HIV InfectionsPhase 1NCT05776108
A Study to Assess the Food Effect and the Relative Bioavailability of the Cabotegravir (CAB) Pediatric Dispersible Tablet (DT) Formulation
A Phase 1 study testing Cabotegravir IR Formulation (reference), Cabotegravir DT Formulation (test 1) and Cabotegravir DT Formulation (test 2) in people with HIV Infections, run by ViiV Healthcare at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- HIV Infections
- What is being tested?
- Cabotegravir IR Formulation (reference), Cabotegravir DT Formulation (test 1) and Cabotegravir DT Formulation (test 2)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- 23 Mar 2023to 8 Jun 2023
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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
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- 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 locations and contacts
1 site in 1 country.
About this study
Official title: 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
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
- Being tested
- Cabotegravir IR Formulation (reference), Cabotegravir DT Formulation (test 1), Cabotegravir DT Formulation (test 2)
- Keywords
- Bioavailability, Cabotegravir, Dispersible tablet, Food effect, Human immunodeficiency virus, Immediate release tablet
- Medical subject headings
- HIV Infections, Acquired Immunodeficiency Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cabotegravir IR Formulation (reference)Drug
Cabotegravir IR Formulation (reference) will be administered.
Cabotegravir DT Formulation (test 1)Drug
Cabotegravir DT Formulation (test 1) will be administered.
Cabotegravir DT Formulation (test 2)Drug
Cabotegravir DT Formulation (test 2) will be administered.
| Study group | Role | What they receive |
|---|---|---|
| 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 . Receives: 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. Receives: 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. Receives: 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. Receives: 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. Receives: 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. Receives: Drug: Cabotegravir IR Formulation (reference); Drug: Cabotegravir DT Formulation (test 1); Drug: Cabotegravir DT Formulation (test 2) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: Up to 168 hours
Maximum observed concentration (Cmax) following administration of CAB DT after a high fat meal
Measured: Up to 168 hours
AUC(0-inf) following administration of CAB DT in fasted state
Measured: Up to 168 hours
AUC(0-last) following administration of CAB DT in fasted state
Measured: Up to 168 hours
Cmax following administration of CAB DT in fasted state
Measured: Up to 168 hours
AUC(0-inf) following administration of CAB IR in fasted state
Measured: Up to 168 hours
AUC(0-last) following administration of CAB IR in fasted state
Measured: Up to 168 hours
Cmax following administration of CAB IR in fasted state
Measured: Up to 168 hours
Secondary outcomes (52)
Apparent terminal phase half-life (T1/2) following administration of CAB DT
Measured: Up to 168 hours
Lag time before observation of drug concentrations in sampled matrix (tlag) following administration of CAB DT
Measured: Up to 168 hours
Time of occurrence of Cmax (Tmax) following administration of CAB DT
Measured: 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
Measured: Up to 72 Hours
Concentration at 24 hours post-dose (C24) of following administration of CAB DT
Measured: At 24 Hours
Apparent oral clearance (CL/F) following administration of CAB DT
Measured: Up to 168 hours
Apparent volume of distribution (Vz/F) following administration of CAB DT
Measured: Up to 168 hours
T1/2 following administration of CAB DT in fasted state
Measured: Up to 168 hours
Tlag following administration of CAB DT in fasted state
Measured: Up to 168 hours
Tmax following administration of CAB DT in fasted state
Measured: Up to 168 hours
AUC(0-72) following administration of CAB DT in fasted state
Measured: Up to 72 Hours
C24 following administration of CAB DT in fasted state
Measured: At 24 Hours
CL/F following administration of CAB DT in fasted state
Measured: Up to 168 hours
Vz/F following administration of CAB DT in fasted state
Measured: Up to 168 hours
T1/2 following administration of CAB IR in fasted state
Measured: Up to 168 hours
Tlag following administration of CAB IR in fasted state
Measured: Up to 168 hours
Tmax following administration of CAB IR in fasted state
Measured: Up to 168 hours
