HealthyPhase 1NCT01746485
Three Times Daily Dosing of UT-15C
A Phase 1 study testing UT-15C in people with Healthy, run by United Therapeutics at 1 site in United States.
Trial summary
To evaluate the pharmacokinetics of three-times daily dosing of UT-15C in healthy volunteers Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- UT-15C
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 19 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2012to Jul 2012
- 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
- Healthy male and female subjects
- aged 18-55 years of age;
- weight between 50 and 100 kg, with a body mass index (BMI) between 19.0 and 29.9 kg/m2, inclusive for female subjects and
- weight between 50 and 120 kg, with a BMI between 19.0 and 32.0 kg/m², inclusive for male subjects.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A PK Evaluation of Three Times Daily Dosing of UT-15C SR Tablets in Healthy Subjects
To evaluate the pharmacokinetics of three-times daily dosing of UT-15C in healthy volunteers
- Conditions
- Healthy
- Being tested
- UT-15C
- Keywords
- Volunteers
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
UT-15CDrug
Also called treprostinil diethanolamine, treprostinil diolamine, UT-15C SR
| Study group | Role | What they receive |
|---|---|---|
| UT-15C | Experimental | Not described Receives: Drug: UT-15C |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area under the curve (AUC) from 0-24hrs after 6 days of TID dosing.
Cmax, tmax, AUC(0-6), AUC(0-24), AUC(6-12), AUC(12-24) and t1/2
Measured: 6 days
Secondary outcomes (1)
PK profile of UT-15C after a single 0.5mg dose on Day 1
Day 1: Cmax, tmax, AUC(0-6), AUC(0-24), AUC(0-t), AUC(0-inf), and t1/2
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2012 (estimated)
- Study startJul 2012
- Primary completionJul 2012
- Study completionJul 2012
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.
- More trials run by United TherapeuticsThe sponsor's other registered studies.
- 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
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- United Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Theresa Pham, MD, Principal investigator, PPD Development, LP
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01746485
- Sponsor's protocol ID
- TDE-DU-102
- Status last verified
- Dec 2012
- First submitted
- 16 Aug 2012
- Last updated
- 12 Dec 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
Jones A, Wang-Smith L, Pham T, Laliberte K. Pharmacokinetics of 3 times a day dosing of oral treprostinil in healthy volunteers. J Cardiovasc Pharmacol. 2014 Mar;63(3):227-32. doi: 10.1097/FJC.0000000000000039.
PubMed 24603117
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A PK Evaluation of Three Times Daily Dosing of UT-15C SR Tablets in Healthy Subjects
- ClinicalTrials.gov ID
- NCT01746485
- Acronym / sponsor ID
- TDE-DU-102
- Conditions
- Healthy
- Keywords
- Volunteers
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- United TherapeuticsIndustry (pharma, biotech, devices)
- Study start
- Jul 2012
- Primary completion
- Jul 2012 (actual)
- Study completion
- Jul 2012 (actual)
- First posted
- 11 Dec 2012 (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.
To evaluate the pharmacokinetics of three-times daily dosing of UT-15C in healthy volunteers
Study design
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| UT-15C | Experimental | Drug: UT-15C |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
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 |
|---|---|---|
| UT-15CAlso: treprostinil diethanolamine, treprostinil diolamine, UT-15C SR | Drug | UT-15C |
Primary outcome
Area under the curve (AUC) from 0-24hrs after 6 days of TID dosing.
Time frame: 6 days
Cmax, tmax, AUC(0-6), AUC(0-24), AUC(6-12), AUC(12-24) and t1/2
1 secondary outcome
PK profile of UT-15C after a single 0.5mg dose on Day 1
Time frame: 1 day
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 12 Dec 2012.
- Derived from this study: PubMed 24603117Jones A, Wang-Smith L, Pham T, Laliberte K. Pharmacokinetics of 3 times a day dosing of oral treprostinil in healthy volunteers. J Cardiovasc Pharmacol. 2014 Mar;63(3):227-32. doi: 10.1097/FJC.0000000000000039.
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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.
Theresa Pham, MD principal investigator
PPD Development, LP
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 UT-15C in people with Healthy, run by United Therapeutics 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?
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 12 Dec 2012. 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?
Area under the curve (AUC) from 0-24hrs after 6 days of TID dosing. (time frame: 6 days). 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 NCT01746485, 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 12 Dec 2012.