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COMPLETEDPHASE1

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

A Phase 1, Single-center, Randomized, Open-label, Single Dose, Three-period, Balanced Crossover Study to Assess the Effect of Food on the Pediatric Dispersible Tablet Formulation of Cabotegravir and to Assess the Relative Bioavailability Between the Pediatric Dispersible Tablet (DT) Formulation and Immediate Release (IR) Tablet Formulation of Cabotegravir in Healthy Adult Participants

NCT05776108•ViiV Healthcare

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - 55 years

Sex

ALL

Healthy Volunteers

Yes

Inclusion Criteria

•Participant must be 18 to 55 years of age inclusive, at the time of signing the informed consent form (ICF).
•Participants who are healthy as determined by the investigator or medically qualified designee based on a medical evaluation including medical history, physical examination, laboratory tests, and cardiac monitoring (history and electrocardiogram).
•Body weight greater than or equal to (\>=) 50.0 kilograms (kg) (110 pounds \[lbs\]) for males and \>= 45 kg (99 lbs) for females and Body mass index within the range 18.5 to 31.0 kilogram per meter square (kg/m2) (inclusive) at Screening.
•Contraceptive use should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.
•* Female: A female participant is eligible to participate if she is not pregnant or breastfeeding and is a Women of non child bearing potential (WONCBP) OR Is a Women of child bearing potential (WOCBP) and using a contraceptive method that is highly effective (with a failure rate of less than (\<)1 percent (%) per year).
•* A WOCBP must have a negative highly sensitive pregnancy test (urine or serum as required by local regulations) within 24 hours before the first dose of study intervention (i.e., Day-1 of each treatment Period)
•* The investigator is responsible for review of medical history, menstrual history, and recent sexual activity to decrease the risk for inclusion of a woman with an early undetected pregnancy.
•Capable of giving signed informed consent.

Exclusion Criteria

•History or presence of/significant history of or current cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematologic, or neurological disorders capable of significantly altering the absorption, metabolism, or elimination of drugs; constituting a risk when taking the study intervention or interfering with the interpretation of data.
•History of seizures, and participants are required to have been seizure free, off anti epileptic drugs for a minimum of 2 years and will only be considered for enrollment following discussion with the Medical Monitor
•Abnormal blood pressure as determined by the investigator.
•Medical history of cardiac arrhythmias, prior myocardial infarction in the past 3 months, or cardiac disease or a family or personal history of long QT syndrome.
•A pre-existing condition interfering with normal gastrointestinal anatomy or motility (e.g., gastroesophageal reflux disease, gastric ulcers, gastritis), hepatic and/or renal function, that could interfere with the absorption, metabolism, and/or excretion of the study intervention.
•Known suspected active Coronavirus disease 2019 (COVID-19) infection OR contact with an individual with known COVID-19 , within 14 days of study enrollment
•Any acute laboratory abnormality at screening which, in the opinion of the investigator, should preclude participation in the study of an investigational compound.
•Any Grade 2 to 4 laboratory abnormality at screening, with Creatine Phosphokinase and lipid abnormalities (e.g., total cholesterol, triglycerides), and ALT abnormalities, will exclude a participant from the study unless the investigator can provide a compelling explanation for the laboratory result(s) and has the assent of the sponsor.
•A positive test result for drugs of abuse (including marijuana), alcohol, or tobacco (indicating active current smoking) at screening or before the first dose of study intervention.
•Unable to refrain from the use of prescription or non-prescription drugs as detailed in the protocol.
+12 more criteria

Locations (1)

GSK Investigational Site

Austin, Texas, United States

Key Dates

Start Date

March 23, 2023

Primary Completion Date

June 8, 2023

Completion Date

June 8, 2023

Last Updated

December 13, 2023

Enrollment

ACTUAL participants

Conditions

HIV Infections

Interventions

Cabotegravir IR Formulation (reference)

DRUG

Cabotegravir DT Formulation (test 1)

DRUG

Cabotegravir DT Formulation (test 2)

DRUG

Skeletal Muscle Energetics and Fatiguability in Older Individuals

NCT04142047

HIVHIV Infections

View study

RECRUITINGPHASE3

A Study to Evaluate the Effectiveness of Long-acting (LA) Cabotegravir (CAB) + Rilpivirine (RPV) LA When Given to Participants With Detectable HIV-1

NCT06694805

HIV Infections

View study

RECRUITING

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: December 13, 2023Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

Skeletal Muscle Energetics and Fatiguability in Older Individuals

A Study to Evaluate the Effectiveness of Long-acting (LA) Cabotegravir (CAB) + Rilpivirine (RPV) LA When Given to Participants With Detectable HIV-1

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