AUC(0-72) following administration of CAB IR in fasted state
Measured: Up to 72 Hours
C24 following administration of CAB IR in fasted state
Measured: Up to 168 hours
CL/F following administration of CAB IR in fasted state
Measured: Up to 168 hours
Vz/F following administration of CAB IR in fasted state
Measured: Up to 168 hours
Number of participants with Non-Serious Adverse events (AEs) and Serious adverse events (SAEs)
Measured: Up to 6 Weeks
Number of participants with AEs by severity
Measured: Up to 6 Weeks
Change from Baseline in Vital sign parameter: Oral Temperature (Degrees Celsius)
Measured: Baseline and Up to 6 Weeks
Change from Baseline in Vital sign parameter: Pulse rate (Beats per minute)
Measured: Baseline and Up to 6 Weeks
Change from Baseline in Vital sign parameter: Respiratory rate (Breaths per minute)
Measured: Baseline and Up to 6 Weeks
Change from Baseline in Vital sign parameter: Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) (Millimeters of mercury)
Measured: Baseline and Up to 6 Weeks
Change from Baseline in Electrocardiogram (ECG) parameters: PR Interval, QRS Interval, QT Interval, Corrected QT interval using the Fridericia formula (QTcF) (Milliseconds)
Measured: Baseline and Up to 6 Weeks
Number of participants with maximum toxicity grade increase from Baseline in hematology, chemistry and urinalysis parameters
Measured: Baseline and Up to 6 Weeks
Change from Baseline in hematology parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils and Platelet Count (Giga cells per Liter)
Measured: Baseline and Up to 6 Weeks
Change from Baseline in hematology parameter: Red Blood Cell Count (Trillion cells per liter)
Measured: Baseline and Up to 6 Weeks
Change from Baseline in hematology parameter: Hemoglobin (Grams per liter)
Measured: Baseline and Up to 6 Weeks
Change from Baseline in hematology parameter: Hematocrit (Proportion of red blood cells in blood)
Measured: Baseline and Up to 6 Weeks
Change from Baseline in hematology parameter: Mean Corpuscular Volume (Femtoliters)
Measured: Baseline and Up to 6 Weeks
Change from Baseline in hematology parameter: Mean Corpuscular Hemoglobin (Picograms)
Measured: Baseline and Up to 6 Weeks
Change from Baseline in hematology parameter: Percentage of Reticulocytes (Percentage of reticulocytes)
Measured: Baseline and Up to 6 Weeks
Change from Baseline in chemistry parameters: Creatinine, Total and Direct Bilirubin (Micromoles per liter)
Measured: Baseline and Up to 6 Weeks
Change from Baseline in chemistry parameters: Calcium, Glucose, Potassium, Sodium, Blood urea nitrogen, Carbon dioxide (Millimoles per liter)
Measured: Baseline and Up to 6 Weeks
Change from Baseline in chemistry parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), and Creatine phosphokinase (International units per liter)
Measured: Baseline and Up to 6 Weeks
Change from Baseline in chemistry parameters: Total Protein (Grams per liter)
Measured: Baseline and Up to 6 Weeks
Number of participants with abnormal urinalysis parameters
Measured: Up to 6 Weeks
Absolute values of hematology parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils and Platelet Count (Giga cells per Liter)
Measured: Up to 6 Weeks
Absolute values of hematology parameter: Red Blood Cell Count (Trillion cells per liter)
Measured: Up to 6 Weeks
Absolute values of hematology parameter: Hemoglobin (Grams per liter)
Measured: Up to 6 Weeks
Absolute values of hematology parameter: Hematocrit (Proportion of red blood cells in blood
Measured: Up to 6 Weeks
Absolute values of hematology parameter: Mean Corpuscular Volume (Femtoliters)
Measured: Up to 6 Weeks
Absolute values of hematology parameter: Mean Corpuscular Hemoglobin (Picograms)
Measured: Up to 6 Weeks
Absolute values of hematology parameter: Percentage of Reticulocytes (Percentage of reticulocytes)
Measured: Up to 6 Weeks
Absolute values of chemistry parameters: Creatinine, Total and Direct Bilirubin (Micromoles per liter)
Measured: Up to 6 Weeks
Absolute values of chemistry parameters: Calcium, Glucose, Potassium, Sodium, Blood urea nitrogen, Carbon dioxide (Millimoles per liter)
Measured: Up to 6 Weeks
Absolute values of chemistry parameters: ALT, ALP, AST and Creatine phosphokinase (International units per liter)
Measured: Up to 6 Weeks
Absolute values of chemistry parameters: Total Protein (Grams per liter)
Measured: Up to 6 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2023
- Study start23 Mar 2023
- Primary completion8 Jun 2023
- Study completion8 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV InfectionsStudies of the same condition, open and under way.
