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

July 31, 2024 updated by: ViiV Healthcare

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
46

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • United Kingdom
      • Nottingham, United Kingdom, NG11 6JS
        • GSK Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  1. Participants must be 18 to 55years of age.
  2. Participants who are overtly healthy.
  3. Negative (Severe Acute Respiratory Syndrome Coronavirus 2) SARs-CoV-2 test prior to dosing.
  4. Has body mass index (BMI) within the range 19-32 (kg/m2).
  5. 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.
  6. Capable of giving signed informed consent.

Exclusion Criteria:

  1. History or presence of disorders capable of significantly altering the absorption, metabolism, or elimination of drugs.
  2. Abnormal blood pressure.
  3. Any malignancy within the past 5 years except certain localized malignancies, or breast cancer within the past 10 years.
  4. Has exclusionary psychiatric, hepatic, cardiovascular, gastrointestinal, respiratory, endocrine, neurological, hematological, or renal condition.
  5. Current or chronic history of liver disease or known hepatic or biliary abnormalities.
  6. Participants with exclusionary electrocardiogram findings.
  7. Past or intended use of exclusionary medications or vaccines.
  8. Exposure > 4 new investigational products within 12 months, previous participation in this study, or current enrolment or participation in another investigational study.
  9. ALT >1.5x upper limit of normal (ULN), total bilirubin >1.5x ULN, and/or estimated serum creatinine clearance <60 mL/min.
  10. History of or current infection with hepatitis B or hepatitis C.
  11. Positive SARS-CoV-2 test, having signs and symptoms suggestive of COVID-19, or contact with known COVID-19 positive person.
  12. Positive HIV antibody test.
  13. 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Part 1 - Regimen A
VH4004280 Formulation A tablet administered in fed conditions.
Drug: VH4004280 Formulation A
Oral administration of VH4004280 Formulation A in fasted or fed conditions.
Experimental: Part 1 - Regimen B
VH4004280 Formulation B tablet administered in fed conditions.
Drug: VH4004280 Formulation B
Oral administration of VH4004280 Formulation B in fasted or fed conditions.
Experimental: Part 1 - Regimen C
VH4004280 Formulation C tablet administered in fed conditions.
Drug: VH4004280 Formulation C
Oral administration of VH4004280 Formulation C in fasted or fed conditions.
Experimental: Part 1 - Optional Regimen D
VH4004280 Formulation D tablet administered in fed conditions.
Drug: VH4004280 Formulation D
Oral administration of VH4004280 Formulation D in fasted or fed conditions.
Experimental: Part 1 - Optional Regimen E
VH4004280 Formulation E tablet administered in fed conditions.
Drug: VH4004280 Formulation E
Oral administration of VH4004280 Formulation E in fasted or fed conditions.
Experimental: Part 2 - Regimen A
VH4004280 Formulation A tablet administered in fasted conditions.
Drug: VH4004280 Formulation A
Oral administration of VH4004280 Formulation A in fasted or fed conditions.
Experimental: Part 2- Optional Regimen 1
VH4004280 Formulation B, C, D, or E tablet administered in fasted conditions.
Drug: VH4004280 Formulation B
Oral administration of VH4004280 Formulation B in fasted or fed conditions.
Drug: VH4004280 Formulation C
Oral administration of VH4004280 Formulation C in fasted or fed conditions.
Drug: VH4004280 Formulation D
Oral administration of VH4004280 Formulation D in fasted or fed conditions.
Drug: VH4004280 Formulation E
Oral administration of VH4004280 Formulation E in fasted or fed conditions.
Experimental: Part 2- Optional Regimen 2
VH4004280 Formulation B, C, D, or E tablet administered in fasted conditions.
Drug: VH4004280 Formulation B
Oral administration of VH4004280 Formulation B in fasted or fed conditions.
Drug: VH4004280 Formulation C
Oral administration of VH4004280 Formulation C in fasted or fed conditions.
Drug: VH4004280 Formulation D
Oral administration of VH4004280 Formulation D in fasted or fed conditions.
Drug: VH4004280 Formulation E
Oral administration of VH4004280 Formulation E in fasted or fed conditions.
Experimental: Part 2- Optional Regimen 3
VH4004280 Formulation B, C, D, or E tablet administered in fasted conditions.
Drug: VH4004280 Formulation B
Oral administration of VH4004280 Formulation B in fasted or fed conditions.
