Hypertension, PulmonaryPhase 1NCT00963001
Effect of Food on the Pharmacokinetics of Oral Treprostinil
A Phase 1 study testing Treprostinil diethanolamine and Standardized meals in people with Hypertension, Pulmonary and Pulmonary Arterial Hypertension, run by United Therapeutics at 1 site in United States.
Trial summary
The purpose of this study is to assess the pharmacokinetic and safety profile of a single dose of oral treprostinil following four different meals of varying caloric and fat content. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Hypertension, Pulmonary, Pulmonary Arterial Hypertension
- What is being tested?
- Treprostinil diethanolamine and Standardized meals
- Type of treatment
- Pill or oral medicine
- How many people
- 32 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2009to Nov 2009
- 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
- Subject is healthy and between the ages of 18 and 55 years, inclusive, at Screening.
- Female subjects must weigh between 45 and 100 kg, inclusive, with a BMI between 19.0-29.9 kg/m2, inclusive at Screening. Male subjects must weigh between 50 and 120 kg, inclusive, with a BMI between 19.0-32.0 kg/m2, inclusive at Screening.
- Subject has a medical history, physical examination, vital signs, ECG and clinical laboratory results within normal limits or considered not clinically significant by the Investigator at Screening.
Who cannot join
- Subject has any clinically relevant abnormality identified during the screening physical examination, 12-lead ECG, or laboratory examinations.
- Subject has a history of anaphylaxis, a documented hypersensitivity reaction, or a clinically significant idiosyncratic reaction to any drug.
- Subject has a clinically significant history of neurological, cardiovascular, respiratory, endocrine, hematological, hepatic, renal, gastrointestinal, genitourinary, pulmonary, and/or musculoskeletal disease; glaucoma; a psychiatric disorder, or any other chronic disease, whether controlled by medication or not.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Different Meal Types on the Pharmacokinetics of a Single 1 mg Oral Dose of UT-15C (Treprostinil Diethanolamine) Sustained Release Tablets in Healthy Volunteers
The purpose of this study is to assess the pharmacokinetic and safety profile of a single dose of oral treprostinil following four different meals of varying caloric and fat content.
- Being tested
- Treprostinil diethanolamine, Standardized meals
- Keywords
- Hypertension, Pulmonary, Treprostinil, Pharmacokinetics, Treprostinil Diethanolamine, Pulmonary Arterial Hypertension
- Medical subject headings
- Hypertension, Pulmonary, Pulmonary Arterial Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Treprostinil diethanolamineDrug
Also called UT-15C, UT-15C SR, Oral treprostinil
Subjects will each receive a single 1 mg sustained release tablet of treprostinil diethanolamine by mouth within 10 minutes of consuming each of four standardized meals on Study Days 1, 8, 15, and 22.
Standardized mealsOther
Each subject will receive one of four different standardized meals of varying caloric and fat content in a randomized sequence such that all subjects will receive all four meals over the course of the study. Each subject will receive one standardized meal for breakfast on Study Days 1, 8, 15, and 22.
What is being measured
The primary outcome is the main question the study is designed to answer.
Treprostinil pharmacokinetics in healthy volunteers following a single oral dose of a 1 mg treprostinil diethanolamine sustained release tablet after four different meal types.
