Healthy SubjectsPhase 1NCT02903095
Single Ascending Dose Study of TD-1439 in Healthy Subjects
A Phase 1 study testing TD-1439 in people with Healthy Subjects, run by Theravance Biopharma at 1 site in United States.
Trial summary
Single ascending dose study to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of TD-1439 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 Subjects
- What is being tested?
- TD-1439
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 66 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2016to Feb 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 19 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Body Mass Index (BMI) 18 to 32 kg/m2 inclusive
- Women of child bearing potential must have a negative pregnancy test and either abstain from sex or use highly effective methods of birth control
- Women of non-childbearing potential are at least 2 years postmenopausal or are surgically sterile
- Males must abstain from sex or use highly effective methods of birth control
- Negative for HIV, and Hepatitis A, B, and C
Who cannot join
- Female subjects who are pregnant, lactating, breastfeeding or planning to become pregnant during the study.
- Subjects with a history of angioedema.
- Subject has 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.
- Subject has acute illness (gastrointestinal, infection [e.g., influenza] or known inflammatory process)
- Subject bradycardia
- Subject has hypertension
Show all 11Show fewer
- Subjects has orthostatic hypotension
- Subjects has orthostatic tachycardia
- Subject has a known personal or family history of congenital long QT syndrome or known family history of sudden death.
- Subject has donated blood or blood components or has had blood loss exceeding 400 mL within the 90 days prior to Screening.
- Additional exclusion criteria apply
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 1, Double-blind, Randomized, Placebo-controlled, Single Ascending Dose Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of TD-1439 in Healthy Subjects
Single ascending dose study to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of TD-1439 in healthy subjects
- Conditions
- Healthy Subjects
- Being tested
- TD-1439, Placebo
- Keywords
- Single ascending dose
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TD-1439Drug
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| TD-1439 | Experimental | Capsule formulation Receives: Drug: TD-1439 |
| Placebo | Placebo comparator | Capsule formulation Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety of TD-1439 by assessing the number and severity of adverse events, including changes in vital signs, physical examination, laboratory safety tests, and ECGs
Measured: From Day 1 through end of study (Day 10)
Secondary outcomes (15)
Pharmacokinetics (PK) of TD-1439 in plasma after multiple doses - peak plasma concentration (Cmax)
Measured: Day 1 through Day 10
PK of TD-1439 in plasma after multiple doses - time to peak plasma concentration (Tmax)
Measured: Day 1 through Day 10
PK of TD-1439 in plasma after multiple doses - time to last measurable concentration (Tlast)
Measured: Day 1 through Day 10
PK of TD-1439 in plasma after multiple doses - area under the plasma concentration vs. time curve from time zero to the last quantifiable concentration (AUC0-t)
Measured: Day 1 through Day 10
PK of TD-1439 in plasma after multiple doses - area under the plasma concentration vs. time curve from time zero to 24 hours postdose (AUC0-24)
Measured: Day 1 through Day 10
PK of TD-1439 in plasma after multiple doses - CL/F (oral plasma clearance)
Measured: Day 1 through Day 10
PK of TD-1439 in plasma after multiple doses - Vz/F (apparent volume of distribution during the terminal phase)
Measured: Day 1 through Day 10
PK of TD-1439 in plasma after multiple doses - t1/2 (half-life)
Measured: Day 1 through Day 10
PK of TD-1439 in urine after multiple doses - Ae (amount excreted in urine)
Measured: Day 1 through Day 10
PK of TD-1439 in urine after multiple doses - Fe (fraction of oral dose excreted in urine)
Measured: Day 1 through Day 10
PK of TD-1439 in urine after multiple doses - Clr (renal clearance)
Measured: Day 1 through Day 10
Pharmacodynamic assessments for plasma atrial natriuretic peptide (ANP) concentrations
Measured: The day before dosing (Day -1) to 3 days after last dose (Day 4)
Pharmacodynamic assessments for urine atrial natriuretic peptide (ANP) concentrations
Measured: The day before dosing (Day -1) to 3 days after last dose (Day 4)
Pharmacodynamic assessments for plasma cyclic guanosine monophosphate (cGMP) concentrations
Measured: The day before dosing (Day -1) to 3 days after last dose (Day 4)
Pharmacodynamic assessments for urine cyclic guanosine monophosphate (cGMP) concentrations
Measured: The day before dosing (Day -1) to 3 days after last dose (Day 4)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2016 (estimated)
- Study startSep 2016
- Primary completionDec 2016
- Study completionFeb 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 66 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
- NCT02903095
- Sponsor's protocol ID
- 0147
- Status last verified
- Jan 2021
- First submitted
- 8 Sep 2016
- 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.
