A Study to Investigate Safety, Tolerability, and Pharmacokinetics (PK) of VH4524184 and the Potential for Changes in Cytochrome P450 3A (CYP3A) Activity
NCT ID: NCT05631704
Last Updated: 2023-01-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE1
105 participants
INTERVENTIONAL
2022-12-02
2023-08-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
SEQUENTIAL
TREATMENT
DOUBLE
Study Groups
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Part 1: Cohort 1: Participants receiving VH4524184 DL1
Eligible participants will receive VH4524184 Dose Level 1 (DL1) during Cohort 1 of Part 1 of the study.
VH4524184
VH4524184 will be administered.
Part 1: Cohort 1: Participants receiving Placebo
Eligible participants will receive Placebo matching VH4524184 DL1 during Cohort 1 of Part 1 of the study.
Placebo
Placebo will be administered.
Part 1: Cohort 2: Participants receiving VH4524184 DL2
Eligible participants will receive VH4524184 DL2 during Cohort 2 of Part 1 of the study.
VH4524184
VH4524184 will be administered.
Part 1: Cohort 2: Participants receiving Placebo
Eligible participants will receive Placebo matching VH4524184 DL2 during Cohort 2 of Part 1 of the study.
Placebo
Placebo will be administered.
Part 1: Cohort 3: Participants receiving VH4524184 DL3
Eligible participants will receive VH4524184 DL3 during Cohort 3 of Part 1 of the study.
VH4524184
VH4524184 will be administered.
Part 1: Cohort 3: Participants receiving Placebo
Eligible participants will receive Placebo matching VH4524184 DL3 during Cohort 3 of Part 1 of the study.
Placebo
Placebo will be administered.
Part 1: Cohort 4: Participants receiving VH4524184 DL4
Eligible participants will receive VH4524184 DL4 during Cohort 4 of Part 1 of the study.
VH4524184
VH4524184 will be administered.
Part 1: Cohort 4: Participants receiving Placebo
Eligible participants will receive Placebo matching VH4524184 DL4 during Cohort 4 of Part 1 of the study.
Placebo
Placebo will be administered.
Part 1: Cohort 5: Participants receiving VH4524184 DL5
Eligible participants will receive VH4524184 DL5 during Cohort 5 (optional) of Part 1 of the study.
VH4524184
VH4524184 will be administered.
Part 1: Cohort 5: Participants receiving Placebo
Eligible participants will receive Placebo matching VH4524184 DL5 during Cohort 5 (optional) of Part 1 of the study.
Placebo
Placebo will be administered.
Part 1: Cohort 6: Participants receiving VH4524184 DL6
Eligible participants will receive VH4524184 DL6 during Cohort 6 (optional) of Part 1 of the study.
VH4524184
VH4524184 will be administered.
Part 1: Cohort 6: Participants receiving Placebo
Eligible participants will receive Placebo matching VH4524184 DL6 during Cohort 6 (optional) of Part 1 of the study.
Placebo
Placebo will be administered.
Part 2: Cohort 7: Participants receiving VH4524184 RL1
Eligible participants will receive VH4524184 Repeat dose Level 1 (RL1) during Cohort 7 (Part 2) of the study.
VH4524184
VH4524184 will be administered.
Part 2: Cohort 7: Participants receiving Placebo
Eligible participants will receive Placebo matching VH4524184 RL1 during Cohort 7 (Part 2) of the study.
Placebo
Placebo will be administered.
Part 2: Cohort 8: Participants receiving VH4524184 RL2
Eligible participants will receive VH4524184 RL2 during Cohort 8 (Part 2) of the study. If Cohort 8 is the highest Part 2 dose cohort, participants may also receive midazolam probe before and following repeat dose administration of VH4524184
VH4524184
VH4524184 will be administered.
Midazolam
Midazolam will be administered in the highest dose cohort in Part 2 (Cohorts 8 or 9).
Part 2: Cohort 8: Participants receiving Placebo
Eligible participants will receive Placebo matching VH4524184 RL2 during Cohort 8 (Part 2) of the study. If Cohort 8 is the highest Part 2 dose cohort, participants may also receive midazolam probe before and following repeat dose administration of Placebo matching VH4524184.
Midazolam
Midazolam will be administered in the highest dose cohort in Part 2 (Cohorts 8 or 9).
Placebo
Placebo will be administered.
Part 2: Cohort 9: Participants receiving VH4524184 RL3
Eligible participants will receive VH4524184 RL3 during Cohort 9 (Part 2) (optional) of the study. If Cohort 9 is the highest Part 2 dose cohort, participants may also receive midazolam probe before and following repeat dose administration of VH4524184.
VH4524184
VH4524184 will be administered.
Midazolam
Midazolam will be administered in the highest dose cohort in Part 2 (Cohorts 8 or 9).
Part 2: Cohort 9: Participants receiving Placebo
Eligible participants will receive Placebo matching VH4524184 RL3 during Cohort 9 (Part 2) (optional) of the study. If Cohort 9 is the highest Part 2 dose cohort, participants may also receive midazolam probe before and following repeat dose administration of Placebo matching VH4524184.
Midazolam
Midazolam will be administered in the highest dose cohort in Part 2 (Cohorts 8 or 9).
Placebo
Placebo will be administered.
