HIV InfectionsPhase 1NCT06168318
A Study to Investigate the Relative Bioavailability and Food Effect of an Oral Capsid Inhibitor Tablet Formulation Compared With Other Oral Tablet Formulations in Male and Female Healthy Participants
A Phase 1 study testing VH4004280 Formulation A, VH4004280 Formulation B and VH4004280 Formulation C in people with HIV Infections, run by ViiV Healthcare at 1 site in United Kingdom.
Trial summary
This is a 3 part study of an investigational capsid inhibitor, VH4004280, in healthy adult participants. The purpose is to evaluate the effect of tablet formulation as well as food on bioavailability. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- HIV Infections
- What is being tested?
- VH4004280 Formulation A, VH4004280 Formulation B and VH4004280 Formulation C
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 18 Dec 2023to 3 Jun 2024
- 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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Participants must be 18 to 55years of age.
- Participants who are overtly healthy.
- Negative (Severe Acute Respiratory Syndrome Coronavirus 2) SARs-CoV-2 test prior to dosing.
- Has body mass index (BMI) within the range 19-32 (kg/m2).
- Participants male at birth must use male condoms, and participants female at birth who are of childbearing potential must be using acceptable forms of birth control.
- Capable of giving signed informed consent.
Who cannot join
- History or presence of disorders capable of significantly altering the absorption, metabolism, or elimination of drugs.
- Abnormal blood pressure.
- Any malignancy within the past 5 years except certain localized malignancies, or breast cancer within the past 10 years.
- Has exclusionary psychiatric, hepatic, cardiovascular, gastrointestinal, respiratory, endocrine, neurological, hematological, or renal condition.
- Current or chronic history of liver disease or known hepatic or biliary abnormalities.
- Participants with exclusionary electrocardiogram findings.
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- Past or intended use of exclusionary medications or vaccines.
- Exposure > 4 new investigational products within 12 months, previous participation in this study, or current enrolment or participation in another investigational study.
- ALT >1.5x upper limit of normal (ULN), total bilirubin >1.5x ULN, and/or estimated serum creatinine clearance <60 mL/min.
- History of or current infection with hepatitis B or hepatitis C.
- Positive SARS-CoV-2 test, having signs and symptoms suggestive of COVID-19, or contact with known COVID-19 positive person.
- Positive HIV antibody test.
- Participants with positive results for illicit drug use, regular use of drugs of abuse, tobacco or nicotine-containing product use, and/or excessive alcohol use.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A 3-part, Phase 1, Single-center, Open-label Study to Assess the Relative Bioavailability of Oral Formulations for an Investigational Capsid Inhibitor in Healthy Adult Participants, and to Evaluate the Effect of Food on Bioavailability for an Investigational Capsid Inhibitor in Healthy Adult Participants
This is a 3 part study of an investigational capsid inhibitor, VH4004280, in healthy adult participants. The purpose is to evaluate the effect of tablet formulation as well as food on bioavailability. Part 1 of the study will compare the relative bioavailability of VH4004280 Formulation A tablets to up to 4 alternative tablet formulations under fed (high fat) conditions. Part 2 of the study will assess the effect of fasted conditions on the bioavailability of VH4004280 Formulation A and alternative, optional formulations, relative to their respective bioavailability under fed conditions in Part 1. The optional Part 3 of the study will assess relative bioavailability of VH4004280 Formulation A to up to 3 alternative formulations, selected from Regimens B, C or D, under fed (lower fat) conditions.
- Conditions
- HIV Infections
- Being tested
- VH4004280 Formulation A, VH4004280 Formulation B, VH4004280 Formulation C, VH4004280 Formulation D, VH4004280 Formulation E
- Keywords
- Human immunodeficiency virus, HIV-1, capsid inhibitor, VH4004280, food effect, fasted conditions, fed conditions, bioavailability
- Medical subject headings
- HIV Infections, Acquired Immunodeficiency Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VH4004280 Formulation ADrug
Oral administration of VH4004280 Formulation A in fasted or fed conditions.
