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

NCT05776108 | Completed Phase 1 FDA Drug

• 1 other identifier: 219679
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Bioavailability; Cabotegravir; Dispersible tablet; Food effect; Human immunodeficiency virus; Immediate release tablet

Outcome Measures

Primary Outcomes (9)

• Area under the concentration-time curve from time zero (pre-dose) extrapolated to infinite time (AUC[0-inf]) following administration of CAB DT after a high fat meal

  Up to 168 hours

• Area under the concentration time curve from time zero (pre-dose) extrapolated to last time of quantifiable concentration (AUC[0-last]) following administration of CAB DT after a high fat meal

  Up to 168 hours

• Maximum observed concentration (Cmax) following administration of CAB DT after a high fat meal

  Up to 168 hours

• AUC(0-inf) following administration of CAB DT in fasted state

  Up to 168 hours

• AUC(0-last) following administration of CAB DT in fasted state

  Up to 168 hours

• Cmax following administration of CAB DT in fasted state

  Up to 168 hours

• AUC(0-inf) following administration of CAB IR in fasted state

  Up to 168 hours

• AUC(0-last) following administration of CAB IR in fasted state

  Up to 168 hours

• Cmax following administration of CAB IR in fasted state

  Up to 168 hours

Secondary Outcomes (52)

• Apparent terminal phase half-life (T1/2) following administration of CAB DT

  Up to 168 hours

• Lag time before observation of drug concentrations in sampled matrix (tlag) following administration of CAB DT

  Up to 168 hours

• Time of occurrence of Cmax (Tmax) following administration of CAB DT

  Up to 168 hours

• Area under the concentration time curve from time zero extrapolated to 72 hours post-dose AUC(0-72) following administration of CAB DT

  Up to 72 Hours

• Concentration at 24 hours post-dose (C24) of following administration of CAB DT

  At 24 Hours

Study Arms (6)

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

EXPERIMENTAL

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 .

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

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

EXPERIMENTAL

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.

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

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

EXPERIMENTAL

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.

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

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

EXPERIMENTAL

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.

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

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

EXPERIMENTAL

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.

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

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

EXPERIMENTAL

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.

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

Interventions

Cabotegravir IR Formulation (reference) DRUG

Cabotegravir IR Formulation (reference) will be administered.

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

Cabotegravir DT Formulation (test 1) DRUG

Cabotegravir DT Formulation (test 1) will be administered.

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

Cabotegravir DT Formulation (test 2) DRUG

Cabotegravir DT Formulation (test 2) will be administered.

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

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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)
• Capable of giving signed informed consent.

You may not qualify if:

• 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.

Sponsors & Collaborators

• ViiV Healthcare: lead

Study Sites (1)

GSK Investigational Site

Austin, Texas, 78744, United States

Location

MeSH Terms

Conditions

HIV Infections; Acquired Immunodeficiency Syndrome

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Slow Virus Diseases

Study Officials

• GSK Clinical Trials

  ViiV Healthcare

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: This is an open-label study
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 8, 2023
• First Posted: March 20, 2023
• Study Start: March 23, 2023
• Primary Completion: June 8, 2023
• Study Completion: June 8, 2023
• Last Updated: December 13, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: Anonymized IPD will be made available within 6 months of publication of primary, key secondary and safety results for studies in product with approved indication(s) or terminated asset(s) across all indications.
• Access Criteria: Anonymized IPD is shared with researchers whose proposals are approved by an Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension may be granted, when justified, for up to 6 months.

Locations

US (1)