Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT02551653 | Positron Emission Tomography (PET) Study to Evaluate Biodistribution of [11C]-GSK2256098 in Healthy Subjects and Idiopathic Pulmonary Arterial Hypertension (PAH) Patients | PHASE1 | COMPLETED | 10 | — | — | Nov 17, 2015 | Mar 14, 2017 | Nov 14, 2018 | 2 | United Kingdom |
The PET scan was acquired to measure the uptake of radiolabeled GSK2256098 in the heart and lungs, assessed as the volume of distribution (VT). The analysis was performed on Safety Population which comprised of all participants who received a microdose of study treatment.
The PET scan was acquired to measure the uptake of radiolabeled GSK2256098 in the heart and lungs, assessed as the mean standardized uptake value (SUV) averaged over the 60 minute period between 30 and 90 minutes. The analysis was performed on Safety Population which comprised of all participants who received a microdose of study treatment.
| Arm | Type | Description |
|---|---|---|
| [11C]-GSK2256098 | EXPERIMENTAL | Subjects will receive single IV bolus injection of \[11C\]-GSK2256098 over about 30 seconds. Each unit dose will contain up to 500 millibecquerel (MBq) of \[11C\]-GSK2256098 with maximum \[11C\]-GSK2256098 mass \<=10 microgram (mcg). |
| Name | Type | Description |
|---|---|---|
| [11C]-GSK2256098 500 MBq | DRUG | \[11C\]-GSK2256098 injection will be provided as IV infusion, 20 mL, containing up to 5% ethanol in saline. |
Inclusion Criteria: Inclusion criteria for healthy volunteers \- Healthy subjects enrolled between 40 to 70 years inclusive at the time of signing the informed consent. Healthy subjects will be recruited to be age (+/-5 years) and gender matched to idiopathic PAH patients. * Healthy as determined...