Pulmonary Arterial HypertensionPhase 1NCT01172496
A Bioavailability Study Comparing Treprostinil Diethanolamine Oral Tablets and Oral Solution in Healthy Volunteers
A Phase 1 study testing treprostinil diethanolamine in people with Pulmonary Arterial Hypertension, run by United Therapeutics at 1 site in United States.
Trial summary
This single center, open label, randomized, two-period, two-sequence cross-over study is designed to evaluate the relative bioavailability of a treprostinil diethanolamine 1 mg tablet in reference to treprostinil diethanolamine 1 mg oral solution (administered as four 0.25 mg doses every 2 hours for a 1 mg total dose)… Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Pulmonary Arterial Hypertension
- What is being tested?
- treprostinil diethanolamine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2010to Aug 2010
- 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 between the ages of 18-55 years of age
- Female subjects must weigh between 55 and 100 kg, with a BMI between 19.0-29.9. kg/m2; inclusive at screening. Male subjects must weigh between 55 and 120 kg, 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.
- Female subjects with childbearing potential will practice abstinence or effective birth control methods from the time of providing written informed consent to the end of the study. Effective birth control is defined as an intrauterine device (IUD), barrier methods preferably in combination with a spermicidal foam or suppository, or the use of oral, transdermal or intra-vaginal hormonal contraceptives.
- Subject agrees to abstain from taking any prescription medication (except contraceptives) for 14 days prior to starting study procedures and to abstain from taking any non-prescription medications (except multivitamins) or herbal supplements for 7 days prior to beginning study procedures until discharge from the study (unless prescribed by the Investigator to treat an AE).
- Subject agrees to abstain from consuming alcohol from 3 days prior beginning study procedures until discharge from the study.
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- Subject agrees to abstain from consuming grapefruit or xanthine-containing food or beverages for 3 days prior beginning study procedures until discharge from the study.
- Subject agrees to refrain from strenuous exercise from beginning study procedures until discharge from the study.
- Subject is able to communicate effectively with study personnel and be considered reliable, willing and cooperative in terms of compliance with the protocol requirements.
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 previous 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.
- The subject has a history of postural hypotension, unexplained syncope, a blood pressure that is less than 85 mmHg systolic or 50 mmHg diastolic, or a pulse rate that is greater than 90 bpm after sitting at rest for 5 minutes at Screening or Baseline.
- Subject has a predisposing condition that could interfere with the absorption, distribution, metabolism, or excretion of drugs.
- Subject has tested positive at the screening visit for HIV infection, HBsAg, or the HCV antibody.
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- Subject is pregnant or lactating.
- Subject currently uses tobacco products or has a history of tobacco use within six months prior to Period 1.
- Subject has a history of alcohol abuse or a history of or current impairment of organ function reasonably related to alcohol abuse.
- Subject has a history of or current evidence of abuse of licit or illicit drugs or a positive urine screen for drugs of abuse.
- Subject has a history of abnormal bleeding tendencies.
- Subject has donated blood or plasma or has lost a significant volume of blood (greater than 450 mL) within four weeks prior to Period 1.
- Subject has participated in any investigational drug study within 30 days prior to Screening.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Comparative Bioavailability Study of UT-15C SR (Treprostinil Diethanolamine, Sustained Release) Oral Tablets and UT-15C (Treprostinil Diethanolamine) Administered as an Oral Solution in Healthy Volunteers
This single center, open label, randomized, two-period, two-sequence cross-over study is designed to evaluate the relative bioavailability of a treprostinil diethanolamine 1 mg tablet in reference to treprostinil diethanolamine 1 mg oral solution (administered as four 0.25 mg doses every 2 hours for a 1 mg total dose) in twenty-four healthy volunteers. Other secondary outcomes of interest include assessment of pharmacokinetic parameters of treprostinil diethanolamine 1 mg tablets and a treprostinil diethanolamine 1 mg oral solution administered as four doses (0.25 mg every 2 hours for a 1 mg total dose) and evaluation of the safety and tolerability of each treatment regimen.