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 Phase 1, Double-blind, Randomized, Placebo-controlled, Single Ascending Dose Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of TD-1439 in Healthy Subjects
- ClinicalTrials.gov ID
- NCT02903095
- Acronym / sponsor ID
- 0147
- Conditions
- Healthy Subjects
- Keywords
- Single ascending dose
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- Theravance BiopharmaIndustry (pharma, biotech, devices)
- Study start
- Sep 2016 (actual)
- Primary completion
- Dec 2016 (actual)
- Study completion
- Feb 2017 (actual)
- First posted
- 16 Sep 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.
Single ascending dose study to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of TD-1439 in healthy subjects
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TD-1439 | Experimental | Drug: TD-1439Capsule formulation |
| Placebo | Placebo comparator | Drug: PlaceboCapsule formulation |
Who may qualify
- Ages
- 19 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Body Mass Index (BMI) 18 to 32 kg/m2 inclusive
- Women of child bearing potential must have a negative pregnancy test and either abstain from sex or use highly effective methods of birth control
- Women of non-childbearing potential are at least 2 years postmenopausal or are surgically sterile
- Males must abstain from sex or use highly effective methods of birth control
- Negative for HIV, and Hepatitis A, B, and C
Key exclusion criteria (11 listed)
- Female subjects who are pregnant, lactating, breastfeeding or planning to become pregnant during the study.
- Subjects with a history of angioedema.
- Subject has 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.
- Subject has acute illness (gastrointestinal, infection [e.g., influenza] or known inflammatory process)
- Subject bradycardia
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-1439 | Drug | TD-1439 |
| Placebo | Drug | Placebo |
Primary outcome
Safety of TD-1439 by assessing the number and severity of adverse events, including changes in vital signs, physical examination, laboratory safety tests, and ECGs
Time frame: From Day 1 through end of study (Day 10)
15 secondary outcomes
Pharmacokinetics (PK) of TD-1439 in plasma after multiple doses - peak plasma concentration (Cmax)
Time frame: Day 1 through Day 10
PK of TD-1439 in plasma after multiple doses - time to peak plasma concentration (Tmax)
Time frame: Day 1 through Day 10
PK of TD-1439 in plasma after multiple doses - time to last measurable concentration (Tlast)
Time frame: Day 1 through Day 10
PK of TD-1439 in plasma after multiple doses - area under the plasma concentration vs. time curve from time zero to the last quantifiable concentration (AUC0-t)
Time frame: Day 1 through Day 10
PK of TD-1439 in plasma after multiple doses - area under the plasma concentration vs. time curve from time zero to 24 hours postdose (AUC0-24)
Time frame: Day 1 through Day 10
PK of TD-1439 in plasma after multiple doses - CL/F (oral plasma clearance)
Time frame: Day 1 through Day 10
PK of TD-1439 in plasma after multiple doses - Vz/F (apparent volume of distribution during the terminal phase)
Time frame: Day 1 through Day 10
PK of TD-1439 in plasma after multiple doses - t1/2 (half-life)
Time frame: Day 1 through Day 10
PK of TD-1439 in urine after multiple doses - Ae (amount excreted in urine)
Time frame: Day 1 through Day 10
PK of TD-1439 in urine after multiple doses - Fe (fraction of oral dose excreted in urine)
Time frame: Day 1 through Day 10
PK of TD-1439 in urine after multiple doses - Clr (renal clearance)
Time frame: Day 1 through Day 10
Pharmacodynamic assessments for plasma atrial natriuretic peptide (ANP) concentrations
Time frame: The day before dosing (Day -1) to 3 days after last dose (Day 4)
Pharmacodynamic assessments for urine atrial natriuretic peptide (ANP) concentrations
Time frame: The day before dosing (Day -1) to 3 days after last dose (Day 4)
Pharmacodynamic assessments for plasma cyclic guanosine monophosphate (cGMP) concentrations
Time frame: The day before dosing (Day -1) to 3 days after last dose (Day 4)
Pharmacodynamic assessments for urine cyclic guanosine monophosphate (cGMP) concentrations
Time frame: The day before dosing (Day -1) to 3 days after last dose (Day 4)
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.
- 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-1439 in people with 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 5 inclusion and 11 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?
Safety of TD-1439 by assessing the number and severity of adverse events, including changes in vital signs, physical examination, laboratory safety tests, and ECGs (time frame: From Day 1 through end of study (Day 10)). 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 19 Jan 2021.