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

> **NCT04484337** · PHASE1 · COMPLETED · sponsor: **ViiV Healthcare** · enrollment: 138 (actual)

## Conditions studied

- HIV Infections

## Interventions

- **DRUG:** Cabotegravir sodium (Oral Lead In)
- **DRUG:** Cabotegravir 400 mg/mL
- **DRUG:** Cabotegravir 200 mg/mL
- **DRUG:** Topical non-steroidal anti-inflammatory drug
- **DRUG:** Topical steroid
- **DRUG:** Placebo creams/gels
- **DRUG:** Recombinant human hyaluronidase PH20 (rHuPH20)

## Key facts

- **NCT ID:** NCT04484337
- **Lead sponsor:** ViiV Healthcare
- **Sponsor class:** INDUSTRY
- **Phase:** PHASE1
- **Study type:** INTERVENTIONAL
- **Status:** COMPLETED
- **Start date:** 2020-07-31
- **Primary completion:** 2023-05-05
- **Final completion:** 2023-05-05
- **Target enrollment:** 138 (ACTUAL)
- **Last updated:** 2023-12-04


## Primary source

ClinicalTrials.gov registry: https://clinicaltrials.gov/study/NCT04484337

## Citation

> US National Library of Medicine, ClinicalTrials.gov registration NCT04484337, "Study to Evaluate Pharmacokinetic (PK), Safety and Tolerability of Cabotegravir (CAB) 400 Milligrams Per Milliliter (mg/mL) Formulation in Healthy Adult Participants". Retrieved via AI Analytics 2026-05-26 from https://api.ai-analytics.org/clinical/NCT04484337. Licensed CC0.

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