A Study to Investigate the Effect of Food on the Bioavailability of a Capsid Inhibitor (CAI) in Male and Female Healthy Participants

NCT06368986 | Completed Phase 1 FDA Drug

• 1 other identifier: 222420
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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

Keywords

Fasted condition; Fed condition; Bioavailability; Capsid inhibitor; VH4011499

Outcome Measures

Primary Outcomes (4)

• Area under the plasma concentration - time curve from time zero (pre-dose) to infinity time (AUC[0-inf]) of VH4011499

  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

  From Day 1 (pre-dose) to Day 28

• Maximum observed plasma drug concentration (Cmax) of VH4011499

  From Day 1 (pre-dose) to Day 28

• Time to maximum observed plasma concentration (Tmax) of VH4011499

  From Day 1 (pre-dose) to Day 28

Secondary Outcomes (4)

• Number of participants with AEs (Adverse Events), by severity

  From Day 1 (pre-dose) to Day 28

• Number of participants with maximum toxicity grade increase from baseline for liver laboratory parameters

  From Day 1 (pre-dose) to Day 28

• Change from baseline in liver panel parameters: total bilirubin and direct bilirubin (micromoles per liter)

  From Day 1 (pre-dose) to Day 28

• Change from baseline in liver panel parameters: ALT, ALP and AST (International units per liter)

  From Day 1 (pre-dose) to Day 28

Study Arms (5)

Part 1 Dose A - Fasted condition

EXPERIMENTAL

VH4011499 Dose A tablet administered in fasted condition.

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).

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).

Drug: VH4011499 Dose B

Part 3 Dose B - Fasted condition

EXPERIMENTAL

VH4011499 Dose B tablet administered in fasted condition.

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).

Drug: VH4011499 Dose B

Interventions

VH4011499 Dose A DRUG

VH4011499 administered in fasted or fed conditions.

Part 1 Dose A - Fasted condition; Part 1 Dose A- Fed condition (high fat meal)

VH4011499 Dose B DRUG

VH4011499 Dose B administered in fasted or fed conditions.

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)

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• Participants who are breastfeeding or plan to become pregnant during the study.
• 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.

Sponsors & Collaborators

• ViiV Healthcare: lead

Study Sites (1)

GSK Investigational Site

Austin, Texas, 78744 -1645, United States

Location

MeSH Terms

Conditions

HIV Infections

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 11, 2024
• First Posted: April 16, 2024
• Study Start: April 17, 2024
• Primary Completion: October 2, 2024
• Study Completion: October 2, 2024
• Last Updated: February 18, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• 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.
• 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.

Locations

US (1)