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Part 1: Cohort 1: Participants receiving VH4524184 DL1 for HIV Suppression

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 up to 5 years

Summary

This trial tests a new drug, VH4524184, in healthy people to see if it is safe and how it affects an enzyme that processes other drugs.

Eligible Conditions

HIV Suppression
Human Immunodeficiency Virus Infection

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

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 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 XII: 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 XIII: 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 XIV: 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 XV: 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 XVI: 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 XVII: 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 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

VH4524184

2024