Rare diseases
Investigational molecules
Locations
Tetracycline hydrochloride BP is an antibiotic belonging to the tetracycline class of medicines. The full chemical name is 4-(Dimethylamino)-1,4,4a,5,5a,6,11,12a-octahydro-3,6,10,12,-12a-pentahydroxy-6-methyl-1,11-dioxo-2-naphthacenecar-boxamide monohydrochloride.[2] It is classified as a tetracycline antibiotic with the ATC code J01AA07.[3] The substance is authorised as a medicine in the UK under authorisation record XI PL 33414/0110, held by Chelonia Healthcare Limited.[1] Other names for the same substance include achromycin, tetracycline phosphate complex, and tetracycline HCl.[4]
Tetracycline is primarily bacteriostatic, meaning it stops bacteria from multiplying rather than killing them directly. It exerts its antimicrobial effect by inhibiting protein synthesis: the drug binds to the 30S ribosomal subunit of bacteria, which prevents them from producing the proteins they need to grow.[2] Tetracycline is active against a broad range of gram-negative and gram-positive organisms. The drugs in the tetracycline class have closely similar antimicrobial spectra, and cross-resistance among them is common.[2] In the registered trial, tetracycline plays a different role: it is used as an auxiliary medicine to label bone, because tetracycline binds to newly formed bone and can be detected later, helping researchers measure bone formation.[1]
Tetracycline hydrochloride BP is available as hard capsules for oral use. The product used in the registered trial is Tetracycline Capsules 250 mg, given orally at a dose of 500 mg.[1] The US product information describes capsules of 250 mg and 500 mg tetracycline hydrochloride for oral administration.[2] An oral solution formulation also exists, containing 125 mg of tetracycline per 5 ml (25 mg per ml).[3]
One registered clinical trial in the EU Clinical Trials Information System involves tetracycline hydrochloride BP. The trial, titled "Repurposing Everolimus to enhance musculoskeletal Vitality and Ageing in The Elderly (RENOVATE)", is a Phase 2 interventional study with 120 participants.[1] It is currently authorised and investigates healthy elderly people with stable medical conditions. The main drug being studied is everolimus (Afinitor 5 mg tablets), while tetracycline capsules serve as an auxiliary medicine to label bone for measuring bone formation.[1] The primary outcome is the change in serum bone formation marker P1NP, a protein fragment released when new bone is made.[1] The brief summary states the aim is to investigate whether everolimus prevents age-related bone loss by enhancing bone formation, improving muscle function, and reducing the burden of biological mechanisms of ageing in elderly persons.[1]
The US product information for tetracycline hydrochloride capsules warns that the drug should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria, to reduce the development of drug-resistant bacteria.[2] The provided sources do not list specific adverse reactions for tetracycline hydrochloride in this context.
Recruiting trials first
Tell us about your condition – we search every trial in Europe and connect you with the right site.
