Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
GSK2838232 PIB · 1 trial · 1 indication
An AE is any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Hematology parameters includes platelet count, red blood cells (RBC) count, mean corpuscular volume (MCV), neutrophils, white blood cells (WBC) count (absolute), mean corpuscular hemoglobin (MCH), lymphocytes, reticulocyte count, mean corpuscular hemoglobin concentration (MCHC), monocytes, hemoglobin, eosinophils, hematocrit and basophils. Hematology parameters will be evaluated at Day -2, Day -1, Day 2, Day 4, Day 14 of each visit.
Hematology parameters includes platelet count, RBC count, MCV, neutrophils, WBC count (absolute), MCH, lymphocytes, reticulocyte count, MCHC, monocytes, hemoglobin, eosinophils, hematocrit and basophils. Hematology parameters will be evaluated at Day -1, Day 2, Day 4, day 8, Day 11, Day 14, Day 17, Day 31 for each cohort
Clinical chemistry parameters includes blood urine nitrogen (BUN), potassium, aspartate aminotransferase (AST), Lipase, Creatinine, Sodium, alanine aminotransferase (ALT), total protein, glucose, chloride, alkaline phosphatase, albumin, magnesium, total carbon dioxide (CO2), total and direct bilirubin, uric acid, calcium, phosphorus and gamma-glutamyl transferase (GGT). Clinical chemistry parameters will be evaluated at Day -2, Day -1, Day 2, Day 4, Day 14 of each visit.
Clinical chemistry parameters includes BUN, potassium, AST, lipase, creatinine, sodium, ALT, total protein, glucose, chloride, alkaline phosphatase, albumin, magnesium, total CO2, total and direct bilirubin, uric acid, calcium, phosphorus and GGT. Clinical chemistry parameters will be evaluated at Day -1, Day 2, Day 4, day 8, Day 11, Day 14, Day 17, Day 31 for each cohort
Urinalysis parameters includes specific gravity, pH, glucose, protein, blood and ketones by dipstick, microscopic examination. Urinalysis parameters will be evaluated at Day -2, Day -1, Day 2, Day 4, Day 14 of each visit.
Urinalysis parameters includes specific gravity, pH, glucose, protein, blood and ketones by dipstick, microscopic examination. Urinalysis parameters will be evaluated at Day -1, Day 2, Day 4, Day 11, Day 14, Day 17, Day 31 for each cohort
Systolic and diastolic blood pressure will be measured on Day 1, pre-dose (triplicate) and 1, 2, 4, 6, 8, 12, 24, 48, and 72hr post-dose during each visit.
Heart rate will be measured on Day 1, pre-dose (triplicate) and 1, 2, 4, 6, 8, 12, 24, 48, and 72hr post-dose during each visit.
Systolic and diastolic blood pressure will be measured on Day -1, Day 1 at pre dose (triplicate), and 1hr, 4hr, 24hr, 48hr and 72hr post dose, Day 4, Day 5, Day 6, Day 7, Day 8, Day 9, Day 10, Day 11 at pre dose (triplicate), and 1hr, 4hr, 24hr, 48hr and 72hr post dose and at follow up during each cohort.
Heart rate will be measured on Day -1, Day 1 at pre dose (triplicate), and 1hr, 4hr, 24hr, 48hr and 72hr post dose, Day 4, Day 5, Day 6, Day 7, Day 8, Day 9, Day 10, Day 11 at pre dose (triplicate), and 1hr, 4hr, 24hr, 48hr and 72hr post dose and at follow up during each cohort.
12-lead ECG will be conducted pre-dose on Day 1 (triplicate), and 1, 2, 4, 6, 8, 12, 24, 48 72 hour post dose.
A single 12-Lead ECG will be conducted at screening and Day -1, Day 1 at pre dose (triplicate), and 1 hour, 12 hour, 24hour, 48 hour and 72 hour post dose, Day 5, Day 8 and Day 11 at pre dose (triplicate), and 1 hr, 12 hour, 24 hour, 48 hour, and 72 hour post dose and at follow up during each cohort.
| Arm | Type | Description |
|---|---|---|
| GSK2838232 PIB (50 mg+100 mg+200 mg)+Placebo | EXPERIMENTAL | During Part 1A, subjects will receive QD single dose of either GSK2838232 50 mg, 100 mg or 200 mg or placebo in each of the four visits (one treatment per visit).Subjects will also receive RTV along with all the doses and QD RTV for 48hours (2 doses) before all doses of GSK2838232 and placebo. |
| GSK2838232 PIB+IR1+IR2 | EXPERIMENTAL | During Part 1B, subjects will receive either GSK2838232 PIB, GSK2838232 IR1 or IR2 in each of the three visits (one treatment per visit) after at least 10 hours fasting and IR1 or IR2 after fat meal at visit 4. |
| GSK2838232 PIB (20mg/50 mg/100 mg/200 mg)/Placebo | EXPERIMENTAL | During Part 2, subjects will receive repeated QD doses of either GSK2838232 (20 mg, 50 mg, 100 mg or 200 mg) or placebo for 11 days. Subjects will also receive RTV along with all the doses of GSK2838232 and placebo. |
| Name | Type | Description |
|---|---|---|
| GSK2838232 PIB | DRUG | GSK2838232 will be available as oral suspension for reconstitution, will be administered as 50, 100 and 200 mg in Part A and as 20, 50, 100 or 200 mg in Part B. |
| GSK2838232 IR1 | DRUG | GSK2838232 will be available as film-coated tablet for oral use |
| GSK2838232 IR2 | DRUG | GSK2838232 will be available as film-coated tablet for oral use |
| Placebo PIB | DRUG | Oral suspension of hydromellulose acetate succinate will be supplied as powder-in-bottle for reconstitution. |
| Ritonavir | DRUG | It is to be purchased by site. It will be white film-coated ovaloid tablets for oral administration. |
Inclusion Criteria: * Age: Between 18 and 55 years of age inclusive, at the time of signing the informed consent. * Healthy as determined by the Investigator or medically qualified designee based on a medical evaluation including medical history, physical examination, laboratory tests and cardiac m...
GSK2838232 PIB is an investigational small molecule being developed for the treatment of Human Immunodeficiency Virus (HIV) infection. It is currently in Phase 1 clinical development and has not been approved by regulatory authorities. The drug is being studied for its potential role in managing HIV infection.
GSK2838232 PIB is being developed by GSK plc, a global biopharmaceutical company listed on the stock exchange under the ticker symbol GSK. The company is conducting clinical trials to evaluate the safety and efficacy of this investigational drug for the treatment of HIV infection.
GSK2838232 PIB is currently in Phase 1 clinical development. It is an investigational drug and has not yet received regulatory approval. The Phase 1 trial has been completed, and the drug is still in the early stages of clinical evaluation for the treatment of HIV infection.
GSK2838232 PIB has one completed Phase 1 clinical trial registered under NCT02795754, titled "Single and Repeated Dose Escalation Study of GSK2838232." The trial enrolled 62 participants in the United States, including healthy volunteers, and evaluated the drug's safety and tolerability.
GSK2838232 PIB is not FDA approved. It is an investigational drug currently in Phase 1 clinical development for the treatment of HIV infection. The drug has not completed the clinical trials required for regulatory approval and remains under investigation for its safety and efficacy.