Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as GSK2339345 (solution), GSK2339345 (Inhaled) Single Dose, GSK2339345 Single Dose
GSK2339345 · 3 trials · 1 indication
Total cough count (8 hours \[hr\] of recording) was conducted at Visits 1, 2 and 3. Coughs were counted by a cough monitor fitted to the participants for 8 hr post Dose 1. The cough count was calculated as the sum of two four hour cough count totals, with the first four hours starting from the time of the first dose and the second four hours starting at the time of the second dose. The cough counts were sum-up by the treatments received by the participants. Number of coughs in 8 hr period was loge transformed and used for the analysis. Values were imputed pro-rata if 8 hr epoch was less than 8 hr. Mean of the total cough counts recorded post dose of every treatment i.e. placebo or GSK2339345 1000mcg was reported.
Total cough count (8 hr of recording) was conducted at Visits 1, 2 and 3. Coughs were counted by a cough monitor fitted to the participants for 8 hr post Dose 1. The cough count was calculated as the sum of two four hour cough count totals, with the first 4-hrs starting from the time of the first dose and the second four hours starting at the time of the second dose. The cough counts were sum-up by the treatments received by the participants. Transient cough was the total number of coughs experienced in the two mins from the start of the first inhalation of a dose. Number of coughs excluding transient cough in 8 hr period was loge transformed and used for the analysis. Values were imputed pro-rata if 8 hr epoch was less than 8 hr. Mean of the total cough counts excluding transient cough recorded post dose of every treatment i.e. placebo or GSK2339345 1000 mcg was reported.
To assess the safety and tolerability of single and repeat inhaled doses of GSK2339345 administered by an aqueous droplet inhaler.
To assess the changes in oropharyngeal sensation caused by single and repeat inhaled doses of GSK2339345 administered by an aqueous droplet inhaler.
Measured by 4 point scale, fingertip electrode assessment, sensation to water temperature, adverse events, water swallow test and assessment of gag reflex
Measurement of types of AEs reported, severity and relationship to study drug
Triplicate measurements will be taken at screening and pre-dose, single measurements at all other timepoints
24 hour Holter ECG will be taken at screening
Triplicate measurements will be taken at screening and pre-dose, single measurements at all other timepoints
To include haematology and clinical biochemistry assessments
| Arm | Type | Description |
|---|---|---|
| Part A | EXPERIMENTAL | Subjects will receive treatment A (placebo) or treatment B (GSK2339345) in 3 visits of part A (one treatment per visit) in one of the following four sequences: ABA, ABB, BAA, and BAB. |
| Part B | EXPERIMENTAL | Subjects will receive treatment A or treatment B in 2 visits of part B (one treatment per visit) in one of the following two sequences: AB and BA. Subjects will then orally inhale 10 microliter (mcL) of a capsaicin solution of strength ranging from 0.49 micromolar (mcM) to 1000 mcM, which will be administered using a breath activated dosimeter approximately 5 minutes post-dosing with treatment A or B at Visits 4 and 5. |
| Part C | EXPERIMENTAL | Subjects will receive treatment A or treatment B in 2 visits of part C (one treatment per visit) in one of the following two sequences: AB and BA. Subjects will then orally inhale 10 mcL of a citric acid solution of strength ranging from 0.03 to 4.0 M, which will be administered using a breath activated dosimeter approximately 5 minutes post-dosing with treatment A or B at Visits 6 and 7. |
| 1. Inhaled GSK2339345/Placebo Single Dose (Cohort 1) | EXPERIMENTAL | administered three ascending doses of GSK2339345 or placebo as a solution via an aqueous droplet inhaler over four treatment periods, with at least 5 days washout between doses |
