Active Mild Ulcerative Colitis, Active Moderate Ulcerative Colitis, Healthy SubjectsPhase 1NCT03103412
TD-3504 SAD in Healthy Subjects and Subjects With Ulcerative Colitis (UC)
A Phase 1 study testing TD-3504 and 15N2-tofacitinib in people with Active Mild Ulcerative Colitis, Active Moderate Ulcerative Colitis, Healthy Subjects, run by Theravance Biopharma at 1 site in United States.
Trial summary
This study is designed to evaluate the safety, tolerability, and pharmacokinetics (PK) of single-dose TD-3504 and single dose 15N2-tofacitinib in healthy subjects and subjects with UC. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Active Mild Ulcerative Colitis, Active Moderate Ulcerative Colitis, Healthy Subjects
- What is being tested?
- TD-3504 and 15N2-tofacitinib
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 32 participants
- Where
- 1 siteUnited States
- Study dates
- 4 May 2017to 8 Nov 2017
- 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
- Male or female between 18 to 55 years old
- Male subjects must abstain from sexual intercourse or use a highly effective method of birth control
- 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
- Body Mass Index (BMI) 18 to 32 kg/m2
- Willing and able to give informed consent
- Additional inclusion criteria apply
Show all 9Show fewer
- Subject has a history of UC
- Subject is either not taking any medication for UC or has been taking a stable dose of ulcerative colitis medications for ≥ 14 days
- Additional inclusion criteria apply
Who cannot join
- Is positive for hepatitis A, B or C, HIV or tuberculosis
- 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 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)
- Additional exclusion criteria apply
- 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 or standard daily multivitamin.
- Additional exclusion criteria apply
Trial locations and contacts
1 site in 1 country.
United States1 site
Anaheim Clinical Trials, LLC
Anaheim, California, 92801
About this study
Official title: Study 0146: A Phase 1a, Double-Blinded, Randomized, Placebo Controlled, Single Ascending Dose (SAD) Study to Evaluate the Safety, Tolerability, and Systemic Exposure of TD-3504 in Healthy Subjects and Subjects With Ulcerative Colitis (UC)
This study is designed to evaluate the safety, tolerability, and pharmacokinetics (PK) of single-dose TD-3504 and single dose 15N2-tofacitinib in healthy subjects and subjects with UC. The relative bioavailability of tofacitinib released from TD-3504 compared to co-administered oral heavy-labeled tofacitinib (15N2-tofacitinib) will also be evaluated.
- Being tested
- TD-3504, 15N2-tofacitinib, Placebo
- Keywords
- Active Mild Ulcerative Colitis, Active Moderate Ulcerative Colitis, Healthy Subjects
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TD-3504Drug
TD-3504
15N2-tofacitinibDrug
15N2-tofacitinib
PlaceboDrug
Placebo
| Study group | Role | What they receive |
|---|---|---|
| TD-3504 Low-Dose | Experimental | 6 healthy subjects and 6 ulcerative colitis subjects will be randomized to receive low-dose TD-3504 and low-dose of 15N2-tofacitinib orally single dose. Receives: Drug: TD-3504; Drug: 15N2-tofacitinib |
| TD-3504 Mid-Dose | Experimental | 6 healthy subjects will be randomized to receive mid-dose TD-3504 and low-dose of 15N2-tofacitinib orally single dose. Receives: Drug: TD-3504; Drug: 15N2-tofacitinib |
| TD-3504 High-Dose | Experimental | 6 healthy subjects will be randomized to receive high-dose TD-3504 and low-dose of 15N2-tofacitinib orally single dose. Receives: Drug: TD-3504; Drug: 15N2-tofacitinib |
| Placebo | Placebo comparator | 6 healthy subjects and 2 ulcerative colitis subjects to receive placebo orally single dose. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety & tolerability of TD-3504 by assessing the number, severity, and type of adverse events
To assess the safety \& tolerability of TD-3504 following single escalating doses of TD-3504 co-administered with a low dose of 15N2 tofacitinib for 8 days in healthy subjects and subjects with UC by assessing the number, severity, and type of treatment related adverse events.
Measured: Day 1 through Day 8
Secondary outcomes (9)
Safety & tolerability of TD-3504 by assessing treatment related changes safety laboratory values
To assess the safety \& tolerability of TD-3504 following single escalating doses of TD-3504 co-administered with a low dose of 15N2 tofacitinib for 8 days in healthy subjects and subjects with UC by assessing treatment related changes safety laboratory values.
Measured: Day 1 through Day 8
Systemic area under the curve of TD-3504
To assess the systemic exposure of TD-3504 following single escalating doses of TD-3504 and co-administered 15N2-tofacitinib.
Measured: Day 1 through Day 4
Systemic Cmax of TD-3504
To assess the systemic exposure of TD-3504 following single escalating doses of TD-3504 and co-administered 15N2-tofacitinib.
Measured: Day 1
Systemic area under the curve of tofacitinib
To assess the systemic exposure of tofacitinib following single escalating doses of TD-3504 and co-administered 15N2-tofacitinib.
Measured: Day 1 through Day 4
Systemic Cmax of tofacitinib
To assess the systemic exposure of tofacitinib following single escalating doses of TD-3504 and co-administered 15N2-tofacitinib.
Measured: Day 1
Systemic area under the curve of 15N2-tofacitinib
To assess the systemic exposure of following single escalating doses of TD-3504 and co-administered 15N2-tofacitinib.
