Intestinal DisordersPhase 1NCT03408470
TD-1473 Absorption, Distribution, Metabolism and Excretion (ADME) Study in Healthy Male Subjects
A Phase 1 study testing TD-1473 oral capsule, [14C]-TD-1473 IV bolus and [14C]-TD-1473 Oral Capsule in people with Intestinal Disorders and Bowel Diseases, Inflammatory, run by Theravance Biopharma at 1 site in United States.
Trial summary
This is an open-label, 2-cohort study to evaluate the absolute bioavailability, absorption, distribution, metabolism and excretion of TD-1473 in healthy male subjects. Subjects in cohort 1 will receive a single oral dose of TD-1473 and a single intravenous bolus dose of [14C]-TD-1473. Read more about this study
- Who is it for?
- Ages 19 to 55 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Intestinal Disorders, Bowel Diseases, Inflammatory
- What is being tested?
- TD-1473 oral capsule, [14C]-TD-1473 IV bolus and [14C]-TD-1473 Oral Capsule
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 31 Jan 2018to 21 Feb 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
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Subject is a healthy, nonsmoking male, 19 to 55 years old, inclusive
- Subject has a body mass index (BMI) 19 to 32 kg/m2, inclusive, and weighs at least 50 kg
- Subject is healthy as determined by the PI or designee based on medical history and physical examination performed at Screening and Day -1
- Additional inclusion criteria apply
Who cannot join
- Subject has any condition possibly affecting drug absorption (e.g., previous surgery on the gastrointestinal tract [including removal of parts of the stomach, bowel, liver, gall bladder, or pancreas])
- Subject has a known hypersensitivity towards medications similar to TD 1473 or excipients contained in TD 1473
- Subject regularly works with ionizing radiation or radioactive material
- Subject has been exposed to ionizing radiations, within 1 year prior to the start of the study, as external irradiation (i.e., radiological examination including CT scan, excluding dental radiography) or internal radiation (i.e., diagnostic nuclear medicine procedure) or have participated in a radiolabeled study in the last 12 months
- Subject, who, for any reason, is deemed by the PI or 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
- Additional exclusion criteria apply
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A 2-Cohort Study to Evaluate the Absolute Bioavailability, Absorption, Distribution, Metabolism and Excretion of TD-1473 Following an Intravenous and an Oral Dose of [14C]-TD-1473 in Healthy Male Subjects
This is an open-label, 2-cohort study to evaluate the absolute bioavailability, absorption, distribution, metabolism and excretion of TD-1473 in healthy male subjects. Subjects in cohort 1 will receive a single oral dose of TD-1473 and a single intravenous bolus dose of [14C]-TD-1473. Subjects in cohort 2 will receive a single oral dose of [14C]-TD-1473 only.
- Conditions
- Intestinal Disorders, Bowel Diseases, Inflammatory
- Being tested
- TD-1473 oral capsule, [14C]-TD-1473 IV bolus, [14C]-TD-1473 Oral Capsule
- Keywords
- Absolute Bioavailability, ADME, Healthy Normal Males
- 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 oral capsuleDrug
(Intervention description included in arm description)
[14C]-TD-1473 IV bolusDrug
(Intervention description included in arm description)
[14C]-TD-1473 Oral CapsuleDrug
(Intervention description included in arm description)
| Study group | Role | What they receive |
|---|---|---|
| TD-1473 Oral Capsule & [14C]-TD-1473 IV bolus | Experimental | Cohort 1 - One oral dose and IV bolus administered 1 hr after oral dose of TD-1473 Receives: Drug: TD-1473 oral capsule; Drug: [14C]-TD-1473 IV bolus |
| [14C]-TD-1473 Oral Capsule | Experimental | Cohort 2 - One oral dose Receives: Drug: [14C]-TD-1473 Oral Capsule |
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 15 days
Time to maximum observed concentration (tmax) in Plasma
Measured: Up to 15 days
Area under the concentration-time curve from hour 0 to the last measurable concentration (AUC0-last) in Plasma
Measured: Up to 15 days
Area under the concentration-time curve extrapolated to infinity (AUC0-inf) in Plasma
Measured: Up to 15 days
Apparent terminal elimination half-life (t1/2) in Plasma
Measured: Up to 15 days
Apparent clearance (Cl/F) in Plasma
Measured: Up to 15 days
Apparent volume of distribution (Vz/F) in Plasma
Measured: Up to 15 days
Absolute bioavailability (%F) in Plasma
Measured: Up to 15 days
Secondary outcomes (5)
Amount excreted in urine (Aeu) over the sampling interval in Urine
Measured: Up to 15 days
Renal clearance (CLr) in Urine
Measured: Up to 15 days
The percent excreted in urine (%Feu) in Urine
Measured: Up to 15 days
Amount excreted in feces (Aef) over the sampling interval in Feces
Measured: Up to 15 days
The percent excreted in feces (%Fef)
Measured: Up to 15 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jan 2018
- Study start31 Jan 2018
- Primary completion21 Feb 2018
