Clinical trial: Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of WCK 5107 Alone and in Combination With Cefepime (NCT02532140)

Eligibility criteria:
Inclusion Criteria:

          1. Male or female, 18-55 years of age (both inclusive).

          2. Have a body mass index of 18-30 kg/m2 (both inclusive) calculated as weight
             (kg)/height (m2).

          3. Medical history without any major pathology/surgery in the last 6 months prior to
             screening.

          4. Resting supine blood pressure of 90-139 (systolic)/40-89 (diastolic) mmHg and a
             resting pulse rate of 40-100 beats per minute.

          5. Calculated creatinine clearance ≥80 mL/min

          6. Computerized 12-lead ECG recording without signs of clinically significant pathology
             and showing no clinically significant deviation as judged by the Principal
             Investigator.

          7. Males willing to use double-barrier contraceptive measures and to not donate sperm
             until 90 days after the follow-up visit.

          8. Females should not be pregnant or breast feeding (pregnancy will be confirmed by a
             urine pregnancy test at screening with confirmation by a serum pregnancy test at
             admission) or of non-childbearing potential at screening.

          9. Females must be either post-menopausal for at least 1 year, surgically sterile
             (bilateral oophorectomy or hysterectomy), or practicing 1 of the acceptable methods of
             birth control.

        Exclusion Criteria:

          1. History/evidence of clinically relevant pathology.

          2. History of clinically significant food or drug allergy, including known
             hypersensitivity to cefepime or any other related drugs.

          3. A positive screen result for drugs of abuse/alcohol at admission to the study center.

          4. Use of prescription medications (with the exception of oral contraceptives and hormone
             replacement therapy) including nonsteroidal anti-inflammatory drugs or sucralfate or
             herbal preparations.

          5. Positive screen result for hepatitis B, hepatitis C, or human immunodeficiency virus
             at screening.

          6. Any strenuous activity within 4 days prior to admission to the study center. Strenuous
             being defined as any hard labor or exercise outside of a subject's usual behavior.

          7. History of blood donation of more than 500 mL in the last 2 months prior to screening.

          8. Current use or has used tobacco- or nicotine-containing products.
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 55 Years

Patient description (medical language): A 63-year-old man comes to the clinic for recent unintentional weight loss. The patient also has epigastric discomfort after meals. He has no known medical problems and takes no medications. His blood pressure is 130/75 and pulse rate is 88/min. He is not febrile. Upper endoscopy shows a lesion in the stomach that shows typical features of diffuse-type adenocarcinoma presenting with signet ring cells that do not form glands.

Patient description (patient's own words): I went to the clinic because I had been losing so much weight that it was concerning. I'm a 63-year-old guy, and it is something rather unusual. I'm always suffering from stomachache after every meal. I've never been sick, and I don't take any medicine. The doctor took my blood pressure and told me it was 130/75, and my pulse rate was 88/min. I'm not febrile! I also had to do an endoscopy, and they found a lesion in my stomach that shows typical features of stomach cancer. I'm totally devastated...

Does the patient match the trial criteria? 0