| Eligibility |
Inclusion Criteria:
1. Willing to participate in the trial, give written informed consent, and comply with
the trial restrictions.
2. Gender: male or female with a negative serum pregnancy test (ß-human chorionic
gonadotropin) at Screening and Day -1; females may be of childbearing potential or of
non-childbearing potential.
3. Age >= 18 years at screening
Exclusion Criteria:
1. Female who is pregnant, lactating, or at risk of becoming pregnant during this trial.
2. History of hypersensitivity or allergy to tebipenem or its derivatives and any
ß-lactam antibiotic.
3. History of hypersensitivity to lidocaine or lidocaine derivatives.
4. Concurrently receiving sodium valproic acid or valproate derivatives.
5. Concurrently receiving probenecid.
6. Body Mass Index (BMI) = 35 kg/m2
7. Creatinine clearance (CrCl) < 50ml/min, as calculated by Cockcroft-Gault using ideal
body weight
8. Presence of anemia, thrombocytopenia, or leukopenia as defined by hematocrit,
platelet, or white blood cell count < 75% of the lower limit of normal
9. Aspartate transaminase, alanine aminotransferase, or alkaline phosphatase greater than
five times upper limit of normal.
10. Total bilirubin greater than three times the upper limit of normal.
11. Any known active co-morbidity listed on medical history i.e., seizures or that becomes
apparent during physical examination.
12. Positive urine drug screen (cocaine, Tetrahydrocannabinol, opiates, benzodiazepines,
and amphetamines).
13. History of regular alcohol consumption exceeding 7 drinks/week for females or 14
drinks/week for men (1 drink = 5 ounces of wine or 12 ounces of beer or 1.5 ounces of
hard liquor) within 6 months of screening.
14. Use of tobacco- or nicotine-containing products in excess of the equivalence of 5
cigarettes per day.
15. Consumption of caffeine within 3 days of the study.
16. Use of prescription or nonprescription drugs, vitamins, or dietary supplements within
7 days or 5 half-lives, whichever is longer (with the exception of acetaminophen at
doses of = 1 g/day). The use of hormonal methods of contraception (including oral and
transdermal contraceptives, injectable progesterone, progestin subdermal implants,
progesterone-releasing intrauterine devices, post-coital contraceptive methods) is
permitted.
17. Males who are not surgically sterilized (with female partners of childbearing
potential) and females of childbearing potential who do not agree to use two highly
effective methods of contraception from screening, during this trial, and for 90 days
after the last dose of study drug.
18. History or current presence of nasal structural abnormalities including a broken nose
or deviated septum.
19. Employee of the Center for Anti-Infective Research and Development, Clinical Research
Center, or the Sponsor.
20. Any other documented reason felt by the investigator to potentially affect the
outcomes of the study.
|
