HIV Infections
Conditions
Keywords
VH3739937, Treatment Naïve, HIV-1
Brief summary
The primary purpose of this study is to assess the antiviral activity of VH3739937 in Human Immunodeficiency Virus Type-1 (HIV-1) infected treatment naive (TN) participants during monotherapy.
Interventions
DRUGVH3739937
VH3739937 will be administered.
DRUGPlacebo
Placebo will be administered.
Sponsors
ViiV Healthcare
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Participants who are overtly healthy (other than HIV infection) as determined by the Investigator or medically qualified designee based on a medical evaluation including medical history, physical examination, laboratory tests, and cardiac monitoring * Positive HIV antibody test * Treatment-naïve: No Antiretrovirals (ARVs) (in combination or monotherapy) received after the diagnosis of HIV-1 infection * Body weight ≥50.0 kilogram (kg) (110 pounds \[lbs\]) for men and ≥45.0 kg (99 lbs) for women and BMI for all participants within the range 18.5-35.0 kilogram per meter square (kg/m\^2). * Capable of giving signed informed consent * Participant must be willing and able to start Combination Antiretrovial Therapy (cART) as selected with the Investigator on Study Day 8 (except in the case of early termination, clinically relevant AE/SAE, lab abnormality, the withdrawal of consent, lost to follow-up, etc., where circumstances could dictate otherwise).
Exclusion criteria
* Current or chronic history of liver disease or known hepatic or biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones) * Participants with primary HIV infection, evidenced by acute retroviral syndrome (e.g., fever, malaise, fatigue, etc) and/or evidence of recent (within 3 months) documented viremia without antibody production and/or evidence of recent (within 3 months) documented seroconversion * Myocardial infarction, acute coronary syndrome, unstable angina, stroke, transient ischemic attack, or intermittent claudication in the past 3 months * The participant has received an investigational HIV vaccine (immunotherapeutic or immunomodulatory) * Regular use of drugs of abuse * Sensitivity to heparin or heparin-induced thrombocytopenia
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Maximum Change From Baseline in Plasma Human Immunodeficiency Virus-1 (HIV-1) Ribonucleic Acid (RNA). | From Day 1 to Day 8 | Plasma samples were collected for the quantitative analysis of plasma HIV-1 RNA. The maximum change from baseline was calculated by determining the largest change from baseline value across all assessment timepoints. This is identified by subtracting the lowest post-dose visit value up to Day 8 (inclusive) from the baseline value. The baseline was defined as the most recent pre-dose assessment with a valid, non-missing value, including measurements from any unscheduled visits. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Reported Deaths | From Day 1 to Day 8 | — |
| Number of Participants With Adverse Events (AEs) Leading to Discontinuation | From Day 1 to Day 8 | An AE is any untoward medical occurrence (an unfavourable/unintended sign - including an abnormal laboratory finding), symptom, or disease (new or exacerbated) in a clinical study participant that is temporally associated with the study intervention. The AE may or may not be considered related to the study intervention. A participant is considered to have discontinued from the study if no new study procedure has been performed or no new information has been collected for him/her since the date of last contact. |
