Clinical trial: Multiple-Ascending-Dose Study to Evaluate the Safety of Propoxyphene Napsylate In Healthy Adult Subjects (NCT01133873)

Eligibility criteria:
Inclusion Criteria:

          -  Body mass index ≥ 18 and ≤ 30 (kg/m2)

          -  Medically healthy with normal screening results, or in the case of results that are
             abnormal; the abnormal results are clinically insignificant (eg, medical history,
             physical examination, neurological assessment, vital signs, oxygen saturation,
             laboratory profiles)

          -  12-lead ECGs (calculations by the electrocardiograph) which have no clinically
             significant findings

          -  Vital signs which are within normal range

          -  No tobacco/nicotine-containing product use for a minimum of 6 months

          -  If female, must be able to adhere to acceptable methods of contraception or be
             postmenopausal or surgically sterile

        Exclusion Criteria:

          -  History or presence of significant cardiovascular, hepatic, renal, hematological,
             gastrointestinal, endocrine, immunologic, dermatologic, or neurological disease

          -  History or presence of any degree of chronic obstructive pulmonary disease

          -  History of suicidal ideations or depression requiring professional intervention
             including counseling or antidepressant medication

          -  Any history of drug or alcohol abuse

          -  Positive drug (urine)/alcohol (breath) testing at screening or check-in

          -  Positive test for human immunodeficiency virus (HIV), hepatitis B surface antigen
             (HBsAg), or hepatitis C antibodies (HCV)

          -  History of hypersensitivity or allergy to propoxyphene or any opioid compound,
             naloxone, naltrexone, palonosetron (Aloxi®), glycerin, senna, or bisacodyl (Dulcolax®)

          -  Use of any prescription medication (with the exception of hormonal contraceptives for
             females) within 2 weeks of enrollment

          -  Use of any over-the-counter medication, including herbal products, within 1 week of
             enrollment

          -  Use of any drugs known to significantly inhibit or induce liver enzymes involved in
             drug metabolism [CYP P450]) within 30 days of enrollment

          -  Blood donation or significant blood loss within 30 days of enrollment

          -  Plasma donation within 7 days of enrollment

          -  Participation in another clinical trial within 30 days of enrollment

          -  Females who are pregnant or lactating

          -  Any other condition or prior therapy, which, in the opinion of the PI, would make the
             subject unsuitable for this study
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 18 Years old.
Subject must be at most 49 Years

Patient description (medical language): A 20-year-old man comes to the clinic for his routine checkup. The patient wears glasses for myopia and takes no medications.  Vital signs are normal.  On physical examination, the patient is tall with long upper extremities and fingers.  The face appears narrow with down-slanted palpebral fissures, flattened malar bones, and a small jaw.  The lungs are clear on auscultation.  The abdomen is soft with no organomegaly. The patient is diagnosed with Marfan syndrome, and he is cooperative with his medical appointments. He is working as driver.

Patient description (patient's own words): I'm a 20-year-old guy, working as a driver and I went to the clinic for my routine checkup. I have myopia, so I wear glasses and I don't take any other medications. My vitals were normal. I also did a physical exam, and I was told that I have long legs, arms, and fingers. They also told me that my face is quite narrow, with down-slanted eyes and a small jaw. My lungs were fine and my tummy too. I have been diagnosed with Marfan syndrome and I haven't been skipping any medical appointments since.

Does the patient match the trial criteria? Entailment