Measured: Immediately prior to through 36 hours post treprostinil diethanolamine dosing for each treatment period (4 treatment periods each separated by a 7-day washout period)
Adverse event monitoring
Measured: From the first dose of treprostinil diethanolamine through study end (Study Day 23/24)
Secondary outcomes (1)
Clinical laboratories
Measured: Study Days 0, 7, 14, 21 and 23
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2009 (estimated)
- Study startSep 2009
- Primary completionNov 2009
- Study completionNov 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hypertension, PulmonaryStudies 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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 32 participants (estimated)
Sponsor and investigators
- Lead sponsor
- United Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Aziz Laurent, MD, Principal investigator, PPD Development, LP
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00963001
- Sponsor's protocol ID
- TDE-PH-115
- Status last verified
- Mar 2010
- First submitted
- 19 Aug 2009
- Last updated
- 8 Mar 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Mar 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Different Meal Types on the Pharmacokinetics of a Single 1 mg Oral Dose of UT-15C (Treprostinil Diethanolamine) Sustained Release Tablets in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT00963001
- Acronym / sponsor ID
- TDE-PH-115
- Keywords
- Hypertension, Pulmonary, Treprostinil, Pharmacokinetics, Treprostinil Diethanolamine, Pulmonary Arterial Hypertension
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (estimated)
- Lead sponsor
- United TherapeuticsIndustry (pharma, biotech, devices)
- Study start
- Sep 2009
- Primary completion
- Nov 2009 (actual)
- Study completion
- Nov 2009 (actual)
- First posted
- 20 Aug 2009 (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.
The purpose of this study is to assess the pharmacokinetic and safety profile of a single dose of oral treprostinil following four different meals of varying caloric and fat content.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Subject is healthy and between the ages of 18 and 55 years, inclusive, at Screening.
- Female subjects must weigh between 45 and 100 kg, inclusive, with a BMI between 19.0-29.9 kg/m2, inclusive at Screening. Male subjects must weigh between 50 and 120 kg, inclusive, with a BMI between 19.0-32.0 kg/m2, inclusive at Screening.
- Subject has a medical history, physical examination, vital signs, ECG and clinical laboratory results within normal limits or considered not clinically significant by the Investigator at Screening.
Key exclusion criteria (3 listed)
- Subject has any clinically relevant abnormality identified during the screening physical examination, 12-lead ECG, or laboratory examinations.
- Subject has a history of anaphylaxis, a documented hypersensitivity reaction, or a clinically significant idiosyncratic reaction to any drug.
- Subject has a clinically significant history of neurological, cardiovascular, respiratory, endocrine, hematological, hepatic, renal, gastrointestinal, genitourinary, pulmonary, and/or musculoskeletal disease; glaucoma; a psychiatric disorder, or any other chronic disease, whether controlled by medication or not.
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 |
|---|---|---|
| Treprostinil diethanolamineAlso: UT-15C, UT-15C SR, Oral treprostinilSubjects will each receive a single 1 mg sustained release tablet of treprostinil diethanolamine by mouth within 10 minutes of consuming each of four standardized meals on Study Days 1, 8, 15, and 22. | Drug | – |
| Standardized mealsEach subject will receive one of four different standardized meals of varying caloric and fat content in a randomized sequence such that all subjects will receive all four meals over the course of the study. Each subject will receive one standardized meal for breakfast on Study Days 1, 8, 15, and 22. | Other | – |
Primary outcome
Treprostinil pharmacokinetics in healthy volunteers following a single oral dose of a 1 mg treprostinil diethanolamine sustained release tablet after four different meal types.
Time frame: Immediately prior to through 36 hours post treprostinil diethanolamine dosing for each treatment period (4 treatment periods each separated by a 7-day washout period)
Adverse event monitoring
Time frame: From the first dose of treprostinil diethanolamine through study end (Study Day 23/24)
1 secondary outcome
Clinical laboratories
Time frame: Study Days 0, 7, 14, 21 and 23
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 8 Mar 2010.
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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.
Aziz Laurent, 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 Treprostinil diethanolamine and Standardized meals in people with Hypertension, Pulmonary and Pulmonary Arterial Hypertension, 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?
The sponsor lists 3 inclusion and 3 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 8 Mar 2010. 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?
Treprostinil pharmacokinetics in healthy volunteers following a single oral dose of a 1 mg treprostinil diethanolamine sustained release tablet after four different meal types. (time frame: Immediately prior to through 36 hours post treprostinil diethanolamine dosing for each treatment period (4 treatment periods each separated by a 7-day washout period)). The study lists 2 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 8 Mar 2010.