Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT02478463 | Pharmacokinetic Study of Cabotegravir Long-acting in Healthy Adult Volunteers | PHASE1 | COMPLETED | 19 | — | — | Feb 27, 2017 | Jul 25, 2019 | Jun 22, 2020 | 2 | United States |
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...