A study in healthy men to find the best formulation for once daily intake of Nintedanib (QSC204583)
Research type
Research Study
Full title
A Phase I study for formulation selection and subsequent optimization of two different oral formulations of Nintedanib in healthy male subjects (open-label, randomised, single-dose study in three parts)
IRAS ID
1004315
Contact name
Elmar Daalman
Contact email
Sponsor organisation
Boehringer Ingelheim Pharma GmbH & Co. KG
Eudract number
2021-003152-16
Clinicaltrials.gov Identifier
Research summary
The Sponsor is developing the test medicine, Nintedanib, for the treatment of fibrosing interstitial lung diseases (ILD). ILD is a group of autoimmune lung disorders that cause scarring of the lungs, which makes it difficult to breath. Nintedanib works by reducing fibrogenesis (scarring) in the lung tissue of ILD patients.
This three part healthy volunteer study will look at how different recipes of the test medicine are taken up by the body compared to the reference product, in order to find the best recipe.
This study will take place at one non-NHS site, enrolling up to 59 male volunteers aged between 18 to 55 years (inclusive).
In Part 1, 2 groups of 15 volunteers will receive 3 doses of Nintedanib on 3 separate occasions (Day 1). One group will receive 2 doses of one recipe and the reference. The other will receive 2 doses of the other recipe and the reference. Volunteers will be discharged on Day 4, with at least 14 days washout between doses.
Part 2 is optional and will follow the same design as Part 1 but with one group of 15 volunteers. One recipe will be selected from Part 1 and optimised.
Part 3 is optional. 14 volunteers will be given 2 doses on 2 separate occasions. One dose will be the selected recipe, and one dose will be reference product, both given once per day.
Volunteer’s blood and urine samples will be taken throughout the study for analysis of the test medicine and for their safety.
Volunteers involved in Part 1 & 2 of the study are expected to be involved in the study for approximately 11 weeks from screening to the follow up visit.
Volunteers involved in Part 3 of the study are expected to be involved for approximately 10 weeks.REC name
HSC REC B
REC reference
22/NI/0038
Date of REC Opinion
21 Feb 2022
REC opinion
Favourable Opinion