Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 2:28 AM
Ignite Modification Date:
2025-12-25 @ 2:28 AM
NCT ID:
NCT02020434
Eligibility Criteria:
Inclusion Criteria:
1. Males and females aged 18 through 80 years of age
2. Willing to abstain from alcohol for 48 hours prior to dosing through discharge
3. Normal volunteer first matched by age (± 10 years), BMI (± 20%), and gender to the mean values of the moderate renal insufficiency group.
4. Have negative test results for HBsAg, anti-HCV antibody and anti-HIV antibody.
5. Voluntarily consent to participate in the study
6. Sexually abstinent or agree to use two approved methods of contraception.
7. Assessment of renal insufficiency for assignment to study groups will be based on measurements of eGFR calculated by the MDRD equation at the Screening Visit to determine eligibility.
Exclusion Criteria:
1. Unstable or new medical conditions (e.g., cardiovascular, respiratory, hepatic, renal, gastrointestinal, autoimmune, endocrine, or neurological disorders)
2. Hypersensitivity or idiosyncratic reaction to β-lactam antibiotics (e.g. penicillins, cephalosporins, or carbapenems)
3. History of clinically significant seizures, head injury, or meningitis.
4. Current evidence or history of malignancy, excluding basal cell carcinoma, in the 2 years prior to Day -1 with no evidence of recurrence.
5. Females who are pregnant, lactating, or have a positive pregnancy test
6. Previously received any dose of Carbavance (RPX2014/RPX7009).
7. Current participation in another investigational study or participation in another investigational clinical study within 30 days prior to the Screening Visit.
8. Blood donation or significant blood loss (i.e., \> 500 mL) within 56 days prior to Day 1.
9. Plasma or platelet donation within 14 days prior to Day -1.
10. Any acute illness requiring antibiotic drug therapy within 30 days prior to Day 1 or a febrile illness within 7 days prior to Day 1.
11. Vigorous exercise from 48 hours prior to Day -1 until the day of discharge from the study.
12. Positive urine drug/alcohol test at the Screening Visit or Day -1
13. Concurrent use of medications known to affect the elimination of serum creatinine (e.g., trimethoprim/sulfamethoxazole \[Bactrim®\] or cimetidine \[Tagamet®\]) and competitors of renal tubular secretion (e.g., probenecid) within 30 days prior to the first dose of study drug
14. Abnormal and clinically significant findings on physical examination, medical history, serum chemistry, hematology, or urinalysis
15. Use of any other prescription or nonprescription drugs, vitamins, grapefruit/grapefruit juice or dietary or herbal supplements within 14 days prior to Day -1.
1. Oral contraceptives are permitted for birth control.
2. Acetaminophen (≤ 1 g/day) and low-dose ASA (i.e., ≤ 325 mg per day) are permitted.
16. Currently receives hemodialysis or peritoneal dialysis.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT02020434
Study Brief:
Protocol Section:
NCT02020434