Inflammatory Bowel DiseasePhase 1NCT03555617
Food-effect, Drug-Drug Interaction (DDI), and Formulation Bridging Study
A Phase 1 study testing TD-1473 and Itraconazole in people with Inflammatory Bowel Disease, run by Theravance Biopharma at 1 site in United States.
Trial summary
This is a Phase 1, open-label, 2-cohort, food-effect, DDI, and formulation bridging study. Read more about this study
- Who is it for?
- Ages 19 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Inflammatory Bowel Disease
- What is being tested?
- TD-1473 and Itraconazole
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Jun 2018to 15 Jul 2018
- 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
- 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
Who cannot join
- Planning to conceive a child during the study or within 2 months 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.
About this study
Official title: A Phase 1, Open-Label, 2-Cohort Study to Assess the Single Dose Pharmacokinetics of Two Formulations of TD-1473 and to Assess the Effect of a High-Fat Meal and Itraconazole on the Pharmacokinetics of TD-1473 in Healthy Subjects
This is a Phase 1, open-label, 2-cohort, food-effect, DDI, and formulation bridging study.
- Conditions
- Inflammatory Bowel Disease
- Being tested
- TD-1473, Itraconazole
- Keywords
- healthy volunteers, drug-drug interaction, itraconazole, CYP3A, P-gp, Inflammatory Bowel Disease, IBD, Irritable Bowel Syndrome, IBS
- Medical subject headings
- Inflammatory Bowel Diseases, Irritable Bowel Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TD-1473Drug
oral capsule/tablet, QD
ItraconazoleDrug
oral solution, QD
| Study group | Role | What they receive |
|---|---|---|
| TD-1473 formulation bridging & food effect | Experimental | Subjects will receive, on Day 1 of each period, a single 100 mg oral dose of the tablet formulation of TD-1473 in the fed or fasted state, or the PIC formulation of TD-1473 in the fasted state, as part of a 3-period, crossover design. Receives: Drug: TD-1473 |
| TD-1473 with Itraconazole | Experimental | Subjects will receive a single 100 mg oral dose of the tablet formulation of TD-1473 in the fasted state on Day 1 of Period 1. In Period 2, subjects will receive, in the fasted state, single oral doses of 200 mg itraconazole solution on Days -4 through 7 for a total of 11 days, with a single 100 mg oral dose of the tablet formulation of TD-1473 co-administered on Day 1. Receives: Drug: TD-1473; Drug: Itraconazole |
| TD-1473 without Itraconazole | Experimental | Subjects will receive a single 100 mg oral dose of the tablet formulation of TD-1473 in the fasted state on Day 1 of Period 1. Receives: Drug: TD-1473 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum observed concentration (Cmax) in Plasma
Measured: Up to 8 days post-dose
Time to maximum observed concentration (tmax) in Plasma
Measured: Up to 8 days post-dose
Area under the concentration-time curve from hour 0 to the last measurable concentration (AUC0-last) in Plasma
Measured: Up to 8 days post-dose
Area under the concentration-time curve extrapolated to infinity (AUC0-inf) in Plasma
Measured: Up to 8 days post-dose
Apparent terminal elimination half-life (t1/2) in Plasma
Measured: Up to 8 days post-dose
Apparent clearance (Cl/F) in Plasma
Measured: Up to 8 days post-dose
Apparent volume of distribution (Vz/F) in Plasma
Measured: Up to 8 days post-dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jun 2018
- Study start13 Jun 2018
- Primary completion15 Jul 2018
- Study completion15 Jul 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Inflammatory Bowel DiseaseStudies 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
- Crossover
- Masking
- None (open label)
- Enrolment
- 36 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
- NCT03555617
- Sponsor's protocol ID
- 0174
- Status last verified
- Jan 2021
- First submitted
- 1 Jun 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 Phase 1, Open-Label, 2-Cohort Study to Assess the Single Dose Pharmacokinetics of Two Formulations of TD-1473 and to Assess the Effect of a High-Fat Meal and Itraconazole on the Pharmacokinetics of TD-1473 in Healthy Subjects
- ClinicalTrials.gov ID
- NCT03555617
- Acronym / sponsor ID
- 0174
- Conditions
- Inflammatory Bowel Disease
- Keywords
- healthy volunteers, drug-drug interaction, itraconazole, CYP3A, P-gp, Inflammatory Bowel Disease, IBD, Irritable Bowel Syndrome
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Theravance BiopharmaIndustry (pharma, biotech, devices)
- Study start
- 13 Jun 2018 (actual)
- Primary completion
- 15 Jul 2018 (actual)
- Study completion
- 15 Jul 2018 (actual)
- First posted
- 13 Jun 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.
This is a Phase 1, open-label, 2-cohort, food-effect, DDI, and formulation bridging study.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| TD-1473 formulation bridging & food effect | Experimental | Drug: TD-1473Subjects will receive, on Day 1 of each period, a single 100 mg oral dose of the tablet formulation of TD-1473 in the fed or fasted state, or the PIC formulation of TD-1473 in the fasted state, as part of a 3-period, crossover design. |
| TD-1473 with Itraconazole | Experimental | Drug: TD-1473, Drug: ItraconazoleSubjects will receive a single 100 mg oral dose of the tablet formulation of TD-1473 in the fasted state on Day 1 of Period 1. In Period 2, subjects will receive, in the fasted state, single oral doses of 200 mg itraconazole solution on Days -4 through 7 for a total of 11 days, with a single 100 mg oral dose of the tablet formulation of TD-1473 co-administered on Day 1. |
| TD-1473 without Itraconazole | Experimental | Drug: TD-1473Subjects will receive a single 100 mg oral dose of the tablet formulation of TD-1473 in the fasted state on Day 1 of Period 1. |
Who may qualify
- Ages
- 19 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 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 (6 listed)
- Planning to conceive a child during the study or within 2 months 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)
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-1473oral capsule/tablet, QD | Drug | TD-1473 formulation bridging & food effect, TD-1473 with Itraconazole, TD-1473 without Itraconazole |
| Itraconazoleoral solution, QD | Drug | TD-1473 with Itraconazole |
Primary outcome
Maximum observed concentration (Cmax) in Plasma
Time frame: Up to 8 days post-dose
Time to maximum observed concentration (tmax) in Plasma
Time frame: Up to 8 days post-dose
Area under the concentration-time curve from hour 0 to the last measurable concentration (AUC0-last) in Plasma
Time frame: Up to 8 days post-dose
Area under the concentration-time curve extrapolated to infinity (AUC0-inf) in Plasma
Time frame: Up to 8 days post-dose
Apparent terminal elimination half-life (t1/2) in Plasma
Time frame: Up to 8 days post-dose
Apparent clearance (Cl/F) in Plasma
Time frame: Up to 8 days post-dose
Apparent volume of distribution (Vz/F) in Plasma
Time frame: Up to 8 days post-dose
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 and Itraconazole in people with Inflammatory Bowel Disease, 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 6 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 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?
Maximum observed concentration (Cmax) in Plasma (time frame: Up to 8 days post-dose). The study lists 7 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.