Pharmacokinetic Study of CXB909 in Healthy Male Subjects

NCT01505907 | Unknown Phase 1 DMC

• 1 other identifier: CXB909-100
• Study Type: interventional
• Target: 40
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Healthy

Keywords

Pharmacokinetics; Safety; Healthy Males

Outcome Measures

Primary Outcomes (1)

• Pharmacokinetic Parameters

  The PK parameters to be determined will include: Tmax, t1/2, Cmax, AUClast, AUCinf, Vd/F and CL/F.

  1 Week

Secondary Outcomes (1)

• Safety

  1 Week

Study Arms (5)

CXB909 15mg

EXPERIMENTAL

CXB909 15mg

Drug: CXB909

CXB909 30mg

EXPERIMENTAL

Drug: CXB909

CXB909 60mg

EXPERIMENTAL

Drug: CXB909

CXB909 120mg

EXPERIMENTAL

Dose

Drug: CXB909

CXB909 250mg

EXPERIMENTAL

Drug: CXB909

Interventions

CXB909 DRUG

CXB909

CXB909 120mg; CXB909 15mg; CXB909 250mg; CXB909 30mg; CXB909 60mg

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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 \< 30.
• Willing and able to be confined to the clinical research unit as required by the protocol.

You may not qualify if:

• 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 CXB909.
• 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).
• History of substance abuse, including alcohol abuse as defined by DSM-IV criteria,within the past 12 months.
• Current use of tobacco products or any nicotine-containing products (e.g., gum, patch)for the prior three months.
• Consumption of alcohol or caffeine/xanthine-containing drinks or foods within 72 hours of dosing on Day 1 (including any type of wines, caffeinated or decaffeinated herbal tea, and grapefruit products (e.g., fresh, canned, or frozen), Seville oranges and pomelos).
• Abnormal screening medical/physical examination, unless the abnormality is considered unlikely to be affected by study participation, or confound interpretation of safety data.
• A clinically significant clinical laboratory or EKG abnormality at screening; includes any of the following: aspartate transaminase (AST), alanine transaminase (ALT), or alkaline phosphate (ALP) \>2.0 x the upper limit of normal (ULN); total bilirubin \>1.5 x the ULN;serum creatinine \>1.5 x the ULN; blood urea nitrogen (BUN) \>1.5 x the ULN; and thyroid stimulating hormone (TSH) and/or free thyroxine (T4) outside of the normal limits.

Sponsors & Collaborators

• CeNeRx BioPharma Inc.: lead

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 5, 2012
• First Posted: January 9, 2012
• Study Start: December 1, 2012
• Primary Completion: December 1, 2013
• Study Completion: December 1, 2014
• Last Updated: January 9, 2012

Record last verified: 2012-01