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 19-year-old girl comes to the clinic due to a left wrist mass.  She noticed swelling on the top of her wrist about 4 months ago and came to the clinic due to cosmetic concerns.  Examination shows a nontender, rounded mass on the dorsal wrist that transilluminates with a penlight. Vital signs are normal. The patient needs to type on her computer almost all day. She is left-handed. She does not smoke or use illicit drugs. She is in sexual relationship with two male partners and uses condoms.

Patient description (patient's own words): I'm a 19-year-old girl and I went to see my doctor because of a mass on my left wrist. I noticed a swelling on top of my wrist, like 4 months ago, and I went the first time to the doctor because it was pretty ugly! My wrist was not tender, and the mass was round and let the light go through when the doctor used a penlight. My blood pressure, breathing and temperature were normal. I'm left-handed and I need to be on my PC all day. I don't smoke or do drugs. I'm sexually active and I have 2 male partners but they all use condoms.

Does the patient match the trial criteria? Entailment