Topic: Respiratory
Conditions
Interventions
Baclofen, central acting GABA-B receptor agonist (mechanistic use), 40 mg, oral tablet
Placebo, 40 mg, oral tablet
Lesogaberan, peripheral acting GABA-B receptor agonist (mechanistic use), 120 mg, o
Sponsors
University Hospital of South Manchester NHS Foundation Trust (UK)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Provision of signed, written and dated informed consent, prior to any study-specific procedures 2. Aged 18 to 70 years 3. Body mass index (BMI) of between 19 and 30 kg/m2 (inclusive) and weight between 50 kg and 100 kg 4. Normal spirometry 5. Clinically normal physical findings 6. Subjects with no concurrent diseases who do not require any medication 7. Female subjects with no childbearing potential or using highly effective method of contraception for at least the previous 3 months Target Gender: Male & Female; Upper Age Limit 70 years ; Lower Age Limit 18 years
Exclusion criteria
Exclusion criteria: 1. History of any clinically significant disease or disorder, in particular no current or past history of chronic cough or respiratory disease. 2. History or presence of gastrointestinal, hepatic or renal disease 3. Any clinically significant illness, medical or surgical procedure or trauma within 4 weeks of the first administration of study medication 4. Any clinically significant abnormalities in clinical chemistry, haematology or urinalysis results Abnormal screening laboratory values in Liver Function tests 5. History of clinically significant orthostatic reaction or syncope 6. Any clinically important abnormalities in rhythm, conduction or morphology of resting ECG according to the investigator 7. Prolonged QTcF>450ms or family history of long QT syndrome
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Emax of Lesogaberan V placebo; Timepoint(s): Change in the maximal number of coughs (Emax) evoked by inhaled capsaicin | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. ED50 of Lesogaberan V placebo; Timepoint(s): Dose of inhaled capsaicin inducing at least half of maximal cough frequency (ED50) 2. Emax of Lesogaberan V Baclofen; Timepoint(s): Change in the maximal number of coughs (Emax) evoked by inhaled capsaicin | — |
Countries
United Kingdom
Outcome results
None listed