Part 3: Cohort 10: VH4524184 Fasted/ VH4524184 Fed
Eligible participants will receive VH4524184 under fasted condition in Treatment Period 1 followed by VH4524184 under fed condition in Treatment Period 2 during Cohort 10 (Part 3) of the study. Treatment Periods will be separated by a washout period.
VH4524184
VH4524184 will be administered.
Interventions
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VH4524184
VH4524184 will be administered.
Midazolam
Midazolam will be administered in the highest dose cohort in Part 2 (Cohorts 8 or 9).
Placebo
Placebo will be administered.
Eligibility Criteria
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Inclusion Criteria
* Participants who are overtly healthy.
* Body weight \>=50.0 kilograms (kg) (110 pounds \[lbs\]) for men and \>=45.0 kg (99 lbs) for women and body mass index within the range 18.5 to 32.0 kilograms per meter square (kg/m\^2) (inclusive).
* Male or female. Male Participants: No contraceptive restrictions for male participants. Female Participants: A female participant (female sex assigned at birth) is eligible to participate if she is not pregnant, or breastfeeding and is not physically able to have a baby.
Exclusion Criteria
* Pre-existing clinically relevant gastro-intestinal disorders.
* Abnormal blood pressure.
* Certain blood or other cancers within the past 5 years.
* Breast cancer within the past 10 years
* Current or chronic history of liver disease or liver or bile tract abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones).
* QT interval corrected for heart rate according to Fridericia's formula (QTcF) \>450 milliseconds (msec).
* Medical history of cardiac arrhythmias or cardiac disease or a family and personal history of long QT syndrome.
* History of seizure
* Any known or suspected pre-existing psychiatric condition, including depression, anxiety and insomnia/sleep disturbances.
* Any positive (abnormal) response to the Columbia Suicide Severity Rating Scale (CSSRS).
* Past or intended use of over-the-counter or prescription medication within 7 days (or 14 days if the drug is a potential enzyme inducer) or 5 half-lives (whichever is longer) prior to dosing and for the duration of the study.
* Receipt of any live vaccine(s) or vaccines against Coronavirus disease 2019 (Covid-19) within 28 days prior to screening or plans to receive such vaccines during the study.
* Exposure to more than 4 new investigational products (including long-acting investigational products) within 12 months prior to the first dosing day.
* Current enrollment or past participation in another investigational study in which an investigational intervention (e.g., drug, human blood product, monoclonal antibody, vaccine, invasive device) was administered within the last 30 days, 5 half-lives or twice the duration of the biological effect of the investigational product (whichever is longer) before signing of consent (OR screening) any other clinical study.
* Participation in the study would result in loss of blood or blood products in excess of 500 milliliters (mL) over a 56-day period.
* Current enrollment or past participation in this clinical study.
* Estimated Glomerular Filtration Rate (eGFR) \<90 milliliters per minute (mL/min) (calculated using Chronic Kidney Disease Epidemiology Collaboration equation) or serum creatinine \>1.1 times Upper limit of normal (ULN).
* Hemoglobin \<12.5 grams per deciliter (g/dL) for men and \<11 g/dL for women
* ALT or AST \>1.5 times ULN
* Total bilirubin \>1.5 times ULN (isolated bilirubin \>1.5 times ULN is acceptable if bilirubin is fractionated and direct bilirubin \<35 percent \[%\]).
* Any significant arrhythmia or Electrocardiogram (ECG) finding
* Presence of hepatitis B surface antigen (HBsAg) at screening.
* Positive Hepatitis C antibody test result at screening
* Positive pre-study drug/alcohol screen.
* Positive human immunodeficiency virus (HIV) antibody test.
* Regular alcohol consumption within 6 months prior to the study
* Regular use of known drugs of abuse
* Urinary cotinine levels indicative of smoking or history or regular use of tobacco- or nicotine-containing products within 6 months prior to screening and at admission.
* Sensitivity to the study drug, or components thereof, midazolam (For Part 2, midazolam probe cohort), excipients contained therein, benzodiazepines, or other drug or other allergy that, in the opinion of the investigator or Sponsor Medical Monitor, contraindicates participation in the study.
18 Years
50 Years
ALL
Yes
Sponsors
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ViiV Healthcare
INDUSTRY
Responsible Party
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Principal Investigators
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GSK Clinical Trials
Role: STUDY_DIRECTOR
ViiV Healthcare
Locations
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GSK Investigational Site
Baltimore, Maryland, United States
Countries
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Central Contacts
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EU GSK Clinical Trials Call Center
Role: CONTACT
Phone: +44 (0) 20 89904466
Email: [email protected]
Facility Contacts
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US GSK Clinical Trials Call Center
Role: primary
EU GSK Clinical Trials Call Centre
Role: backup
References
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Rogg L, Underwood M, Hanan N, Castillo-Mancilla JR, Kahl L, Halliday F, Ghita GL, Jeffrey JL, Byrne S, Onodera T, Horton J, Gartland M. Phase 1 Evaluation of VH4524184, a Third-Generation Integrase Strand Transfer Inhibitor With an Enhanced Resistance Profile. Clin Infect Dis. 2025 Mar 21:ciaf135. doi: 10.1093/cid/ciaf135. Online ahead of print.
Other Identifiers
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218803
Identifier Type: -
Identifier Source: org_study_id