Gram-negative pathogens producing serine &beta
Conditions
Interventions
Ceftibuten will be given as oral capsules with 240 milliliters (mL) of water.
Whether subjects will receive ceftibuten or placebo will be determined by
chance. Per group, 9 volunteers will receive
Sponsors
Venatorx Pharmaceuticals, Inc.
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 1. Willing to participate in the trial, give written informed consent, and comply with the trial restrictions. 2. Gender: male or female; females may be of childbearing potential (using highly effective contraception) with a negative serum pregnancy test, or of nonchildbearing potential, at screening and Day 1. 3. Age: 18 to 55 years, inclusive, at screening. 4. Body mass index (BMI): >=18.5 kg/m2 and
Exclusion criteria
Exclusion criteria: 1. Employee of the CRO, CRC, or the Sponsor. 2. Female (or male with a partner) who is pregnant, lactating, or planning to attempt to become pregnant during this study or within 90 days after the last administration of study drug. 3. Use of any investigational drug or device within 30 days prior to screening (90 days for an injectable biological agent). Participation in more than 4 other drug studies in the 12 months prior to the first drug administration in the current study. 4. Congenital or acquired immunodeficiency syndrome. 5. History or presence of current cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, autoimmune, hematologic, neoplastic, or neurologic disorders or any other disease that, in the opinion of the Investigator, poses an unacceptable risk to the subject. Further criteria apply
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To evaluate the safety of increasing doses of oral ceftibuten (at and beyond the currently approved dose level) in healthy adult volunteers. Safety will be evaluated by the collection of adverse events (AEs), vital signs, clinical laboratory data, electrocardiograms (ECGs), and physical examinations. | — |
Secondary
| Measure | Time frame |
|---|---|
| To evaluate the pharmacokinetics (PK) of increasing doses of ceftibuten (cis- and trans-) following single and multiple doses in healthy adult volunteers as measured by plasma and urine drug concentrations. | — |
Countries
Netherlands
Outcome results
None listed