A FIH study to investigate the safety, tolerability and PK of P218
Research type
Research Study
Full title
A Phase I study to investigate the safety, tolerability and pharmacokinetic profile and food effect of P218 in healthy adult volunteers
IRAS ID
207755
Contact name
Ulrike Lorch
Contact email
Sponsor organisation
Medicines for Malaria Venture
Eudract number
2016-001933-29
Duration of Study in the UK
0 years, 6 months, 29 days
Research summary
We are conducting a first-in-human clinical study for P218 in healthy males and females of non-childbearing potential. P218 is being developed for treatment of malaria. \nIt is thought that P218 will be effective for the treatment of pyrimethamine P. falciparum resistant strains of malaria. \nThe main aim of the study is to determine the safety profile of the P218 is and how much of it is in the blood and urine (pharmacokinetics) after administration. \nWe will study the safety profile of P218 by assessing ECGs, clinical laboratory samples (blood and urine) and vital signs (blood pressure, heart rate etc.). \nIn both Part A and B we will assess; (1) the levels of P218 (and its breakdown product) in the blood; (2) the effects of P218 on the levels of folate (i.e. folic acid) in blood; and (3) identification of genetic factors which may predict the response of treatment with P218.\nIn Part A, 64 subjects (8 subjects in 8 cohorts) will receive single ascending doses of P218 (or placebo). In this part we will also assess (1) how safe and how well tolerated each dose of P218 is when given as a single, oral dose under fasted conditions; and (2) the cardiac safety of P218. \nIn Part B, the food effect on P218 will be studied. Eight subjects in one cohort will each receive a single dose in both fed, (a high-fat FDA approved breakfast), and fasted states. In this part we will also assess (1) how food will affect the levels of P218 when given as a single, oral dose; and (2) the effect of P218 acyl glucuronide against Plasmodium parasite (the parasite that causes malaria) and determine if other breakdown products of P218 are present and active against Plasmodium. \n
REC name
South Central - Berkshire B Research Ethics Committee
REC reference
16/SC/0375
Date of REC Opinion
4 Aug 2016
REC opinion
Further Information Favourable Opinion