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

From the Clinical Research Center, Department of Biomedicine (Ms Casanova, Ms Baselgia-Jeker, Dr Beglinger) and Division of Gastroenterology (Dr Beglinger), University Hospital, Basel, Switzerland; Ardana Bioscience Ltd, Edinburgh, United Kingdom (Dr MacLean, Ms Neave, Dr Larsen, Dr Skillern); and Department of Clinical Pharmacology, University Hospital, Basel, Switzerland (Dr Drewe).

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 (C_max) 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). C_max of growth hormone occurs at a significantly (P = .001) later stage with food (C_max = 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.

Key Words: Ghrelin • growth hormone • humans • pharmacokinetics • pharmacodynamics

Address for reprints: Christoph Beglinger, MD, Department of Gastroenterology, University Hospital, CH-4031 Basel, Switzerland.

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