Gastroparesis Clinical Trial
Official title:
A Single Dose, Open Label, Nonrandomized, Study to Evaluate the Pharmacokinetics and Absolute Bioavailability of GSK962040 Given as an Oral Dose Simultaneously With an Intravenous Microtracer Dose of [14C]-GSK962040 in Healthy Volunteers
The purpose of this study is to determine the absolute oral bioavailability and intravenous pharmacokinetics of GSK962040. The oral dose of 50 mg has been selected because it was well tolerated following single oral administration and it is considered to be within therapeutic dose range. The need to characterize the intravenous disposition of GSK962040 is in anticipation of drug use in special populations such as critically.
GSK962040 is a selective non-peptide motilin receptor agonist which is being developed for the treatment of conditions associated with slow rates of gastric emptying. The purpose of this study is to determine the absolute bioavailability and the metabolic profile of GSK962040. Subjects will be administered a single oral dose of 50 mg followed by a single intravenous dose of 10 mL containing 100 microgram (not more than 270 nCi, 10 kBq) 14C GSK962040, administered by infusion over 15 minutes, beginning at 90 min after administration of the oral dose (approximate Cmax). The oral dose of 50 mg was well tolerated following single oral administration and is predicted to be a therapeutic dose. There is need to characterize GSK962040 disposition in anticipation of drug use in special populations such as critically ill patients. The intravenous (infused) microdose (100 microgram) is 500-fold lower than the oral dose, therefore exposure to GSK962040 originating from the infused microdose is considered negligible. ;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT03941288 -
Efficacy and Safety of Cannabidiol for Gastroparesis and Functional Dyspepsia
|
Phase 2 | |
| Terminated |
NCT03285308 -
A Safety and Efficacy Study of Relamorelin in Diabetic Gastroparesis 01
|
Phase 3 | |
| Completed |
NCT00733551 -
Evaluation of the Safety, Tolerability and Pharmacokinetics of Repeat Oral Doses of GSK962040 Administered to Healthy Adult Subjects.
|
Phase 1 | |
| Completed |
NCT01650714 -
Endoscopic Full Thickness Biopsy, Gastric Wall.
|
N/A | |
| Completed |
NCT01452815 -
Affects of Once-daily Oral Administration of TZP-102 on the Treatment of Symptoms Associated With Diabetic Gastroparesis
|
Phase 2 | |
| Completed |
NCT01039974 -
GSK962040 Drug-drug Interaction Study With Ketoconazole
|
Phase 1 | |
| Terminated |
NCT04844190 -
Use of EndoFLIP and Manometry Prior to G-POEM
|
N/A | |
| Enrolling by invitation |
NCT06215547 -
Medtronic Enterra II Neurostimulator
|
N/A | |
| Completed |
NCT04026997 -
A Phase 2 Study of CIN-102 in Adults With Idiopathic and Diabetic Gastroparesis
|
Phase 2 | |
| Completed |
NCT00562848 -
A Study to Evaluate Safety, Side Effects, Muscle Activity and Speed of Gastric Emptying of GSK962040
|
Phase 1 | |
| Enrolling by invitation |
NCT04207996 -
Vagus Nerve Response in Gastroparesis Patients
|
||
| Completed |
NCT04607304 -
ABCA2 GIRMS Analytical Validation Clinical Performance Study
|
N/A | |
| Recruiting |
NCT06068114 -
Gastric Pathophysiology in Diabetes
|
||
| Completed |
NCT03259841 -
Ultrasound Assessment of Gastric Contents in Fasted Patient Undergoing Cholecystectomy
|
||
| Active, not recruiting |
NCT04300127 -
Pioglitazone for Idiopathic Gastroparesis
|
Early Phase 1 | |
| Recruiting |
NCT01696734 -
Domperidone in Treating Patients With Gastrointestinal Disorders
|
Phase 3 | |
| Terminated |
NCT04635306 -
13C-Spirulina Nitrogen Content GEBT Study
|
N/A | |
| Withdrawn |
NCT02420925 -
Effect of Celiac Plexus Block on Gastric Emptying and Symptoms Caused by Gastroparesis
|
N/A | |
| Recruiting |
NCT00777439 -
Domperidone for Refractory Gastrointestinal Disorders
|
N/A | |
| Terminated |
NCT00760461 -
Domperidone in Refractory Gastroparesis
|
Phase 2 |