NCT04484337 - Study to Evaluate Pharmacokinetic (PK), Safety and Tolerability of Cabotegravir (CAB) 400 Milligrams Per Milliliter (mg/mL) Formulation in Healthy Adult Participants | Biotech Hunter

Enrollment

138

Participants

Timeline

Start Date

July 31, 2020

Primary Completion Date

May 5, 2023

Study Completion Date

May 5, 2023

Conditions

HIV Infections

Interventions

DRUG

Cabotegravir sodium (Oral Lead In)

CAB will be available as 30 mg tablets for oral administration.

DRUG

Cabotegravir 400 mg/mL

CAB 400 mg/mL will be available for administration by IM injection or SC Injection.

DRUG

Cabotegravir 200 mg/mL

CAB 200 mg/mL will be available for administration by IM injection or SC Injection.

DRUG

Topical non-steroidal anti-inflammatory drug

Non-steroidal anti-inflammatory drug will be available for topical application

DRUG

Topical steroid

Steroid will be available for topical application

DRUG

Placebo creams/gels

Placebo creams/gels will be available for topical application

DRUG

Recombinant human hyaluronidase PH20 (rHuPH20)

rHuPH20 will be available for administration by SC Injection

Trial Locations (5)

GSK Investigational Site, Auckland

GSK Investigational Site, Orlando

GSK Investigational Site, Austin

GSK Investigational Site, Las Vegas

GSK Investigational Site, Berlin