- More trials run by ViiV HealthcareThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- ViiV Healthcare
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- GSK Clinical Trials, Study director, ViiV Healthcare
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05776108
- Sponsor's protocol ID
- 219679
- Status last verified
- Dec 2023
- First submitted
- 8 Mar 2023
- Last updated
- 13 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Qualified researchers may request access to anonymized individual patient-level data (IPD) and related study documents of the eligible studies via the Data Sharing Portal. Details on GSK's data sharing criteria can be found at: https://www.gsk.com/en-gb/innovation/trials/data-transparency/
Study at a glance
From the registry record, last updated by the sponsor on 13 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT05776108
- Acronym / sponsor ID
- 219679
- Conditions
- HIV Infections
- Keywords
- Bioavailability, Cabotegravir, Dispersible tablet, Food effect, Human immunodeficiency virus, Immediate release tablet
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- ViiV HealthcareIndustry (pharma, biotech, devices)
- Study start
- 23 Mar 2023 (actual)
- Primary completion
- 8 Jun 2023 (actual)
- Study completion
- 8 Jun 2023 (actual)
- First posted
- 20 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| CAB IR Formulation (reference)/CAB DT Formulation (Test 1)/CAB DT Formulation (Test 2) | Experimental | Drug: Cabotegravir IR Formulation (reference), Drug: Cabotegravir DT Formulation (test 1), Drug: Cabotegravir DT Formulation (test 2)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 . |
| CAB DT Formulation (Test 1)/CAB IR Formulation (reference)/CAB DT Formulation (test 2) | Experimental | Drug: Cabotegravir IR Formulation (reference), Drug: Cabotegravir DT Formulation (test 1), Drug: Cabotegravir DT Formulation (test 2)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. |
| CAB DT Formulation (test 2)/CAB IR Formulation (reference)/CAB DT Formulation (test 1) | Experimental | Drug: Cabotegravir IR Formulation (reference), Drug: Cabotegravir DT Formulation (test 1), Drug: Cabotegravir DT Formulation (test 2)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. |
| CAB IR Formulation (reference)/CAB DT Formulation (test 2)/CAB DT Formulation (test 1) | Experimental | Drug: Cabotegravir IR Formulation (reference), Drug: Cabotegravir DT Formulation (test 1), Drug: Cabotegravir DT Formulation (test 2)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. |
| CAB DT Formulation (test 1)/CAB DT Formulation (test 2)/CAB IR Formulation (reference) | Experimental | Drug: Cabotegravir IR Formulation (reference), Drug: Cabotegravir DT Formulation (test 1), Drug: Cabotegravir DT Formulation (test 2)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. |
| CAB DT Formulation (test 2)/CAB DT Formulation (test 1)/CAB IR Formulation (reference) | Experimental | Drug: Cabotegravir IR Formulation (reference), Drug: Cabotegravir DT Formulation (test 1), Drug: Cabotegravir DT Formulation (test 2)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. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- 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.
- Capable of giving signed informed consent.
Key exclusion criteria (22 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cabotegravir IR Formulation (reference)Cabotegravir IR Formulation (reference) will be administered. | Drug | 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)Cabotegravir DT Formulation (test 1) will be administered. | Drug | 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)Cabotegravir DT Formulation (test 2) will be administered. | Drug | 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) |
Primary outcome
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
Time frame: 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
Time frame: Up to 168 hours
Maximum observed concentration (Cmax) following administration of CAB DT after a high fat meal
Time frame: Up to 168 hours
AUC(0-inf) following administration of CAB DT in fasted state
Time frame: Up to 168 hours
AUC(0-last) following administration of CAB DT in fasted state
Time frame: Up to 168 hours
Cmax following administration of CAB DT in fasted state
Time frame: Up to 168 hours
AUC(0-inf) following administration of CAB IR in fasted state
Time frame: Up to 168 hours
AUC(0-last) following administration of CAB IR in fasted state
Time frame: Up to 168 hours
Cmax following administration of CAB IR in fasted state
Time frame: Up to 168 hours
52 secondary outcomes
Apparent terminal phase half-life (T1/2) following administration of CAB DT
Time frame: Up to 168 hours
Lag time before observation of drug concentrations in sampled matrix (tlag) following administration of CAB DT
Time frame: Up to 168 hours
Time of occurrence of Cmax (Tmax) following administration of CAB DT
Time frame: 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
Time frame: Up to 72 Hours
