Navigation Links
Intravenous (IV) Administration of Cempra Pharmaceutical's Solithromycin (CEM-101) Demonstrates Excellent Systemic Tolerability in a Phase 1 Clinical Trial
Date:5/7/2011

CHAPEL HILL, N.C., May 7, 2011 /PRNewswire/ -- Cempra Pharmaceuticals, a developer of differentiated antibiotics, today announced an oral presentation showing that intravenous (IV) solithromycin demonstrates excellent tolerability and a favorable pharmacokinetic (PK) profile at IV doses up to 800 mg.  Oral administration of solithromycin also showed excellent tolerability in previously reported Phase 1 studies.  The presentation will be at the 21st European Congress of Clinical Microbiology and Infectious Diseases (ECCMID)/27th International Congress of Chemotherapy (ICC), May 7 to 10, 2011, in Milan, Italy.  Cempra will also present additional in vitro activity data on both of the company's clinical candidates, solithromycin and TAKSTA (CEM-102 or fusidic acid).

Solithromycin IV Phase 1 Study

The Phase 1 study (Abstract O-95) was a single-center, randomized, double-blind, placebo-controlled dose-escalation study in healthy volunteers.  Forty-two subjects were enrolled in the single ascending dose portion of the study and divided into seven dose cohorts of 25, 50, 100, 200, 400 and 800 mg of solithromycin and placebo.  Subjects were monitored for 48 hours post-dose for safety and PK assessments.

There were no serious adverse events or clinically significant laboratory abnormalities.  The drug candidate demonstrated a favorable PK profile in single doses up to 800 mg and achieved clinically relevant plasma concentrations of about 4 micrograms/mL.  Intravenous exposure was 1.3 to three fold higher than that observed with equivalent oral doses.

"Solithromycin is currently in
'/>"/>

SOURCE Cempra Pharmaceuticals
Copyright©2010 PR Newswire.
All rights reserved

Page: 1 2 3 4 5 6 7

Related medicine technology :

