The purpose of this clinical phase I/II study is to investigate the safety and tolerability of 177Lu-OPS201 used for the treatment of patients with neuroendocrine tumors (NETs). Secondary objectives of these study are the assessment of biodistribution, dosimetry and preliminary efficacy of 177Lu-OPS201.
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.
The purpose of this study is to evaluate safety and the way the body absorbs, distributes and gets rid of the study drug tovorafenib in the body in Japanese children, adolescents and young adults with specific brain tumours. This includes how the drug is absorbed, distributed and eliminated from the body (called pharmacokinetics). The study
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
The test treatment, IPN60170 (Mesdopetam), is in development for the treatment of levodopa -induced dyskinesia in Parkinson’s Disease. Parkinson’s Disease is a progressive nervous system condition that affects movement, caused by nerve cells in a specific area of the brain called the substantia nigra deteriorating or dying. Dyskinesia is uncontrolled or involuntary muscle movements that
This study will investigate the pharmacokinetics (PK), safety, and tolerability of IPN60170 and its metabolites in smokers and nonsmokers healthy male participants. IPN60170 is being developed as a potential treatment to reduce levodopa-induced dyskinesia (LID) and psychosis in patients with Parkinson’s Disease (PD).
The aim of this study was to learn how the highest and the total amount of fidrisertib in the blood change when taken with phenytoin or itraconazole, compared with when taken alone.