VH4004280 Formulation BDrug
Oral administration of VH4004280 Formulation B in fasted or fed conditions.
VH4004280 Formulation CDrug
Oral administration of VH4004280 Formulation C in fasted or fed conditions.
VH4004280 Formulation DDrug
Oral administration of VH4004280 Formulation D in fasted or fed conditions.
VH4004280 Formulation EDrug
Oral administration of VH4004280 Formulation E in fasted or fed conditions.
| Study group | Role | What they receive |
|---|---|---|
| Part 1 - Regimen A | Experimental | VH4004280 Formulation A tablet administered in fed conditions. Receives: Drug: VH4004280 Formulation A |
| Part 1 - Regimen B | Experimental | VH4004280 Formulation B tablet administered in fed conditions. Receives: Drug: VH4004280 Formulation B |
| Part 1 - Regimen C | Experimental | VH4004280 Formulation C tablet administered in fed conditions. Receives: Drug: VH4004280 Formulation C |
| Part 1 - Optional Regimen D | Experimental | VH4004280 Formulation D tablet administered in fed conditions. Receives: Drug: VH4004280 Formulation D |
| Part 1 - Optional Regimen E | Experimental | VH4004280 Formulation E tablet administered in fed conditions. Receives: Drug: VH4004280 Formulation E |
| Part 2 - Regimen A | Experimental | VH4004280 Formulation A tablet administered in fasted conditions. Receives: Drug: VH4004280 Formulation A |
| Part 2- Optional Regimen 1 | Experimental | VH4004280 Formulation B, C, D, or E tablet administered in fasted conditions. Receives: Drug: VH4004280 Formulation B; Drug: VH4004280 Formulation C; Drug: VH4004280 Formulation D; Drug: VH4004280 Formulation E |
| Part 2- Optional Regimen 2 | Experimental | VH4004280 Formulation B, C, D, or E tablet administered in fasted conditions. Receives: Drug: VH4004280 Formulation B; Drug: VH4004280 Formulation C; Drug: VH4004280 Formulation D; Drug: VH4004280 Formulation E |
| Part 2- Optional Regimen 3 | Experimental | VH4004280 Formulation B, C, D, or E tablet administered in fasted conditions. Receives: Drug: VH4004280 Formulation B; Drug: VH4004280 Formulation C; Drug: VH4004280 Formulation D; Drug: VH4004280 Formulation E |
| Part 3 - Optional Regimen 1 | Experimental | VH4004280 Formulation A, B, C or D tablet administered in lower fat conditions. Receives: Drug: VH4004280 Formulation A; Drug: VH4004280 Formulation B; Drug: VH4004280 Formulation C; Drug: VH4004280 Formulation D |
| Part 3- Optional Regimen 2 | Experimental | VH4004280 Formulation A, B, C or D tablet administered in lower fat conditions. Receives: Drug: VH4004280 Formulation A; Drug: VH4004280 Formulation B; Drug: VH4004280 Formulation C; Drug: VH4004280 Formulation D |
| Part 3 - Optional Regimen 3 | Experimental | VH4004280 Formulation A, B, C or D tablet administered in lower fat conditions. Receives: Drug: VH4004280 Formulation A; Drug: VH4004280 Formulation B; Drug: VH4004280 Formulation C; Drug: VH4004280 Formulation D |
| Part 3 - Optional Regimen 4 | Experimental | VH4004280 Formulation A, B, C or D tablet administered in lower fat conditions. Receives: Drug: VH4004280 Formulation A; Drug: VH4004280 Formulation B; Drug: VH4004280 Formulation C; Drug: VH4004280 Formulation D |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area under the plasma concentration - time curve from time zero (pre-dose) to infinity time (AUC[0-inf]) of VH4004280 in fed conditions (after a high-fat or lower-fat meal)
Measured: From Day 1 to Day 49
Area under the plasma drug concentration - time curve from zero (pre-dose) to the end of the dosing interval at steady state (AUC[0-tlast) of VH4004280 in fed conditions (after a high-fat or lower-fat meal)
Measured: From Day 1 to Day 49
Maximum observed plasma drug concentration (Cmax) of VH4004280 in fed conditions(after a high-fat or lower-fat meal)
