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

NCT04484337 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 138

Last updated 2023-12-04

No results posted yet for this study

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

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

Sponsors & Collaborators

  • ViiV Healthcare

    lead INDUSTRY

Principal Investigators

  • GSK Clinical Trials · ViiV Healthcare

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-07-31
Primary Completion
2023-05-05
Completion
2023-05-05
FDA Drug
Yes

Countries

  • United States
  • New Zealand

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04484337 on ClinicalTrials.gov