- Conditions
- Pulmonary Arterial Hypertension
- Being tested
- treprostinil diethanolamine
- Medical subject headings
- Pulmonary Arterial Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
treprostinil diethanolamineDrug
Subjects will be administered a 1 mg dose of treprostinil diethanolamine as a single tablet, and treprostinil diethanolamine oral solution 0.25 mg dose every 2 hours for four doses (1 mg total).
| Study group | Role | What they receive |
|---|---|---|
| 1 mg tablet; 1mg solution | Experimental | Not described Receives: Drug: treprostinil diethanolamine |
| 1mg solution; 1mg tablet | Experimental | Not described Receives: Drug: treprostinil diethanolamine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Plasma treprostinil concentrations
Pharmacokinetic blood sampling will occur twice for each subject. Pharmacokinetic parameters will be derived from treprostinil concentration-time data
Measured: 1 month
Secondary outcomes (1)
vital sign measurements, clinical laboratory parameters, electrocardiograms (ECGs) and adverse events (AEs)
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2010 (estimated)
- Study startAug 2010
- Primary completionAug 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulmonary Arterial HypertensionStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 24 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
- NCT01172496
- Sponsor's protocol ID
- TDE-PH-123
- Status last verified
- Jul 2010
- First submitted
- 28 Jul 2010
- Last updated
- 13 Oct 2010
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparative Bioavailability Study of UT-15C SR (Treprostinil Diethanolamine, Sustained Release) Oral Tablets and UT-15C (Treprostinil Diethanolamine) Administered as an Oral Solution in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT01172496
- Acronym / sponsor ID
- TDE-PH-123
- Conditions
- Pulmonary Arterial Hypertension
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- United TherapeuticsIndustry (pharma, biotech, devices)
- Study start
- Aug 2010
- Primary completion
- Aug 2010 (actual)
- First posted
- 29 Jul 2010 (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.
This single center, open label, randomized, two-period, two-sequence cross-over study is designed to evaluate the relative bioavailability of a treprostinil diethanolamine 1 mg tablet in reference to treprostinil diethanolamine 1 mg oral solution (administered as four 0.25 mg doses every 2 hours for a 1 mg total dose) in twenty-four healthy volunteers. Other secondary outcomes of interest include assessment of pharmacokinetic parameters of treprostinil diethanolamine 1 mg tablets and a treprostinil diethanolamine 1 mg oral solution administered as four doses (0.25 mg every 2 hours for a 1 mg total dose) and evaluation of the safety and tolerability of each treatment regimen.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 mg tablet; 1mg solution | Experimental | Drug: treprostinil diethanolamine |
| 1mg solution; 1mg tablet | Experimental | Drug: treprostinil diethanolamine |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- Subject is healthy between the ages of 18-55 years of age
- Female subjects must weigh between 55 and 100 kg, with a BMI between 19.0-29.9. kg/m2; inclusive at screening. Male subjects must weigh between 55 and 120 kg, 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.
- Female subjects with childbearing potential will practice abstinence or effective birth control methods from the time of providing written informed consent to the end of the study. Effective birth control is defined as an intrauterine device (IUD), barrier methods preferably in combination with a spermicidal foam or suppository, or the use of oral, transdermal or intra-vaginal hormonal contraceptives.
- Subject agrees to abstain from taking any prescription medication (except contraceptives) for 14 days prior to starting study procedures and to abstain from taking any non-prescription medications (except multivitamins) or herbal supplements for 7 days prior to beginning study procedures until discharge from the study (unless prescribed by the Investigator to treat an AE).
Key exclusion criteria (13 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 previous 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.
- The subject has a history of postural hypotension, unexplained syncope, a blood pressure that is less than 85 mmHg systolic or 50 mmHg diastolic, or a pulse rate that is greater than 90 bpm after sitting at rest for 5 minutes at Screening or Baseline.
- Subject has a predisposing condition that could interfere with the absorption, distribution, metabolism, or excretion of drugs.
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 diethanolamineSubjects will be administered a 1 mg dose of treprostinil diethanolamine as a single tablet, and treprostinil diethanolamine oral solution 0.25 mg dose every 2 hours for four doses (1 mg total). | Drug | 1 mg tablet; 1mg solution, 1mg solution; 1mg tablet |
Primary outcome
Plasma treprostinil concentrations
Time frame: 1 month
Pharmacokinetic blood sampling will occur twice for each subject. Pharmacokinetic parameters will be derived from treprostinil concentration-time data
1 secondary outcome
vital sign measurements, clinical laboratory parameters, electrocardiograms (ECGs) and adverse events (AEs)
Time frame: 1 month
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 13 Oct 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 in people with 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 9 inclusion and 13 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 13 Oct 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?
Plasma treprostinil concentrations (time frame: 1 month). 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 13 Oct 2010.