study for TD 1473 and/or subject has previously taken tofacitinib or other JAK inhibitors.
- Subject participated in another clinical trial of an investigational drug (or medical device) within 30 days
- Subject is unwilling to abstain from ingestion of caffeine or xanthine-containing products
- Subject is unwilling to abstain from alcohol beginning 24 hours prior to study start
- Subject has history of alcoholism or drug abuse
- Female subject who is pregnant and/or lactating
- Subject has positive results at Screening for human immunodeficiency virus (HIV), hepatitis A virus (HAV) antibodies, hepatitis B virus antigen (HBsAg), hepatitis B core antibodies (HBcAb), or hepatitis C virus (HCV) antibody
- Subject has confirmed or suspected severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection (COVID-19)
- Subject consumed grapefruit/Seville orange and/or grapefruit juice within 14 days prior to study
- Subject consumed cruciferous vegetables (e.g., kale, broccoli, watercress, collard greens, kohlrabi, Brussels sprouts, mustard greens) or charbroiled meats beginning 7 days prior to study start and is unwilling to abstain from consuming such vegetables during the study
- Subject uses or has used nicotine-containing products within 6 months prior to study start
- Subject has acute illness (GI illness, infection (e.g., influenza) or know inflammatory process) at screening or pre-dose period.
- Subject has poor venous access that limits phlebotomy
- Subject donated blood or had significant blood loss within 56 days prior to study start
- Subject donated plasma within 7 days prior to study start
- Subject has abnormal screening ECG based on certain parameters or designated by the PI or designee to be clinically significant.
- Subject has personal or known family history of congenital long QT syndrome or known family history of sudden death
- Subject has history of hypersensitivity to drugs with a clinically significant reaction or any clinically significant hypersensitivities
- Subject has known hypersensitivity to contents of the study drug including excipients, or drugs from a similar chemical class as TD-1473
- Subject has history of severe allergic reaction or severe hypersensitivity or idiosyncratic reaction to any food, medication, insect or bee sting, or previous status asthmaticus (e.g., acute severe asthma attacks)
- Subject has history of latent or active tuberculosis
- Subject received a live viral vaccine within 8 weeks of study start
- Subject, who, for any reason, is deemed by the Principal Investigator, designee, or Sponsor to be inappropriate for this study or have any condition which would confound or interfere with the evaluation of the safety, tolerability, and PK of the investigational drug or prevent compliance with the study protocol
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Theravance Biopharma Investigational Site
Cypress, California, 90630
Theravance Biopharma Investigational Site
Lincoln, Nebraska, 68502
About this study
Official title: A Phase 1, Two-Part, Open-Label Study to Assess the Relative Bioavailability of Two TD-1473 Tablet Formulations Under Fasted and Fed Conditions in Healthy Subjects and the Pharmacokinetics of TD-1473 in Healthy Chinese Subjects
This is a Phase 1, 2-part, open-label study. Part A will be a formulation bridging and food effect study in healthy adult subjects. Part B will be an assessment of pharmacokinetics (PK) in healthy adult Chinese subjects.
Read the detailed description
In study Part A, healthy adult subjects will receive the following treatments in a cross-over design with a ≥10-day washout period between doses:
- Treatment A: Single dose of [Tablet A] TD-1473 proposed commercial tablet formulation on Day 1 in a fasted state;
- Treatment B: Single dose of [Tablet A] TD-1473 proposed commercial tablet formulation on Day 1 in a fed state;
- Treatment C: Single dose of [Tablet B] TD-1473 current clinical tablet formulation on Day 1 in a fasted state;
- Treatment D: Single dose of [Tablet B] TD-1473 current clinical tablet formulation on Day 1 in a fed state.
In study Part B, healthy adult Chinese subjects will receive Treatment A: Single dose of [Tablet A] TD-1473 proposed commercial tablet formulation on Day 1 in a fasted state.
