Repeat doses of BAY1902607 in healthy males & PoC in chronic cough pts
Research type
Research Study
Full title
Two-part, double-blind, placebo-controlled, randomized, parallel-group study: (Part 1) in healthy male subjects to assess safety and tolerability of ascending repeated oral doses of BAY 1902607 including its effect on the pharmacokinetics of a sub-therapeutic dose of midazolam (MDZ), followed by (Part 2) a two-way crossover administration of four different doses of BAY 1902607 in patients with refractory chronic cough to assess safety, tolerability and efficacy for proof of concept
IRAS ID
242717
Contact name
Tatjana Gust
Contact email
Sponsor organisation
Bayer AG
Eudract number
2018-000129-29
Duration of Study in the UK
0 years, 11 months, 31 days
Research summary
This study will investigate the safety and tolerability of ascending repeated oral doses of BAY 1902607 in healthy subjects plus the effect of BAY 1902607 on the pharmacokinetics (PK) of a sub-therapeutic 1 mg dose of midazolam (Part 1). This study will also investigate the safety, tolerability and efficacy of BAY 1902607 in patients with refractory chronic cough (Part 2).
Part 1 of the study is a randomized, placebo-controlled, double-blind, sequential parallel-group design with repeated doses of BAY 1902607 or placebo administered over 2 weeks. In each dose cohort 12 subjects will be included (9 receiving active, 3 receiving placebo). 4 different ascending doses will be administered in the study. Dosing will start with the lowest dose; escalation to each higher dose of BAY 1902607 will only take place according to specified rules after review of safety, tolerability and PK data from the preceding dose group.
In each dose group, subjects will also receive a sub-therapeutic dose of midazolam on Day -1 and Day 13 allowing an intraindividual comparison of the drug-drug interaction for subinduction of midazolam.Part 2 of the study is two-arm crossover design with repeated doses of BAY 1902607 or placebo administered over two periods (Period A, Period B) of 16 days each, with a 3- to 4-week washout period between the two periods. In Period A, the 4 ascending doses of BAY 1902607 will be given (each dose for 4 days); in Period B, the matching placebo doses will be administered. The patients will be randomized to a treatment sequence of either Period A-Period B or Period B-Period A (crossover principle).
REC name
North West - Greater Manchester Central Research Ethics Committee
REC reference
18/NW/0098
Date of REC Opinion
8 May 2018
REC opinion
Further Information Favourable Opinion