HIV InfectionsPhase 1NCT06368986
A Study to Investigate the Effect of Food on the Bioavailability of a Capsid Inhibitor (CAI) in Male and Female Healthy Participants
A Phase 1 study testing VH4011499 Dose A and VH4011499 Dose B in people with HIV Infections, run by ViiV Healthcare at 1 site in United States.
Trial summary
The purpose of this study is to evaluate effect of food (in fasted and fed conditions) on the bioavailability of CAI VH4011499. 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?
- VH4011499 Dose A and VH4011499 Dose B
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Apr 2024to 2 Oct 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 who are 18 to 55 years of age.
- Participants who are overtly healthy.
- One SARs-CoV-2 negative test is required prior to dosing
- Body weight within 50-100 kg and body mass index (BMI) within the range 19-32 kg/m2 (inclusive).
- Capable of giving signed informed consent.
- 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.
Who cannot join
- History or presence of disorders capable of significantly altering the absorption, metabolism, or elimination of drugs.
- Current or chronic liver disease, hepatic or biliary abnormalities, or relevant hepatitis.
- Abnormal blood pressure.
- Any malignancy within the past 5 years except certain localized malignancies, or breast cancer within the past 10 years. Participants with exclusionary electrocardiogram findings.Positive HIV test or ongoing behaviors that put the participant at high risk for HIV acquisition.
- Participants who are breastfeeding or plan to become pregnant during the study.
- Past or intended use of exclusionary medications or vaccines.
Show all 12Show fewer
- Exposure to >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: An Open Label, Phase 1 Study to Assess the Effect of Food on Bioavailability for an Investigational Capsid Inhibitor in Healthy Adult Participants
The purpose of this study is to evaluate effect of food (in fasted and fed conditions) on the bioavailability of CAI VH4011499.
- Conditions
- HIV Infections
- Being tested
- VH4011499 Dose A, VH4011499 Dose B
- Keywords
- Fasted condition, Fed condition, Bioavailability, Capsid inhibitor, VH4011499
- Medical subject headings
- HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VH4011499 Dose ADrug
VH4011499 administered in fasted or fed conditions.
VH4011499 Dose BDrug
VH4011499 Dose B administered in fasted or fed conditions.
| Study group | Role | What they receive |
|---|---|---|
| Part 1 Dose A - Fasted condition | Experimental | VH4011499 Dose A tablet administered in fasted condition. Receives: Drug: VH4011499 Dose A |
| Part 1 Dose A- Fed condition (high fat meal) | Experimental | VH4011499 Dose A tablet administered in fed condition (high fat meal). Receives: Drug: VH4011499 Dose A |
| Part 2 Dose B - Optional - Fed condition (low fat meal) | Experimental | VH4011499 Dose B tablet administered in fed condition (low fat meal). Receives: Drug: VH4011499 Dose B |
| Part 3 Dose B - Fasted condition | Experimental | VH4011499 Dose B tablet administered in fasted condition. Receives: Drug: VH4011499 Dose B |
| Part 3 Dose B - Fed condition (high fat meal) | Experimental | VH4011499 Dose B tablet administered in fed condition (high fat meal). Receives: Drug: VH4011499 Dose B |
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 VH4011499
Measured: From Day 1 (pre-dose) to Day 28
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 VH4011499
Measured: From Day 1 (pre-dose) to Day 28
Maximum observed plasma drug concentration (Cmax) of VH4011499
Measured: From Day 1 (pre-dose) to Day 28
Time to maximum observed plasma concentration (Tmax) of VH4011499
Measured: From Day 1 (pre-dose) to Day 28
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, Grade 5 = death.
Measured: From Day 1 (pre-dose) to Day 28
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 (pre-dose) to Day 28
Change from baseline in liver panel parameters: total bilirubin and direct bilirubin (micromoles per liter)
Measured: From Day 1 (pre-dose) to Day 28
Change from baseline in liver panel parameters: ALT, ALP and AST (International units per liter)
Measured: From Day 1 (pre-dose) to Day 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2024
- Study start17 Apr 2024
- Primary completion2 Oct 2024
- Study completion2 Oct 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 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
- NCT06368986
- Sponsor's protocol ID
- 222420
- Status last verified
- Jan 2025
- First submitted
- 11 Apr 2024
- Last updated
- 18 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Study Sponsor will assess requests from qualified researchers for anonymized individual patient-level data and related study documents. Data sharing is subject to certain criteria, conditions, and exceptions. For further information, refer to https://www.viiv-studyregister.com/documents/About\_ViiV\_Patient\_Level\_Data\_Sharing\_Final\_25Sep2023.pdf
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open Label, Phase 1 Study to Assess the Effect of Food on Bioavailability for an Investigational Capsid Inhibitor in Healthy Adult Participants
- ClinicalTrials.gov ID
- NCT06368986
- Acronym / sponsor ID
- 222420
- Conditions
- HIV Infections
- Keywords
- Fasted condition, Fed condition, Bioavailability, Capsid inhibitor, VH4011499
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- ViiV HealthcareIndustry (pharma, biotech, devices)
- Study start
- 17 Apr 2024 (actual)
- Primary completion
- 2 Oct 2024 (actual)
- Study completion
- 2 Oct 2024 (actual)
- First posted
- 16 Apr 2024 (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.
