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Pharmacokinetic-pharmacodynamic modeling of ipamorelin, a growth hormone releasing peptide, in human volunteers
Plain-language summary
Paraphrased from the published abstract below — not a verdict on whether anything works.
This trial characterized the pharmacokinetics and pharmacodynamics of ipamorelin, a growth hormone releasing peptide, in healthy male volunteers using a dose-escalation design with 5 infusion rates (4.21, 14.02, 42.13, 84.27 and 140.45 nmol/kg over 15 minutes), with eight subjects at each dose level. The authors report dose-proportional pharmacokinetics, a terminal half-life of 2 hours, clearance of 0.078 L/h/kg, and a steady-state volume of distribution of 0.22 L/kg. GH stimulation appeared as a single release episode peaking near 0.67 hours with exponential decline at all doses. Using an indirect response model, they estimated the concentration for half-maximal GH stimulation at 214 nmol/L and a maximal GH production rate of 694 mIU/L/h. Inter-individual variability was larger for the pharmacodynamic than pharmacokinetic parameters.
Abstract
To examine the pharmacokinetics (PK) and pharmacodynamics (PD) of ipamorelin, a growth hormone (GH) releasing peptide, in healthy volunteers. A trial was conducted with a dose escalation design comprising 5 different infusion rates (4.21, 14.02, 42.13, 84.27 and 140.45 nmol/kg over 15 minutes) with eight healthy male subjects at each dose level. Concentrations of ipamorelin and growth hormone were measured. The PK parameters showed dose-proportionality, with a short terminal half-life of 2 hours, a clearance of 0.078 L/h/kg and a volume of distribution at steady-state of 0.22 L/kg. The time course of GH stimulation by ipamorelin showed a single episode of GH release with a peak at 0.67 hours and an exponential decline to negligible GH concentration at all doses. The ipamorelin-GH concentration relationship was characterized using an indirect response model and population fitting. The model employed a zero-order GH release rate over a finite duration of time to describe the episodic release of GH. Ipamorelin induces the release of GH at all dose levels with the concentration (SC50) required for half-maximal GH stimulation of 214 nmol/L and a maximal GH production rate of 694 mIU/L/h. The inter-individual variability of the PD parameters was larger than that of the PK parameters. The proposed PK/PD model provides a useful characterization of ipamorelin disposition and GH responses across a range of doses.
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