| Maximum Observed Plasma Concentration (Cmax) of VH3739937 on QD Dosing | Pre-dose, 1 hour (h), 2 h, 4h, 5h, 6h, 7h, 8h, 9h, 10h, 12h post-dose on Day 1 | Blood samples were collected at indicated timepoints for PK analysis. |
| Time to Maximum Concentration (Tmax) of VH3739937 on QD Dosing | Pre-dose, 1 hour (h), 2 h, 4h, 5h, 6h, 7h, 8h, 9h, 10h, 12h post-dose on Day 1 | Blood samples were collected at indicated timepoints for PK analysis. Tmax is defined as the time to reach maximum observed plasma concentration (Cmax). |
| Concentration at 24 Hours (C24) Post Dose of VH3739937 on QD Dosing | At 24h post-dose on Day 1 | C24 is defined as concentration at nominal time of 24 hours after dosing. Blood samples were collected at indicated timepoints for PK analysis. |
| Area Under the Concentration-time Curve From Zero to 24h (AUC[0-24]) of VH3739937 on QD Dosing. | Pre-dose, 1 hour (h), 2 h, 4h, 5h, 6h, 7h, 8h, 9h, 10h, 12h, 24h post-dose on Day 1 | Blood samples were collected at indicated timepoints for PK analysis. |
| Cmax of VH3739937 at Steady State (Cmax, ss) on QD Dosing | Pre-dose, 1 hour (h), 2 h, 4h, 5h, 6h, 7h, 8h, 9h, 10h, 12h post-dose on Day 7 | Blood samples were collected at indicated timepoints for PK analysis. |
| Number of Participants With Serious Adverse Events (SAEs) During Study Intervention Period | From Day 1 to Day 8 | An SAE is defined as any untoward medical occurrence that results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect in the offspring of a study participant, results in abnormal pregnancy outcomes or any other situation based on appropriate medical or scientific judgement. |
| C24 of VH3739937 at Steady State (C24, ss) on QD Dosing | At 24h post-dose on Day 7 | Blood samples were collected at indicated timepoints for PK analysis. |
| AUC(0-24) of VH3739937 at Steady State (AUC[0-24], ss) on QD Dosing | Pre-dose, 1 hour (h), 2 h, 4h, 5h, 6h, 7h, 8h, 9h, 10h, 12h, 24h post-dose on Day 7 | Blood samples were collected at indicated timepoints for PK analysis. |
| Cmax Post Single Dose of VH3739937 | Pre-dose, 1 hour (h), 2 h, 4h, 5h, 6h, 7h, 8h, 9h, 10h, 12h, 24h, 48h, 72h, 96h, 120h, 144h, 168h post-dose (single dose administered on Day 1) | Blood samples were collected at indicated timepoints for PK analysis. |
| Tmax Post Single Dose of VH3739937 | Pre-dose, 1 hour (h), 2 h, 4h, 5h, 6h, 7h, 8h, 9h, 10h, 12h, 24h, 48h, 72h, 96h, 120h, 144h, 168h post-dose (single dose administered on Day 1) | Blood samples were collected at indicated timepoints for PK analysis. |
| Concentration at 168 Hours (C168) Post Single Dose of VH3739937 | At 168 hours post-dose (single dose administered on Day 1) | C168 is defined as concentration of VH3739937 at a nominal time of 168 hours after dosing. Blood samples were collected at indicated timepoints for PK analysis. |
| Area Under the Concentration-time Curve From Zero to 168h [AUC(0-168)] Post Single Dose of VH3739937 | Pre-dose, 1 hour (h), 2 h, 4h, 5h, 6h, 7h, 8h, 9h, 10h, 12h, 24h, 48h, 72h, 96h, 120h, 144h, 168h post-dose (single dose administered on Day 1) | Blood samples were collected at indicated timepoints for analysis. |
| Tmax of VH3739937 at Steady State (Tmax, ss) on QD Dosing | Pre-dose, 1 hour (h), 2 h, 4h, 5h, 6h, 7h, 8h, 9h, 10h, 12h post-dose on Day 7 | Blood samples were collected at indicated timepoints for PK analysis. Tmax is defined as the time to reach the maximum observed plasma concentration (Cmax). |
Countries
Argentina, Greece, Italy, Poland, Spain, United States
Participant flow
Pre-assignment details
This study was terminated due to Sponsor decision.