Concentration at 24 hours post-dose (C24) of following administration of CAB DT
Time frame: At 24 Hours
Apparent oral clearance (CL/F) following administration of CAB DT
Time frame: Up to 168 hours
Apparent volume of distribution (Vz/F) following administration of CAB DT
Time frame: Up to 168 hours
T1/2 following administration of CAB DT in fasted state
Time frame: Up to 168 hours
Tlag following administration of CAB DT in fasted state
Time frame: Up to 168 hours
Tmax following administration of CAB DT in fasted state
Time frame: Up to 168 hours
AUC(0-72) following administration of CAB DT in fasted state
Time frame: Up to 72 Hours
C24 following administration of CAB DT in fasted state
Time frame: At 24 Hours
CL/F following administration of CAB DT in fasted state
Time frame: Up to 168 hours
Vz/F following administration of CAB DT in fasted state
Time frame: Up to 168 hours
T1/2 following administration of CAB IR in fasted state
Time frame: Up to 168 hours
Tlag following administration of CAB IR in fasted state
Time frame: Up to 168 hours
Tmax following administration of CAB IR in fasted state
Time frame: Up to 168 hours
AUC(0-72) following administration of CAB IR in fasted state
Time frame: Up to 72 Hours
C24 following administration of CAB IR in fasted state
Time frame: Up to 168 hours
CL/F following administration of CAB IR in fasted state
Time frame: Up to 168 hours
Vz/F following administration of CAB IR in fasted state
Time frame: Up to 168 hours
Number of participants with Non-Serious Adverse events (AEs) and Serious adverse events (SAEs)
Time frame: Up to 6 Weeks
Number of participants with AEs by severity
Time frame: Up to 6 Weeks
Change from Baseline in Vital sign parameter: Oral Temperature (Degrees Celsius)
Time frame: Baseline and Up to 6 Weeks
Change from Baseline in Vital sign parameter: Pulse rate (Beats per minute)
Time frame: Baseline and Up to 6 Weeks
Change from Baseline in Vital sign parameter: Respiratory rate (Breaths per minute)
Time frame: Baseline and Up to 6 Weeks
Change from Baseline in Vital sign parameter: Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) (Millimeters of mercury)
Time frame: Baseline and Up to 6 Weeks
Change from Baseline in Electrocardiogram (ECG) parameters: PR Interval, QRS Interval, QT Interval, Corrected QT interval using the Fridericia formula (QTcF) (Milliseconds)
Time frame: Baseline and Up to 6 Weeks
Number of participants with maximum toxicity grade increase from Baseline in hematology, chemistry and urinalysis parameters
Time frame: Baseline and Up to 6 Weeks
Change from Baseline in hematology parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils and Platelet Count (Giga cells per Liter)
Time frame: Baseline and Up to 6 Weeks
Change from Baseline in hematology parameter: Red Blood Cell Count (Trillion cells per liter)
Time frame: Baseline and Up to 6 Weeks
Change from Baseline in hematology parameter: Hemoglobin (Grams per liter)
Time frame: Baseline and Up to 6 Weeks
Change from Baseline in hematology parameter: Hematocrit (Proportion of red blood cells in blood)
Time frame: Baseline and Up to 6 Weeks
Change from Baseline in hematology parameter: Mean Corpuscular Volume (Femtoliters)
Time frame: Baseline and Up to 6 Weeks
Change from Baseline in hematology parameter: Mean Corpuscular Hemoglobin (Picograms)
Time frame: Baseline and Up to 6 Weeks
Change from Baseline in hematology parameter: Percentage of Reticulocytes (Percentage of reticulocytes)
Time frame: Baseline and Up to 6 Weeks
Change from Baseline in chemistry parameters: Creatinine, Total and Direct Bilirubin (Micromoles per liter)
Time frame: Baseline and Up to 6 Weeks
Change from Baseline in chemistry parameters: Calcium, Glucose, Potassium, Sodium, Blood urea nitrogen, Carbon dioxide (Millimoles per liter)
Time frame: Baseline and Up to 6 Weeks
Change from Baseline in chemistry parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), and Creatine phosphokinase (International units per liter)
Time frame: Baseline and Up to 6 Weeks
Change from Baseline in chemistry parameters: Total Protein (Grams per liter)
Time frame: Baseline and Up to 6 Weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Dec 2023.
- Individual participant dataSharing planned: Yes. Qualified researchers may request access to anonymized individual patient-level data (IPD) and related study documents of the eligible studies via the Data Sharing Portal. Details on GSK's data sharing criteria can be found at: https://www.gsk.com/en-gb/innovation/trials/data-transparency/
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
GSK Clinical Trials study director
ViiV Healthcare
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Cabotegravir IR Formulation (reference), Cabotegravir DT Formulation (test 1) and Cabotegravir DT Formulation (test 2) in people with HIV Infections, run by ViiV Healthcare at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 (time frame: Up to 168 hours). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Dec 2023.