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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
56
Cabotegravir Formulation F will be administered
Cabotegravir Formulation G will be administered
GSK Investigational Site
Austin, Texas, United States
Maximum observed plasma concentration (Cmax) of cabotegravir
Time frame: Up to Week 52
Time of maximum observed plasma concentration (tmax) of cabotegravir
Time frame: Up to Week 52
Area under the concentration - time curve from time zero to 4 weeks following the injection (AUC[0-4]) of cabotegravir
Time frame: Up to Week 4
Plasma Concentration of cabotegravir at Week 4
Time frame: Week 4
Number of participants with adverse events (AEs) based on severity
Time frame: Up to Week 52
Absolute value of haematology parameter: Platelet count (cells per microliter)
Time frame: Up to Week 52
Absolute value of haematology parameter: Red Blood Cell Count (RBC) (million cells per microliter)
Time frame: Up to Week 52
Absolute values of haematology parameters: haemoglobin (Hgb) (grams per decilitre)
Time frame: Up to Week 52
Absolute values of haematology parameters: haematocrit (Proportion of red blood cells in blood)
Time frame: Up to Week 52
Absolute value of haematology parameter: Mean Corpuscle Volume (MCV) (Femtoliters)
Time frame: Up to Week 52
Absolute value of haematology parameter: Mean Corpuscle haemoglobin (MCH) (Picograms)
Time frame: Up to Week 52
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Absolute values of haematology parameters: Reticulocytes (Percentage of reticulocytes)
Time frame: Up to Week 52
Absolute values of haematology parameters: Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils (giga cells per litre)
Time frame: Up to Week 52
Absolute values of Clinical Chemistry parameters: Glucose (fasting), Blood Urea Nitrogen (BUN), Creatinine, Sodium, Potassium, Calcium, Direct Bilirubin and Total Bilirubin (milligrams per decilitre)
Time frame: Up to Week 52
Absolute values of Clinical Chemistry parameters: AST/SGOT, ALT/ SGPT, ALP and CPK (International Units per litre)
Clinical chemistry parameters such as Aspartate Aminotransferase (AST) / Serum Glutamic-Oxaloacetic Transaminase (SGOT), Alanine Aminotransferase (ALT)/ Serum Glutamic-Pyruvic Transaminase and (SGPT), Alkaline phosphatase (ALP) and Creatinine Phosphokinase (CPK) will be analysed.
Time frame: Up to Week 52
Absolute values of Clinical chemistry parameters: Total Protein (Grams per deciliter)
Time frame: Up to Week 52
Absolute values of Clinical chemistry parameters: Estimated Glomerular Filtration Rate (eGFR2) (millilitres per minute)
Time frame: Up to Week 52
Change from Baseline in haematology parameter: Platelet count (cells per microliter)
Time frame: Baseline (Day 1) and up to Week 52
Change from Baseline in haematology parameter: Red Blood Cell Count (RBC) (million cells per microliter)
Time frame: Baseline (Day 1) and up to Week 52
Change from baseline in haematology parameters: haematocrit (Proportion of red blood cells in blood)
Time frame: Baseline (Day 1) and up to Week 52
Change from baseline in haematology parameter: Mean Corpuscle Volume (MCV) (Femtoliters)
Time frame: Baseline (Day 1) and up to Week 52
Change from baseline in haematology parameter: Mean Corpuscle haemoglobin (MCH) (Picograms)
Time frame: Baseline (Day 1) and up to Week 52
Change from baseline in haematology parameters: Reticulocytes (Percentage of reticulocytes)
Time frame: Baseline (Day 1) and up to Week 52
Change from baseline in haematology parameters: Differential count of Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils (giga cells per litre)
Time frame: Baseline (Day 1) and up to Week 52
Change from baseline in Clinical Chemistry parameters: Glucose (fasting), Blood Urea Nitrogen (BUN), Creatinine, Sodium, Potassium, Calcium, Direct Bilirubin and Total Bilirubin (milligrams per decilitre)
Time frame: Baseline (Day 1) and up to Week 52
Change from baseline in Clinical Chemistry parameters: AST/SGOT, ALT/ SGPT, ALP and CPK (International Units per litre)
Clinical chemistry parameters such as Aspartate Aminotransferase (AST) / Serum Glutamic-Oxaloacetic Transaminase (SGOT), Alanine Aminotransferase (ALT)/ Serum Glutamic-Pyruvic Transaminase and (SGPT), Alkaline phosphatase (ALP) and Creatinine Phosphokinase (CPK) will be analysed
Time frame: Baseline (Day 1) and up to Week 52
Change from baseline in Clinical chemistry parameters: Total Protein (Grams per deciliter)
Time frame: Baseline (Day 1) and up to Week 52
Change from baseline in Clinical chemistry parameters: Estimated Glomerular Filtration Rate (eGFR) (millilitres per minute)
Time frame: Baseline (Day 1) and up to Week 52
Area under the concentration - time curve from time zero to infinity (AUC[0-inf]) of cabotegravir
Time frame: Up to Week 52
Area under the concentration - time curve from time zero to time of last quantifiable concentration [AUC(0-last)] of cabotegravir
Time frame: Up to Week 52
Plasma Concentration of cabotegravir at Week 8,12 and 24
Time frame: Week 8, 12 and 24
Apparent terminal phase half-life (t1/2) of cabotegravir
Time frame: Up to Week 52
Apparent long-acting absorption rate constant (KA-LA) of cabotegravir
Time frame: Up to Week 52
Dose proportionality of cabotegravir based on AUC(0-inf), AUC(0-last), Cmax, and plasma concentration (Unit of measure: Slope of log dose)
Time frame: Up to Week 52
Number of participants with maximum post-baseline QTc values compared to baseline by category (to <=450 milliseconds (msec) or no change, to >450 msec to <=480 msec, to >480 msec to <=500 msec, and to >500 msec)
Time frame: Up to Week 52
Number of participants with maximum post-baseline increase in QTc values compared to baseline based on category (increase <=30 msec, increase of 31-60 msec, and increase of >60 msec)
Time frame: Up to Week 52
Number of participants with worst case post-baseline values relative to potential clinical importance criteria compared to baseline for diastolic blood pressure (DBP), systolic blood pressure (SBP) and pulse rate
Number of participants with worst case post-baseline values relative to potential clinical importance criteria compared to baseline will be categorized into change to low, change to within range or no change, and change to high
Time frame: Up to Week 52