HealthyPhase 1NCT02657122
SAD and MAD Study to Evaluate Safety, Tolerability, and Pharmacokinetics (PK) of TD-1473 in Healthy Subjects
A Phase 1 study testing TD-1473 for SAD and TD-1473 for MAD in people with Healthy, run by Theravance Biopharma at 1 site in United States.
Trial summary
The purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics of single ascending doses and multiple ascending doses of the investigational drug TD-1473 compared to placebo in healthy subjects. Read more about this study
- Who is it for?
- Ages 19 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- TD-1473 for SAD and TD-1473 for MAD
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 72 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2015to Apr 2016
- 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
- Healthy male or female 19 to 55 years old
- Willing and able to give informed consent
- Body Mass Index (BMI) 18 to 30 kg/m2
- Women of child bearing potential must have a negative pregnancy test and either abstain from sex or use a highly effective method of birth control
- Additional inclusion criteria apply
Who cannot join
- Positive for hepatitis A, B, or C, HIV, or tuberculosis (TB)
- Clinically significant abnormalities in baseline results of laboratory evaluations
- Evidence or history of clinically significant allergic (except for untreated, asymptomatic, seasonal allergies at time of dosing), hematological, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, or neurological disease
- Participated in another clinical trial of an investigational drug (or medical device) within 30 days prior to Screening (or within 60 days prior to Screening if investigational drug was a biologic), or is currently participating in another trial of an investigational drug (or medical device)
- Use of prescription drugs or any chronic over the counter medications within 14 days prior to clinic admission or requires continuing use during study participation, with the exception of hormonal contraceptives or hormone replacement therapy.
- Additional exclusion criteria apply
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Double-blinded, Randomized, Placebo-controlled, Single Ascending Dose (SAD) and Multiple Ascending Dose (MAD) Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of TD-1473 in Healthy Subjects
The purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics of single ascending doses and multiple ascending doses of the investigational drug TD-1473 compared to placebo in healthy subjects.
- Conditions
- Healthy
- Being tested
- TD-1473 for SAD, Placebo for SAD, TD-1473 for MAD, Placebo for MAD
- Keywords
- Single ascending dose, SAD, multiple ascending dose, MAD, Phase 1, first-in-human, volunteers, TD-1473
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TD-1473 for SADDrug
SAD: Healthy subjects meeting eligibility criteria will be sequentially randomized to each dose cohort (up to 5 dose ascending cohorts) to receive either TD-1473 or placebo. The study drug (TD-1473 or placebo) will be administered orally as a single dose.
Placebo for SADDrug
SAD: Healthy subjects meeting eligibility criteria will be sequentially randomized to each dose cohort (up to 5 dose ascending cohorts) to receive either TD-1473 or placebo. The study drug (TD-1473 or placebo) will be administered orally as a single dose.
TD-1473 for MADDrug
MAD: Healthy subjects meeting eligibility criteria will be sequentially randomized to each dose cohort (up to 4 cohorts) to receive either TD-1473 or placebo. The study drug (TD-1473 or placebo) will be administered orally for a total of 14 days of dosing.
Placebo for MADDrug
MAD: Healthy subjects meeting eligibility criteria will be sequentially randomized to each dose cohort (up to 4 cohorts) to receive either TD-1473 or placebo. The study drug (TD-1473 or placebo) will be administered orally for a total of 14 days of dosing.
