Part 1: Cohort 1: Participants receiving VH4524184 DL1 for Human Immunodeficiency Virus (HIV) Infection

Q: For whom is this clinical research available?

<p>This <a href="https://www.withpower.com/clinical-trials/sci">sci</a>entific inquiry is in search of 105 individuals that are living with Human Immunodeficiency Virus (HIV) and aged between 18 to 50. For prospective candidates to be considered, they must meet the following criteria: chronological age from 18-50 years old, healthily functioning bodies that weight at least 110 lbs for males or 99 lbs for females along with a Body Mass Index within a <a href="https://www.withpower.com/clinical-trials/ra">ra</a>nge of 18.5 - 32 kg/m^2 respectively; male participants have no contraceptive restrictions while female applicants need to not be expecting, lactating nor physically capable of bearing children.</p>

Phase-Based Progress Estimates

Effectiveness

Safety

GSK Investigational Site, Baltimore, MDHuman Immunodeficiency Virus (HIV) InfectionVH4524184 - Drug

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Eligibility

18 - 50

All Sexes

What conditions do you have?

Select

Eligibility

18 - 50

All Sexes

What conditions do you have?

Select

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.

Treatment Effectiveness

Effectiveness Progress

1 of 3

Similar Trials

Part A; Cohort 3

Part 3, Sequence 2

PF-07817883 FORM-1 Fasted in PART-3

Study Objectives

32 Primary · 3 Secondary · Reporting Duration: Baseline (Day 1) and up to 6.5 weeks

Week 4

Part 1: Change from Baseline in Aspartate aminotransferase (AST), Alanine aminotransferase (ALT) and Alkaline phosphatase (ALP) (International units per liter)

Part 1: Change from Baseline in International normalized ratio (INR) (Ratio)

Part 1: Change from Baseline in Prothrombin time and Partial Thromboplastin Time (Seconds)

Part 1: Change from Baseline in Total bilirubin and Direct bilirubin (Micromoles per liter)

Part 1: Number of participants with maximum toxicity grade increase from Baseline in liver panel laboratory parameters; AST, ALT, ALP, Total bilirubin, Direct bilirubin, Prothrombin time, Partial Thromboplastin Time and INR

Week 5

Part 2: Change from Baseline in AST, ALT and ALP (International units per liter)

Part 2: Change from Baseline in INR (Ratio)

Part 2: Change from Baseline in Prothrombin time and Partial Thromboplastin Time (Seconds)

Part 2: Change from Baseline in Total bilirubin and Direct bilirubin (Micromoles per liter)

Part 2: Number of participants with maximum toxicity grade increase from Baseline in liver panel laboratory parameters; AST, ALT, ALP, Total bilirubin, Direct bilirubin, Prothrombin time, Partial Thromboplastin Time and INR

Part 3: Change from Baseline in AST, ALT and ALP (International units per liter)

Part 3: Change from Baseline in INR (Ratio)

Part 3: Change from Baseline in Prothrombin time and Partial Thromboplastin Time (Seconds)

Part 3: Change from Baseline in Total bilirubin and Direct bilirubin (Micromoles per liter)

Part 3: Number of participant with maximum toxicity grade increase from Baseline in liver panel laboratory parameters; AST, ALT, ALP, Total bilirubin, Direct bilirubin, Prothrombin time, Partial Thromboplastin Time and INR

Up to 4 weeks

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: Maximum observed plasma drug concentration (Cmax) following dosing of VH4524184

Part 1: Number of participants with adverse events based on severity

Part 1: Number of participants with serious adverse events (SAE) and non-serious adverse events (non-SAE)

Part 1: Number of participants with treatment emergent Grade 3 or Grade 4 laboratory abnormalities

Part 1: Percentage of participants who discontinue treatment due to adverse events (AE)

Part 1: Time to maximum observed plasma drug concentration (tmax) following dosing of VH4524184

Up to 6.5 weeks

Part 2: Area under the plasma concentration-time curve from zero (pre-dose) to the end of the dosing interval at steady state (AUC[0-tau]) following dosing of VH4524184

Part 2: Cmax following dosing of VH4524184

Part 2: Number of participants with SAE and non-SAE

Part 2: Number of participants with adverse events by severity

Part 2: Number of participants with treatment emergent Grade 3 or Grade 4 laboratory abnormalities

Part 2: Percentage of participants who discontinue treatment due to AE

Part 2: T1/2 following dosing of VH4524184

Part 2: Tmax following dosing of VH4524184

Part 3: Number of participants with SAE and non-SAE

Part 3: Number of participants with adverse events based on severity

Part 3: Number of participants with treatment emergent Grade 3 or Grade 4 laboratory abnormalities

Part 3: Percentage of participants who discontinue treatment due to AE

Trial Safety

Safety Progress

1 of 3

Similar Trials

Part A; Cohort 3

Part 3, Sequence 2

PF-07817883 FORM-1 Fasted in PART-3

Trial Design

19 Treatment Groups

Part 1: Cohort 1: Participants receiving VH4524184 DL1

1 of 19

Part 1: Cohort 3: Participants receiving VH4524184 DL3

1 of 19

Part 1: Cohort 4: Participants receiving VH4524184 DL4

1 of 19

Part 3: Cohort 10: VH4524184 Fasted/ VH4524184 Fed

1 of 19

Part 1: Cohort 2: Participants receiving VH4524184 DL2

1 of 19

Part 1: Cohort 6: Participants receiving VH4524184 DL6

1 of 19

Part 2: Cohort 8: Participants receiving VH4524184 RL2

1 of 19

Part 2: Cohort 9: Participants receiving VH4524184 RL3

1 of 19

Part 2: Cohort 7: Participants receiving VH4524184 RL1

1 of 19

Part 1: Cohort 5: Participants receiving VH4524184 DL5

1 of 19

Part 1: Cohort 6: Participants receiving Placebo

1 of 19

Part 2: Cohort 9: Participants receiving Placebo

1 of 19

Part 1: Cohort 2: Participants receiving Placebo

1 of 19

Part 1: Cohort 4: Participants receiving Placebo

1 of 19

Part 1: Cohort 5: Participants receiving Placebo

1 of 19

Part 2: Cohort 7: Participants receiving Placebo

1 of 19

Part 1: Cohort 3: Participants receiving Placebo

1 of 19

Part 1: Cohort 1: Participants receiving Placebo

1 of 19

Part 2: Cohort 8: Participants receiving Placebo

1 of 19

Experimental Treatment

Non-Treatment Group

105 Total Participants · 19 Treatment Groups

Primary Treatment: Part 1: Cohort 1: Participants receiving VH4524184 DL1 · Has Placebo Group · Phase 1

Part 1: Cohort 1: Participants receiving VH4524184 DL1

Drug