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

Phase 1 Completed 138 enrolled ViiV Healthcare

RandomizedSequentialDouble-blindTreatment

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.

Timeline

Start: 2020-07-31
Primary completion: 2023-05-05
Completion: 2023-05-05

Publications

Han K, Benn P, Sievers J, Dorey D, Warwick-Sanders M, Hareedy R, Harkness L, Leemereise C, Offenbecker K, Donatti C, Brimhall DB, Schwabe C, Boyle C, Hassman MA, Knowles S, D'Amico R, Spreen WR. A Randomized Phase 1 Study Evaluating Pharmacokinetics, Safety, and Tolerability of a High-Concentration, Long-Acting Cabotegravir Formulation in Adults Without HIV. Clin Pharmacol Drug Dev. 2025 Jul;14(7):528-541. doi: 10.1002/cpdd.1538. Epub 2025 Apr 29.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Cabotegravir	Small molecule	30 mg	Oral
Subject	Cabotegravir	Small molecule	100 mg	Oral
Subject	Cabotegravir	Small molecule	200 mg	Oral
Subject	Cabotegravir	Small molecule	300 mg	Oral
Subject	Cabotegravir	Small molecule	400 mg	Oral
Subject	Cabotegravir	Small molecule	800 mg	Oral
Subject	rHuPH20	Protein / enzyme biologic	5000 iu	Subcutaneous

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

Summary

Timeline

Publications

Drugs

Indications