GSK Investigational Site
Austin, Texas, 78744 -1645, United States
NCT Number: NCT06368986
The purpose of this study is to evaluate effect of food (in fasted and fed conditions) on the bioavailability of CAI VH4011499.
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Notify Me18 year–55 year
All sexes
Interventional
Phase 1
Austin, Texas, 78744 -1645, United States
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
VH4011499 administered in fasted or fed conditions.
VH4011499 Dose B administered in fasted or fed conditions.
Time frame: From Day 1 (pre-dose) to Day 28
Time frame: From Day 1 (pre-dose) to Day 28
Time frame: From Day 1 (pre-dose) to Day 28
Time frame: From Day 1 (pre-dose) to Day 28
Time frame: From Day 1 (pre-dose) to Day 28
An AE is any untoward medical occurrence in a participant or clinical investigation participant and can be any sign, symptom, or disease temporally associated with the use of a medicinal product. The severity scale is assessed as following: Grade 1 = mild symptoms causing no or minimal interference with usual social and functional activities with intervention not indicated. Grade 2 = moderate symptoms causing greater than minimal interference with usual social and functional activities with intervention indicated. Grade 3 = severe symptoms causing inability to perform usual social and functional activities with intervention or hospitalization indicated. Grade 4 = potentially life-threatening symptoms causing inability to perform self-care functions with intervention indicated to prevent permanent impairment, persistent disability, or death, Grade 5 = death.
Time frame: From Day 1 (pre-dose) to Day 28
The assessed laboratory assessments include Alanine aminotransferase (ALT), Aspartate aminotransferase (AST), alkaline phosphatase (ALP), direct bilirubin and total bilirubin, in both fed and fasted conditions.
Time frame: From Day 1 (pre-dose) to Day 28
Time frame: From Day 1 (pre-dose) to Day 28
ViiV Healthcare
Industry
An Open Label, Phase 1 Study to Assess the Effect of Food on Bioavailability for an Investigational Capsid Inhibitor in 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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