1. Marshall Edwards Announces Publication of Phase II Clinical Trial Results Highlighting Activity of Intravenous Phenoxodiol
2. New Model Provides Insights Into Intravenous and Subcutaneous Immunoglobulin Pharmacokinetics in Patients With Primary Immunodeficiencies
3. Jennerex and Transgene Announce Initiation of Clinical Trial of Intravenous JX-594 in Patients With Refractory Metastatic Colorectal Cancer
4. Reportlinker Adds Global Intravenous (IV) Iron Drugs Industry
5. Hospira to Standardize Intravenous (I.V.) Administration Sets Portfolio to Non-DEHP
6. Reportlinker Adds Intravenous Equipment - A World Market Intelligence Report
7. Cadence Pharmaceuticals Announces FDA Extends New Drug Application Review for Intravenous Acetaminophen by Three Months
8. Iontophoretic Drug Delivery System (IDDS) Containing Lidocaine and Epinephrine is Effective in Reducing Pain Associated With Insertion of an Intravenous Catheter in a Phase 2 Clinical Trial
9. Calixa Therapeutics Announces Positive Phase 1 Results for CXA-101, a Novel Intravenous Cephalosporin Antibiotic with Excellent Anti-Pseudomonal Activity
10. Pivotal Phase III Data Confirm the Efficacy and Safety of Arpidas Intravenous Iclaprim in Treating Patients With Complicated Skin and Skin Structure Infections
11. Jennerex Completes the Treatment of First Patient Cohort in Phase 1 Trial With Intravenous Delivery of JX-594 Oncolytic Virus
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:1/14/2014)... Jan. 14, 2014  Luminex Corporation (Nasdaq: LMNX ) ... fourth quarter of 2013 on Monday, February 3, 2014. A ... the close of trading. (Logo: http://photos.prnewswire.com/prnh/20100104/LUMINEXLOGO ... discuss the operating highlights and financial results for the fourth ...
(Date:1/14/2014)... , Jan. 14, 2014 /PRNewswire-iReach/ -- Acumed,s new ... targeting guide with accompanying instrumentation to place and insert ... to the soft tissue (e.g. ligament) repair or reconstruction ... repair heals. (Photo: http://photos.prnewswire.com/prnh/20140114/MN45636 ) ...
(Date:1/14/2014)... , Jan. 14, 2014   Oligomerix, Inc. , a ... therapeutics for Alzheimer,s disease (AD) and related neurodegenerative disorders, ... Valhalla, NY as of January ... space at New York Medical College. Oligomerix, ...
Breaking Medicine Technology:Luminex Corporation Fourth Quarter Earnings Release Scheduled for February 3, 2014 2Luminex Corporation Fourth Quarter Earnings Release Scheduled for February 3, 2014 3Acumed introduces the Scapho-Lunate Inter Carpal (SLIC) Screw System 2Acumed introduces the Scapho-Lunate Inter Carpal (SLIC) Screw System 3Oligomerix Relocates Corporate Headquarters and Secures Additional Laboratory Space from New York Medical College 2
... Mich., Dec. 3 Stryker Corporation (NYSE: SYK ) ... to repurchase up to $750 million of its common stock. ... by the Company,s management based on their evaluation of market conditions, ... considerations. Purchases may be made from time to time in ...
... CAMBRIDGE, Mass., Dec. 3, 2009 Raytheon BBN Technologies, a ... has licensed its patented, award-winning stereo digital mammography (SDM) technology ... SDM technology with the Aspire HD FFDM system. Combined with ... stereo images for 3-D viewing. FUJIFILM will display the Raytheon ...
Cached Medicine Technology:Stryker Announces $750 Million Share Repurchase Program and Declares a $0.15 Per Share Quarterly Dividend 2Raytheon BBN Technologies Licenses Stereo Digital Mammography Technology to FUJIFILM Corporation 2Raytheon BBN Technologies Licenses Stereo Digital Mammography Technology to FUJIFILM Corporation 3
(Date:4/17/2014)... PHILADELPHIA The presence of chronic inflammation in ... aggressive, prostate cancer, and this association was found ... levels, according to a study published in ... of the American Association for Cancer Research. , ... some participants of the placebo arm of the ...
(Date:4/17/2014)... the most popular vaccine brands for children may not ... overlooking some cost factors when choosing vaccines, driving the ... according to a new study by University of Illinois ... be driven by numerous factors," says Sheldon H. Jacobson, ... computer science and of mathematics at the U. of ...
(Date:4/17/2014)... Two recent papers by a University of Colorado ... scientists develop treatments or vaccines for Dengue fever, ... other disease-causing flaviviruses. , Jeffrey S. Kieft, PhD, ... the School of Medicine and an early career ... colleagues recently published articles in the scholarly journals ...
(Date:4/17/2014)... personnel who served in Iraq and Afghanistan and ... (TBI) were compared to military personnel without TBI ... in measures of overall disability, cognitive function, post-traumatic ... reported in an article in Journal of ... Liebert, Inc., publishers. The article is available free ...
(Date:4/17/2014)... CHICAGO, IL, April 17, 2014-- Colic affects about one ... accounts for numerous pediatric visits during the first several ... of colic symptoms was showing promise; however, the April ... (BMJ2014;348:g2107; Sung, Valerie) reported on a study, "Probiotics ... probiotic L reuteri for infant colic ...
Breaking Medicine News(10 mins):Health News:Chronic inflammation may be linked to aggressive prostate cancer 2Health News:Chronic inflammation may be linked to aggressive prostate cancer 3Health News:Study recalculates costs of combination vaccines 2Health News:CU researchers discover target for treating dengue fever 2Health News:Long-term effects of battle-related 'blast plus impact' concussive TBI in US military 2Health News:New study says probiotic use for infant colic is not effective in reducing symptoms 2
... Losing weight can help reduce your risk of cancer if ... effective in lowering that risk, an expert says. Diets ... changes in eating habits and also provide a variety of ... clinical dietitian in the clinical nutrition department at the University ...
... Urinary tract infections are common in women, costing an ... in the United States alone. These infections frequently ... A depletion of vaginal lactobacilli, a type of ... suggests that replenishing these bacteria may be beneficial. Researchers ...
... , cancer scientists Ana Soto and Carlos Sonnenschein pit their ... cancer against the widely accepted Somatic Mutation Theory (SMT) in ... theories have formally opposed each other championed by authors ... forum for discussion. Soto and Sonnenschein, from Tufts University, ...
... , THURSDAY, April 14 (HealthDay News) -- ... target the new organ can develop accelerated narrowing of ... may lead to organ rejection. That,s the finding ... kidney biopsies from 99 kidney transplant patients -- 40 ...
... a statin before having major elective surgery reduces potentially ... an upcoming issue of the Journal of the ... than 230 million major elective surgeries are performed around ... develop kidney injury soon after surgery, often due to ...
... , Thursday, April 14 (HealthDay News) -- Just as the ... world,s languages also originated there and spread across the globe, ... analyzed the phonemes -- distinct units of sound that differentiate ... pattern mirrors that of human genetic diversity. As humans ...
Cached Medicine News:Health News:A Good Diet Includes Many Cancer-Fighting Foods: Expert 2Health News:Statins may protect against kidney complications following elective surgery 2Health News:Human Language Origins Traced to Africa, Study Finds 2
PDA formatted guide containing outlines and detailed information on the diagnosis and treatment of HIV infection and AIDS....
PDA version of the best-selling guide....
PDA application contains 15,000+ ICD-9-CM Diagnosis codes....
More than 200 key diagnostic and treatment tables culled from Tierney's Current Medical Diagnostics and Treatment 2003....
Medicine Products: