Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
GSK3772701 · 2 trials · 1 indication
A SAE is defined as any untoward medical occurrence that, at any dose: results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect in the offspring of a study participant; abnormal pregnancy outcomes; or any other situation according to medical or scientific judgment. The intensity of SAEs is assessed as per the Division of Acquired Immunodeficiency Syndrome (DAIDS) criteria Version 2.1 where grades are defined based on numeric criteria as follows Grade 1: mild; Grade 2: moderate; Grade 3: severe; Grade 4: potentially life-threatening; Grade 5: death. A higher grade indicates greater severity. Any = occurrence of the event regardless of intensity grade and treatment relationship. Treatment related = occurrence of the event which, in the investigator's opinion, is related to the administered treatment regardless of the intensity grade.
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention. The intensity of non-serious AEs is assessed using the DAIDS criteria Version 2.1 where grades are defined based on numeric criteria as follows Grade 1: mild; Grade 2: moderate; Grade 3: severe; Grade 4: potentially life-threatening; Grade 5: death. A higher grade indicates greater severity. Any = occurrence of the event regardless of intensity grade and treatment relationship. Treatment related = occurrence of the event which, in the investigator's opinion, is related to the administered treatment regardless of the intensity grade.
| Arm | Type | Description |
|---|---|---|
| Cohort 1_Single Dose | EXPERIMENTAL | Participants receive a single GSK3772701 600 mg dose on Day 1. |
| Cohort 2_ Single Dose | EXPERIMENTAL | Participants receive a single GSK3772701 900 mg dose on Day 1. |
| Cohort 3_ Repeat Dose | EXPERIMENTAL | Participants receive a daily 150 mg dose of GSK3772701 on Day 1 and Day 2. |
| Cohort 4_ Repeat Dose | EXPERIMENTAL | Participants receive a daily 400 mg dose of GSK3772701 on Day 1 and Day 2. |
| Cohort 5_ Repeat Dose | EXPERIMENTAL | Participants receive a daily 50 mg dose of GSK3772701 on Day 1, Day 2 and Day 3. |
| Study participants | EXPERIMENTAL | Healthy participants receive Midazolam (MDZ) on days 1, 3, 6 and 10, and GSK3772701 on days 3, 4 and 5. |
| Name | Type | Description |
|---|---|---|
| GSK3772701 600 mg | DRUG | A 600 mg dose of GSK3772701 administered orally, as 4 capsules of 150 mg. |
| GSK3772701 900 mg | DRUG | A 900 mg dose of GSK3772701 administered orally, as 6 capsules of 150 mg. |
| GSK3772701 150 mg | DRUG | A daily 150 mg dose of GSK3772701 administered orally on Day 1 and Day 2, as 1 capsule. |
| GSK3772701 400 mg | DRUG | A daily 400 mg dose of GSK3772701 administered orally on Day 1 and Day 2, as 2 capsules of 150 mg and 1 capsule of 100 mg. |
| GSK3772701 50 mg | DRUG | A daily 50 mg dose of GSK3772701 administered orally on Day 1, Day 2 and Day 3, as 1 capsule. |
| Midazolam (MDZ) | DRUG | Participants receive MDZ orally. |
| GSK3772701 | DRUG | Participants receive GSK3772701 orally. |
Inclusion Criteria: * Male and female patients aged 18 to 65 years. * Presence of malaria due to mono-infection with P. falciparum confirmed by: * Fever, as defined by axillary temperature \>=37.5°C or oral/tympanic temperature \>=38°C and, * Microscopically confirmed P. falciparum malaria par...
GSK3772701 is an investigational small molecule being developed for the treatment of uncomplicated Plasmodium falciparum malaria. It is currently in Phase 2 clinical development and is not yet approved by regulatory authorities. The drug is being studied in adult patients with this form of malaria.
GSK3772701 is a novel antimalarial pyrrolidinamide. Its specific molecular target has not been disclosed in the available information. The drug is being evaluated for its antimalarial activity in clinical trials.
GSK3772701 is being developed by GSK plc, a global biopharmaceutical company listed on the London Stock Exchange under the ticker GSK. The company is conducting clinical trials to evaluate the drug's safety and efficacy in treating falciparum malaria.
GSK3772701 is in Phase 2 clinical development. It is being studied in a Phase 2A trial for uncomplicated P. falciparum malaria, and a Phase 1 drug-interaction study is also ongoing. The drug is investigational and has not received regulatory approval.
GSK3772701 is being evaluated in two clinical trials. NCT07545681 is a Phase 2A study in adult patients with uncomplicated P. falciparum malaria, enrolling 70 participants. NCT07670377 is a Phase 1 drug-interaction study in healthy participants aged 18 to 55 years, enrolling 20 participants in the United States.
Yes, GSK3772701 600 mg refers to the same drug, GSK3772701, at a specific dose strength. The 600 mg formulation is being studied in clinical trials for the treatment of falciparum malaria. The drug is also known by this alternative name in trial documentation.