Please use this identifier to cite or link to this item: http://ahro.austin.org.au/austinjspui/handle/1/12512
Title: Pharmacokinetics of the ghrelin agonist capromorelin in a single ascending dose Phase-I safety trial in spinal cord-injured and able-bodied volunteers.
Authors: Ellis, A G;Zeglinski, P T;Brown, Douglas J;Frauman, Albert G;Millard, M;Furness, J B
Affiliation: Department of Medicine, University of Melbourne, Austin Health, Heidelberg, Victoria, Australia.
1] Department of Medicine, University of Melbourne, Austin Health, Heidelberg, Victoria, Australia [2] Spinal Research Institute, Royal Talbot Rehabilitation Centre, Victoria, Australia.
1] Clinical Pharmacology and Therapeutics, Austin Health, Heidelberg, Victoria, Australia [2] Department of Medicine, University of Melbourne, Austin Health, Heidelberg, Victoria, Australia.
Spinal Research Institute, Royal Talbot Rehabilitation Centre, Victoria, Australia.
1] Spinal Research Institute, Royal Talbot Rehabilitation Centre, Victoria, Australia [2] Department of Anatomy and Neuroscience, University of Melbourne, Parkville, Victoria, Australia.
Issue Date: 2-Dec-2014
Citation: Spinal Cord 2014; 53(2): 103-8
Abstract: Single centre, single ascending dose study.To compare the pharmacokinetics and assess the safety of capromorelin, a compound that has potential to treat constipation following spinal cord injury (SCI), in groups of able-bodied and SCI volunteers.Local population from Victoria, Australia.Following initial screening and baseline blood collections, participants received ascending oral doses (20, 50 and then 100 mg at least 1-week apart) of capromorelin after pre-dose blood collection, followed by blood collections over the following 12 h for pharmacokinetic analysis and 1-week and 4-week follow-up blood collections for safety evaluations. Blood pressure and heart rate were monitored.No serious adverse events were recorded following any dose in either the able-bodied group or the SCI group. There were no abnormal blood pressure or heart rate changes. Minor adverse events resolved quickly without the need for treatment. Pharmacokinetic behaviour was broadly similar between groups, with both exhibiting dose-dependent increases in Cmax and AUC0-∞. The SCI participants showed greater variance in pharmacokinetic parameters and had a slightly delayed Tmax and half-life.Capromorelin at the doses tested was safe and well tolerated in both SCI and able-bodied participants and also showed similar pharmacokinetics with dose-dependent increases in concentration and drug exposure.
Internal ID Number: 25448190
URI: http://ahro.austin.org.au/austinjspui/handle/1/12512
DOI: 10.1038/sc.2014.218
URL: http://www.ncbi.nlm.nih.gov/pubmed/25448190
Type: Journal Article
Appears in Collections:Journal articles

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