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

ViiV Healthcare

Status and phase: Completed; Phase 1

Conditions: HIV Infections

Treatments: Drug: Cabotegravir DT Formulation (test 1); Drug: Cabotegravir IR Formulation (reference); Drug: Cabotegravir DT Formulation (test 2)

Study type: Interventional

Funder types: Industry

Identifiers

NCT05776108

219679

Details and patient eligibility

About

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.

Enrollment: 24 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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.
• Unwillingness to abstain from excessive consumption of any food or drink detailed in the protocol.
• Would not be able to accommodate the blood loss during participation in the study
• Exposure to more than 4 new chemical entities within 12 months prior to the first dosing day.
• Current enrollment or past participation in another investigational study as detailed in the protocol.
• Treatment with biologic agents (such as monoclonal antibodies including marketed drugs) within 3 months or 5 half-lives (whichever is longer) prior to dosing. - Current enrollment or past participation in this clinical study.
• Positive hepatitis B and/or C test result at screening or within 3 months prior to first dose of study intervention.
• Positive pre-study drug/alcohol screen, including Tetrahydrocannabinol
• Positive Human immunodeficiency virus (HIV) antibody test (4th generation assay required).
• Regular use of tobacco- or nicotine-containing products within 6 months prior to screening
• History of regular alcohol consumption within 6 months of the study,
• History of sensitivity, prior intolerance or hypersensitivity to any of the study interventions, or components thereof, or a history of drug or other allergy that, in the opinion of the investigator or medical monitor, contraindicates their participation.
• Participant and/or his her family is part of sponsor, clinical site, third party personnel.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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24 participants in 6 patient groups

CAB IR Formulation (reference)/CAB DT Formulation (Test 1)/CAB DT Formulation (Test 2)

Experimental group

Description:

Participants will receive CAB IR Formulation (reference) under fasted conditions in treatment period 1 followed by CAB DT Formulation (test 1) under fasted conditions in treatment period 2 followed by CAB DT Formulation (test 2) under fed conditions in treatment period 3. There will be a minimum washout period of 14 days between each treatment .

Treatment:

Drug: Cabotegravir DT Formulation (test 2)

Drug: Cabotegravir IR Formulation (reference)

Drug: Cabotegravir DT Formulation (test 1)

CAB DT Formulation (Test 1)/CAB IR Formulation (reference)/CAB DT Formulation (test 2)

Experimental group

Description:

Participants will receive CAB DT Formulation (test 1) under fasted conditions in treatment period 1 followed by CAB IR Formulation (reference) under fasted conditions in treatment period 2 followed by CAB DT Formulation (test 2) under fed conditions in treatment period 3. There will be a minimum washout period of 14 days between each treatment.

Treatment:

Drug: Cabotegravir DT Formulation (test 2)

Drug: Cabotegravir IR Formulation (reference)

Drug: Cabotegravir DT Formulation (test 1)

CAB DT Formulation (test 2)/CAB IR Formulation (reference)/CAB DT Formulation (test 1)

Experimental group

Description:

Participants will receive CAB DT Formulation (test 2) under fed conditions in treatment period 1 followed by CAB IR Formulation (reference) under fasted conditions in treatment period 2 followed by CAB DT Formulation (test 1) under fasted conditions in treatment period 3. There will be a minimum washout period of 14 days between each treatment.

Treatment:

Drug: Cabotegravir DT Formulation (test 2)

Drug: Cabotegravir IR Formulation (reference)

Drug: Cabotegravir DT Formulation (test 1)

CAB IR Formulation (reference)/CAB DT Formulation (test 2)/CAB DT Formulation (test 1)

Experimental group

Description:

Participants will receive CAB IR Formulation (reference) under fasted conditions in treatment period 1 followed by CAB DT Formulation (test 2) under fed conditions in treatment period 2 followed by CAB DT Formulation (test 1) under fasted conditions in treatment period 3. There will be a minimum washout period of 14 days between each treatment.

Treatment:

Drug: Cabotegravir DT Formulation (test 2)

Drug: Cabotegravir IR Formulation (reference)

Drug: Cabotegravir DT Formulation (test 1)

CAB DT Formulation (test 1)/CAB DT Formulation (test 2)/CAB IR Formulation (reference)

Experimental group

Description:

Participants will receive CAB DT Formulation (test 1) under fasted conditions in treatment period 1 followed by CAB DT Formulation (test 2) under fed conditions in treatment period 2 followed by CAB IR Formulation (reference) under fasted conditions in treatment period 3. There will be a minimum washout period of 14 days between each treatment.

Treatment:

Drug: Cabotegravir DT Formulation (test 2)

Drug: Cabotegravir IR Formulation (reference)

Drug: Cabotegravir DT Formulation (test 1)

CAB DT Formulation (test 2)/CAB DT Formulation (test 1)/CAB IR Formulation (reference)

Experimental group

Description:

Participants will receive CAB DT Formulation (test 2) under fed conditions in treatment period 1 followed by CAB DT Formulation (test 1) under fasted conditions in treatment period 2 followed by CAB IR Formulation (reference) under fasted conditions in treatment period 3. There will be a minimum washout period of 14 days between each treatment.

Treatment:

Drug: Cabotegravir DT Formulation (test 2)

Drug: Cabotegravir IR Formulation (reference)

Drug: Cabotegravir DT Formulation (test 1)