Renal excretion is a minor elimination route of telotristat etiprate. So this trial is intended to assess the drug behaviour in subjects with decreased renal function. This is a staged study with Part B contingent upon the results of Part A. Part A will enrol a total of 16 subjects, eight with severely impaired renal
The purpose of the protocol is to assess the pharmacokinetics, safety and tolerability of a single dose of telotristat etiprate in subjects with various stages of hepatic impairment compared to healthy control subjects.
This study will be conducted to support the registration of the lanreotide Autogel 120 mg formulation in China for the treatment of GEP-NETs and treatment of clinical symptoms of NETs. The study will include a screening period of up to 4 weeks followed by a 48-week intervention period. After completion of the main study period,
The purpose of the protocol is to assess the efficacy of the triptorelin 6 month PR (Prolonged Release) formulation in suppressing LH (Luteinising hormone) levels to prepubertal levels (defined as a peak LH ?5 IU/L) after i.v. GnRH (Gonadotropin-releasing Hormone) stimulation at Month 6 (Day 169) in Chinese children with CPP (Central Precocious Puberty).
The purpose of this study is to observe whether the Triptorelin pamoate 15mg (3-month formulation) effectiveness in Chinese population of CPP children has the same or similar trend with that in overseas CPP population. This is measured by assessing the proportion of children who have a suppressed Luteinizing Hormone (LH) response to Gonadotropin Releasing Hormone
The main aim of this study will be to assess the effectiveness and safety of the 6-month formulation of triptorelin pamoate in Chinese participants. Participants will have locally advanced and advanced cancer of the prostate. Prostate cancer is cancer that forms in tissues of the prostate (a gland in the male reproductive system). Advanced prostate
To assess the efficacy of triptorelin pamoate prolonged release (PR) 3-month formulation in Chinese female subjects with endometriosis by demonstrating the non-inferiority of triptorelin pamoate PR 3-month formulation injected once as compared to triptorelin acetate PR 1-month formulation injected 3 times consecutively.
This study will evaluate the effects of food on how much test drug is able to access the circulation and reach the target area (known as bioavailability). The test drug, elafibranor (IPN60190), is in development for the treatment of primary biliary cholangitis (PBC). PBC is a rare, long-term autoimmune disease of the liver. An autoimmune
This study is intended to measure the blood levels of Elafibranor and one of its metabolites in Japanese and non-Asian Healthy Participants, to be able to compare how the body absorbs, distributes, and eliminates Elafibranor after Repeat Administration, in order to support inclusion of Japanese patients in the planned clinical studies with elafibranor.
This Phase 1 study is part of the global development plan, which includes plans to seek marketing approval of IPN60170 in Japan and China. The Japan Pharmaceuticals and Medical Devices Agency (PMDA) and the National Medical Products Administration (NMPA) in China request that the full pharmacokinetic (PK) profile of a new drug entity be assessed