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A Study to Assess the Food Effect and the Relative Bioavailability of the Cabotegravir (CAB) Pediatric Dispersible Tablet (DT) Formulation

NCT05776108 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2023-12-13

No results posted yet for this study

Summary

This study will assess the relative bioavailability of the CAB DT formulation relative to that of the CAB IR formulation and to assess the effect of food on the CAB DT formulation.

Conditions

  • HIV Infections

Interventions

DRUG

Cabotegravir IR Formulation (reference)

Cabotegravir IR Formulation (reference) will be administered.

DRUG

Cabotegravir DT Formulation (test 1)

Cabotegravir DT Formulation (test 1) will be administered.

DRUG

Cabotegravir DT Formulation (test 2)

Cabotegravir DT Formulation (test 2) will be administered.

Sponsors & Collaborators

  • ViiV Healthcare

    lead INDUSTRY

Principal Investigators

  • GSK Clinical Trials · ViiV Healthcare

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

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

Timeline & Regulatory

Start
2023-03-23
Primary Completion
2023-06-08
Completion
2023-06-08
FDA Drug
Yes

Countries

  • United States

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 NCT05776108 on ClinicalTrials.gov