Clinical trial: Absorption, Distribution, Metabolism and Excretion (ADME) Study of BMS-986020 (NCT02068053)

Eligibility criteria:
For more information regarding BMS clinical trial participation, please visit
        www.BMSStudyConnect.com

        Inclusion Criteria:

          -  Healthy male subjects as determined by no clinically significant deviation from normal
             in medical history, physical examination, ECGs, and clinical laboratory determinations

          -  Body weight of at least 50 kg (110 lbs), Body mass index (BMI) of 18.0 to 32.0 kg/m2,
             inclusive. Body mass index = weight (kg)/[height(m)]2

          -  Men, ages 18 to 50 years, inclusive

          -  Men who are sexually active with women of childbearing potential (WOCBP) (except those
             with vasectomy with documented azoospermia 90 days after procedure) must agree to
             follow instructions for method(s) of contraception for the duration of treatment plus
             5 half-lives of the investigational drug (4 days) plus 90 days (duration of sperm
             turnover) for a total of 94 days post-treatment completion

        Exclusion Criteria:

          -  Any significant acute or chronic medical illness

          -  Current or recent (within 3 months of study drug administration) gastrointestinal
             disease

          -  Current or recent history of constipation or irregular bowel movements (less than once
             per 2 days)

          -  Any major surgery within 4 weeks of study drug administration

          -  Any gastrointestinal surgery that could impact upon the absorption of study drug,
             including cholecystectomy

          -  History of Gilbert's Syndrome

          -  Donation of blood or plasma to a blood bank or in a clinical study (except a screening
             visit) within 4 weeks of study drug administration (within 2 weeks for plasma only)

          -  Blood transfusion within 4 weeks of study drug administration

          -  Inability to tolerate oral medication

          -  Inability to be venipunctured and/or tolerate venous access

          -  Recent (within 6 months of study drug administration) history of smoking

          -  Evidence of organ dysfunction or any clinically significant deviation from normal in
             physical examination, vital signs, ECGs, or clinical laboratory determinations beyond
             what is consistent with the target population

          -  History of allergy to LPA1 antagonists or related compounds
Male
Accepts Healthy Volunteers
Subject must be at least 18 Years old.
Subject must be at most 50 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