Participants by arm
| Arm | Count |
|---|---|
| VH3739937 Low Dose Group Participants received a low dose of VH3739937 as loading Dose 1 (LD1) on Day 1, followed by a once-daily (QD) dose of VH3739937 as maintenance Dose 1 (MD1) from Days 2 through 7, where MD1 was lower than LD1. On Day 8, all participants transitioned to standard-of-care (SOC) combination antiretroviral therapy (cART) and continued study assessments through Day 25. | 7 |
| VH3739937 Medium Dose Group Participants received a medium dose of VH3739937 as loading Dose 2 (LD2) on Day 1, followed by a QD dose of VH3739937 as maintenance Dose 2 (MD2) from Days 2 through 7, where MD2 was lower than LD2. On Day 8, all participants transitioned to SOC cART and continued study assessments through Day 25. | 6 |
| VH3739937 High Dose Group Participants received a single high dose (Dose 3) of VH3739937 on Day 1. On Day 8, all participants transitioned to SOC cART and continued study assessments through Day 25. | 6 |
| Placebo Once Daily (QD) Participants received Placebo QD from Day 1 through Day 7. On Day 8, all participants transitioned to SOC cART and continued study assessments through Day 25. | 1 |
| Placebo Single Dose (SD) Participants received Placebo SD on Day 1. On Day 8, all participants transitioned to SOC cART and continued study assessments through Day 25. | 1 |
| Total | 21 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 |
|---|---|---|---|---|---|---|
| Overall Study | Withdrawal by Subject | 1 | 0 | 0 | 0 | 0 |
Baseline characteristics
| Characteristic | Total | VH3739937 Low Dose Group | VH3739937 Medium Dose Group | VH3739937 High Dose Group | Placebo Once Daily (QD) | Placebo Single Dose (SD) |
|---|---|---|---|---|---|---|
| Age, Continuous | 34.3 Years STANDARD_DEVIATION 10.77 | 30.1 Years STANDARD_DEVIATION 5.52 | 38.2 Years STANDARD_DEVIATION 9.68 | 35.7 Years STANDARD_DEVIATION 14.32 | 48.0 Years | 19.0 Years |
| Race/Ethnicity, Customized American Indian or Alaska Native | 1 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized Black or African American | 1 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized Unknown | 1 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized White | 18 Participants | 7 Participants | 5 Participants | 4 Participants | 1 Participants | 1 Participants |
| Sex: Female, Male Female | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Male | 21 Participants | 7 Participants | 6 Participants | 6 Participants | 1 Participants | 1 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk |
|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 7 | 0 / 6 | 0 / 6 | 0 / 1 | 0 / 1 |
| other Total, other adverse events | 3 / 7 | 2 / 6 | 5 / 6 | 0 / 1 | 0 / 1 |
| serious Total, serious adverse events | 0 / 7 | 1 / 6 | 0 / 6 | 0 / 1 | 0 / 1 |
Outcome results
Primary
Maximum Change From Baseline in Plasma Human Immunodeficiency Virus-1 (HIV-1) Ribonucleic Acid (RNA).
Plasma samples were collected for the quantitative analysis of plasma HIV-1 RNA. The maximum change from baseline was calculated by determining the largest change from baseline value across all assessment timepoints. This is identified by subtracting the lowest post-dose visit value up to Day 8 (inclusive) from the baseline value. The baseline was defined as the most recent pre-dose assessment with a valid, non-missing value, including measurements from any unscheduled visits.
Time frame: From Day 1 to Day 8
Population: The analysis was performed on the full analysis set (FAS) which included all randomized participants who received at least one full dose of study treatment. Only participants with data available at the specified timepoints were included in this analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| VH3739937 Low Dose Group | Maximum Change From Baseline in Plasma Human Immunodeficiency Virus-1 (HIV-1) Ribonucleic Acid (RNA). | -116909.43 copies/milliliter (c/mL) | Standard Deviation 187489.611 |
| VH3739937 Medium Dose Group | Maximum Change From Baseline in Plasma Human Immunodeficiency Virus-1 (HIV-1) Ribonucleic Acid (RNA). | -130461.67 copies/milliliter (c/mL) | Standard Deviation 106486.489 |
| VH3739937 High Dose Group | Maximum Change From Baseline in Plasma Human Immunodeficiency Virus-1 (HIV-1) Ribonucleic Acid (RNA). | -126026.67 copies/milliliter (c/mL) | Standard Deviation 190725.475 |
| Placebo Once Daily (QD) | Maximum Change From Baseline in Plasma Human Immunodeficiency Virus-1 (HIV-1) Ribonucleic Acid (RNA). | -428000.00 copies/milliliter (c/mL) | — |
| Placebo Single Dose (SD) | Maximum Change From Baseline in Plasma Human Immunodeficiency Virus-1 (HIV-1) Ribonucleic Acid (RNA). | -14200.00 copies/milliliter (c/mL) | — |
Secondary
Area Under the Concentration-time Curve From Zero to 168h [AUC(0-168)] Post Single Dose of VH3739937
Blood samples were collected at indicated timepoints for analysis.