Drug: VH4004280 Formulation C
Oral administration of VH4004280 Formulation C in fasted or fed conditions.
Drug: VH4004280 Formulation D
Oral administration of VH4004280 Formulation D in fasted or fed conditions.
Drug: VH4004280 Formulation E
Oral administration of VH4004280 Formulation E in fasted or fed conditions.
Experimental: Part 3 - Optional Regimen 1
VH4004280 Formulation A, B, C or D tablet administered in lower fat conditions.
Drug: VH4004280 Formulation A
Oral administration of VH4004280 Formulation A in fasted or fed conditions.
Drug: VH4004280 Formulation B
Oral administration of VH4004280 Formulation B in fasted or fed conditions.
Drug: VH4004280 Formulation C
Oral administration of VH4004280 Formulation C in fasted or fed conditions.
Drug: VH4004280 Formulation D
Oral administration of VH4004280 Formulation D in fasted or fed conditions.
Experimental: Part 3- Optional Regimen 2
VH4004280 Formulation A, B, C or D tablet administered in lower fat conditions.
Drug: VH4004280 Formulation A
Oral administration of VH4004280 Formulation A in fasted or fed conditions.
Drug: VH4004280 Formulation B
Oral administration of VH4004280 Formulation B in fasted or fed conditions.
Drug: VH4004280 Formulation C
Oral administration of VH4004280 Formulation C in fasted or fed conditions.
Drug: VH4004280 Formulation D
Oral administration of VH4004280 Formulation D in fasted or fed conditions.
Experimental: Part 3 - Optional Regimen 3
VH4004280 Formulation A, B, C or D tablet administered in lower fat conditions.
Drug: VH4004280 Formulation A
Oral administration of VH4004280 Formulation A in fasted or fed conditions.
Drug: VH4004280 Formulation B
Oral administration of VH4004280 Formulation B in fasted or fed conditions.
Drug: VH4004280 Formulation C
Oral administration of VH4004280 Formulation C in fasted or fed conditions.
Drug: VH4004280 Formulation D
Oral administration of VH4004280 Formulation D in fasted or fed conditions.
Experimental: Part 3 - Optional Regimen 4
VH4004280 Formulation A, B, C or D tablet administered in lower fat conditions.
Drug: VH4004280 Formulation A
Oral administration of VH4004280 Formulation A in fasted or fed conditions.
Drug: VH4004280 Formulation B
Oral administration of VH4004280 Formulation B in fasted or fed conditions.
Drug: VH4004280 Formulation C
Oral administration of VH4004280 Formulation C in fasted or fed conditions.
Drug: VH4004280 Formulation D
Oral administration of VH4004280 Formulation D in fasted or fed conditions.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
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
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
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
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
From Day 1 to Day 49

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Number of participants with AEs (Adverse Events), by severity
Time Frame: From Day 1 to Day 49
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.
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
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.
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
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
From Day 1 to Day 49

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
ViiV Healthcare

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 18, 2023

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 3, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 3, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 4, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 4, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 13, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 2, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 31, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 220095

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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/

IPD Sharing Time Frame

Anonymized IPD will be made available within 6 months of publication of primary, key secondary and safety results for studies in product with approved indication(s) or terminated asset(s) across all indications.

IPD Sharing Access Criteria

Anonymized IPD is shared with researchers whose proposals are approved by an Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension may be granted, when justified, for up to 6 months.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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