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COMPLETED
NCT04484337
PHASE1

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

Sponsor: ViiV Healthcare

View on ClinicalTrials.gov

Summary

This is an active control, randomized study to investigate the safety, tolerability and PK of repeat dose administration of long-acting CAB 400 mg/mL formulation intramuscular (IM) (gluteus medius and vastus lateralis) and subcutaneous (SC) (abdominal) injections in healthy adult participants.

Official title: A Phase 1, Two-part, Double-blind, Active-control, Randomized Study to Evaluate the Pharmacokinetics, Safety and Tolerability of Repeat-Dose Cabotegravir (CAB 400 mg/mL Formulation) Long-Acting Injection Following Subcutaneous or Intramuscular Administration in Healthy Adult Participants

Key Details

Gender

All

Age Range

18 Years - 50 Years

Study Type

INTERVENTIONAL

Enrollment

138

Start Date

2020-07-31

Completion Date

2023-05-05

Last Updated

2026-05-29

Healthy Volunteers

Yes

Conditions

Interventions

DRUG

Cabotegravir sodium (Oral Lead In)

CAB 30 mg tablets administered orally.

DRUG

Cabotegravir 400 mg/mL

CAB 400 mg/mL administered intramascularly or subcutaneously.

DRUG

Cabotegravir 200 mg/mL

CAB 200 mg/mL administered intramascularly or subcutaneously.

DRUG

Topical Non-steroidal anti-inflammatory drug (NSAID)

NSAID applied topically.

DRUG

Topical steroid

Steroid medication applied topically.

DRUG

Topical NSAID placebo

Placebo for NSAID applied topically.

DRUG

Recombinant human hyaluronidase PH20 (rHuPH20)

rHuPH20 administered subcutaneously.

DRUG

Topical steroid placebo

Placebo for steroid applied topically.

Locations (5)

GSK Investigational Site

Orlando, Florida, United States

GSK Investigational Site

Las Vegas, Nevada, United States

GSK Investigational Site

Berlin, New Jersey, United States

GSK Investigational Site

Austin, Texas, United States

GSK Investigational Site

Auckland, New Zealand