GSK Investigational Site
Austin, Texas, 78744, United States
NCT Number: NCT06033547
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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Notify Me18 year–55 year
All sexes
Interventional
Phase 1
Austin, Texas, 78744, United States
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Cabotegravir Formulation F will be administered
Cabotegravir Formulation G will be administered
Time frame: Up to Week 52
Time frame: Up to Week 52
Time frame: Up to Week 4
Time frame: Week 4
Time frame: Up to Week 52
Time frame: Up to Week 52
Time frame: Up to Week 52
Time frame: Up to Week 52
Time frame: Up to Week 52
Time frame: Up to Week 52
Time frame: Up to Week 52
Time frame: Up to Week 52
Time frame: Up to Week 52
Time frame: Up to Week 52
Time frame: Up to Week 52
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
Time frame: Up to Week 52
Time frame: Baseline (Day 1) and up to Week 52
Time frame: Baseline (Day 1) and up to Week 52
Time frame: Baseline (Day 1) and up to Week 52
Time frame: Baseline (Day 1) and up to Week 52
Time frame: Baseline (Day 1) and up to Week 52
Time frame: Baseline (Day 1) and up to Week 52
Time frame: Baseline (Day 1) and up to Week 52
Time frame: Baseline (Day 1) and up to Week 52
Time frame: Baseline (Day 1) and up to Week 52
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
Time frame: Baseline (Day 1) and up to Week 52
Time frame: Up to Week 52
Time frame: Up to Week 52
Time frame: Week 8, 12 and 24
Time frame: Up to Week 52
Time frame: Up to Week 52
Time frame: Up to Week 52
Time frame: Up to Week 52
Time frame: Up to Week 52
Time frame: Up to Week 52
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
ViiV Healthcare
Industry
A Phase I, Open-label, Single Dose Escalation Study to Evaluate the Pharmacokinetics, Safety and Tolerability of Two Different Formulations of Long-acting Cabotegravir Administered to Healthy Adult Participants
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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