Time frame: Pre-dose, 1 hour (h), 2 h, 4h, 5h, 6h, 7h, 8h, 9h, 10h, 12h, 24h, 48h, 72h, 96h, 120h, 144h, 168h post-dose (single dose administered on Day 1)
Population: The analysis was performed on the PK set. Only participants with data available at the mentioned timepoints were included in this analysis.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| VH3739937 Low Dose Group | Area Under the Concentration-time Curve From Zero to 168h [AUC(0-168)] Post Single Dose of VH3739937 | 144443.90 h*ng/mL | Geometric Coefficient of Variation 39.51 |
Secondary
Area Under the Concentration-time Curve From Zero to 24h (AUC[0-24]) of VH3739937 on QD Dosing.
Blood samples were collected at indicated timepoints for PK analysis.
Time frame: Pre-dose, 1 hour (h), 2 h, 4h, 5h, 6h, 7h, 8h, 9h, 10h, 12h, 24h post-dose on Day 1
Population: The analysis was performed on the PK set. Only participants with data available at the mentioned timepoints were included in this analysis.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| VH3739937 Low Dose Group | Area Under the Concentration-time Curve From Zero to 24h (AUC[0-24]) of VH3739937 on QD Dosing. | 6573.08 Hour nanogram per milliliter (h*ng/mL) | Geometric Coefficient of Variation 27.55 |
| VH3739937 Medium Dose Group | Area Under the Concentration-time Curve From Zero to 24h (AUC[0-24]) of VH3739937 on QD Dosing. | 20679.28 Hour nanogram per milliliter (h*ng/mL) | Geometric Coefficient of Variation 36.73 |
Secondary
AUC(0-24) of VH3739937 at Steady State (AUC[0-24], ss) on QD Dosing
Blood samples were collected at indicated timepoints for PK analysis.
Time frame: Pre-dose, 1 hour (h), 2 h, 4h, 5h, 6h, 7h, 8h, 9h, 10h, 12h, 24h post-dose on Day 7
Population: The analysis was performed on the PK set. Only participants with data available at the mentioned timepoints were included in this analysis.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| VH3739937 Low Dose Group | AUC(0-24) of VH3739937 at Steady State (AUC[0-24], ss) on QD Dosing | 6610.59 h*ng/mL | Geometric Coefficient of Variation 16.57 |
| VH3739937 Medium Dose Group | AUC(0-24) of VH3739937 at Steady State (AUC[0-24], ss) on QD Dosing | 23871.02 h*ng/mL | Geometric Coefficient of Variation 30.24 |
Secondary
C24 of VH3739937 at Steady State (C24, ss) on QD Dosing
Blood samples were collected at indicated timepoints for PK analysis.
Time frame: At 24h post-dose on Day 7
Population: The analysis was performed on the PK set. Only participants with data available at the mentioned timepoints were included in this analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| VH3739937 Low Dose Group | C24 of VH3739937 at Steady State (C24, ss) on QD Dosing | 263.67 ng/mL | Standard Deviation 26.493 |
| VH3739937 Medium Dose Group | C24 of VH3739937 at Steady State (C24, ss) on QD Dosing | 937.50 ng/mL | Standard Deviation 344.099 |
Secondary
Cmax of VH3739937 at Steady State (Cmax, ss) on QD Dosing
Blood samples were collected at indicated timepoints for PK analysis.
Time frame: Pre-dose, 1 hour (h), 2 h, 4h, 5h, 6h, 7h, 8h, 9h, 10h, 12h post-dose on Day 7
Population: The analysis was performed on the PK set. Only participants with data available at the mentioned timepoints were included in this analysis.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| VH3739937 Low Dose Group | Cmax of VH3739937 at Steady State (Cmax, ss) on QD Dosing | 327.09 ng/mL | Geometric Coefficient of Variation 10.31 |
| VH3739937 Medium Dose Group | Cmax of VH3739937 at Steady State (Cmax, ss) on QD Dosing | 1221.20 ng/mL | Geometric Coefficient of Variation 27.79 |
Secondary
Cmax Post Single Dose of VH3739937
Blood samples were collected at indicated timepoints for PK analysis.
