HIV InfectionsPhase 1NCT05631704
A Study to Investigate Safety, Tolerability, and Pharmacokinetics (PK) of VH4524184 and the Potential for Changes in Cytochrome P450 3A (CYP3A) Activity
A Phase 1 study testing VH4524184 and Midazolam in people with HIV Infections, run by ViiV Healthcare at 1 site in United States.
Trial summary
This study is designed to investigate the safety, tolerability and PK of VH4524184 (GSK4524184) and the potential of VH4524184 to inhibit or induce CYP3A activity in healthy participants. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- HIV Infections
- What is being tested?
- VH4524184 and Midazolam
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 84 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Dec 2022to 27 Jul 2023
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Participant must be 18 to 50 years of age.
- 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.
Who cannot join
- History or presence of clinical condition that could significantly alter how medicines are absorbed, broken down or eliminated from the body; be risky to the participant, or make it difficult to interpret the data from the study.
- 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).
Show all 31Show fewer
- 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
- Exclusion criteria for Screening ECG (a single repeat is allowed for eligibility determination): Heart rate:<45 or >100 beats per minute (bpm) (Males), <50 or >100 bpm (Females); PR interval: <120 or >220 msec; QRS duration: <70 or >120 msec and QTcF interval: >450 msec.
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 1 Double-Blind (Sponsor-unblinded), Placebo-Controlled Randomized, Single and Multiple Ascending Dose First-Time-in-Human Study to Investigate the Safety, Tolerability, and Pharmacokinetics of VH4524184 and the Potential for Changes in Cytochrome P450 3A (CYP3A) Activity
This study is designed to investigate the safety, tolerability and PK of VH4524184 (GSK4524184) and the potential of VH4524184 to inhibit or induce CYP3A activity in healthy participants.
- Conditions
- HIV Infections
- Being tested
- VH4524184, Midazolam, Placebo
- Keywords
- First-time-in-human, GSK4524184, Healthy volunteers, Multiple Ascending Dose, Single Ascending Dose, VH4524184
- Medical subject headings
- HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VH4524184Drug
VH4524184 will be administered.
MidazolamDrug
Midazolam will be administered in the highest dose cohort in Part 2 (Cohorts 8 or 9).
PlaceboDrug
Placebo will be administered.
| Study group | Role | What they receive |
|---|---|---|
| Part 1: Cohort 1: Participants receiving VH4524184 DL1 | Experimental | Eligible participants will receive VH4524184 Dose Level 1 (DL1) during Cohort 1 of Part 1 of the study. Receives: Drug: VH4524184 |
| Part 1: Cohort 1: Participants receiving Placebo | Placebo comparator | Eligible participants will receive Placebo matching VH4524184 DL1 during Cohort 1 of Part 1 of the study. Receives: Drug: Placebo |
| Part 1: Cohort 2: Participants receiving VH4524184 DL2 | Experimental | Eligible participants will receive VH4524184 DL2 during Cohort 2 of Part 1 of the study. Receives: Drug: VH4524184 |
| Part 1: Cohort 2: Participants receiving Placebo | Placebo comparator | Eligible participants will receive Placebo matching VH4524184 DL2 during Cohort 2 of Part 1 of the study. Receives: Drug: Placebo |
| Part 1: Cohort 3: Participants receiving VH4524184 DL3 | Experimental | Eligible participants will receive VH4524184 DL3 during Cohort 3 of Part 1 of the study. Receives: Drug: VH4524184 |
| Part 1: Cohort 3: Participants receiving Placebo | Placebo comparator | Eligible participants will receive Placebo matching VH4524184 DL3 during Cohort 3 of Part 1 of the study. Receives: Drug: Placebo |
