Clinical trials
CINNAMON
Identifier
NCT06039579
Link
https://clinicaltrials.gov/study/NCT06039579
Phase
Phase II
Status
Completed
Sponsor
ViiV Healthcare
More details
The primary purpose of the study is to evaluate the antiviral activity of orally administered VH4004280 and VH4011499 monotherapy over 10 days in human immunodeficiency virus (HIV-1) infected Treatment-Naïve (TN) participants.
Purpose
Proof of Concept Treatment Study of Orally Administered VH4004280 or VH4011499 in HIV-1 Infected Adults
Interventions
Intervention 1
VH4004280
Intervention 2
VH4011499
Intervention 3
VH4004280 Matching Placebo
Intervention 4
VH4011499 Matching Placebo
Countries
United States of America
Argentina
Canada
France
Germany
Italy
Mexico
Spain
United Kingdom
Sites / Institutions
Not provided
Trials dates
Anticipated Start Date
Not provided
Actual Start Date
2023-10-25
Anticipated Date of Last Follow-up
2024-09-17
Estimated Primary Completion Date
Not provided
Estimated Completion Date
Not provided
Actual Primary Completion Date
2024-06-24
Actual Completion Date
2024-06-24
Studied populations
Age Cohort
Genders
Accepts pregnant individuals
Unspecified
Accepts lactating individuals
Unspecified
Accepts healthy individuals
No
Comments about the studied
populations
Inclusion Criteria:
* Participants who are overtly healthy (other than HIV-1 infection).
* Screening cluster of differentiation-4 (CD4+) T-cell count greater than or equal to (≥)200 cells/microliter (µL).
* Documented HIV-1 infection and Screening plasma HIV-1 RNA ≥3000 copies/milliliter (mL).
* Treatment-naïve: Defined as no antiretroviral therapy received after the diagnosis of HIV-1 infection. Prior use of oral pre-exposure prophylaxis (PreP) is permitted. Prior use of parenteral PreP is exclusionary.
* Has body mass index (BMI) within the range of 18.5-31.0 kilograms per meter square (kg/m\^2).
* 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.
* Participants capable of
Health status
Not provided
Study type
Interventional (clinical trial)
Enrollment
44
Allocation
Randomized
Intervention model
Parallel Assignment
Intervention
model description
Not provided
Masking
Double-blind masking
Masking description
Not provided
Frequency of administration
Not provided
Studied LA-formulation(s)
Tablet
Studied route(s) of administration
Oral
Use case
Treatment
Key resources
Not provided
220095
Identifier
NCT06168318
Link
https://clinicaltrials.gov/study/NCT06168318
Phase
Phase I
Status
Completed
Sponsor
ViiV Healthcare
More details
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) condi
Purpose
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
Interventions
Intervention 1
VH4004280 Formulation A
Intervention 2
VH4004280 Formulation B
Intervention 3
VH4004280 Formulation C
Intervention 4
VH4004280 Formulation D
Intervention 5
VH4004280 Formulation E
Countries
United Kingdom
Sites / Institutions
Not provided
Trials dates
Anticipated Start Date
Not provided
Actual Start Date
2023-12-18
Anticipated Date of Last Follow-up
2024-07-31
Estimated Primary Completion Date
Not provided
Estimated Completion Date
Not provided
Actual Primary Completion Date
2024-06-03
Actual Completion Date
2024-06-03
Studied populations
Age Cohort
Genders
Accepts pregnant individuals
Unspecified
Accepts lactating individuals
Unspecified
Accepts healthy individuals
Yes
Comments about the studied
populations
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 psyc
Health status
Not provided
Study type
Interventional (clinical trial)
Enrollment
46
Allocation
Not provided
Intervention model
Sequential assignment
Intervention
model description
Not provided
Masking
Open label
Masking description
Not provided
Frequency of administration
Not provided
Studied LA-formulation(s)
Tablet
Studied route(s) of administration
Oral
Use case
Unspecified
Key resources
Not provided
218306
Identifier
NCT06012136
Link
https://clinicaltrials.gov/study/NCT06012136
Phase
Phase I
Status
Recruiting
Sponsor
ViiV Healthcare
More details
The primary purpose of the study is to investigate safety and tolerability following single and multiple ascending subcutaneous (SC) and intramuscular (IM) doses of capsid inhibitors in healthy participants. The study will also describe the pharmacokinetics following single and multiple ascending SC and IM doses of capsid inhibitors in healthy participants.
Purpose
A Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of a Single Suspension Injection of Investigational Capsid Inhibitors Compared to Placebo in Healthy Adults
Interventions
Intervention 1
VH4004280
Intervention 2
Placebo
Intervention 3
VH4011499
Countries
United States of America
Sites / Institutions
Not provided
Trials dates
Anticipated Start Date
Not provided
Actual Start Date
2023-08-24
Anticipated Date of Last Follow-up
2025-04-17
Estimated Primary Completion Date
2026-09-02
Estimated Completion Date
2026-09-02
Actual Primary Completion Date
Not provided
Actual Completion Date
Not provided
Studied populations
Age Cohort
Genders
Accepts pregnant individuals
Unspecified
Accepts lactating individuals
Unspecified
Accepts healthy individuals
Yes
Comments about the studied
populations
Inclusion Criteria:
* Participants who are overtly healthy.
* Participants who are negative on a single test for Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) (approved molecular polymerase chain reaction (PCR), point of care test), performed on the day of admission (Day -1). A negative result is required prior to the administration of study intervention on Day 1.