- Conditions
- Intestinal Disorder, Bowel Diseases, Inflammatory
- Being tested
- TD-1473 [Tablet A], TD-1473 [Tablet B]
- Keywords
- Healthy Caucasian Subjects, Healthy Chinese Subjects, Ethnobridging
- Medical subject headings
- Intestinal Diseases, Inflammatory Bowel Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TD-1473 [Tablet A]Drug
TD-1473 [Tablet A] (1 Tablet = Dose A) proposed commercial tablet formulation
TD-1473 [Tablet B]Drug
TD-1473 [Tablet B] (2 Tablets = Dose A) current clinical tablet formulation
| Study group | Role | What they receive |
|---|---|---|
| Part A, Sequence 1 | Experimental | Part A, Sequence 1 = Treatment (Tx) C, Tx A, Tx C, Tx A
Single oral dose of treatment on Day 1 of each period in a 4-way crossover design with a ≥10-day washout between treatments Receives: Drug: TD-1473 [Tablet A]; Drug: TD-1473 [Tablet B] |
| Part A, Sequence 2 | Experimental | Part A, Sequence 2: Tx D, Tx B, Tx D, Tx B
Single oral dose of treatment on Day 1 of each period in a 4-way crossover design with a ≥10-day washout period between treatments Receives: Drug: TD-1473 [Tablet A]; Drug: TD-1473 [Tablet B] |
| Part A, Sequence 3 | Experimental | Part A, Sequence 3: Tx C, Tx A, Tx D, Tx B
Single oral dose of treatment on Day 1 of each period in a 4-way crossover design with a ≥10-day washout period between treatments Receives: Drug: TD-1473 [Tablet A]; Drug: TD-1473 [Tablet B] |
| Part A, Sequence 4 | Experimental | Part A, Sequence 4: Tx D, Tx B, Tx C, Tx A
Single oral dose of treatment on Day 1 of each period in a 4-way crossover design with a ≥10-day washout period between treatments Receives: Drug: TD-1473 [Tablet A]; Drug: TD-1473 [Tablet B] |
| Part A, Sequence 5 | Experimental | Part A, Sequence 5: Tx A, Tx C, Tx A, Tx C
Single oral dose of treatment on Day 1 of each period in a 4-way crossover design with a ≥10-day washout period between treatments Receives: Drug: TD-1473 [Tablet A]; Drug: TD-1473 [Tablet B] |
| Part A, Sequence 6 | Experimental | Part A, Sequence 6: Tx B, Tx D, Tx B, Tx D
Single oral dose of treatment on Day 1 of each period in a 4-way crossover design with a ≥10-day washout period between treatments Receives: Drug: TD-1473 [Tablet A]; Drug: TD-1473 [Tablet B] |
| Part A, Sequence 7 | Experimental | Part A, Sequence 7: Tx A, Tx C, Tx B, Tx D
Single oral dose of treatment on Day 1 of each period in a 4-way crossover design with a ≥10-day washout period between treatments Receives: Drug: TD-1473 [Tablet A]; Drug: TD-1473 [Tablet B] |
| Part A, Sequence 8 | Experimental | Part A, Sequence 8: Tx B, Tx D, Tx A, Tx C
Single oral dose of treatment on Day 1 of each period in a 4-way crossover design with a ≥10-day washout period between treatments Receives: Drug: TD-1473 [Tablet A]; Drug: TD-1473 [Tablet B] |
| Part B,Treatment A | Experimental | Single oral dose of Treatment A on Day 1 Receives: Drug: TD-1473 [Tablet A] |
What is being measured
The primary outcome is the main question the study is designed to answer.
AUC0-t
Area under the concentration-time curve, from time 0 to the last observed non-zero concentration (AUC0-t) of TD-1473 in Plasma
Measured: Predose and at prespecified time points up to 5 days after dosing on Day 1 of each period
AUC0-inf
Area under the concentration-time curve, from time 0 extrapolated to infinity (AUC0-inf) of TD-1473 in Plasma
Measured: Predose and at prespecified time points up to 5 days after dosing on Day 1 of each period
Cmax
Maximum observed concentration (Cmax) of TD-1473 in Plasma
Measured: Predose and at prespecified time points up to 5 days after dosing on Day 1 of each period
Secondary outcomes (1)
Adverse events
Number and severity of treatment emergent adverse events.