| Part 1: Cohort 4: Participants receiving VH4524184 DL4 | Experimental | Eligible participants will receive VH4524184 DL4 during Cohort 4 of Part 1 of the study. Receives: Drug: VH4524184 |
| Part 1: Cohort 4: Participants receiving Placebo | Placebo comparator | Eligible participants will receive Placebo matching VH4524184 DL4 during Cohort 4 of Part 1 of the study. Receives: Drug: Placebo |
| Part 1: Cohort 5: Participants receiving VH4524184 DL5 | Experimental | Eligible participants will receive VH4524184 DL5 during Cohort 5 (optional) of Part 1 of the study. Receives: Drug: VH4524184 |
| Part 1: Cohort 5: Participants receiving Placebo | Placebo comparator | Eligible participants will receive Placebo matching VH4524184 DL5 during Cohort 5 (optional) of Part 1 of the study. Receives: Drug: Placebo |
| Part 1: Cohort 6: Participants receiving VH4524184 DL6 | Experimental | Eligible participants will receive VH4524184 DL6 during Cohort 6 (optional) of Part 1 of the study. Receives: Drug: VH4524184 |
| Part 1: Cohort 6: Participants receiving Placebo | Placebo comparator | Eligible participants will receive Placebo matching VH4524184 DL6 during Cohort 6 (optional) of Part 1 of the study. Receives: Drug: Placebo |
| Part 2: Cohort 7: Participants receiving VH4524184 RL1 | Experimental | Eligible participants will receive VH4524184 Repeat dose Level 1 (RL1) during Cohort 7 (Part 2) of the study. Receives: Drug: VH4524184 |
| Part 2: Cohort 7: Participants receiving Placebo | Placebo comparator | Eligible participants will receive Placebo matching VH4524184 RL1 during Cohort 7 (Part 2) of the study. Receives: Drug: Placebo |
| Part 2: Cohort 8: Participants receiving VH4524184 RL2 | Experimental | 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 Receives: Drug: VH4524184; Drug: Midazolam |
| Part 2: Cohort 8: Participants receiving Placebo | Placebo comparator | 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. Receives: Drug: Midazolam; Drug: Placebo |
| Part 2: Cohort 9: Participants receiving VH4524184 RL3 | Experimental | 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. Receives: Drug: VH4524184; Drug: Midazolam |
| Part 2: Cohort 9: Participants receiving Placebo | Placebo comparator | 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. Receives: Drug: Midazolam; Drug: Placebo |
| Part 3: Cohort 10: VH4524184 Fasted/ VH4524184 Fed | Experimental | 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. Receives: Drug: VH4524184 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Part 1: Number of participants with serious adverse events (SAE) and non-serious adverse events (non-SAE)
Measured: Up to 4 weeks
Part 2: Number of participants with SAE and non-SAE
Measured: Up to 6.5 weeks
Part 3: Number of participants with SAE and non-SAE
Measured: Up to 6.5 weeks
Part 1: Number of participants with adverse events based on severity
Measured: Up to 4 weeks
Part 2: Number of participants with adverse events by severity
Measured: Up to 6.5 weeks
Part 3: Number of participants with adverse events based on severity
Measured: Up to 6.5 weeks
Part 1: Percentage of participants who discontinue treatment due to adverse events (AE)
Measured: Up to 4 weeks
Part 2: Percentage of participants who discontinue treatment due to AE
Measured: Up to 6.5 weeks
Part 3: Percentage of participants who discontinue treatment due to AE
Measured: Up to 6.5 weeks
Part 1: Change from Baseline in Aspartate aminotransferase (AST), Alanine aminotransferase (ALT) and Alkaline phosphatase (ALP) (International units per liter)
Measured: Baseline (Day 1) and up to 4 weeks
Part 2: Change from Baseline in AST, ALT and ALP (International units per liter)
Measured: Baseline (Day 1) and up to 6.5 weeks
Part 3: Change from Baseline in AST, ALT and ALP (International units per liter)
Measured: Baseline (Day 1) and up to 6.5 weeks
Part 1: Change from Baseline in Total bilirubin and Direct bilirubin (Micromoles per liter)
Measured: Baseline (Day 1) and up to 4 weeks
