Long-acting Cabotegravir Formulations in Healthy Adults

Palo Alto (17 mi)

Age: 18 - 65

Sex: Any

Travel: May be covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Waitlist Available

Sponsor: ViiV Healthcare

No Placebo Group

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?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 Criteria

Healthy adults over 40 kg and BMI of 18-32, not pregnant or breastfeeding, with no major health issues. Must test negative for COVID-19 on admission day, agree to use effective contraception, and have no history of drug abuse or high-risk behaviors for HIV infection.

Inclusion Criteria

I am a woman of childbearing potential and use highly effective birth control.

I weigh at least 40 kg and my BMI is between 18 and 32.

Exclusion Criteria

I have had a heart attack before.

I have a genetic blood clotting disorder like haemophilia or VWD.

I have not been exposed to more than four new drugs in the last year.

I have a history of liver disease or known liver problems.

I haven't had significant seizures or needed treatment for them in the last 2 years.

Treatment Details

The trial is testing two different long-acting formulations of Cabotegravir (Formulation F followed by G) in healthy participants to assess their safety, tolerability, and how the body processes them.

2Treatment groups

Experimental Treatment

Group I: Part B: Participants receiving Cabotegravir Formulation GExperimental Treatment1 Intervention

Group II: Part A: Participants receiving Cabotegravir Formulation FExperimental Treatment1 Intervention