Phase I, Randomized, Double-Blind, Placebo Controlled, Dose Escalation,Single Dose, Safety, Tolerance, and Pharmacokinetic Study of CXB909 in Healthy Male Volunteers

CeNeRx BioPharma Inc.0 sites40 target enrollmentDecember 2012

ConditionsHealthy

InterventionsCXB909

DrugsCXB909

Overview

Phase: Phase 1
Intervention: CXB909
Conditions: Healthy
Sponsor: CeNeRx BioPharma Inc.
Enrollment: 40
Primary Endpoint: Pharmacokinetic Parameters
Last Updated: 14 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Similar Trials

Overview

Brief Summary

The primary objective of this dose escalation study is to examine the safety, tolerability, and pharmacokinetic properties of single-doses of CXB909, compared to placebo, in healthy male volunteers. This study may evaluate five (5) dose levels of CXB909; however, the number of dose levels, as well as the dosages, may be adjusted after evaluation of in-study analysis of the safety, tolerability, and pharmacokinetic data. This study will attempt to identify the maximum tolerated single dose of CXB909.

Registry

clinicaltrials.gov

Start Date

December 2012

End Date

December 2014

Last Updated

14 years ago

Study Type

Interventional

Study Design

Single Group

Sex

Male

Investigators

Sponsor

CeNeRx BioPharma Inc.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Male, 18 to 50 years of age.
•Able to read, understand, and provide written/dated informed consent before screening in the study, and must be willing to comply with all study procedures.
•In good general health as ascertained by thorough medical history, physical examination (PE)including measurement of supine and standing vital signs, clinical laboratory studies, and 12-lead electrocardiogram (EKG).
•Body Mass Index (BMI) \> 21 and \<
•Willing and able to be confined to the clinical research unit as required by the protocol.

Exclusion Criteria

•Presence of a significant acute or chronic medical disorder that might complicate evaluation of the study drug such as:
•Any cardiovascular or cardiac condition.
•Supine SBP≥145 mmHg and/or DBP ≥90 mmHg at Screening.
•Diabetes mellitus.
•Malignancy and/or chemotherapy within two years of screening, other than basal cell carcinoma. Malignancies more than two years prior may not preclude participation; however, must be reviewed on a case-by-case basis by the CeNeRx BioPharma, Inc., medical monitor.
•Known or suspected hypersensitivity to CXB
•Any gastrointestinal disease or digestive disorder, neurological, pulmonary, hepatic, renal, hematologic, endocrine and/or metabolic disease or disorder.
•Current or past psychiatric illness.
•Use of any prescription medications within 14 days of study drug administration.
•Use of any over-the-counter (OTC) medication within seven days of study drug administration (including herbal remedies).