| Study group | Role | What they receive |
|---|---|---|
| TD-1473 for SAD | Experimental | 6 of out 8 subjects per cohort will be randomized to receive TD-1473 Receives: Drug: TD-1473 for SAD |
| Placebo for SAD | Placebo comparator | 2 of out 8 subjects per cohort will be randomized to receive placebo Receives: Drug: Placebo for SAD |
| TD-1473 for MAD | Experimental | 6 of out 8 subjects per cohort will be randomized to receive TD-1473 Receives: Drug: TD-1473 for MAD |
| Placebo for MAD | Placebo comparator | 2 of out 8 subjects per cohort will be randomized to receive placebo Receives: Drug: Placebo for MAD |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate the safety and tolerability of SAD and MAD of TD-1473 in healthy subjects by assessing the number, severity and type of adverse events, including changes in vital signs, physical examinations, laboratory safety tests and ECGs
Measured: Day 1 through Day 8 (SAD) or 21 (MAD)
Secondary outcomes (12)
Area under curve (AUC) in plasma, urine and feces
Measured: Day 1 through Day 4-6 (SAD)
Cmax in plasma, urine and feces
Measured: Day 1 through Day 4-6 (SAD)
Tmax in plasma, urine and feces
Measured: Day 1 through Day 4-6 (SAD)
Terminal elimination half-life (t1/2) in plasma, urine and feces
Measured: Day 1 through Day 4-6 (SAD)
Amount excreted in urine (Aeu)
Measured: Day 1 through Day 4-6 (SAD)
Amount excreted in feces (Aef)
Measured: Day 1 through Day 4-6 (SAD)
AUC in plasma, urine and feces
Measured: Day 1 through Day 17-19 (MAD)
Cmax in plasma, urine and feces
Measured: Day 1 through Day 17-19 (MAD)
Tmax in plasma, urine and feces
Measured: Day 1 through Day 17-19 (MAD)
t1/2 in plasma, urine and feces
Measured: Day 1 through Day 17-19 (MAD)
Aeu
Measured: Day 1 through Day 17-19 (MAD)
Aef
Measured: Day 1 through Day 17-19 (MAD)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jan 2016 (estimated)
- Study startDec 2015
- Primary completionApr 2016
- Study completionApr 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HealthyStudies 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 72 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
- NCT02657122
- Sponsor's protocol ID
- 0140
- Status last verified
- Jan 2021
- First submitted
- 25 Nov 2015
- Last updated
- 19 Jan 2021
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No: Theravance Biopharma, Inc. will not be sharing individual de-identified participant data or other relevant study documents.
Publications
Sandborn WJ, Nguyen DD, Beattie DT, Brassil P, Krey W, Woo J, Situ E, Sana R, Sandvik E, Pulido-Rios MT, Bhandari R, Leighton JA, Ganeshappa R, Boyle DL, Abhyankar B, Kleinschek MA, Graham RA, Panes J. Development of Gut-Selective Pan-Janus Kinase Inhibitor TD-1473 for Ulcerative Colitis: A Translational Medicine Programme. J Crohns Colitis. 2020 Sep 16;14(9):1202-1213. doi: 10.1093/ecco-jcc/jjaa049.
PubMed 32161949
Study at a glance
From the registry record, last updated by the sponsor on 19 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-blinded, Randomized, Placebo-controlled, Single Ascending Dose (SAD) and Multiple Ascending Dose (MAD) Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of TD-1473 in Healthy Subjects
- ClinicalTrials.gov ID
- NCT02657122
- Acronym / sponsor ID
- 0140
- Conditions
- Healthy
- Keywords
- Single ascending dose, SAD, multiple ascending dose, MAD, Phase 1, first-in-human, volunteers, TD-1473
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- Theravance BiopharmaIndustry (pharma, biotech, devices)
- Study start
- Dec 2015 (actual)
- Primary completion
- Apr 2016 (actual)
- Study completion
- Apr 2016 (actual)
- First posted
- 15 Jan 2016 (estimated)
- 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.
The purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics of single ascending doses and multiple ascending doses of the investigational drug TD-1473 compared to placebo in healthy subjects.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| TD-1473 for SAD | Experimental | Drug: TD-1473 for SAD6 of out 8 subjects per cohort will be randomized to receive TD-1473 |
| Placebo for SAD | Placebo comparator | Drug: Placebo for SAD2 of out 8 subjects per cohort will be randomized to receive placebo |
| TD-1473 for MAD | Experimental | Drug: TD-1473 for MAD6 of out 8 subjects per cohort will be randomized to receive TD-1473 |
| Placebo for MAD | Placebo comparator | Drug: Placebo for MAD2 of out 8 subjects per cohort will be randomized to receive placebo |
Who may qualify
- Ages
- 19 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Healthy male or female 19 to 55 years old
- Willing and able to give informed consent
- Body Mass Index (BMI) 18 to 30 kg/m2
- Women of child bearing potential must have a negative pregnancy test and either abstain from sex or use a highly effective method of birth control
- Additional inclusion criteria apply
Key exclusion criteria (6 listed)
- Positive for hepatitis A, B, or C, HIV, or tuberculosis (TB)
- Clinically significant abnormalities in baseline results of laboratory evaluations
- Evidence or history of clinically significant allergic (except for untreated, asymptomatic, seasonal allergies at time of dosing), hematological, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, or neurological disease
- Participated in another clinical trial of an investigational drug (or medical device) within 30 days prior to Screening (or within 60 days prior to Screening if investigational drug was a biologic), or is currently participating in another trial of an investigational drug (or medical device)
- Use of prescription drugs or any chronic over the counter medications within 14 days prior to clinic admission or requires continuing use during study participation, with the exception of hormonal contraceptives or hormone replacement therapy.
