J Clin Pharmacol
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First published on March 17, 2009, doi:10.1177/0091270008330160

The Journal of Clinical Pharmacology 2009;49:553.

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©© 2009 American College of Clinical Pharmacology, Inc.
The Journal of Clinical Pharmacology, 10.1177/0091270008330160

Article

Effect of Food on the Pharmacokinetics and Pharmacodynamics of an Oral Ghrelin Agonist (ARD-07) in Healthy Subjects

Carol M. MacLean 1, Anna-Tina Casanova 2, Luisa Baselgia-Jeker 2, Nicola Neave 1, Finn Larsen 1, Laurence Skillern 1, Juergen Drewe 2, and Christoph Beglinger 2*

1 Ardana Bioscience Ltd, Edinburgh, United Kingdom
2 University Hospital, Basel, Switzerland

* To whom correspondence should be addressed. E-mail: beglinger{at}tmr.ch.


  Abstract
ARD-07 (also known as EP01572) is a peptidomimetic growth hormone secretagogue that can be administered orally. The primary objective of this study is to determine the effects of a meal on the oral bioavailability of ARD-07 after a single oral dose (0.5 mg/kg). In addition, the pharmacodynamic effects (growth hormone release, insulin-like growth factor-1 concentrations) and the tolerability of ARD-07 are investigated in this open-label, randomized, crossover study. Sixteen healthy subjects (8 males, 8 females) receive ARD-07 on 2 different days; the treatment consists of a single oral dose of ARD-07 (0.5 mg/kg body weight), once with and the second day without a test meal. Plasma kinetics of ARD-07 and pharmacodynamic effects are quantified by specific assays. Results are given as mean ± SEM: The area under the curve for 0 to 24 hours is approximately twice as high without food (27.8 ± 4.1) than with food (13.7 ± 1.2; P = .002). The maximum observed ARD-07 concentration relative to dose administration (Cmax) is more than twice as high without food (10.6 ± 1.6 ng/mL) than with food (4.4 ± 0.5 ng/mL; P = .001). Cmax of growth hormone occurs at a significantly (P = .001) later stage with food (Cmax = 13.0 ± 3.5 ng/mL) than without food (37.1 ± 5.3 ng/mL). Food has a marked effect on the absorption of ARD-07: there is a significant difference in bioavailability between administration of oral ARD-07 with and without food.
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