Track topics on Twitter Track topics that are important to you
The purpose of this study is to quantify the magnitude of the effect of itraconazole co-administration on the PK of savolitinib. The exposure to savolitinib is predicted to increase when co-administered with the potent CYP3A4 inhibitor itraconazole since CYP3A4 (via CYP450) is involved in the elimination of savolitinib.
This study will be an open-label, 3-period, fixed-sequence study in healthy male subjects conducted at a single study centre.
The study will comprise:
A screening period of maximum 28 days;
- Three treatment periods:
- Treatment Period 1 consists of 15 days with admission on Study Day -1, followed by a single dose administration of savolitinib on Study Day 1, followed by a washout period of at least 14 days. Subjects will be discharged from the study centre on Day 3, after the last PK sample is collected.
- Treatment Period 2 consists of 4 days with admission on Study Day 14, followed by itraconazole administration for 3 days (200 mg BID on Study Day 15, 200 mg QD on Study Days 16 and 17).
- Treatment Period 3 consists of 3 days, starting immediately after the end of Treatment Period 2, comprising of single dose administration of savolitinib (200 mg) on Study Day 18 and itraconazole administration (200 mg QD) on Study Day 18 and 19. The subjects will be discharged from the study centre on Study Day 20 after the last PK sample.
- The Follow-up Visit will occur at least 14 days after the last dose of savolitinib in Treatment Period 3.
- Subjects will be admitted to the study centre on 2 different occasions: Day -1 (Study Day -1) to Day 3 (Study Day 3) of Treatment Period 1 and Day-1 (Study Day 14) of Treatment Period 2 to Day 3 (Study Day 20) of Treatment Period 3.
The study drugs will be administered as follows:
- Treatment Period 1: Single administration of savolitinib (200 mg) will occur on Study Day 1 after a high-fat, high-calorie breakfast followed by PK sampling for 48 hours.
- Treatment Period 2: Itraconazole will be administered (200 mg BID) on Study Day 15, and (200 mg QD) on Study Days 16 and 17, 1 hour before breakfast (and before dinner, when applicable).
- Treatment Period 3: A single combination of itraconazole (200 mg) 1 hour before breakfast + savolitinib (200 mg) after a high-fat, high-calorie breakfast on Study Day 18, and a single dose of itraconazole (200 mg) on Study Day 19, 1 hour before breakfast.
Each subject will be involved in the study for up to 60 days.
Not yet recruiting
Published on BioPortfolio: 2019-10-16T10:39:37-0400
This study is being carried out to see if the drugs MEDI4736, Savolitinib and Tremelimumab can be used alone or in combination to reduce the size of tumours in patients with kidney cancer....
This is a phase I, open-label, 3 treatment period, fixed-sequence study in healthy non-Japanese vasectomized male subjects, aged 18 to 55 years or healthy non-Japanese male subjects over 4...
This is a single-center, randomized, open lebal, single-dose, three-period, crossover clinical study in healthy Chinese male subjects to assess the pharmacokinetics and bioequivalence/bioa...
This study (the SAVANNAH study) will investigate the efficacy of osimertinib in combination with savolitinib in patients with EGFRm+ and MET+, locally advanced or metastatic NSCLC who have...
Two-part phase 1B clinical trial combining cextuximab and savolitinib for treating Ras wild-type colorectal cancer (CRC). Part 1 will assess the safety and tolerability of this drug combin...
Hydroxypropyl methylcellulose acetate succinate (HPMCAS) has gained popularity as a carrier for amorphous solid dispersion (ASD) because of its ability to maintain drugs in supersaturated state after ...
A brain tumour is amongst most devastating and challenging condition to overcome with suitable treatment as the drug has to cross the blood-brain barrier (BBB) with several physiological barriers like...
Immunotherapeutic strategies have revolutionised cancer therapy in recent years, bringing meaningful improvements in outcomes for patients with previously intractable conditions. These successes have,...
In order to evaluate the susceptibility profile of itraconazole in light of the new cut-off points, we analyzed in vitro and clinical data. The in vitro activity of itraconazole was compared with that...
We report a case of solid papillary carcinoma (SPC) of the breast, of which the cytologic findings of the nipple discharge and the fine needle aspiration (FNA), and the pathology of the resected tumou...
One of the triazole ANTIFUNGAL AGENTS that inhibits cytochrome P-450-dependent enzymes resulting in impairment of ERGOSTEROL synthesis. It has been used against histoplasmosis, blastomycosis, cryptococcal meningitis & aspergillosis.
Garbage, refuse, or sludge, or other discarded materials from a wastewater treatment plant, water supply treatment plant, and air pollution control facility that include solid, semi-solid, or contained material. It does not include materials dissolved in domestic sewage, irrigation return flows, or industrial discharges.
Fractionation of a vaporized sample as a consequence of partition between a mobile gaseous phase and a stationary phase held in a column. Two types are gas-solid chromatography, where the fixed phase is a solid, and gas-liquid, in which the stationary phase is a nonvolatile liquid supported on an inert solid matrix.
The action by which the surface of a liquid where it contacts a solid is elevated or depressed, because of the relative attraction of the molecules of the liquid for each other and for those of the solid. (McGraw-Hill Dictionary of Scientific and Technical Terms, 4th ed)
A phenomenon in which the surface of a liquid where it contacts a solid is elevated or depressed, because of the relative attraction of the molecules of the liquid for each other and for those of the solid. (from McGraw-Hill Dictionary of Scientific and Technical Terms, 4th ed)
Within medicine, nutrition (the study of food and the effect of its components on the body) has many different roles. Appropriate nutrition can help prevent certain diseases, or treat others. In critically ill patients, artificial feeding by tubes need t...
The Top 100 Pharmaceutical Companies
Top 10 biotech and pharmaceutical companies worldwide based on market value in 2015 2015 ranking of the global top 10 biotech and pharmaceutical companies based on revenue (in billion U.S. dollars) Johnson & Johnson, U.S. 74...