Part 2: Change from Baseline in Total bilirubin and Direct bilirubin (Micromoles per liter)
Measured: Baseline (Day 1) and up to 6.5 weeks
Part 3: Change from Baseline in Total bilirubin and Direct bilirubin (Micromoles per liter)
Measured: Baseline (Day 1) and up to 6.5 weeks
Part 1: Change from Baseline in Prothrombin time and Partial Thromboplastin Time (Seconds)
Measured: Baseline (Day 1) and up to 4 weeks
Part 2: Change from Baseline in Prothrombin time and Partial Thromboplastin Time (Seconds)
Measured: Baseline (Day 1) and up to 6.5 weeks
Part 3: Change from Baseline in Prothrombin time and Partial Thromboplastin Time (Seconds)
Measured: Baseline (Day 1) and up to 6.5 weeks
Part 1: Change from Baseline in International normalized ratio (INR) (Ratio)
Measured: Baseline (Day 1) and up to 4 weeks
Part 2: Change from Baseline in INR (Ratio)
Measured: Baseline (Day 1) and up to 6.5 weeks
Part 3: Change from Baseline in INR (Ratio)
Measured: Baseline (Day 1) and up to 6.5 weeks
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
Measured: Baseline (Day 1) and up to 4 weeks
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
Measured: Baseline (Day 1) and up to 6.5 weeks
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
Measured: Baseline (Day 1) and up to 6.5 weeks
Part 1: Area under the plasma-concentration time curve from zero (pre-dose) extrapolated to infinite time (AUC[0-infinity]) following dosing of VH4524184
Measured: Up to 4 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
Measured: Up to 6.5 weeks
Part 1: Maximum observed plasma drug concentration (Cmax) following dosing of VH4524184
Measured: Up to 4 weeks
Part 2: Cmax following dosing of VH4524184
Measured: Up to 6.5 weeks
Part 1: Time to maximum observed plasma drug concentration (tmax) following dosing of VH4524184
Measured: Up to 4 weeks
Part 2: Tmax following dosing of VH4524184
Measured: Up to 6.5 weeks
Part 1: Apparent terminal half-life (t1/2) following dosing of VH4524184
Measured: Up to 4 weeks
Part 2: T1/2 following dosing of VH4524184
Measured: Up to 6.5 weeks
Secondary outcomes (3)
Part 1: Number of participants with treatment emergent Grade 3 or Grade 4 laboratory abnormalities
Measured: Up to 4 weeks
Part 2: Number of participants with treatment emergent Grade 3 or Grade 4 laboratory abnormalities
Measured: Up to 6.5 weeks
Part 3: Number of participants with treatment emergent Grade 3 or Grade 4 laboratory abnormalities
Measured: Up to 6.5 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Nov 2022
- Study start2 Dec 2022
- Primary completion27 Jul 2023
- Study completion27 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HIV InfectionsStudies of the same condition, open and under way.
- More trials run by ViiV HealthcareThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Model description
- Participants will receive escalating doses of VH4524184 or placebo in Part 1 and Part 2 of the study. In Part 3, participants will receive VH4524184 under fasted and fed conditions.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 84 participants (actual)
Sponsor and investigators
- Lead sponsor
- ViiV Healthcare
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- GSK Clinical Trials, Study director, ViiV Healthcare
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05631704
- Sponsor's protocol ID
- 218803
- Status last verified
- Dec 2025
- First submitted
- 18 Nov 2022
- Last updated
- 29 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Qualified researchers may request access to anonymized individual patient-level data (IPD) and related study documents of the eligible studies via the Data Sharing Portal. Details on GSK's data sharing criteria can be found at: https://www.gsk.com/en-gb/innovation/trials/data-transparency/
Publications
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 Oct 6;81(3):510-520. doi: 10.1093/cid/ciaf135.
