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 drug being developed for the treatment of Plasmodium falciparum malaria. It is a novel antimalarial pyrrolidinamide and is currently in Phase 2 clinical development. It is not yet approved for any indication.
GSK3772701 is being studied for the treatment of uncomplicated Plasmodium falciparum malaria in adults. Clinical testing has focused on patients with this form of malaria, as well as healthy volunteers in drug-interaction assessments. It remains investigational and is not approved for use.
GSK3772701 is being developed by GSK plc, which trades under the ticker GSK. The company is the sponsor of the clinical program evaluating the drug in Plasmodium falciparum malaria.
GSK3772701 is in Phase 2 clinical development. A Phase 2A study in adult patients with uncomplicated P. falciparum malaria is planned but not yet recruiting, and a Phase 1 drug-interaction study in healthy participants has been completed.
GSK3772701 has been studied in two registered trials. NCT07670377 was a completed Phase 1 drug-interaction assessment in healthy participants aged 18 to 55 in the United States. NCT07545681 is a Phase 2A study in adults with uncomplicated P. falciparum malaria that is not yet recruiting.