« Return to News | Clinical Intelligence

Arena posts phase I trial results

Wednesday, July 13, 2011 10:17 AM

Arena Pharmaceuticals has announced results from a phase I clinical trial of APD811, an orally bioavailable agonist of the prostacyclin receptor intended for the treatment of pulmonary arterial hypertension, or PAH.

The randomized, double-blind, placebo-controlled trial evaluated the safety, tolerability and pharmacokinetics of 0.03mg, 0.05mg, 0.1mg and 0.2mg single doses of APD811. The trial evaluated 32 healthy volunteers in four cohorts of eight participants each—six randomized to APD811 and two to placebo. APD811 was rapidly absorbed and demonstrated dose-proportional pharmacokinetic exposure over the tested dose range. The terminal half-life was approximately 20 hours.

The most frequent treatment-emergent adverse events were headache, vomiting, nausea, jaw pain and flushing. Dose-limiting adverse events of nausea and vomiting occurred at the 0.2mg dose. As compared to placebo, heart rate trended higher at the 0.05mg, 0.1mg and 0.2mg doses and the corrected QT (QTc) interval trended higher at the 0.1mg and 0.2mg doses. Arena believes the QTc observation is not supported by pre-clinical data and will further evaluate this in future studies. No serious adverse events were reported.

"We are encouraged by the results of this early-stage clinical trial that suggest APD811 has the potential for once-daily oral dosing, and our next step will be to evaluate the safety, tolerability and pharmacokinetics of multiple dosing and the optimal titration schedule in a phase Ib trial," said William R. Shanahan, M.D., Arena's senior vice president and Chief Medical Officer.

Share:          
CLINICAL TRIAL RESOURCES

Search:

NEWS ONLINE ARCHIVE

Browse by:

CWWeekly

December 17

Medici Global says its Alzheimer's Facebook page demonstrates the need for more early detection trials

Analysts: Expect more equity purchases of CROs in 2013

Already a subscriber?
Log in to your digital subscription.

Subscribe to CWWeekly.

The CenterWatch Monthly

January 2013

Parexel celebrates 30 years of change, growth
CRO's founder and chairman reflects on challenges of the past, present and future

Strategies for increasing patient diversity in trials
Sponsors look to improve racial, ethnic recruitment without going overseas

Already a subscriber?
Log in to your digital subscription.

Purchase the January issue.

Subscribe to The CenterWatch Monthly.

December 2012

Publicity, regulation tightening reins on use of KOLs
Debate rages over need to revamp how sponsors use, pay medical experts

Time may be right to makeover the investigator brochure
Size, complexity prevent critical document from being thoroughly read

Already a subscriber?
Log in to your digital subscription.

Purchase the December issue.

Subscribe to The CenterWatch Monthly.

JobWatch centerwatch.com/jobwatch

Featured Jobs

More Jobs

 

Copyright © 1995-2013 CenterWatch.