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 for SADSAD: Healthy subjects meeting eligibility criteria will be sequentially randomized to each dose cohort (up to 5 dose ascending cohorts) to receive either TD-1473 or placebo. The study drug (TD-1473 or placebo) will be administered orally as a single dose. | Drug | TD-1473 for SAD |
| Placebo for SADSAD: Healthy subjects meeting eligibility criteria will be sequentially randomized to each dose cohort (up to 5 dose ascending cohorts) to receive either TD-1473 or placebo. The study drug (TD-1473 or placebo) will be administered orally as a single dose. | Drug | Placebo for SAD |
| TD-1473 for MADMAD: Healthy subjects meeting eligibility criteria will be sequentially randomized to each dose cohort (up to 4 cohorts) to receive either TD-1473 or placebo. The study drug (TD-1473 or placebo) will be administered orally for a total of 14 days of dosing. | Drug | TD-1473 for MAD |
| Placebo for MADMAD: Healthy subjects meeting eligibility criteria will be sequentially randomized to each dose cohort (up to 4 cohorts) to receive either TD-1473 or placebo. The study drug (TD-1473 or placebo) will be administered orally for a total of 14 days of dosing. | Drug | Placebo for MAD |
Primary outcome
To evaluate the safety and tolerability of SAD and MAD of TD-1473 in healthy subjects by assessing the number, severity and type of adverse events, including changes in vital signs, physical examinations, laboratory safety tests and ECGs
Time frame: Day 1 through Day 8 (SAD) or 21 (MAD)
12 secondary outcomes
Area under curve (AUC) in plasma, urine and feces
Time frame: Day 1 through Day 4-6 (SAD)
Cmax in plasma, urine and feces
Time frame: Day 1 through Day 4-6 (SAD)
Tmax in plasma, urine and feces
Time frame: Day 1 through Day 4-6 (SAD)
Terminal elimination half-life (t1/2) in plasma, urine and feces
Time frame: Day 1 through Day 4-6 (SAD)
Amount excreted in urine (Aeu)
Time frame: Day 1 through Day 4-6 (SAD)
Amount excreted in feces (Aef)
Time frame: Day 1 through Day 4-6 (SAD)
AUC in plasma, urine and feces
Time frame: Day 1 through Day 17-19 (MAD)
Cmax in plasma, urine and feces
Time frame: Day 1 through Day 17-19 (MAD)
Tmax in plasma, urine and feces
Time frame: Day 1 through Day 17-19 (MAD)
t1/2 in plasma, urine and feces
Time frame: Day 1 through Day 17-19 (MAD)
Aeu
Time frame: Day 1 through Day 17-19 (MAD)
Aef
Time frame: Day 1 through Day 17-19 (MAD)
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 19 Jan 2021.
- Derived from this study: PubMed 32161949Sandborn WJ, Nguyen DD, Beattie DT, Brassil P, Krey W, Woo J, Situ E, Sana R, Sandvik E, Pulido-Rios MT, Bhandari R, Leighton JA, Ganeshappa R, Boyle DL, Abhyankar B, Kleinschek MA, Graham RA, Panes J. Development of Gut-Selective Pan-Janus Kinase Inhibitor TD-1473 for Ulcerative Colitis: A Translational Medicine Programme. J Crohns Colitis. 2020 Sep 16;14(9):1202-1213. doi: 10.1093/ecco-jcc/jjaa049.
- 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 for SAD and TD-1473 for MAD in people with Healthy, 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 5 inclusion and 6 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 19 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. Some participants in this study may receive a placebo. 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?
To evaluate the safety and tolerability of SAD and MAD of TD-1473 in healthy subjects by assessing the number, severity and type of adverse events, including changes in vital signs, physical examinations, laboratory safety tests and ECGs (time frame: Day 1 through Day 8 (SAD) or 21 (MAD)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02657122, which also lists 1 linked publication.
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 19 Jan 2021.