Measured: From Day 1 to Day 49
Time to maximum observed plasma concentration (Tmax) of VH4004280 in fed conditions (after a high-fat or lower-fat meal)
Measured: From Day 1 to Day 49
Secondary outcomes (4)
Number of participants with AEs (Adverse Events), by severity
An AE is any untoward medical occurrence in a participant or clinical investigation participant and can be any sign, symptom, or disease temporally associated with the use of a medicinal product. The severity scale is assessed as following: Grade 1 = mild symptoms causing no or minimal interference with usual social and functional activities with intervention not indicated. Grade 2 = moderate symptoms causing greater than minimal interference with usual social and functional activities with intervention indicated. Grade 3 = severe symptoms causing inability to perform usual social and functional activities with intervention or hospitalization indicated. Grade 4 = potentially life-threatening symptoms causing inability to perform self-care functions with intervention indicated to prevent permanent impairment, persistent disability, or death.
Measured: From Day 1 to Day 49
Number of participants with maximum toxicity grade increase from baseline for liver laboratory parameters
The assessed laboratory assessments include Alanine aminotransferase (ALT), Aspartate aminotransferase (AST), alkaline phosphatase (ALP), direct bilirubin and total bilirubin, in both fed and fasted conditions.
Measured: From Day 1 to Day 49
Change from baseline in liver panel parameters: Total bilirubin and direct bilirubin (micromoles per liter)
Measured: From Day 1 to Day 49
Change from baseline in liver panel parameters: ALT, ALP and AST (International units per liter)
Measured: From Day 1 to Day 49
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2023
- Study start18 Dec 2023
- Primary completion3 Jun 2024
- Study completion3 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- ViiV Healthcare
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06168318
- Sponsor's protocol ID
- 220095
- Status last verified
- Jul 2024
- First submitted
- 4 Dec 2023
- Last updated
- 2 Aug 2024
- 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/
Study at a glance
From the registry record, last updated by the sponsor on 2 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A 3-part, Phase 1, Single-center, Open-label Study to Assess the Relative Bioavailability of Oral Formulations for an Investigational Capsid Inhibitor in Healthy Adult Participants, and to Evaluate the Effect of Food on Bioavailability for an Investigational Capsid Inhibitor in Healthy Adult Participants
- ClinicalTrials.gov ID
- NCT06168318
- Acronym / sponsor ID
- 220095
- Conditions
- HIV Infections
- Keywords
- Human immunodeficiency virus, HIV-1, capsid inhibitor, VH4004280, food effect, fasted conditions, fed conditions, bioavailability
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- ViiV HealthcareIndustry (pharma, biotech, devices)
- Study start
- 18 Dec 2023 (actual)
- Primary completion
- 3 Jun 2024 (actual)
- Study completion
- 3 Jun 2024 (actual)
- First posted
- 13 Dec 2023 (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 is a 3 part study of an investigational capsid inhibitor, VH4004280, in healthy adult participants. The purpose is to evaluate the effect of tablet formulation as well as food on bioavailability. Part 1 of the study will compare the relative bioavailability of VH4004280 Formulation A tablets to up to 4 alternative tablet formulations under fed (high fat) conditions. Part 2 of the study will assess the effect of fasted conditions on the bioavailability of VH4004280 Formulation A and alternative, optional formulations, relative to their respective bioavailability under fed conditions in Part 1. The optional Part 3 of the study will assess relative bioavailability of VH4004280 Formulation A to up to 3 alternative formulations, selected from Regimens B, C or D, under fed (lower fat) conditions.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 13
