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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part A: Participants receiving Cabotegravir Formulation F | Experimental |
| |
| Part B: Participants receiving Cabotegravir Formulation G | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cabotegravir Formulation F | Drug | Cabotegravir Formulation F will be administered |
|
| Measure | Description | Time Frame |
|---|---|---|
| Maximum observed plasma concentration (Cmax) of cabotegravir | Up to Week 52 | |
| Time of maximum observed plasma concentration (tmax) of cabotegravir | Up to Week 52 | |
| Area under the concentration - time curve from time zero to 4 weeks following the injection (AUC[0-4]) of cabotegravir | Up to Week 4 | |
| Plasma Concentration of cabotegravir at Week 4 | Week 4 | |
| Number of participants with adverse events (AEs) based on severity | Up to Week 52 | |
| Absolute value of haematology parameter: Platelet count (cells per microliter) | Up to Week 52 | |
| Absolute value of haematology parameter: Red Blood Cell Count (RBC) (million cells per microliter) | Up to Week 52 | |
| Absolute values of haematology parameters: haemoglobin (Hgb) (grams per decilitre) | Up to Week 52 | |
| Absolute values of haematology parameters: haematocrit (Proportion of red blood cells in blood) | Up to Week 52 | |
| Absolute value of haematology parameter: Mean Corpuscle Volume (MCV) (Femtoliters) |
| Measure | Description | Time Frame |
|---|---|---|
| Area under the concentration - time curve from time zero to infinity (AUC[0-inf]) of cabotegravir | Up to Week 52 | |
| Area under the concentration - time curve from time zero to time of last quantifiable concentration [AUC(0-last)] of cabotegravir | Up to Week 52 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GSK Investigational Site | Austin | Texas | 78744 | United States |
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/
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.
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.
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| Cabotegravir Formulation G | Drug | Cabotegravir Formulation G will be administered |
|
| Up to Week 52 |
| Absolute value of haematology parameter: Mean Corpuscle haemoglobin (MCH) (Picograms) | Up to Week 52 |
| Absolute values of haematology parameters: Reticulocytes (Percentage of reticulocytes) | Up to Week 52 |
| Absolute values of haematology parameters: Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils (giga cells per litre) | 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) | 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. | Up to Week 52 |
| Absolute values of Clinical chemistry parameters: Total Protein (Grams per deciliter) | Up to Week 52 |
| Absolute values of Clinical chemistry parameters: Estimated Glomerular Filtration Rate (eGFR2) (millilitres per minute) | Up to Week 52 |
| Change from Baseline in haematology parameter: Platelet count (cells per microliter) | Baseline (Day 1) and up to Week 52 |
| Change from Baseline in haematology parameter: Red Blood Cell Count (RBC) (million cells per microliter) | Baseline (Day 1) and up to Week 52 |
| Change from baseline in haematology parameters: haematocrit (Proportion of red blood cells in blood) | Baseline (Day 1) and up to Week 52 |
| Change from baseline in haematology parameter: Mean Corpuscle Volume (MCV) (Femtoliters) | Baseline (Day 1) and up to Week 52 |
| Change from baseline in haematology parameter: Mean Corpuscle haemoglobin (MCH) (Picograms) | Baseline (Day 1) and up to Week 52 |
| Change from baseline in haematology parameters: Reticulocytes (Percentage of reticulocytes) | 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) | 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) | 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 | Baseline (Day 1) and up to Week 52 |
| Change from baseline in Clinical chemistry parameters: Total Protein (Grams per deciliter) | Baseline (Day 1) and up to Week 52 |
| Change from baseline in Clinical chemistry parameters: Estimated Glomerular Filtration Rate (eGFR) (millilitres per minute) | Baseline (Day 1) and up to Week 52 |
| Plasma Concentration of cabotegravir at Week 8,12 and 24 | Week 8, 12 and 24 |
| Apparent terminal phase half-life (t1/2) of cabotegravir | Up to Week 52 |
| Apparent long-acting absorption rate constant (KA-LA) of cabotegravir | 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) | 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) | 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) | 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 | Up to Week 52 |
| ID | Term |
|---|---|
| D015658 | HIV Infections |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D015229 | Sexually Transmitted Diseases, Viral |
| D012749 | Sexually Transmitted Diseases |
| D016180 | Lentivirus Infections |
| D012192 | Retroviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |
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