Prolonged stimulation of growth hormone (GH) and insulin-like growth factor I secretion by CJC-1295, a long-acting analog of GH-releasing hormone, in healthy adults.
CJC-1295 administration resulted in sustained increases in GH and IGF-I levels in healthy adults without serious adverse reactions.
Where it sits
this study against the rest of the cjc-1295 without dac (modified grf 1-29) corpusSummary and findings
This study measured the pharmacokinetic and pharmacodynamic effects of CJC-1295, a long-acting GHRH analog, in healthy adults. Participants received ascending doses of CJC-1295 or placebo over a duration of 28 to 49 days. The results indicated sustained increases in GH and IGF-I levels without serious adverse reactions.
Abstract
Context Therapeutic use of GHRH to enhance GH secretion is limited by its short duration of action. Objective The objective of this study was to examine the pharmacokinetic profile, pharmacodynamic effects, and safety of CJC-1295, a long-acting GHRH analog. Design The study design was two randomized, placebo-controlled, double-blind, ascending dose trials with durations of 28 and 49 d. Setting The study was performed at two investigational sites. Participants Healthy subjects, ages 21-61 yr, were studied. Interventions CJC-1295 or placebo was administered sc in one of four ascending single doses in the first study and in two or three weekly or biweekly doses in the second study. Main outcome measures The main outcome measures were peak concentrations and area under the curve of GH and IGF-I; standard pharmacokinetic parameters were used for CJC-1295. Results After a single injection of CJC-1295, there were dose-dependent increases in mean plasma GH concentrations by 2- to 10-fold for 6 d or more and in mean plasma IGF-I concentrations by 1.5- to 3-fold for 9-11 d. The estimated half-life of CJC-1295 was 5.8-8.1 d. After multiple CJC-1295 doses, mean IGF-I levels remained above baseline for up to 28 d. No serious adverse reactions were reported. Conclusions Subcutaneous administration of CJC-1295 resulted in sustained, dose-dependent increases in GH and IGF-I levels in healthy adults and was safe and relatively well tolerated, particularly at doses of 30 or 60 microg/kg. There was evidence of a cumulative effect after multiple doses. These data support the potential utility of CJC-1295 as a therapeutic agent.
Background
Not reported in abstract.
Methods
Not reported in abstract.
Results
Not reported in abstract.
Interpretation
Not reported in abstract.
Limitations
Not reported in abstract.