| Arm | Type | Receives |
|---|---|---|
| Part 1 - Regimen A | Experimental | Drug: VH4004280 Formulation AVH4004280 Formulation A tablet administered in fed conditions. |
| Part 1 - Regimen B | Experimental | Drug: VH4004280 Formulation BVH4004280 Formulation B tablet administered in fed conditions. |
| Part 1 - Regimen C | Experimental | Drug: VH4004280 Formulation CVH4004280 Formulation C tablet administered in fed conditions. |
| Part 1 - Optional Regimen D | Experimental | Drug: VH4004280 Formulation DVH4004280 Formulation D tablet administered in fed conditions. |
| Part 1 - Optional Regimen E | Experimental | Drug: VH4004280 Formulation EVH4004280 Formulation E tablet administered in fed conditions. |
| Part 2 - Regimen A | Experimental | Drug: VH4004280 Formulation AVH4004280 Formulation A tablet administered in fasted conditions. |
| Part 2- Optional Regimen 1 | Experimental | Drug: VH4004280 Formulation B, Drug: VH4004280 Formulation C, Drug: VH4004280 Formulation D, Drug: VH4004280 Formulation EVH4004280 Formulation B, C, D, or E tablet administered in fasted conditions. |
| Part 2- Optional Regimen 2 | Experimental | Drug: VH4004280 Formulation B, Drug: VH4004280 Formulation C, Drug: VH4004280 Formulation D, Drug: VH4004280 Formulation EVH4004280 Formulation B, C, D, or E tablet administered in fasted conditions. |
| Part 2- Optional Regimen 3 | Experimental | Drug: VH4004280 Formulation B, Drug: VH4004280 Formulation C, Drug: VH4004280 Formulation D, Drug: VH4004280 Formulation EVH4004280 Formulation B, C, D, or E tablet administered in fasted conditions. |
| Part 3 - Optional Regimen 1 | Experimental | Drug: VH4004280 Formulation A, Drug: VH4004280 Formulation B, Drug: VH4004280 Formulation C, Drug: VH4004280 Formulation DVH4004280 Formulation A, B, C or D tablet administered in lower fat conditions. |
| Part 3- Optional Regimen 2 | Experimental | Drug: VH4004280 Formulation A, Drug: VH4004280 Formulation B, Drug: VH4004280 Formulation C, Drug: VH4004280 Formulation DVH4004280 Formulation A, B, C or D tablet administered in lower fat conditions. |
| Part 3 - Optional Regimen 3 | Experimental | Drug: VH4004280 Formulation A, Drug: VH4004280 Formulation B, Drug: VH4004280 Formulation C, Drug: VH4004280 Formulation DVH4004280 Formulation A, B, C or D tablet administered in lower fat conditions. |
| Part 3 - Optional Regimen 4 | Experimental | Drug: VH4004280 Formulation A, Drug: VH4004280 Formulation B, Drug: VH4004280 Formulation C, Drug: VH4004280 Formulation DVH4004280 Formulation A, B, C or D tablet administered in lower fat conditions. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Participants must be 18 to 55years of age.
- Participants who are overtly healthy.
- Negative (Severe Acute Respiratory Syndrome Coronavirus 2) SARs-CoV-2 test prior to dosing.
- Has body mass index (BMI) within the range 19-32 (kg/m2).
- Participants male at birth must use male condoms, and participants female at birth who are of childbearing potential must be using acceptable forms of birth control.
Key exclusion criteria (13 listed)
- History or presence of disorders capable of significantly altering the absorption, metabolism, or elimination of drugs.
- Abnormal blood pressure.
- Any malignancy within the past 5 years except certain localized malignancies, or breast cancer within the past 10 years.
- Has exclusionary psychiatric, hepatic, cardiovascular, gastrointestinal, respiratory, endocrine, neurological, hematological, or renal condition.
