Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
GSK961081 · 3 trials · 1 indication
Pre-dose change in AM FEV1 on day 29 vs baseline . (defined as the mean values recorded 11 and 12 hours after the PM dose on day 28)
Plasma samples for PK analysis were drawn on Day (D) 1 at indicated time points. The AUC from time zero (0M) to 2h (AUC 0-2) was area under the plasma concentration-time curve over the 2h time period. AUC(0-6) was area under the plasma concentration-time curve from 0M to 6h. AUC(0-t) was area under the plasma concentration-time curve from 0M to last quantifiable concentration. The AUC extrapolated to infinity (inf) (AUC\[0-inf\]) was calculated as the sum of AUC(0-t) and Ct/lambda z, where Ct is the observed GSK961081 concentration obtained from the log-linear regression analysis of the last quantifiable time-point and lambda z is the terminal phase rate constant estimated by linear regression analysis of the log transformed concentration-time data. The number of time points used in the estimation of lambda z. Different participants may have been analyzed at different time points; thus, the overall number of participants analyzed reflects everyone in the PK population.
Plasma samples for PK analysis were drawn on D1 at indicated time points. The first occurrence of the maximum observed GSK961081 concentration determined directly from the raw concentration-time data after each single dose. All participants were present at the time of measurement.
Plasma samples for PK analysis were drawn on D1 at indicated time points. The t-last and t-max was determined directly from the raw concentration-time data after each single dose. The t-half was obtained as the ratio of ln2/lambda z, where ln(2) is the natural logarithm of 2 (approximately 0.693) and lambda z is the terminal phase rate constant estimated by linear regression analysis of the log transformed concentration-time data after each single dose. Data for adjusted mean is presented as least square mean. Only those participants available at the specified time points were analyzed (represented by n=x,x,x in the category titles). Different participants may have been analyzed at different time points; thus, the overall number of participants analyzed reflects everyone in the All Subjects population.
Lung function tests (FEV1) was recorded whilst the participant was in a sitting position (if taken whilst the participant was on the bed, their legs should be over the edge). All lung function tests was repeated, until three technically acceptable measurements were made. Each measurement should be done at least 1 M apart. Participants must be resting in the body box for at least 30 seconds prior to any assessments. The FEV1 was measured at 15, 30 M, 1, 4, 12 and 24 h post dose of each treatment period on D1 and 14. Data for adjusted mean is presented as least square mean. Only those participants available at the specified time points were analyzed (represented by n=x,x,x,x in the category titles). Different participants may have been analyzed at different time points; thus, the overall number of participants analyzed reflects everyone in the All Subjects population. Data for adjusted mean is presented as least square mean.
Blood samples will be collected to estimate the area under the concentration-time curve from zero (pre-dose) to last common time of quantifiable concentration across all treatments for an analyte where t'=common time AUC(0-t') of GSK961081 following concurrent administration of GSK961081 and fluticasone furoate via DPI in comparison to GSK961081 DISKUS
| Arm | Type | Description |
|---|---|---|
| GSK961081 100 mcg QD | EXPERIMENTAL | - |
| GSK961081 100mcg BD | EXPERIMENTAL | - |
| GSK961081 200mcg QD | EXPERIMENTAL | - |
| GSK961081 400mcg QD | EXPERIMENTAL | - |
| GSK961081 400mcg BD | EXPERIMENTAL | - |
| GSK961081 800mcg QD | EXPERIMENTAL | - |
| Salmeterol 50mcg BD | ACTIVE_COMPARATOR | - |
| Placebo | PLACEBO_COMPARATOR | - |
| GSK961081 | OTHER | GSK961081 |
| Sequence 1 | EXPERIMENTAL | Participants will receive the study treatment in the following order: ABFCED in each period (one per period). Where A=GSK961081 administered from DISKUS, B=GSK961081 Single strip (SS) administered from DPI, C=GSK961081 Dual Strip (DS) administered from DPI with a filled (lactose) second strip (DS configuration), D=GSK961081/fluticasone furoate (GSK961081/FF) administered from DPI (GSK961081 higher dose), E=FF DS administered from DPI with a filled (lactose) second strip (dual strip configuration), F=GSK961081/FF administered from DPI (GSK961081 lower dose). |
| Sequence 2 | EXPERIMENTAL | Participants will receive the study treatment in the following order: BCADFE in each period (one per period) |
| Sequence 3 | EXPERIMENTAL | Participants will receive the study treatment in the following order: CDBEAF in each period (one per period) |
| Sequence 4 | EXPERIMENTAL | Participants will receive the study treatment in the following order: DECFBA in each period (one per period) |
| Sequence 5 | EXPERIMENTAL | Participants will receive the study treatment in the following order: EFDACB in each period (one per period) |
| Sequence 6 | EXPERIMENTAL | Participants will receive the study treatment in the following order: FAEBDC in each period (one per period) |
| Name | Type | Description |
|---|---|---|
| GSK961081 | DRUG | Comparison of different doses and dosing regimens of the drug |
| Salmeterol | DRUG | Positive control |
| Placebo | DRUG | Placebo arm |
| Fluticasone furoate | DRUG | Dry white powder |
Inclusion Criteria: * Outpatient Subjects * Subjects who give their signed and dated informed consent to participate * 40 or more years of age, inclusive, at Visit 1 * Male or females * Subjects with an established clinical history of COPD * Current or previous cigarette smokers with a history of ≥...
GSK961081 is an investigational small molecule being developed for the treatment of chronic obstructive pulmonary disease (COPD). It has been studied in Phase 2 clinical trials for this respiratory condition, with completed studies evaluating its efficacy, safety, and tolerability in patients with COPD.
GSK961081 is being developed by GSK plc, a pharmaceutical company listed on the stock exchange under the ticker symbol GSK. The company has sponsored multiple clinical trials to investigate the drug's potential in treating chronic obstructive pulmonary disease.
GSK961081 is in Phase 2 clinical development for chronic obstructive pulmonary disease. It has completed three clinical trials, including two Phase 2 studies and one Phase 1 study. The drug is investigational and has not been approved by regulatory authorities.
GSK961081 has been studied in three completed clinical trials: NCT00478738, a Phase 2 study in healthy volunteers and COPD patients; NCT01319019, a Phase 2 dose-ranging study in COPD patients; and NCT02064504, a Phase 1 pharmacokinetic study. These trials enrolled a total of 567 participants.
No, GSK961081 is not the same as fluticasone furoate. However, a clinical trial (NCT02064504) studied the pharmacokinetics of GSK961081 and fluticasone furoate when administered alone or in combination, suggesting they may be used together in COPD treatment.