Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
belapectin · 1 trial · 1 indication
Statistical comparison of the pharmacokinetic AUC0-∞ parameters of belapectin in plasma from varying degrees of hepatic impairment to normal hepatic function following a single intravenous dose . AUC0-∞ = area under the concentration-time curve from time 0 to infinity.
Statistical comparison of the pharmacokinetic AUC0-t parameters of belapectin in plasma from varying degrees of hepatic impairment to normal hepatic function following a single intravenous dose. AUC0-t = area under the concentration-time curve from time 0 to the last measurable concentration.
Statistical comparison of the pharmacokinetic Cmax parameters of belapectin in plasma from varying degrees of hepatic impairment to normal hepatic function following a single intravenous dose. Cmax = maximum observed concentration
Statistical comparison of the pharmacokinetic t1/2 parameters of belapectin in plasma from varying degrees of hepatic impairment to normal hepatic function following a single intravenous dose. t1/2 = terminal elimination half-life.
| Arm | Type | Description |
|---|---|---|
| Group 1 | ACTIVE_COMPARATOR | 16 matched healthy subjects with normal hepatic function |
| Group 2 | ACTIVE_COMPARATOR | 8 subjects with mild hepatic impairment (Child-Pugh Class A \[4 x subjects with a score of 5 and 4 x subjects with a score of 6\]) |
| Group 3 | ACTIVE_COMPARATOR | 8 subjects with moderate hepatic impairment (Child-Pugh Class B \[score of 7 to 9\]) |
| Group 4 | ACTIVE_COMPARATOR | 8 subjects with severe hepatic impairment (Child-Pugh Class C \[score of 10 to 14\]). |
| Name | Type | Description |
|---|---|---|
| belapectin | DRUG | intravenous |
Inclusion Criteria: All Subjects 1. Males or females, of any race, between 18 and 75 years of age, inclusive. 2. Body mass index between 18.0 and 45.0 kg/m2, inclusive. 3. Females of childbearing potential will not be pregnant or lactating and must have a negative result on an approved pregnancy t...
Belapectin is an investigational small molecule being studied for hepatic impairment, a condition in which the liver is unable to function normally. It is being developed by Galectin Therapeutics Inc. (GALT) and is currently in Phase 1 clinical development.
Belapectin is being developed by Galectin Therapeutics Inc., a biopharmaceutical company traded on the NASDAQ under the ticker symbol GALT. The company is conducting clinical research to evaluate the drug's safety and tolerability in patients with hepatic impairment.
Belapectin is in Phase 1 clinical development. It has completed one Phase 1 trial, NCT04332432, which evaluated the drug in 38 participants with hepatic impairment. The drug is investigational and has not been approved by regulatory authorities.
Belapectin has one completed clinical trial, NCT04332432, titled 'GT-032 Belapectin Hepatic Impairment.' This Phase 1 study enrolled 38 participants with hepatic impairment in the United States, including healthy volunteers, and was actively controlled but not randomized or double-blinded.
Belapectin is not FDA approved. It is an investigational drug currently in Phase 1 clinical development for hepatic impairment. The FDA has granted it fast track designation, which is intended to expedite the development and review of drugs for serious conditions.