Repeat doses of BAY1817080 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 volunteers to assess safety and tolerability of ascending repeated oral doses of BAY 1817080, followed by (Part 2), two-way crossover administration of four different doses in patients with refractory chronic cough to assess safety, tolerability and efficacy for proof of concept
IRAS ID
230709
Contact name
Bo Guo
Contact email
Sponsor organisation
Bayer AG
Eudract number
2017-001620-22
Duration of Study in the UK
1 years, 0 months, 11 days
Research summary
This study will investigate the safety and tolerability of repeated doses of BAY 1817080 in healthy male volunteers (Part 1) and, for the first time, efficacy data obtained in patients suffering from refractory chronic cough (Part 2).
Part 1 of the study is a randomised, placebo controlled, double blind, parallel-group design with repeated doses of BAY 1817080 or placebo administered over 2 weeks. In each dose cohort (10 mg, 50 mg, 200 mg or 750 mg BAY 1817080) 12 subjects will be included (9 receiving active, 3 receiving placebo). Dosing will start with the lowest dose of 10 mg and escalation to each higher dose of BAY 1817080 will only take place according to specified rules after review of safety, tolerability and PK data from the preceding dose.
Part 2 of the study is two-arm cross-over design with repeated doses of BAY 1817080 or placebo (4 times dose and 2 times placebo) administered over two periods (period A, period B) of 3 weeks each with a 3 to 4-week wash-out period between the two periods. The patients will be randomised to a treatment sequence of either period A/period B, or period B/period A (cross-over principle).
REC name
London - West London & GTAC Research Ethics Committee
REC reference
17/LO/1103
Date of REC Opinion
23 Nov 2017
REC opinion
Further Information Favourable Opinion