| 2. Inhaled GSK2339345/Placebo Repeat Dose (Cohort 2) | EXPERIMENTAL | administered a dose of GSK2339345 or placebo, four times a day on two consecutive days. Each subject will receive either GSK2339345 or matching placebo as a solution administered via an aqueous droplet inhaler |
| GSK2339345 (solution) (part A) | EXPERIMENTAL | Part A |
| GSK2339345/ Placebo/ Lidocaine (nebulised) (part B) | EXPERIMENTAL | Part B |
| Name | Type | Description |
|---|---|---|
| GSK2339345 | DRUG | Clear colorless solution in clear glass vial for oral inhalation via aqueous droplet inhaler with unit dose strength of 1000 microgram (mcg) inhaled in two actuations. |
| Placebo | DRUG | Clear colorless solution of 0.9% sodium chloride for oral inhalation via aqueous droplet inhaler inhaled in two actuations. |
| GSK2339345 (Inhaled) Single Dose | DRUG | 250, 1000 and 2000 microgram (proposed doses) |
| Placebo (Inhaled) Single Dose | OTHER | Inhaled 0.9% sodium chloride solution |
| GSK2339345 (Inhaled) Repeat Dose | DRUG | 2000 microgram (proposed dose) administered 4 times a day for two consecutive days |
| Placebo (Inhaled) Repeat Dose | OTHER | Inhaled 0.9% sodium cholride solution |
| GSK2339345 (solution) | DRUG | 3, 6, 15, 30, 60 and 120 micrograms (proposed doses). 2 alternating cohorts of 6 subjects. Each subject to receive 3 ascending doses with washout of at least 48 hours between doses. Rinse, Gargle and Spit. |
| GSK2339345 (nebulised) | DRUG | 25, 100, 250, 1000 and 2000 micrograms (proposed doses). Subjects randomised to receive three ascending doses (with each dose given on two consecutive days). Washout of at least 6 days between treatment periods. Nebulised. |
| Placebo (0.9% sodium chloride solution) | DRUG | Administered on Day 1 of one of the treatment periods in part B. Randomised. Nebulised. |
| Lidocaine | DRUG | 40mg dose. Administered on Day 2 of one of the treatment periods in part B. Randomised. Nebulised. |
Inclusion Criteria * Chronic Idiopathic Cough patients according to the criteria listed below, determined by a responsible and experienced physician, based on a medical evaluation: Idiopathic cough defined as chronic cough resistant to treatment targeted at potential triggers. Chronic cough defined...
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| GSK plc Sponsored ADR | GSK | 2 | PHASE3 | Camlipixant |
| Trevi Therapeutics, Inc. | TRVI | 1 | PHASE2 | Haduvio (nalbuphine ER) |
GSK2339345 is an investigational small molecule developed by GSK plc for cough. It has been studied in Phase 1 and Phase 2 clinical trials conducted in the United Kingdom. The program includes three completed trials with a combined enrollment of 83 participants, and no trials are currently active.
GSK2339345 is being developed for the treatment of cough. All three of its completed clinical trials listed cough as the condition under study. It remains an investigational agent and is not an approved therapy for cough or any other indication.
GSK2339345 is developed by GSK plc, which trades under the ticker GSK. The company sponsored the clinical program evaluating the compound in cough, including Phase 1 and Phase 2 studies conducted in the United Kingdom.
GSK2339345 has reached Phase 2 in clinical development. Its Phase 2 trial, the hypertussive challenge study NCT01899768, has completed, as have its two Phase 1 studies. No trials are currently active, and the compound is investigational rather than approved.
GSK2339345 has been evaluated in three completed trials: NCT01899768, a Phase 2 hypertussive challenge study in cough with 16 participants; NCT01587716, a Phase 1 safety, tolerability and pharmacokinetics study with 36 healthy male volunteers; and NCT01494636, a Phase 1 safety, tolerability, PK and PD study with 31 healthy male subjects. All were conducted in the United Kingdom.
Yes. GSK2339345 (solution), GSK2339345 (Inhaled) Single Dose, and GSK2339345 Single Dose are alternative names used for the same investigational compound, GSK2339345. Searches using any of these names refer to the GSK plc small molecule studied in cough.