A study to assess the interaction of acohol and oral treprostinil.
This study will compare the effects of ethanol on the PKs of a 1 mg dose of UT-15C in
healthy volunteers to determine the in vivo effects of ethanol, including the timing of
ethanol consumption in relation to UT-15C ingestion.
This is an open-label, randomized, single-center, four-way (period), crossover study in
which 28 healthy volunteers will receive a single 1 mg oral dose of UT-15C and/or ethanol.
Eligible subjects will be randomly assigned to one of four treatment sequences such that all
subjects will receive all four sequences in a pre-specified order.
1. The subject voluntarily gives informed consent to participate in the study.
2. Women of child bearing potential includes any female who has experienced menarche and
who has not undergone successful surgical sterilization. Women of childbearing
potential must practice true abstinence from intercourse when it is in line with
their preferred and usual lifestyle, or use two different forms of highly effective
contraception for the duration of the study, and for at least 30 days after
discontinuing study medication. Medically acceptable forms of effective contraception
include: (1) approved hormonal contraceptives (such as birth control pills), (2)
barrier methods used with a spermicide, (3) an intrauterine device, or (4) partner
vasectomy. For women of childbearing potential, a negative urine pregnancy test is
required at Screening and Baseline prior to initiating study medication.
3. The subject, if male, must use a condom during the length of the study, and for at
least 48 hours after discontinuing study medication.
4. Healthy male and female subjects aged 21-55 years of age at the time of signing the
5. Weight between 55 and 100 kg, with a BMI between 19.0-29.9 kg/m2, inclusive for
female subjects and weight between 55 and 120 kg, with a BMI between 19.0-32.0 kg/m2,
inclusive for male subjects.
6. Regular consumption of ethanol with no recent changes in pattern of consumption
7. In the opinion of the Principal Investigator, the subject is able to communicate
effectively with study personnel, and is considered reliable, willing and likely to
be cooperative with protocol requirements, including attending all study visits.
1. The subject is pregnant or lactating.
2. Subject has any clinically relevant abnormality identified during the screening
physical examination, 12-lead ECG, or laboratory examinations.
3. Subject has a history of anaphylaxis, a previous documented hypersensitivity
reaction, or a clinically significant idiosyncratic reaction to any drug.
4. 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.
5. Subject has a history of postural hypotension, or unexplained syncope.
6. Subject has a blood pressure that is less than 85 mmHg systolic or 50 mmHg diastolic
at Screening or Baseline.
7. Subject has a pulse rate that is greater than 90 bpm after sitting at rest for 5
minutes at Screening or Baseline.
8. Subject has a blood pressure that is greater than 150 mmHg systolic or 90 mmHg
diastolic at Screening or Baseline.
9. Subject has a predisposing condition that could interfere with the absorption,
distribution, metabolism, or excretion of drugs.
10. Subject has tested positive at the screening visit for HIV infection, HBsAg, or the
11. Subject currently uses tobacco products or has a history of tobacco use within two
months prior to Baseline.
12. Subject has a history of ethanol abuse or a history of or current impairment of organ
function reasonably related to ethanol abuse.
13. Subject has a history of or current evidence of abuse of licit or illicit drugs,
including a positive urine screen for drugs of abuse at Screening or Baseline.
14. Subject has a history of abnormal bleeding tendencies.
15. Subject has donated blood or plasma or has lost a significant volume of blood within
four weeks prior to Baseline.
16. Subject has clinically significant abnormal laboratory values in the opinion of the
17. Subject has participated in a research study within the last 30 days.