Measured: Day 1 through Day 7 of each period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Oct 2020
- Study start16 Oct 2020
- Primary completion24 Dec 2020
- Study completion27 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intestinal DisorderStudies 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
- Crossover
- Masking
- None (open label)
- Enrolment
- 58 participants (actual)
Sponsor and investigators
- Lead sponsor
- Theravance Biopharma
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Study Director, Study director, Theravance Biopharma
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04587713
- Sponsor's protocol ID
- 0184
- Status last verified
- Apr 2021
- First submitted
- 7 Oct 2020
- Last updated
- 9 Apr 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 9 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Two-Part, Open-Label Study to Assess the Relative Bioavailability of Two TD-1473 Tablet Formulations Under Fasted and Fed Conditions in Healthy Subjects and the Pharmacokinetics of TD-1473 in Healthy Chinese Subjects
- ClinicalTrials.gov ID
- NCT04587713
- Acronym / sponsor ID
- 0184
- Conditions
- Intestinal Disorder, Bowel Diseases, Inflammatory
- Keywords
- Healthy Caucasian Subjects, Healthy Chinese Subjects, Ethnobridging
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 58 participants (actual)
- Lead sponsor
- Theravance BiopharmaIndustry (pharma, biotech, devices)
- Study start
- 16 Oct 2020 (actual)
- Primary completion
- 24 Dec 2020 (actual)
- Study completion
- 27 Dec 2020 (actual)
- First posted
- 14 Oct 2020 (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.
This is a Phase 1, 2-part, open-label study. Part A will be a formulation bridging and food effect study in healthy adult subjects. Part B will be an assessment of pharmacokinetics (PK) in healthy adult Chinese subjects.
Detailed description
In study Part A, healthy adult subjects will receive the following treatments in a cross-over design with a ≥10-day washout period between doses:
- Treatment A: Single dose of [Tablet A] TD-1473 proposed commercial tablet formulation on Day 1 in a fasted state;
- Treatment B: Single dose of [Tablet A] TD-1473 proposed commercial tablet formulation on Day 1 in a fed state;
- Treatment C: Single dose of [Tablet B] TD-1473 current clinical tablet formulation on Day 1 in a fasted state;
- Treatment D: Single dose of [Tablet B] TD-1473 current clinical tablet formulation on Day 1 in a fed state.
In study Part B, healthy adult Chinese subjects will receive Treatment A: Single dose of [Tablet A] TD-1473 proposed commercial tablet formulation on Day 1 in a fasted state.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 9
| Arm | Type | Receives |
|---|---|---|
| Part A, Sequence 1 | Experimental | Drug: TD-1473 [Tablet A], Drug: TD-1473 [Tablet B]Part A, Sequence 1 = Treatment (Tx) C, Tx A, Tx C, Tx A Single oral dose of treatment on Day 1 of each period in a 4-way crossover design with a ≥10-day washout between treatments |
| Part A, Sequence 2 | Experimental | Drug: TD-1473 [Tablet A], Drug: TD-1473 [Tablet B]Part A, Sequence 2: Tx D, Tx B, Tx D, Tx B Single oral dose of treatment on Day 1 of each period in a 4-way crossover design with a ≥10-day washout period between treatments |
| Part A, Sequence 3 | Experimental | Drug: TD-1473 [Tablet A], Drug: TD-1473 [Tablet B]Part A, Sequence 3: Tx C, Tx A, Tx D, Tx B Single oral dose of treatment on Day 1 of each period in a 4-way crossover design with a ≥10-day washout period between treatments |
| Part A, Sequence 4 | Experimental | Drug: TD-1473 [Tablet A], Drug: TD-1473 [Tablet B]Part A, Sequence 4: Tx D, Tx B, Tx C, Tx A Single oral dose of treatment on Day 1 of each period in a 4-way crossover design with a ≥10-day washout period between treatments |
| Part A, Sequence 5 | Experimental | Drug: TD-1473 [Tablet A], Drug: TD-1473 [Tablet B]Part A, Sequence 5: Tx A, Tx C, Tx A, Tx C Single oral dose of treatment on Day 1 of each period in a 4-way crossover design with a ≥10-day washout period between treatments |
| Part A, Sequence 6 | Experimental | Drug: TD-1473 [Tablet A], Drug: TD-1473 [Tablet B]Part A, Sequence 6: Tx B, Tx D, Tx B, Tx D Single oral dose of treatment on Day 1 of each period in a 4-way crossover design with a ≥10-day washout period between treatments |
