A Randomized, Double-blind, Placebo-controlled, Sequential group, Dose-escalation Study to Evaluate the Safety and Pharmacokinetics of Single and Repeat Doses of Ceftibuten Administered Orally for 10 days in Healthy Adult Volunteers

Completed

Conditions: Gram-negative pathogens producing serine &beta
lactamases
serious infections
10004018

Registration Number: NL-OMON49030

Lead Sponsor: Venatorx Pharmaceuticals, Inc.

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 36

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 <= 30.0 kg/m2.
5. Normal blood pressure, defined as a systolic value greater than or equal to
90 mm Hg and less than 140 mm Hg and a diastolic value greater than or equal to
45 mm Hg and less than 90 mm Hg (screening and Day -1).

Further criteria apply

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

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>To evaluate the safety of increasing doses of oral ceftibuten (at and beyond<br /><br>the currently approved dose level) in healthy adult volunteers. Safety will be<br /><br>evaluated by the collection of adverse events (AEs), vital signs, clinical<br /><br>laboratory data, electrocardiograms (ECGs), and physical examinations.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>To evaluate the pharmacokinetics (PK) of increasing doses of ceftibuten (cis-<br /><br>and trans-) following single and multiple doses in healthy adult volunteers as<br /><br>measured by plasma and urine drug concentrations.</p><br>