Measured: Day 1 through Day 4
Systemic Cmax of 15N2-tofacitinib
To assess the systemic exposure of following single escalating doses of TD-3504 and co-administered 15N2-tofacitinib.
Measured: Day 1
Tofacitinib relative bioavailability by area under the curve comparison
To assess the relative bioavailability of tofacitinib from TD-3504 relative to 15N2-tofacitinib.
Measured: Day 1 through Day 4
Tofacitinib relative bioavailability by Cmax comparison
To assess the relative bioavailability of tofacitinib from TD-3504 relative to 15N2-tofacitinib.
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2017
- Study start4 May 2017
- Primary completion8 Nov 2017
- Study completion8 Nov 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Active Mild Ulcerative Colitis, Active Moderate Ulcerative Colitis, Healthy SubjectsStudies 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
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 32 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
- NCT03103412
- Sponsor's protocol ID
- 0146
- Status last verified
- Jan 2021
- First submitted
- 24 Mar 2017
- 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
- Study 0146: A Phase 1a, Double-Blinded, Randomized, Placebo Controlled, Single Ascending Dose (SAD) Study to Evaluate the Safety, Tolerability, and Systemic Exposure of TD-3504 in Healthy Subjects and Subjects With Ulcerative Colitis (UC)
- ClinicalTrials.gov ID
- NCT03103412
- Acronym / sponsor ID
- 0146
- Keywords
- Active Mild Ulcerative Colitis, Active Moderate Ulcerative Colitis, Healthy Subjects
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Theravance BiopharmaIndustry (pharma, biotech, devices)
- Study start
- 4 May 2017 (actual)
- Primary completion
- 8 Nov 2017 (actual)
- Study completion
- 8 Nov 2017 (actual)
- First posted
- 6 Apr 2017 (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 study is designed to evaluate the safety, tolerability, and pharmacokinetics (PK) of single-dose TD-3504 and single dose 15N2-tofacitinib in healthy subjects and subjects with UC. The relative bioavailability of tofacitinib released from TD-3504 compared to co-administered oral heavy-labeled tofacitinib (15N2-tofacitinib) will also be evaluated.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| TD-3504 Low-Dose | Experimental | Drug: TD-3504, Drug: 15N2-tofacitinib6 healthy subjects and 6 ulcerative colitis subjects will be randomized to receive low-dose TD-3504 and low-dose of 15N2-tofacitinib orally single dose. |
| TD-3504 Mid-Dose | Experimental | Drug: TD-3504, Drug: 15N2-tofacitinib6 healthy subjects will be randomized to receive mid-dose TD-3504 and low-dose of 15N2-tofacitinib orally single dose. |
| TD-3504 High-Dose | Experimental | Drug: TD-3504, Drug: 15N2-tofacitinib6 healthy subjects will be randomized to receive high-dose TD-3504 and low-dose of 15N2-tofacitinib orally single dose. |
| Placebo | Placebo comparator | Drug: Placebo6 healthy subjects and 2 ulcerative colitis subjects to receive placebo orally single dose. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- Male or female between 18 to 55 years old
- Male subjects must abstain from sexual intercourse or use a highly effective method of birth control
- 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
- Body Mass Index (BMI) 18 to 32 kg/m2
- Willing and able to give informed consent
Key exclusion criteria (7 listed)
- Is positive for hepatitis A, B or C, HIV or tuberculosis
- 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 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)
- Additional exclusion criteria apply
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-3504TD-3504 | Drug | TD-3504 High-Dose, TD-3504 Low-Dose, TD-3504 Mid-Dose |
| 15N2-tofacitinib15N2-tofacitinib | Drug | TD-3504 High-Dose, TD-3504 Low-Dose, TD-3504 Mid-Dose |
| PlaceboPlacebo | Drug | Placebo |
Primary outcome
Safety & tolerability of TD-3504 by assessing the number, severity, and type of adverse events
Time frame: Day 1 through Day 8
To assess the safety \& tolerability of TD-3504 following single escalating doses of TD-3504 co-administered with a low dose of 15N2 tofacitinib for 8 days in healthy subjects and subjects with UC by assessing the number, severity, and type of treatment related adverse events.
9 secondary outcomes
Safety & tolerability of TD-3504 by assessing treatment related changes safety laboratory values
Time frame: Day 1 through Day 8
Systemic area under the curve of TD-3504
Time frame: Day 1 through Day 4
Systemic Cmax of TD-3504
Time frame: Day 1
Systemic area under the curve of tofacitinib
Time frame: Day 1 through Day 4
Systemic Cmax of tofacitinib
Time frame: Day 1
Systemic area under the curve of 15N2-tofacitinib
Time frame: Day 1 through Day 4
Systemic Cmax of 15N2-tofacitinib
Time frame: Day 1
Tofacitinib relative bioavailability by area under the curve comparison
Time frame: Day 1 through Day 4
Tofacitinib relative bioavailability by Cmax comparison
Time frame: Day 1
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.
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-3504 and 15N2-tofacitinib in people with Active Mild Ulcerative Colitis, Active Moderate Ulcerative Colitis, Healthy Subjects, 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 9 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. 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?
Safety & tolerability of TD-3504 by assessing the number, severity, and type of adverse events (time frame: Day 1 through Day 8). 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.