- Current or chronic history of liver disease or known hepatic or biliary abnormalities.
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 |
|---|---|---|
| VH4004280 Formulation AOral administration of VH4004280 Formulation A in fasted or fed conditions. | Drug | Part 1 - Regimen A, Part 2 - Regimen A, Part 3 - Optional Regimen 1, Part 3 - Optional Regimen 3, Part 3 - Optional Regimen 4, Part 3- Optional Regimen 2 |
| VH4004280 Formulation BOral administration of VH4004280 Formulation B in fasted or fed conditions. | Drug | Part 1 - Regimen B, Part 2- Optional Regimen 1, Part 2- Optional Regimen 2, Part 2- Optional Regimen 3, Part 3 - Optional Regimen 1, Part 3 - Optional Regimen 3, Part 3 - Optional Regimen 4, Part 3- Optional Regimen 2 |
| VH4004280 Formulation COral administration of VH4004280 Formulation C in fasted or fed conditions. | Drug | Part 1 - Regimen C, Part 2- Optional Regimen 1, Part 2- Optional Regimen 2, Part 2- Optional Regimen 3, Part 3 - Optional Regimen 1, Part 3 - Optional Regimen 3, Part 3 - Optional Regimen 4, Part 3- Optional Regimen 2 |
| VH4004280 Formulation DOral administration of VH4004280 Formulation D in fasted or fed conditions. | Drug | Part 1 - Optional Regimen D, Part 2- Optional Regimen 1, Part 2- Optional Regimen 2, Part 2- Optional Regimen 3, Part 3 - Optional Regimen 1, Part 3 - Optional Regimen 3, Part 3 - Optional Regimen 4, Part 3- Optional Regimen 2 |
| VH4004280 Formulation EOral administration of VH4004280 Formulation E in fasted or fed conditions. | Drug | Part 1 - Optional Regimen E, Part 2- Optional Regimen 1, Part 2- Optional Regimen 2, Part 2- Optional Regimen 3 |
Primary outcome
Area under the plasma concentration - time curve from time zero (pre-dose) to infinity time (AUC[0-inf]) of VH4004280 in fed conditions (after a high-fat or lower-fat meal)
Time frame: From Day 1 to Day 49
Area under the plasma drug concentration - time curve from zero (pre-dose) to the end of the dosing interval at steady state (AUC[0-tlast) of VH4004280 in fed conditions (after a high-fat or lower-fat meal)
Time frame: From Day 1 to Day 49
Maximum observed plasma drug concentration (Cmax) of VH4004280 in fed conditions(after a high-fat or lower-fat meal)
Time frame: From Day 1 to Day 49
Time to maximum observed plasma concentration (Tmax) of VH4004280 in fed conditions (after a high-fat or lower-fat meal)
Time frame: From Day 1 to Day 49
4 secondary outcomes
Number of participants with AEs (Adverse Events), by severity
Time frame: From Day 1 to Day 49
Number of participants with maximum toxicity grade increase from baseline for liver laboratory parameters
Time frame: From Day 1 to Day 49
Change from baseline in liver panel parameters: Total bilirubin and direct bilirubin (micromoles per liter)
Time frame: From Day 1 to Day 49
Change from baseline in liver panel parameters: ALT, ALP and AST (International units per liter)
Time frame: From Day 1 to Day 49
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 2 Aug 2024.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
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 VH4004280 Formulation A, VH4004280 Formulation B and VH4004280 Formulation C in people with HIV Infections, run by ViiV Healthcare at 1 site in United Kingdom.
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 6 inclusion and 13 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 2 Aug 2024. 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 Kingdom. 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. 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?
Area under the plasma concentration - time curve from time zero (pre-dose) to infinity time (AUC[0-inf]) of VH4004280 in fed conditions (after a high-fat or lower-fat meal) (time frame: From Day 1 to Day 49). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 2 Aug 2024.