PubMed 40117383
Study at a glance
From the registry record, last updated by the sponsor on 29 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Double-Blind (Sponsor-unblinded), Placebo-Controlled Randomized, Single and Multiple Ascending Dose First-Time-in-Human Study to Investigate the Safety, Tolerability, and Pharmacokinetics of VH4524184 and the Potential for Changes in Cytochrome P450 3A (CYP3A) Activity
- ClinicalTrials.gov ID
- NCT05631704
- Acronym / sponsor ID
- 218803
- Conditions
- HIV Infections
- Keywords
- First-time-in-human, GSK4524184, Healthy volunteers, Multiple Ascending Dose, Single Ascending Dose, VH4524184
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 84 participants (actual)
- Lead sponsor
- ViiV HealthcareIndustry (pharma, biotech, devices)
- Study start
- 2 Dec 2022 (actual)
- Primary completion
- 27 Jul 2023 (actual)
- Study completion
- 27 Jul 2023 (actual)
- First posted
- 30 Nov 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is designed to investigate the safety, tolerability and PK of VH4524184 (GSK4524184) and the potential of VH4524184 to inhibit or induce CYP3A activity in healthy participants.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind (participant, investigator)
- Number of arms
- 19
- Model description
- Participants will receive escalating doses of VH4524184 or placebo in Part 1 and Part 2 of the study. In Part 3, participants will receive VH4524184 under fasted and fed conditions.
| Arm | Type | Receives |
|---|---|---|
| Part 1: Cohort 1: Participants receiving VH4524184 DL1 | Experimental | Drug: VH4524184Eligible participants will receive VH4524184 Dose Level 1 (DL1) during Cohort 1 of Part 1 of the study. |
| Part 1: Cohort 1: Participants receiving Placebo | Placebo comparator | Drug: PlaceboEligible participants will receive Placebo matching VH4524184 DL1 during Cohort 1 of Part 1 of the study. |
| Part 1: Cohort 2: Participants receiving VH4524184 DL2 | Experimental | Drug: VH4524184Eligible participants will receive VH4524184 DL2 during Cohort 2 of Part 1 of the study. |
| Part 1: Cohort 2: Participants receiving Placebo | Placebo comparator | Drug: PlaceboEligible participants will receive Placebo matching VH4524184 DL2 during Cohort 2 of Part 1 of the study. |
| Part 1: Cohort 3: Participants receiving VH4524184 DL3 | Experimental | Drug: VH4524184Eligible participants will receive VH4524184 DL3 during Cohort 3 of Part 1 of the study. |
| Part 1: Cohort 3: Participants receiving Placebo | Placebo comparator | Drug: PlaceboEligible participants will receive Placebo matching VH4524184 DL3 during Cohort 3 of Part 1 of the study. |
| Part 1: Cohort 4: Participants receiving VH4524184 DL4 | Experimental | Drug: VH4524184Eligible participants will receive VH4524184 DL4 during Cohort 4 of Part 1 of the study. |
| Part 1: Cohort 4: Participants receiving Placebo | Placebo comparator | Drug: PlaceboEligible participants will receive Placebo matching VH4524184 DL4 during Cohort 4 of Part 1 of the study. |
| Part 1: Cohort 5: Participants receiving VH4524184 DL5 | Experimental | Drug: VH4524184Eligible participants will receive VH4524184 DL5 during Cohort 5 (optional) of Part 1 of the study. |
| Part 1: Cohort 5: Participants receiving Placebo | Placebo comparator | Drug: PlaceboEligible participants will receive Placebo matching VH4524184 DL5 during Cohort 5 (optional) of Part 1 of the study. |
| Part 1: Cohort 6: Participants receiving VH4524184 DL6 | Experimental | Drug: VH4524184Eligible participants will receive VH4524184 DL6 during Cohort 6 (optional) of Part 1 of the study. |
| Part 1: Cohort 6: Participants receiving Placebo | Placebo comparator | Drug: PlaceboEligible participants will receive Placebo matching VH4524184 DL6 during Cohort 6 (optional) of Part 1 of the study. |
| Part 2: Cohort 7: Participants receiving VH4524184 RL1 | Experimental | Drug: VH4524184Eligible participants will receive VH4524184 Repeat dose Level 1 (RL1) during Cohort 7 (Part 2) of the study. |
| Part 2: Cohort 7: Participants receiving Placebo | Placebo comparator | Drug: PlaceboEligible participants will receive Placebo matching VH4524184 RL1 during Cohort 7 (Part 2) of the study. |
| Part 2: Cohort 8: Participants receiving VH4524184 RL2 | Experimental | Drug: VH4524184, Drug: MidazolamEligible 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 |
| Part 2: Cohort 8: Participants receiving Placebo | Placebo comparator | Drug: Midazolam, Drug: PlaceboEligible 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. |
| Part 2: Cohort 9: Participants receiving VH4524184 RL3 | Experimental | Drug: VH4524184, Drug: MidazolamEligible 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. |
| Part 2: Cohort 9: Participants receiving Placebo | Placebo comparator | Drug: Midazolam, Drug: PlaceboEligible 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. |
| Part 3: Cohort 10: VH4524184 Fasted/ VH4524184 Fed | Experimental | Drug: VH4524184Eligible 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. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Participant must be 18 to 50 years of age.
