VH4524184
DrugVH4524184 will be administered.
NCT Number: NCT07066722
The aim of the study is to gather information on how the drug behaves in healthy adults, how it is absorbed, and how it interacts when taken with other medicines.
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Notify Me18 year–60 year
All sexes
Interventional
Phase 1
GSK Investigational Site, Lenexa, Kansas, United States
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
22.Positive pre- study drug/alcohol screen. 23. Poor metabolizers of CYP2C9 and / or CYP2C19 as assessed by genotype testing. HLA-B*1502 positive as applicable to specified cohort.
Other exclusion criteria 24. Regular alcohol consumption exceeding specified limits. 25. Regular use of known drugs of abuse. 26. Nicotine use within 6 months. 27. Sensitivity or allergy to the study drug. 28. ALT >1.5×ULN. 29. Total bilirubin >1.5×ULN. 30. Significant arrhythmias or ECG findings that may compromise participant safety according to the investigator or VH Medical Monitor's assessment.
VH4524184 will be administered.
Itraconazole will be administered.
Other names: Sporanox
Rifabutin will be administered.
Other names: Mycobutin
Extended phenytoin sodium will be administered.
Other names: Dilantin
Metformin will be administered.
Other names: Glumetza
Digoxin will be administered.
Other names: Lanoxin
Time frame: Up to Day 18
Time frame: Up to day 18
Time frame: Up to day 18
Time frame: At Day 1, Day 14, Day 19 and Day 22
Time frame: At Day 1, Day 14, Day 19 and Day 22
Time frame: At Day 1, Day 14, Day 19 and Day 22
Time frame: At Day 1 and Day 15
Time frame: At Day 1 and Day 15
Time frame: At Day 1 and Day 15
Time frame: At Day 1 and Day 15
Time frame: From Day 1 up to Day 42
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention. Severity of grades are defined as Grade 1= Mild, Grade 2= Moderate, Grade 3= Severe, Grade 4= Potentially Life- Threatening.
Time frame: Throughout the study treatment period (from Day 1 up to Day 33)
Time frame: From Day 1 up to Day 42
Time frame: From Day 1 up to Day 42
Toxicity is graded using the DAIDS criteria Version 2.1 where grades were defined based on numeric criteria as follows Grade 1: mild; Grade 2: moderate; Grade 3: severe or medically significant; Grade 4: potentially life-threatening. A higher grade indicates greater severity.
Time frame: At Day 1
Time frame: At Day 1
Time frame: At Day 1
Time frame: At Day 1, Day 14, Day 19 and Day 22
Time frame: At Day 1, Day 14, Day 19 and Day 22
Time frame: At Day 1, Day 14, Day 19 and Day 22
Time frame: At Day 1 and Day 15
Time frame: At Day 1 and Day 15
Time frame: At Day 1 and Day 14
Time frame: At Day 1 and Day 14
Time frame: At Day 1 and Day 11
Time frame: At Day 1 and Day 19
Time frame: Day 1 and Day 22
Time frame: Day 1 and Day 22
ViiV Healthcare
Industry
A Phase 1, Open-Label Study to Evaluate the Relative Bioavailability and the Effect of Food on VH4524184 Tablet Formulations, and to Evaluate the Potential for VH4524184 Drug-Drug-Interactions 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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