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GSK961081 for infusion · 1 trial · 1 indication
The following PK parameter will be measured: Area under the concentration-time curve from time zero (pre-dose) extrapolated to infinite time (AUC\[0 inf\])
The following PK parameter will be measured: Area under the concentration-time curve from time zero (pre-dose) to last time of quantifiable concentration (AUC\[0-t\]).
The following PK parameter will be measured: maximum observed plasma concentration (Cmax)
The following PK parameter will be measured: time of occurrence of Cmax (Tmax)
The following PK parameter will be measured: terminal phase half-life (t1/2)
| Arm | Type | Description |
|---|---|---|
| [14C]-GSK961081 IV+GSK961081 inhalation; [14C]-GSK961081 oral | EXPERIMENTAL | On Day 1 of Treatment Period 1, after an overnight fast of at least 8 hours, each subject will receive \[14C\] GSK961081 4 micrograms (mcg) by IV infusion over 1 hour. Within 5 minutes after the start of infusion, subjects will take 1200 mcg non-radiolabelled GSK961081 by inhalation. After Treatment Period 1, there will be a washout of at least 2 weeks. On Day 1 of Treatment Period 2, after an overnight fast of at least 8 hours, each subject will take 200 mcg \[14C\]-GSK961081 as an oral solution. |
| Name | Type | Description |
|---|---|---|
| [14C]-GSK961081 solution for IV infusion | DRUG | Subjects will receive 10 mL of solution equivalent to 4 mcg of \[14C\]-GSK961081 (approximately 6.2 kilobecquerel \[kBq\]) intravenously as a single dose over 1 hour. |
| [14C]-GSK961081 oral solution | DRUG | Subjects will receive 10 mL of solution equivalent to 200 mcg of \[14C\]-GSK961081 (approximately 311 kBq) orally as a single dose with up to 250 mL of water. |
| GSK961081 dry powder for inhalation | DRUG | Subjects will receive single dose of 4 actuations of 300 mcg GSK961081 per actuation (1200 mcg GSK961081 total) as inhalation immediately after the start of infusion. |
Inclusion Criteria: * Between 30 and 55 years of age inclusive, at the time of signing the informed consent. * Healthy as determined by the investigator or medically qualified designee based on a medical evaluation including medical history, physical examination, vital signs, laboratory tests, and ...
GSK961081 for infusion is an investigational small molecule being developed by Theravance Biopharma, Inc. (TBPH) for the treatment of chronic obstructive pulmonary disease (COPD). It is currently in Phase 1 clinical development, meaning it is still being studied in early-stage trials and is not yet approved for any use.
GSK961081 for infusion is being studied for use in chronic obstructive pulmonary disease (COPD). It is an investigational small molecule in Phase 1 development, intended to address this respiratory condition. As of now, it has not been approved by regulatory authorities, and its safety and efficacy are still being evaluated in clinical trials.
GSK961081 for infusion is being developed by Theravance Biopharma, Inc., a biopharmaceutical company traded under the ticker symbol TBPH. The drug is an investigational small molecule in Phase 1 clinical development for chronic obstructive pulmonary disease (COPD).
GSK961081 for infusion is in Phase 1 clinical development. It is an investigational small molecule being studied for chronic obstructive pulmonary disease (COPD). The drug has completed one Phase 1 trial, but it remains in early-stage development and is not yet approved for commercial use.
GSK961081 for infusion has been studied in one completed Phase 1 clinical trial, identified as NCT02663089. This was a single-dose study in healthy male subjects aged 30 years and older, conducted in the United Kingdom, to evaluate the drug's absorption, distribution, metabolism, and excretion (ADME). The trial enrolled 6 participants.