Time frame: Pre-dose, 1 hour (h), 2 h, 4h, 5h, 6h, 7h, 8h, 9h, 10h, 12h, 24h, 48h, 72h, 96h, 120h, 144h, 168h post-dose (single dose administered on Day 1)
Population: The analysis was performed on the PK set. Only participants with data available at the mentioned timepoints were included in this analysis.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| VH3739937 Low Dose Group | Cmax Post Single Dose of VH3739937 | 2058.35 ng/mL | Geometric Coefficient of Variation 35.5 |
Secondary
Concentration at 168 Hours (C168) Post Single Dose of VH3739937
C168 is defined as concentration of VH3739937 at a nominal time of 168 hours after dosing. Blood samples were collected at indicated timepoints for PK analysis.
Time frame: At 168 hours post-dose (single dose administered on Day 1)
Population: The analysis was performed on the PK set. Only participants with data available at the mentioned timepoints were included in this analysis.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| VH3739937 Low Dose Group | Concentration at 168 Hours (C168) Post Single Dose of VH3739937 | 297.25 ng/mL | Geometric Coefficient of Variation 35.19 |
Secondary
Concentration at 24 Hours (C24) Post Dose of VH3739937 on QD Dosing
C24 is defined as concentration at nominal time of 24 hours after dosing. Blood samples were collected at indicated timepoints for PK analysis.
Time frame: At 24h post-dose on Day 1
Population: The analysis was performed on the PK set. Only participants with data available at the mentioned timepoints were included in this analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| VH3739937 Low Dose Group | Concentration at 24 Hours (C24) Post Dose of VH3739937 on QD Dosing | 276.29 ng/mL | Standard Deviation 102.761 |
| VH3739937 Medium Dose Group | Concentration at 24 Hours (C24) Post Dose of VH3739937 on QD Dosing | 860.17 ng/mL | Standard Deviation 321.21 |
Secondary
Maximum Observed Plasma Concentration (Cmax) of VH3739937 on QD Dosing
Blood samples were collected at indicated timepoints for PK analysis.
Time frame: Pre-dose, 1 hour (h), 2 h, 4h, 5h, 6h, 7h, 8h, 9h, 10h, 12h post-dose on Day 1
Population: The analysis was performed on the Pharmacokinetic (PK) set which included all participants in the Safety analysis set who had at least 1 PK assessment. Only participants with data available at the mentioned timepoints were included in this analysis.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| VH3739937 Low Dose Group | Maximum Observed Plasma Concentration (Cmax) of VH3739937 on QD Dosing | 397.62 nanogram per milliliter (ng/mL) | Geometric Coefficient of Variation 28.42 |
| VH3739937 Medium Dose Group | Maximum Observed Plasma Concentration (Cmax) of VH3739937 on QD Dosing | 1225.91 nanogram per milliliter (ng/mL) | Geometric Coefficient of Variation 34.36 |
Secondary
Number of Participants With Adverse Events (AEs) Leading to Discontinuation
An AE is any untoward medical occurrence (an unfavourable/unintended sign - including an abnormal laboratory finding), symptom, or disease (new or exacerbated) in a clinical study participant that is temporally associated with the study intervention. The AE may or may not be considered related to the study intervention. A participant is considered to have discontinued from the study if no new study procedure has been performed or no new information has been collected for him/her since the date of last contact.
Time frame: From Day 1 to Day 8
Population: The analysis was performed on the safety set. Only participants with data available at the specified timepoints were included in this analysis.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| VH3739937 Low Dose Group | Number of Participants With Adverse Events (AEs) Leading to Discontinuation | 0 Participants |
| VH3739937 Medium Dose Group | Number of Participants With Adverse Events (AEs) Leading to Discontinuation | 0 Participants |
| VH3739937 High Dose Group | Number of Participants With Adverse Events (AEs) Leading to Discontinuation | 0 Participants |
| Placebo Once Daily (QD) | Number of Participants With Adverse Events (AEs) Leading to Discontinuation | 0 Participants |
| Placebo Single Dose (SD) | Number of Participants With Adverse Events (AEs) Leading to Discontinuation | 0 Participants |
Secondary
Number of Participants With Serious Adverse Events (SAEs) During Study Intervention Period
An SAE is defined as any untoward medical occurrence that results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect in the offspring of a study participant, results in abnormal pregnancy outcomes or any other situation based on appropriate medical or scientific judgement.
