Clinical trial: An Open-Label, Single-Dose Study to Determine the Metabolism and Elimination of 14C-Perampanel in Healthy Male Subjects (NCT02116907)

Eligibility criteria:
Inclusion Criteria

          1. Healthy male 18 to 55 years, inclusive, at the time of informed consent

          2. Body mass index (BMI) of 18 to 30 kg/m2, inclusive, at Screening

          3. Must have had a successful vasectomy (confirmed azoospermia) or they and their female
             partners must not be of childbearing potential or must be practicing highly effective
             contraception throughout the study period and for 90 days after study drug
             discontinuation. No sperm donation is allowed during the study period and for 90 days
             after study drug discontinuation.

          4. Provide written informed consent

          5. Willing and able to comply with all aspects of the protocol

        Exclusion Criteria

          1. Participated in a 14C research study within the 6 months before Day-2. The total
             exposure from this and any previous study must be within the recommended levels
             considered safe (per 21 Code of Federal Regulations [CFR] 361.1)

          2. Exposure to clinically significant radiation within 12 months before Day-2

          3. Clinically significant illness that requires medical treatment within 8 weeks or a
             clinically significant infection that requires medical attention within 4 weeks of
             dosing
Male
Accepts Healthy Volunteers
Subject must be at least 18 Years old.
Subject must be at most 55 Years

Patient description (medical language): A 30-year-old man who is a computer scientist came to the clinic with the lab result stating azoospermia.  The patient is sexually active with his wife and does not use any contraception methods.  They have been trying to conceive for the past year with no success.  The patient has a past medical history of recurrent pneumonia, shortness of breath, and  persistent cough that produces large amounts of thick sputum. The patient had multiple lung infections during childhood. He does not smoke, use illicit drugs or alcohol.  The patient has no history of other medical conditions including allergies or any kind of surgery.  On physical examination, the digits show clubbing.  An ultrasound shows bilateral absence of the vas deferens, and FEV1 was 75% on the respiratory function test.

Patient description (patient's own words): I'm a 30-year-old computer scientist. I did some lab tests that came back quite alarming, stating that I have azoospermia?! I'm sexually active with my wife and we don't use contraception. We've been trying to have a child for the past year. I have a medical history of pneumonia and shortness of breath and regular wet cough. I had several lung infections when I was a kid. That's why I'm very careful and don't smoke, do drugs, or drink. I don't have other medical conditions including allergies or any kind of surgery. The doctor did the clubbing test on my fingers, which was positive. I also did an ultrasound and it showed that I'm missing the tubes that carry sperm around. I also had a 75% for my respiratory function test.

Does the patient match the trial criteria? Contradiction