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Part 2: Cohort 8: Participants receiving VH4524184 RL2 for Human Immunodeficiency Virus Infection

Phase 1
Recruiting
Research Sponsored by ViiV Healthcare
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline (day 1) and up to 6.5 weeks
Awards & highlights

Study Summary

This trial tests a new drug to see if it's safe and how it affects the body, with the potential to modify how other drugs work.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline (day 1) and up to 6.5 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline (day 1) and up to 6.5 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Part 1: Apparent terminal half-life (t1/2) following dosing of VH4524184
Part 1: Area under the plasma-concentration time curve from zero (pre-dose) extrapolated to infinite time (AUC[0-infinity]) following dosing of VH4524184
Part 1: Change from Baseline in Aspartate aminotransferase (AST), Alanine aminotransferase (ALT) and Alkaline phosphatase (ALP) (International units per liter)
+29 more
Secondary outcome measures
Part 1: Number of participants with treatment emergent Grade 3 or Grade 4 laboratory abnormalities
Part 2: Number of participants with treatment emergent Grade 3 or Grade 4 laboratory abnormalities
Part 3: Number of participants with treatment emergent Grade 3 or Grade 4 laboratory abnormalities

Trial Design

19Treatment groups
Experimental Treatment
Placebo Group
Group I: Part 3: Cohort 10: VH4524184 Fasted/ VH4524184 FedExperimental Treatment1 Intervention
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.
Group II: Part 2: Cohort 9: Participants receiving VH4524184 RL3Experimental Treatment2 Interventions
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.
Group III: Part 2: Cohort 8: Participants receiving VH4524184 RL2Experimental Treatment2 Interventions
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
Group IV: Part 2: Cohort 7: Participants receiving VH4524184 RL1Experimental Treatment1 Intervention
Eligible participants will receive VH4524184 Repeat dose Level 1 (RL1) during Cohort 7 (Part 2) of the study.
Group V: Part 1: Cohort 6: Participants receiving VH4524184 DL6Experimental Treatment1 Intervention
Eligible participants will receive VH4524184 DL6 during Cohort 6 (optional) of Part 1 of the study.
Group VI: Part 1: Cohort 5: Participants receiving VH4524184 DL5Experimental Treatment1 Intervention
Eligible participants will receive VH4524184 DL5 during Cohort 5 (optional) of Part 1 of the study.
Group VII: Part 1: Cohort 4: Participants receiving VH4524184 DL4Experimental Treatment1 Intervention
Eligible participants will receive VH4524184 DL4 during Cohort 4 of Part 1 of the study.
Group VIII: Part 1: Cohort 3: Participants receiving VH4524184 DL3Experimental Treatment1 Intervention
Eligible participants will receive VH4524184 DL3 during Cohort 3 of Part 1 of the study.
Group IX: Part 1: Cohort 2: Participants receiving VH4524184 DL2Experimental Treatment1 Intervention
Eligible participants will receive VH4524184 DL2 during Cohort 2 of Part 1 of the study.
Group X: Part 1: Cohort 1: Participants receiving VH4524184 DL1Experimental Treatment1 Intervention
Eligible participants will receive VH4524184 Dose Level 1 (DL1) during Cohort 1 of Part 1 of the study.
Group XI: Part 1: Cohort 1: Participants receiving PlaceboPlacebo Group1 Intervention
Eligible participants will receive Placebo matching VH4524184 DL1 during Cohort 1 of Part 1 of the study.
Group XII: Part 1: Cohort 4: Participants receiving PlaceboPlacebo Group1 Intervention
Eligible participants will receive Placebo matching VH4524184 DL4 during Cohort 4 of Part 1 of the study.
Group XIII: Part 1: Cohort 6: Participants receiving PlaceboPlacebo Group1 Intervention
Eligible participants will receive Placebo matching VH4524184 DL6 during Cohort 6 (optional) of Part 1 of the study.
Group XIV: Part 1: Cohort 5: Participants receiving PlaceboPlacebo Group1 Intervention
Eligible participants will receive Placebo matching VH4524184 DL5 during Cohort 5 (optional) of Part 1 of the study.
Group XV: Part 1: Cohort 2: Participants receiving PlaceboPlacebo Group1 Intervention
Eligible participants will receive Placebo matching VH4524184 DL2 during Cohort 2 of Part 1 of the study.
Group XVI: Part 2: Cohort 7: Participants receiving PlaceboPlacebo Group1 Intervention
Eligible participants will receive Placebo matching VH4524184 RL1 during Cohort 7 (Part 2) of the study.
Group XVII: Part 2: Cohort 9: Participants receiving PlaceboPlacebo Group2 Interventions
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.
Group XVIII: Part 2: Cohort 8: Participants receiving PlaceboPlacebo Group2 Interventions
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.
Group XIX: Part 1: Cohort 3: Participants receiving PlaceboPlacebo Group1 Intervention
Eligible participants will receive Placebo matching VH4524184 DL3 during Cohort 3 of Part 1 of the study.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Midazolam
2018
Completed Phase 4
~1910

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Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

ViiV HealthcareLead Sponsor
361 Previous Clinical Trials
468,542 Total Patients Enrolled
GSK Clinical TrialsStudy DirectorViiV Healthcare
3,596 Previous Clinical Trials
6,144,236 Total Patients Enrolled
~43 spots leftby May 2025
Unbiased ResultsWe believe in providing patients with all the options.
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