NCT04484337

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

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 138 (actual)
• Sponsor: ViiV Healthcare · Industry
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

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.

Conditions

• HIV Infections

Interventions

Type	Name	Description
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

Timeline

• Start date: 2020-07-31
• Primary completion: 2023-05-05
• Completion: 2023-05-05
• First posted: 2020-07-23
• Last updated: 2023-12-04

Locations

5 sites across 2 countries: United States, New Zealand

Regulatory

• FDA-regulated drug study