- 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.
Key exclusion criteria (31 listed)
- History or presence of clinical condition that could significantly alter how medicines are absorbed, broken down or eliminated from the body; be risky to the participant, or make it difficult to interpret the data from the study.
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VH4524184VH4524184 will be administered. | Drug | Part 1: Cohort 1: Participants receiving VH4524184 DL1, Part 1: Cohort 2: Participants receiving VH4524184 DL2, Part 1: Cohort 3: Participants receiving VH4524184 DL3, Part 1: Cohort 4: Participants receiving VH4524184 DL4, Part 1: Cohort 5: Participants receiving VH4524184 DL5, Part 1: Cohort 6: Participants receiving VH4524184 DL6, Part 2: Cohort 7: Participants receiving VH4524184 RL1, Part 2: Cohort 8: Participants receiving VH4524184 RL2, Part 2: Cohort 9: Participants receiving VH4524184 RL3, Part 3: Cohort 10: VH4524184 Fasted/ VH4524184 Fed |
| MidazolamMidazolam will be administered in the highest dose cohort in Part 2 (Cohorts 8 or 9). | Drug | Part 2: Cohort 8: Participants receiving Placebo, Part 2: Cohort 8: Participants receiving VH4524184 RL2, Part 2: Cohort 9: Participants receiving Placebo, Part 2: Cohort 9: Participants receiving VH4524184 RL3 |
| PlaceboPlacebo will be administered. | Drug | Part 1: Cohort 1: Participants receiving Placebo, Part 1: Cohort 2: Participants receiving Placebo, Part 1: Cohort 3: Participants receiving Placebo, Part 1: Cohort 4: Participants receiving Placebo, Part 1: Cohort 5: Participants receiving Placebo, Part 1: Cohort 6: Participants receiving Placebo, Part 2: Cohort 7: Participants receiving Placebo, Part 2: Cohort 8: Participants receiving Placebo, Part 2: Cohort 9: Participants receiving Placebo |
Primary outcome
Part 1: Number of participants with serious adverse events (SAE) and non-serious adverse events (non-SAE)
Time frame: Up to 4 weeks
Part 2: Number of participants with SAE and non-SAE
Time frame: Up to 6.5 weeks
Part 3: Number of participants with SAE and non-SAE
Time frame: Up to 6.5 weeks
Part 1: Number of participants with adverse events based on severity
Time frame: Up to 4 weeks
Part 2: Number of participants with adverse events by severity
Time frame: Up to 6.5 weeks
Part 3: Number of participants with adverse events based on severity
Time frame: Up to 6.5 weeks
Part 1: Percentage of participants who discontinue treatment due to adverse events (AE)
Time frame: Up to 4 weeks
Part 2: Percentage of participants who discontinue treatment due to AE
Time frame: Up to 6.5 weeks
Part 3: Percentage of participants who discontinue treatment due to AE
Time frame: Up to 6.5 weeks
Part 1: Change from Baseline in Aspartate aminotransferase (AST), Alanine aminotransferase (ALT) and Alkaline phosphatase (ALP) (International units per liter)
Time frame: Baseline (Day 1) and up to 4 weeks
Part 2: Change from Baseline in AST, ALT and ALP (International units per liter)
Time frame: Baseline (Day 1) and up to 6.5 weeks
Part 3: Change from Baseline in AST, ALT and ALP (International units per liter)
Time frame: Baseline (Day 1) and up to 6.5 weeks
Part 1: Change from Baseline in Total bilirubin and Direct bilirubin (Micromoles per liter)
Time frame: Baseline (Day 1) and up to 4 weeks
Part 2: Change from Baseline in Total bilirubin and Direct bilirubin (Micromoles per liter)
Time frame: Baseline (Day 1) and up to 6.5 weeks
Part 3: Change from Baseline in Total bilirubin and Direct bilirubin (Micromoles per liter)
