ADME study of IV 14C-Uproleselan in Healthy Subjects (QCL117752)
Research type
Research Study
Full title
An Open Label, Single-Dose, Single-Period Study Designed to Assess the Mass Balance Recovery, Metabolite Profile and Metabolite Identification of 14C-Uproleselan (GMI-1271) Administered via the Intravenous Route to Healthy Subjects
IRAS ID
245722
Contact name
Helen Thackray
Contact email
Sponsor organisation
GlycoMimetics, Inc.
Eudract number
2018-001154-95
Duration of Study in the UK
0 years, 1 months, 5 days
Research summary
The Sponsor, GlycoMimetics, Inc., is developing the test medicine uproleselan (GMI-1271) as an intravenous (IV) medicine (a solutions administered directly into the vein) to treat cancer. Uproleselan is being evaluated as a treatment for acute myeloid leukemia (AML) or multiple myeloma (MM). These are forms of cancer that involve the bone marrow and blood.
The study will try to identify the amount of radioactivity found in blood, urine and faecal samples after a single IV radiolabelled dose of the test medicine is given to healthy volunteers. ‘Radiolabelled’ means that the test medicine has a radioactive component which helps us to track where the medicine is in the body. Samples of blood, urine and faeces will be taken throughout the study to look at the concentrations of the radiolabelled drug.
The study will also aim to provide blood, urine and faecal samples to look at the breakdown products (metabolites) of the test medicine and to find out the structure of these products.
The study will consist of a single part involving up to 6 healthy male volunteers. The 6 volunteers will each receive a single IV dose of 800 mg test medicine in the fasted state. Blood, urine and faecal samples will then be collected at regular intervals from each volunteer who will be resident in the clinical unit for up to 10 days. It is planned that volunteers will be on site for 8 days, unless they do not reach the required recovery limits.
REC name
London - Hampstead Research Ethics Committee
REC reference
18/LO/1232
Date of REC Opinion
17 Jul 2018
REC opinion
Favourable Opinion