* Male or female participants of non-childbearing potential.
* Capable of giving signed informed consent.
Exclusion Criteria:
* History or presence of cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematological, neurological or psychiatric disorders capable of significantly altering the absorption, metabolism, or elimination of drugs; constituting a risk when taking the study interven
Health status
Not provided
Study type
Interventional (clinical trial)
Enrollment
208
Allocation
Randomized
Intervention model
Sequential assignment
Intervention
model description
Not provided
Masking
Double-blind masking
Masking description
Not provided
Frequency of administration
Not provided
Studied LA-formulation(s)
Not provided
Studied route(s) of administration
Subcutaneous
Intramuscular
To be determined
Use case
Unspecified
Key resources
Not provided
217058
Identifier
NCT05163522
Link
https://clinicaltrials.gov/study/NCT05163522
Phase
Phase I
Status
Completed
Sponsor
ViiV Healthcare
More details
This FTIH study aims to evaluate the safety, tolerability and PK of the novel investigational Human immunodeficiency virus (HIV)-1 capsid inhibitor VH4004280 in healthy adults. The study will be conducted in 3 parts: Part 1 will investigate single ascending doses (SAD), Part 2 will investigate multiple ascending doses and drug-drug interaction (MAD/MAD DDI) Part 3 will investigate single dose relative bioavailability (RBA) of a new formulation of VH4004280.
Purpose
First-Time-in-Human (FTIH) Study to Evaluate the Safety, Tolerability and Pharmacokinetics (PK) of VH4004280 in Healthy Participants
Interventions
Intervention 1
VH4004280
Intervention 2
Placebo
Intervention 3
Midazolam
Countries
United States of America
Sites / Institutions
Not provided
Trials dates
Anticipated Start Date
Not provided
Actual Start Date
2021-12-13
Anticipated Date of Last Follow-up
2023-08-29
Estimated Primary Completion Date
Not provided
Estimated Completion Date
Not provided
Actual Primary Completion Date
2023-06-21
Actual Completion Date
2023-06-21
Studied populations
Age Cohort
Genders
Accepts pregnant individuals
Unspecified
Accepts lactating individuals
Unspecified
Accepts healthy individuals
Yes
Comments about the studied
populations
Inclusion criteria:
* Participant must be 18 to 55 years of age inclusive.
* Participants who are overtly healthy.
* Male or female participants of non-childbearing potential.
* Capable of giving signed informed consent.
Exclusion criteria:
* History or presence of cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematological, neurological or psychiatric disorders capable of significantly altering the absorption, metabolism, or elimination of drugs; constituting a risk when taking the study drug or interfering with the interpretation of data.
* Abnormal blood pressure.
* Symptomatic herpes zoster.
* Evidence of active or latent tuberculosis (TB).
* Lymphoma, leukemia, or any malignancy within the past 5 years except for basal cell or squamous epithelial carcino
Health status
Not provided
Study type
Interventional (clinical trial)
Enrollment
73
Allocation
Randomized
Intervention model
Sequential assignment
Intervention
model description
Not provided
Masking
Double-blind masking
Masking description
Not provided
Frequency of administration
Not provided
Studied LA-formulation(s)
Not provided
Studied route(s) of administration
To be determined
Use case
Unspecified
Key resources
Not provided
Supporting material
Publications
Thakkar N, Griesel R, Pierce A, et al. Clinical Pharmacokinetics and Safety of a New HIV-1 Capsid Inhibitor, VH4004280, After Oral Administration in Adults Without HIV. Infect Dis Ther. Published online April 26, 2025. doi:10.1007/s40121-025-01154-x
Introduction: The pharmacokinetics, drug-drug interaction potential, and safety of a new HIV-1 capsid inhibitor, VH4004280 (VH-280), are described in this first-time-in-human study.
Methods: This randomized, double-blind, placebo-controlled, phase 1 study assessed oral VH-280 in adults without HIV. In parts 1 and 3, VH-280 was administered as powder-in-bottle (PiB) and tablet formulations, respectively, in single ascending doses. In part 2, VH-280 was administered as a PiB formulation once daily for 14 days in multiple ascending doses. In addition, in part 2, the effect of VH-280 on cytochrome P450 3A (CYP3A) activity was evaluated using midazolam as a probe substrate.
Results: In total, 73 participants were included (VH-280, n = 57; placebo, n = 16). Plasma exposures for VH-280 were broadly dose-proportional, and median time to maximum observed concentration was 9.0-17.0 h for the PiB and tablet formulations. Geometric mean terminal half-life was 145.8-207.8 h (> 6 days). Compared with PiB, exposures for the tablet formulation were 45-56% lower. Concomitant administration of midazolam after single and multiple doses of VH-280 did not result in clinically significant changes in midazolam or 1-hydroxymidazolam exposures; therefore, VH-280 is not anticipated to inhibit or induce CYP3A4. VH-280 was well-tolerated. Frequency of adverse events (AEs) was comparable between placebo and VH-280 groups. Adverse events related to VH-280 were primarily grade 1. There were no serious AEs, AEs leading to withdrawal from drug or study, or deaths. No trends in vital signs, electrocardiograms, or laboratory hematology parameters were observed, and there were no clinically relevant changes in chemistry parameters.
Conclusions: Data from this first-time-in-human study further characterize the pharmacokinetics of VH-280 after oral administration, providing support for the development of new capsid inhibitors as part of a complete long-acting regimen for the treatment and prevention of HIV-1.
Clinical trial registration: ClinicalTrials.gov, NCT05163522.
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