Clinical trial: Biomarker Development for Future PAC1 Antagonists With Maxadilan (NCT02355756)

Eligibility criteria:
Inclusion Criteria:

          -  Subject is a white male ≥18 and ≤ 45 years of age.

          -  Subject is a nonsmoker for at least 6 months prior to study start.

          -  Subject has a body mass index between 18-28 kg/m2.

          -  Subject is judged to be in good health on the basis of medical history, physical
             examination, vital signs, electrocardiogram, and routine laboratory data (including
             complete blood count, complete chemistry panel, prothrombin time and activated partial
             thromboplastin time (see Appendix C).

          -  Subjects must agree to practice a highly effective method of birth control during the
             study and for 1 week after dosing. Highly effective method of birth control includes
             sexual abstinence, vasectomy, or a condom in combination with hormonal birth control
             or intrauterine device (female partner).

          -  Subjects must agree not to donate sperm for the duration of the study.

          -  Subject understands the procedures and agrees to participate in the study by giving
             written informed consent.

          -  Subject agrees to refrain from strenuous physical activity 3 days before the screening
             visit, each study period and poststudy visit.

        Exclusion Criteria:

          -  Subject has a history of any illness (including migraine) or has had/is expected to
             have surgery within 1 month of the start of the study which, in the investigator's
             opinion, might confound the results of the study.

          -  Subject has eczema, scleroderma, psoriasis, dermatitis, or keloids, tumors, ulcers,
             burns, flaps, or grafts on their forearm or other abnormality of the skin which may
             interfere with the study assessments.

          -  Subject has excessive hair growth on volar surface of the forearm.

          -  Subject cannot avoid excessive tanning (any exposure to sunlight or a tanning bed
             which would cause a sunburn reaction) throughout the study and cannot cover forearms
             for 24 hours prior to each treatment period.

          -  Subject has a history of significant (drug) allergies including adverse experiences of
             a serious nature related to the administration of either a marketed or investigational
             drug or allergic reactions related to insect bites

          -  Subject currently uses any prescription or nonprescription drugs on a regular basis
             which cannot be discontinued for the duration of the study; subject has used any
             prescription or nonprescription medication within 14 days of the start of the study.

          -  Subject currently uses lotions, oils, depilatory preparations, or other topical
             treatments on the arms on a regular basis which cannot be discontinued for the
             duration of the study; subject has used any topical treatments within 7 days of the
             start of the study.

          -  Subject is a habitual and heavy consumer of coffee or caffeinated beverages (more than
             approximately 4 cups of tea, coffee, or cola drinks/day) at the time of the study.
             Subjects who have reduced their consumption to 4 cups of coffee/day at least 1 week
             prior to enrollment may participate. Subjects who cannot restrain from caffeinated
             beverages 12 hours before the study visit.

          -  Subject is unable to refrain from drinking alcohol 24 hours prior to maxadilan dosing,
             is currently a regular user (including "recreational use") of any illicit drugs, or
             has a history of drug (including alcohol) abuse.

          -  Subject has a positive urine drug test or alcohol breath test at screening or predose
             in period 1. The drug screens will include amphetamines / methamphetamines,
             methylenedioxymethamphetamine, benzodiaze-pines, barbiturates, cocaine, cannabis,
             tricyclic antidepressants, methadone and opiates.

          -  Subject is a smoker, cannot refrain from being around second hand smoke 24 hours prior
             to maxadilan dosing, or uses nicotine-containing products. Ex-smokers should have
             ceased smoking at least 6 months prior to screening. Nonsmokers will be confirmed by
             negative urinary cotinine tests at screening and predose period 1.

          -  Subject has any of the following vital sign measurements at screening: Heart Rate <40
             or >100 beats/min, Diastolic Blood Pressure <50 or >89 mmHg, Systolic Blood Pressure
             <90 or >139 mmHg, Temperature <35 or >37.4 degrees Celsius, Respiration rate <7 or >25
             R/min.

          -  Subject has any significant ECG abnormality.

          -  The subject has a positive prestudy human immunodeficiency virus-1/2 antibodies
             (HIV-1/2Ab), Positive Hepatitis B Surface Antigen (HepBsAg) (indicative of chronic
             Hepatitis B) or detectable Hepatitis C virus Ribonucleic acid (RNA) by Polymerase
             Chain Reaction (PCR) (indicative of active Hepatitis C - screening is generally done
             by Hepatitis C Antibody (HepCAb), followed by Hepatitis C virus RNA by PCR if HepCAb
             is positive) result at screening.

          -  Subject has been involved in testing an investigational drug in another clinical study
             within the last 4 weeks.

          -  Subject is in a situation or has a condition which, in the opinion of the
             investigator, may interfere with optimal participation in the study.
Male
Accepts Healthy Volunteers
Subject must be at least 18 Years old.
Subject must be at most 45 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? Contradiction