| Part A, Sequence 7 | Experimental | Drug: TD-1473 [Tablet A], Drug: TD-1473 [Tablet B]Part A, Sequence 7: Tx A, Tx C, Tx B, Tx D Single oral dose of treatment on Day 1 of each period in a 4-way crossover design with a ≥10-day washout period between treatments |
| Part A, Sequence 8 | Experimental | Drug: TD-1473 [Tablet A], Drug: TD-1473 [Tablet B]Part A, Sequence 8: Tx B, Tx D, Tx A, Tx C Single oral dose of treatment on Day 1 of each period in a 4-way crossover design with a ≥10-day washout period between treatments |
| Part B,Treatment A | Experimental | Drug: TD-1473 [Tablet A]Single oral dose of Treatment A on Day 1 |
Who may qualify
- Ages
- 19 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Subject is a non-smoking male or female adult
- Subject (females) must be of non-childbearing potential or if of childbearing potential, subject must not be pregnant or breastfeeding, and must agree to use highly effective birth control and must not donate ova through 30 days after last dose of study drug.
- Subject (males) must agree to use contraception to prevent pregnancy/partner exposure and must not donate sperm through 30 days after last dose of study drug.
- Subject has a body mass index (BMI) 19 to 30 kg/m^2, inclusive and weighs at least 50 kg
- Subject is healthy as determined by the Principal Investigator or designee based on medical history and physical examinations performed at Screening and Day -1 of Period 1
Key exclusion criteria (30 listed)
- Subject is planning to conceive a child during the study or within 1 month after the last dose of TD 1473
- Subject has evidence or history of clinically significant allergic disease, hematological, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, or neurological disease
- Subject has history of venous thrombosis
- Subject has any clinically significant abnormalities in the results of laboratory evaluations, or liver function tests exceeding the upper limit of normal in the screening or pre-dose period
- Subject has creatinine clearance as calculated by Cockcroft-Gault formula <90mL/min at screening or pre-dose period.
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 [Tablet A]TD-1473 [Tablet A] (1 Tablet = Dose A) proposed commercial tablet formulation | Drug | Part A, Sequence 1, Part A, Sequence 2, Part A, Sequence 3, Part A, Sequence 4, Part A, Sequence 5, Part A, Sequence 6, Part A, Sequence 7, Part A, Sequence 8, Part B,Treatment A |
| TD-1473 [Tablet B]TD-1473 [Tablet B] (2 Tablets = Dose A) current clinical tablet formulation | Drug | Part A, Sequence 1, Part A, Sequence 2, Part A, Sequence 3, Part A, Sequence 4, Part A, Sequence 5, Part A, Sequence 6, Part A, Sequence 7, Part A, Sequence 8 |
Primary outcome
AUC0-t
Time frame: Predose and at prespecified time points up to 5 days after dosing on Day 1 of each period
Area under the concentration-time curve, from time 0 to the last observed non-zero concentration (AUC0-t) of TD-1473 in Plasma
AUC0-inf
Time frame: Predose and at prespecified time points up to 5 days after dosing on Day 1 of each period
Area under the concentration-time curve, from time 0 extrapolated to infinity (AUC0-inf) of TD-1473 in Plasma
Cmax
Time frame: Predose and at prespecified time points up to 5 days after dosing on Day 1 of each period
Maximum observed concentration (Cmax) of TD-1473 in Plasma
1 secondary outcome
Adverse events
Time frame: Day 1 through Day 7 of each period
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 9 Apr 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.
Study Director study director
Theravance Biopharma
2 sites 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 [Tablet A] and TD-1473 [Tablet B] in people with Intestinal Disorder and Bowel Diseases, Inflammatory, run by Theravance Biopharma at 2 sites 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 8 inclusion and 30 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 9 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
AUC0-t (time frame: Predose and at prespecified time points up to 5 days after dosing on Day 1 of each period). The study lists 3 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 9 Apr 2021.