Time frame: Baseline (Day 1) and up to 6.5 weeks
Part 1: Change from Baseline in Prothrombin time and Partial Thromboplastin Time (Seconds)
Time frame: Baseline (Day 1) and up to 4 weeks
Part 2: Change from Baseline in Prothrombin time and Partial Thromboplastin Time (Seconds)
Time frame: Baseline (Day 1) and up to 6.5 weeks
Part 3: Change from Baseline in Prothrombin time and Partial Thromboplastin Time (Seconds)
Time frame: Baseline (Day 1) and up to 6.5 weeks
Part 1: Change from Baseline in International normalized ratio (INR) (Ratio)
Time frame: Baseline (Day 1) and up to 4 weeks
Part 2: Change from Baseline in INR (Ratio)
Time frame: Baseline (Day 1) and up to 6.5 weeks
Part 3: Change from Baseline in INR (Ratio)
Time frame: Baseline (Day 1) and up to 6.5 weeks
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
Time frame: Baseline (Day 1) and up to 4 weeks
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
Time frame: Baseline (Day 1) and up to 6.5 weeks
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
Time frame: Baseline (Day 1) and up to 6.5 weeks
Part 1: Area under the plasma-concentration time curve from zero (pre-dose) extrapolated to infinite time (AUC[0-infinity]) following dosing of VH4524184
Time frame: Up to 4 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
Time frame: Up to 6.5 weeks
Part 1: Maximum observed plasma drug concentration (Cmax) following dosing of VH4524184
Time frame: Up to 4 weeks
Part 2: Cmax following dosing of VH4524184
Time frame: Up to 6.5 weeks
Part 1: Time to maximum observed plasma drug concentration (tmax) following dosing of VH4524184
Time frame: Up to 4 weeks
Part 2: Tmax following dosing of VH4524184
Time frame: Up to 6.5 weeks
Part 1: Apparent terminal half-life (t1/2) following dosing of VH4524184
Time frame: Up to 4 weeks
Part 2: T1/2 following dosing of VH4524184
Time frame: Up to 6.5 weeks
3 secondary outcomes
Part 1: Number of participants with treatment emergent Grade 3 or Grade 4 laboratory abnormalities
Time frame: Up to 4 weeks
Part 2: Number of participants with treatment emergent Grade 3 or Grade 4 laboratory abnormalities
Time frame: Up to 6.5 weeks
Part 3: Number of participants with treatment emergent Grade 3 or Grade 4 laboratory abnormalities
Time frame: Up to 6.5 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Dec 2025.
- Derived from this study: PubMed 40117383Rogg 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 Oct 6;81(3):510-520. doi: 10.1093/cid/ciaf135.
- Individual participant dataSharing planned: Yes. Qualified researchers may request access to anonymized individual patient-level data (IPD) and related study documents of the eligible studies via the Data Sharing Portal. Details on GSK's data sharing criteria can be found at: https://www.gsk.com/en-gb/innovation/trials/data-transparency/
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
GSK Clinical Trials study director
ViiV Healthcare
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing VH4524184 and Midazolam in people with HIV Infections, run by ViiV Healthcare at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 31 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Part 1: Number of participants with serious adverse events (SAE) and non-serious adverse events (non-SAE) (time frame: Up to 4 weeks). The study lists 32 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05631704, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Dec 2025.