ArticleClinical pharmacology in drug development2015
An open-label clinical trial of the effects of age and gender on the pharmacodynamics, pharmacokinetics and safety of the ghrelin receptor agonist anamorelin.
Article in Clinical pharmacology in drug development, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 9 papers, 1 of them a synthesis that pooled it.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
9 citing papers in PubMed, 1 synthesis or guideline pooled it, 17 citations in OpenAlex.
- Anamorelin for cancer anorexia-cachexia syndrome: a systematic review and meta-analysis.Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer · 2017Pooled it
- Appetite and food intake results from phase I studies of anamorelin.Journal of cachexia, sarcopenia and muscle · 2019Trial
- ROMANA 3: a phase 3 safety extension study of anamorelin in advanced non-small-cell lung cancer (NSCLC) patients with cachexia.Annals of oncology : official journal of the European Society for Medical Oncology · 2017Trial
- The Role of Ghrelin and Ghrelin Signaling in Aging.International journal of molecular sciences · 2017Review
- Anamorelin hydrochloride in the treatment of cancer anorexia-cachexia syndrome: design, development, and potential place in therapy.Drug design, development and therapy · 2017Review
- Unlocking the wasting enigma: Highlights from the 8th Cachexia Conference.Journal of cachexia, sarcopenia and muscle · 2016Article
- The times they are a-changin': the Cachexia Conference goes annual.Journal of cachexia, sarcopenia and muscle · 2016Article
- Anamorelin hydrochloride for the treatment of cancer-anorexia-cachexia in NSCLC.Expert opinion on pharmacotherapy · 2015Review
- Anamorelin and Conduction Defects: A Literature Review and Analysis of the Japanese Pharmacovigilance Database.In vivo (Athens, Greece)Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
4 authors at 3 institutions in 2 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
purposeTo assess the effect of age and gender on the pharmacokinetics (PK) of the ghrelin receptor agonist anamorelin.
methodsThree demographic cohorts of healthy subjects were enrolled in this single-center, open-label study. Subjects received a single oral dose (25 mg) of anamorelin HCl. Serial blood samples were collected over 24 hours to assess anamorelin PK and circulating growth hormone (GH) levels. Data were compared with a reference cohort.
resultsAnamorelin was rapidly absorbed in all cohorts; peak concentrations were observed 30-45 minutes and 2-4 hours post-dose, which declined biexponentially with mean terminal half-lives of 6-7 hours. An age effect on C
conclusionsWhile PK parameters do suggest higher exposure in females, this effect is considered to be modest given the variability of the 6-8 subjects per cohort. Moreover, no such effect was observed in the pharmacodynamic responses, thus, dose adjustment for age and gender is considered unnecessary.
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.