A Single Dose Study in Healthy Japanese and Non-Japanese subjects
Research type
Research Study
Full title
A Single Dose Study to Evaluate the Exposure-Response Relationship between Galunisertib (LY2157299) and QT Interval in Healthy Japanese and Non-Japanese Subjects
IRAS ID
202563
Contact name
Jim Bush
Contact email
Sponsor organisation
Eli Lilly and Company
Eudract number
2015-005261-23
Clinicaltrials.gov Identifier
Duration of Study in the UK
0 years, 1 months, 25 days
Research summary
Galunisertib is an investigational medication. This is an open label (study staff and the volunteers will know which drug and dose being administered) study which enrols healthy Japanese and non-Japanese volunteers. There are two parts;
Part A - assess single 150-mg and 300-mg doses of galunisertib in healthy Japanese volunteers
Part B - assess single 150-mg and 300-mg doses of galunisertib in healthy non- Japanese volunteers.Volunteers in each part will be randomly allocated to receive either 1 (150 mg dose) or two 150 mg tablets (300 mg dose) in a 1:1 manner. In Part A, 20 Japanese volunteers will be enrolled in Cohorts 1 and 2 (150 mg and 300 mg, respectively). In Part B, 20 non-Japanese volunteers will be enrolled in Cohorts 3 and 4 (150 mg and 300 mg, respectively).
Approximately 40 volunteers may be enrolled to ensure that at least 32 volunteers (16 Japanese and 16 non-Japanese) complete the study.
Upon successful completion of a screening visit, volunteers will be admitted to the clinical research unit (CRU) on Day -1. Volunteers will fast overnight (minimum of 8 hours) beginning on the evening of Day -1. On Day 1, volunteers will begin continuous 12-lead Holter monitoring (continuous tape recording of volunteers ECG) approximately 2 hours before study drug administration and will continue until 72 hours post-dose. On Day 1, volunteers will receive a single dose of galunisertib in the fasted state. While in the CRU, volunteers will undergo assessments (including blood pressure/pulse measurements, laboratory tests, ECGs, physical examinations, and adverse event recording), and blood samples will be collected for the measurement of plasma concentrations of galunisertib
Volunteers may be discharged from the CRU on Day 4 and will return to the CRU for a follow-up assessment 7-10 days after administration of their dose of study drug.
REC name
North East - York Research Ethics Committee
REC reference
16/NE/0077
Date of REC Opinion
19 Apr 2016
REC opinion
Further Information Favourable Opinion