QT study to evaluate single oral doses of BI 1015550 (QSC301328)
Research type
Research Study
Full title
Thorough QT study to evaluate the effects of BI 1015550 as single doses following oral administration on cardiac safety parameters (double-blind, randomized, placebo-controlled, five-period crossover, with open-label moxifloxacin as positive control) in healthy male and female subjects
IRAS ID
1008273
Contact name
Kapilkumar Undaviya
Contact email
Sponsor organisation
Boehringer Ingelheim Ltd
Clinicaltrials.gov Identifier
Research summary
The Sponsor is developing the test medicine, BI 1015550, for the potential treatment of Idiopathic Pulmonary Fibrosis (IPF) and other forms of progressive pulmonary fibrosis. IPF is a condition in which the lungs become scarred, making it increasingly difficult to breathe. In people with IPF the tiny sacs of air found in their lungs, known as alveoli, become damaged which can cause scarring on the alveoli making it difficult for oxygen to pass through them into the blood.
This one part, 5 period healthy volunteer study will try to identify the effect of different doses of the test medicine on the heart rhythm as well as the safety and tolerability of the test medicine. Furthermore, moxifloxacin is a marketed medicine used in the treatment of various infections and is associated with prolonging an aspect of the heart’s rhythm when given at doses of 400 mg. Moxifloxacin will be given to volunteers in one treatment period to act as a positive control for heart rate assessments.
This study will take place at one non-NHS site, enrolling up to 45 male and female volunteers aged between 18-50.
In all treatment periods volunteers will be admitted to the clinic on Day -1. In 2 periods, volunteers will receive single oral doses of the test medicine, with a different dose level in each period. In another 2 periods volunteers will receive matching placebo for each dose level to maintain the blinded cohort design. In 1 additional period, volunteers will receive a single dose of moxifloxacin. In all periods they will be dosed in the fasted state. Volunteers will be discharged on Day 2 of each period and there will be a minimum 7-day break between each dosing period. Volunteers will have a follow-up visit 7-15 days post final dose.
Volunteers blood and urine will be taken throughout the study for analysis of the test medicine and for their safety.
Volunteers are expected to be involved in this study for approximately 12 weeks from screening to the follow-up visit.
REC name
London - Harrow Research Ethics Committee
REC reference
23/LO/0726
Date of REC Opinion
3 Oct 2023
REC opinion
Further Information Favourable Opinion