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A Study to Investigate the Pharmacokinetics, Safety, and Tolerability of Two Different Formulations of Long-acting Cabotegravir in Healthy Adult Participants | Clinical Trials | Clareo Health

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A Study to Investigate the Pharmacokinetics, Safety, and Tolerability of Two Different Formulations of Long-acting Cabotegravir in Healthy Adult Participants

A Phase I, Open-label, Single Dose Escalation Study to Evaluate the Pharmacokinetics, Safety and Tolerability of Two Different Formulations of Long-acting Cabotegravir Administered to Healthy Adult Participants

NCT06033547•ViiV Healthcare

View on ClinicalTrials.gov

Summary

The primary purpose of the study is to investigate the safety, tolerability, and pharmacokinetic (PK) profiles of two different cabotegravir formulations in healthy adult participants. The study will initially start with the assessment of Cabotegravir Formulation F. Once the clinical batch of Cabotegravir Formulation G is available, this formulation will be assessed.

Eligibility

Age

18 - 55 years

Sex

ALL

Healthy Volunteers

Yes

Inclusion Criteria

•Participants who are overtly healthy as determined by medical evaluation including medical history, physical examination, laboratory tests, and cardiac monitoring
•Body weight =\>40 kilogram (kg) and body mass index (BMI) within the range =\>18 to =\<32 kilogram per meter square (kg/m\^2)
•Participants who are negative on a single test for Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2)(approved molecular polymerase chain reaction \[PCR\] laboratory or point of care test) performed on the day of admission. A negative result is required prior to the administration of study intervention on Day 1.
•Contraceptive use by men and women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies
•Participants assigned female at birth are eligible to participate if they are not pregnant or breastfeeding, and at least one of the following conditions applies:
•Is not a woman of childbearing potential (WOCBP) OR
•Is a WOCBP and using a contraceptive method that is highly effective, with a failure rate of \<1% from the time of screening and inclusive of the entire time while on the study.
•A WOCBP must have a negative highly sensitive pregnancy test (urine or serum as required by local regulations) within the 30 days before the first dose of study intervention.
•Capable of giving written informed consent

Exclusion Criteria

•Current presence or history of cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, haematological, or neurological disorders.
•Current or chronic history of liver disease or known hepatic or biliary abnormalities.
•History of ongoing or clinically relevant seizure disorder within the previous 2 years, including participants who have required treatment for seizures within this time period.
•Participants who in the investigator's judgment, poses a significant suicidality risk. Participant's history of suicidal behavior and/or suicidal ideation should be considered when evaluating for suicide risk.
•Positive SARS-CoV-2 polymerase chain reaction test, having signs and symptoms which in the opinion of the investigator are suggestive of COVID-19 (i.e., fever, cough etc) within 14 days of inpatient admission, or having contact with known COVID-19 positive person/s in the 14 days prior to inpatient admission.
•Human immunodeficiency virus (HIV-1 or HIV-2) infection as indicated by positive antibody/antigen test.
•History of or on-going high-risk behaviors that, in the opinion of the investigator, may put the participant at increased risk for HIV infection including, but not limited to, participants in HIV discordant relationships, or men who report current or prior unprotected anal sex with other men and those reporting prior or current injecting drug use.
•Presence of hepatitis B surface antigen (HBsAg), or positive hepatitis C antibody test result at screening or within 3 months prior to first dose of study treatment.
•Abnormal blood pressure.
•Evidence of previous myocardial infarction.
+19 more criteria

Locations (1)

GSK Investigational Site

Austin, Texas, United States

Key Dates

Start Date

September 12, 2023

Primary Completion Date

July 25, 2025

Completion Date

July 25, 2025

Last Updated

February 6, 2026

Enrollment

ACTUAL participants

Conditions

HIV Infections

Interventions

Cabotegravir Formulation F

DRUG

Cabotegravir Formulation G

DRUG

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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: February 6, 2026Data 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 Investigate the Pharmacokinetics, Safety, and Tolerability of Two Different Formulations of Long-acting Cabotegravir in Healthy Adult Participants

Inclusion Criteria

Exclusion Criteria

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