Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Cabotegravir once daily for 28 days · 1 trial · 2 indications
Blood samples were collected to measure cabotegravir concentration in blood plasma following a single 600 mg IM dose at indicated time-points. Evaluable Pharmacokinetic (PK) Plasma Parameter Summary Population comprised of all participants who underwent plasma PK sampling following oral dose in treatment period 1 and IM injection in treatment period 2 and had evaluable PK parameters estimated and no major protocol deviation.
Vaginal tissue samples were collected to measure cabotegravir concentration following a single 600 mg IM dose at indicated time-points. Evaluable Tissue-Fluid and PK Parameter Population (Oral plus IM) comprised of all participants who underwent sampling following oral dose in treatment period 1 and IM injection in treatment period 2 and have both evaluable PK and evaluable tissues-fluid parameters estimated in vaginal tissue/cervical tissue/cervicovaginal fluid/rectal tissue/rectal fluid.
Cervical tissue samples were collected to measure cabotegravir concentration following a single 600 mg IM dose at indicated time-points.
Cervicovaginal fluid samples were collected to measure cabotegravir concentration following a single 600 mg IM dose at indicated time-points.
Rectal tissue samples were collected to measure cabotegravir concentration following a single 600 mg IM dose at indicated time-points.
Rectal fluid samples were collected to measure cabotegravir concentration following a single 600 mg IM dose at indicated time-points.
| Arm | Type | Description |
|---|---|---|
| Cabotegravir | EXPERIMENTAL | Subject will receive CAB 30 mg tablet once daily oral dose for 28 days (4 weeks) followed by a washout period of 14 to 42 days. After the washout, subject will receive a single dose of CAB LA 600 mg IM to gluteal region. |
| Name | Type | Description |
|---|---|---|
| Cabotegravir tablet 30 mg once daily for 28 days. | DRUG | GSK1265744B, lactose monohydrate, microcrystalline cellulose, hypromellose, sodium starch glycolate, magnesium stearate, Aquarius film-coating, white BP18237 |
| Cabotegravir injection 3 mL (200 mg/mL) IM given once on Day 1. | DRUG | Cabotegravir will be supplied as sterile suspension for injection 200 mg/mL vial. Each vial appears as sterile white to slightly colored suspension containing 200 mg/mL of CAB for administration by intramuscular (intragluteal) injection and will be administered as 1 × 3 mL Injections (3 mL \[600 mg\] total) IM given once on Day 1 of injection phase |
Inclusion Criteria: * 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 monito...
Cabotegravir once daily for 28 days is an investigational small molecule being studied for the prevention or treatment of Human Immunodeficiency Virus (HIV) infection. It is currently in Phase 1 clinical development, meaning it has not yet been approved by regulatory authorities and remains under investigation.
Cabotegravir once daily for 28 days is being developed by GSK plc, a global biopharmaceutical company traded on the New York Stock Exchange under the ticker symbol GSK. The company is conducting clinical trials to evaluate the drug's safety and pharmacokinetics in healthy volunteers.
Cabotegravir once daily for 28 days is in Phase 1 clinical development. This early-stage trial focuses on evaluating the drug's pharmacokinetics and safety profile. The drug is investigational and has not received FDA approval, as it is still undergoing clinical testing.
Cabotegravir once daily for 28 days is associated with one completed Phase 1 clinical trial, registered as NCT02478463. This study, titled "Pharmacokinetic Study of Cabotegravir Long-acting in Healthy Adult Volunteers," enrolled 19 participants in the United States and evaluated the drug's pharmacokinetic properties.
Cabotegravir once daily for 28 days is a formulation of cabotegravir, and the clinical trial NCT02478463 refers to the drug as "cabotegravir long-acting." The once-daily oral regimen for 28 days represents a specific dosing schedule being studied in this Phase 1 trial.