The purpose of this study is to evaluate effect of food (in fasted and fed conditions) on the bioavailability of CAI VH4011499.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Part 1 Dose A - Fasted condition | Experimental | Drug: VH4011499 Dose AVH4011499 Dose A tablet administered in fasted condition. |
| Part 1 Dose A- Fed condition (high fat meal) | Experimental | Drug: VH4011499 Dose AVH4011499 Dose A tablet administered in fed condition (high fat meal). |
| Part 2 Dose B - Optional - Fed condition (low fat meal) | Experimental | Drug: VH4011499 Dose BVH4011499 Dose B tablet administered in fed condition (low fat meal). |
| Part 3 Dose B - Fasted condition | Experimental | Drug: VH4011499 Dose BVH4011499 Dose B tablet administered in fasted condition. |
| Part 3 Dose B - Fed condition (high fat meal) | Experimental | Drug: VH4011499 Dose BVH4011499 Dose B tablet administered in fed condition (high fat meal). |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Participants who are 18 to 55 years of age.
- Participants who are overtly healthy.
- One SARs-CoV-2 negative test is required prior to dosing
- Body weight within 50-100 kg and body mass index (BMI) within the range 19-32 kg/m2 (inclusive).
- Capable of giving signed informed consent.
Key exclusion criteria (12 listed)
- History or presence of disorders capable of significantly altering the absorption, metabolism, or elimination of drugs.
- Current or chronic liver disease, hepatic or biliary abnormalities, or relevant hepatitis.
- Abnormal blood pressure.
- Any malignancy within the past 5 years except certain localized malignancies, or breast cancer within the past 10 years. Participants with exclusionary electrocardiogram findings.Positive HIV test or ongoing behaviors that put the participant at high risk for HIV acquisition.
- Participants who are breastfeeding or plan to become pregnant during the study.
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 |
|---|---|---|
| VH4011499 Dose AVH4011499 administered in fasted or fed conditions. | Drug | Part 1 Dose A - Fasted condition, Part 1 Dose A- Fed condition (high fat meal) |
| VH4011499 Dose BVH4011499 Dose B administered in fasted or fed conditions. | Drug | Part 2 Dose B - Optional - Fed condition (low fat meal), Part 3 Dose B - Fasted condition, Part 3 Dose B - Fed condition (high fat meal) |
Primary outcome
Area under the plasma concentration - time curve from time zero (pre-dose) to infinity time (AUC[0-inf]) of VH4011499
Time frame: From Day 1 (pre-dose) to Day 28
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 VH4011499
Time frame: From Day 1 (pre-dose) to Day 28
Maximum observed plasma drug concentration (Cmax) of VH4011499
Time frame: From Day 1 (pre-dose) to Day 28
Time to maximum observed plasma concentration (Tmax) of VH4011499
Time frame: From Day 1 (pre-dose) to Day 28
4 secondary outcomes
Number of participants with AEs (Adverse Events), by severity
Time frame: From Day 1 (pre-dose) to Day 28
Number of participants with maximum toxicity grade increase from baseline for liver laboratory parameters
Time frame: From Day 1 (pre-dose) to Day 28
Change from baseline in liver panel parameters: total bilirubin and direct bilirubin (micromoles per liter)
Time frame: From Day 1 (pre-dose) to Day 28
Change from baseline in liver panel parameters: ALT, ALP and AST (International units per liter)
Time frame: From Day 1 (pre-dose) to Day 28
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 18 Feb 2025.
- Individual participant dataSharing planned: Yes. Study Sponsor will assess requests from qualified researchers for anonymized individual patient-level data and related study documents. Data sharing is subject to certain criteria, conditions, and exceptions. For further information, refer to https://www.viiv-studyregister.com/documents/About_ViiV_Patient_Level_Data_Sharing_Final_25Sep2023.pdf
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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 VH4011499 Dose A and VH4011499 Dose B 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 6 inclusion and 12 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 18 Feb 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. 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 VH4011499 (time frame: From Day 1 (pre-dose) to Day 28). 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 18 Feb 2025.