Time frame: From Day 1 to Day 8
Population: The analysis was performed on the safety set which included all randomized participants who took at least 1 partial or full dose of study treatment. Only participants with data available at the specified timepoints were included in this analysis.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| VH3739937 Low Dose Group | Number of Participants With Serious Adverse Events (SAEs) During Study Intervention Period | 0 Participants |
| VH3739937 Medium Dose Group | Number of Participants With Serious Adverse Events (SAEs) During Study Intervention Period | 0 Participants |
| VH3739937 High Dose Group | Number of Participants With Serious Adverse Events (SAEs) During Study Intervention Period | 0 Participants |
| Placebo Once Daily (QD) | Number of Participants With Serious Adverse Events (SAEs) During Study Intervention Period | 0 Participants |
| Placebo Single Dose (SD) | Number of Participants With Serious Adverse Events (SAEs) During Study Intervention Period | 0 Participants |
Secondary
Number of Reported Deaths
Time frame: From Day 1 to Day 8
Population: The analysis was performed on the safety set. Only participants with data available at the specified timepoints were included in this analysis.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| VH3739937 Low Dose Group | Number of Reported Deaths | 0 Participants |
| VH3739937 Medium Dose Group | Number of Reported Deaths | 0 Participants |
| VH3739937 High Dose Group | Number of Reported Deaths | 0 Participants |
| Placebo Once Daily (QD) | Number of Reported Deaths | 0 Participants |
| Placebo Single Dose (SD) | Number of Reported Deaths | 0 Participants |
Secondary
Time to Maximum Concentration (Tmax) of VH3739937 on QD Dosing
Blood samples were collected at indicated timepoints for PK analysis. Tmax is defined as the time to reach maximum observed plasma concentration (Cmax).
Time frame: Pre-dose, 1 hour (h), 2 h, 4h, 5h, 6h, 7h, 8h, 9h, 10h, 12h post-dose on Day 1
Population: The analysis was performed on the PK set. Only participants with data available at the mentioned timepoints were included in this analysis.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| VH3739937 Low Dose Group | Time to Maximum Concentration (Tmax) of VH3739937 on QD Dosing | 6.00 hour (h) |
| VH3739937 Medium Dose Group | Time to Maximum Concentration (Tmax) of VH3739937 on QD Dosing | 7.56 hour (h) |
Secondary
Tmax of VH3739937 at Steady State (Tmax, ss) on QD Dosing
Blood samples were collected at indicated timepoints for PK analysis. Tmax is defined as the time to reach the maximum observed plasma concentration (Cmax).
Time frame: Pre-dose, 1 hour (h), 2 h, 4h, 5h, 6h, 7h, 8h, 9h, 10h, 12h post-dose on Day 7
Population: The analysis was performed on the PK set. Only participants with data available at the mentioned timepoints were included in this analysis.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| VH3739937 Low Dose Group | Tmax of VH3739937 at Steady State (Tmax, ss) on QD Dosing | 5.07 hour (h) |
| VH3739937 Medium Dose Group | Tmax of VH3739937 at Steady State (Tmax, ss) on QD Dosing | 7.48 hour (h) |
Secondary
Tmax Post Single Dose of VH3739937
Blood samples were collected at indicated timepoints for PK analysis.
Time frame: Pre-dose, 1 hour (h), 2 h, 4h, 5h, 6h, 7h, 8h, 9h, 10h, 12h, 24h, 48h, 72h, 96h, 120h, 144h, 168h post-dose (single dose administered on Day 1)
Population: The analysis was performed on the PK set. Only participants with data available at the mentioned timepoints were included in this analysis.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| VH3739937 Low Dose Group | Tmax Post Single Dose of VH3739937 | 8.08 hour (h) |