- Study completion21 Feb 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intestinal DisordersStudies 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
- None (open label)
- Enrolment
- 20 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
- NCT03408470
- Sponsor's protocol ID
- 0152
- Status last verified
- Jan 2021
- First submitted
- 12 Jan 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 2-Cohort Study to Evaluate the Absolute Bioavailability, Absorption, Distribution, Metabolism and Excretion of TD-1473 Following an Intravenous and an Oral Dose of [14C]-TD-1473 in Healthy Male Subjects
- ClinicalTrials.gov ID
- NCT03408470
- Acronym / sponsor ID
- 0152
- Conditions
- Intestinal Disorders, Bowel Diseases, Inflammatory
- Keywords
- Absolute Bioavailability, ADME, Healthy Normal Males
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Theravance BiopharmaIndustry (pharma, biotech, devices)
- Study start
- 31 Jan 2018 (actual)
- Primary completion
- 21 Feb 2018 (actual)
- Study completion
- 21 Feb 2018 (actual)
- First posted
- 24 Jan 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 an open-label, 2-cohort study to evaluate the absolute bioavailability, absorption, distribution, metabolism and excretion of TD-1473 in healthy male subjects. Subjects in cohort 1 will receive a single oral dose of TD-1473 and a single intravenous bolus dose of [14C]-TD-1473. Subjects in cohort 2 will receive a single oral dose of [14C]-TD-1473 only.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TD-1473 Oral Capsule & [14C]-TD-1473 IV bolus | Experimental | Drug: TD-1473 oral capsule, Drug: [14C]-TD-1473 IV bolusCohort 1 - One oral dose and IV bolus administered 1 hr after oral dose of TD-1473 |
| [14C]-TD-1473 Oral Capsule | Experimental | Drug: [14C]-TD-1473 Oral CapsuleCohort 2 - One oral dose |
Who may qualify
- Ages
- 19 to 55 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Subject is a healthy, nonsmoking male, 19 to 55 years old, inclusive
- Subject has a body mass index (BMI) 19 to 32 kg/m2, inclusive, and weighs at least 50 kg
- Subject is healthy as determined by the PI or designee based on medical history and physical examination performed at Screening and Day -1
- Additional inclusion criteria apply
Key exclusion criteria (6 listed)
- Subject has any condition possibly affecting drug absorption (e.g., previous surgery on the gastrointestinal tract [including removal of parts of the stomach, bowel, liver, gall bladder, or pancreas])
- Subject has a known hypersensitivity towards medications similar to TD 1473 or excipients contained in TD 1473
- Subject regularly works with ionizing radiation or radioactive material
- Subject has been exposed to ionizing radiations, within 1 year prior to the start of the study, as external irradiation (i.e., radiological examination including CT scan, excluding dental radiography) or internal radiation (i.e., diagnostic nuclear medicine procedure) or have participated in a radiolabeled study in the last 12 months
- Subject, who, for any reason, is deemed by the PI or 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
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 oral capsule(Intervention description included in arm description) | Drug | TD-1473 Oral Capsule & [14C]-TD-1473 IV bolus |
| [14C]-TD-1473 IV bolus(Intervention description included in arm description) | Drug | TD-1473 Oral Capsule & [14C]-TD-1473 IV bolus |
| [14C]-TD-1473 Oral Capsule(Intervention description included in arm description) | Drug | [14C]-TD-1473 Oral Capsule |
Primary outcome
Maximum observed concentration (Cmax) in Plasma
Time frame: Up to 15 days
Time to maximum observed concentration (tmax) in Plasma
Time frame: Up to 15 days
Area under the concentration-time curve from hour 0 to the last measurable concentration (AUC0-last) in Plasma
Time frame: Up to 15 days
Area under the concentration-time curve extrapolated to infinity (AUC0-inf) in Plasma
Time frame: Up to 15 days
Apparent terminal elimination half-life (t1/2) in Plasma
Time frame: Up to 15 days
Apparent clearance (Cl/F) in Plasma
Time frame: Up to 15 days
Apparent volume of distribution (Vz/F) in Plasma
Time frame: Up to 15 days
Absolute bioavailability (%F) in Plasma
Time frame: Up to 15 days
5 secondary outcomes
Amount excreted in urine (Aeu) over the sampling interval in Urine
Time frame: Up to 15 days
Renal clearance (CLr) in Urine
Time frame: Up to 15 days
The percent excreted in urine (%Feu) in Urine
Time frame: Up to 15 days
Amount excreted in feces (Aef) over the sampling interval in Feces
Time frame: Up to 15 days
The percent excreted in feces (%Fef)
Time frame: Up to 15 days
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 oral capsule, [14C]-TD-1473 IV bolus and [14C]-TD-1473 Oral Capsule in people with Intestinal Disorders and Bowel Diseases, Inflammatory, 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 4 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 15 days). The study lists 8 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.