Anaplastic Large-cell Lymphoma, Hodgkin Lymphoma
Conditions
Keywords
Lymphoma, Hodgkin, Anaplastic Large-cell, Relapsed, Refractory, Antigens, CD30, Antibody-Drug Conjugate, Antibodies, Monoclonal, Lymphoma, Non-Hodgkin, Lymphoma, Large-Cell, Anaplastic, Monomethyl auristatin E, Drug Therapy, Immunotherapy, Hematologic Diseases
Brief summary
This is an open-label trial to estimate the concentrations of brentuximab vedotin in relapsed/refractory Hodgkin lymphoma (HL) or relapsed/refractory systemic anaplastic large cell lymphoma (sALCL) participants treated with either brentuximab vedotin or brentuximab vedotin + rifampicin.
Interventions
DRUGbrentuximab vedotin
Brentuximab vedotin will be administered every 3 weeks at a dose of 1.8 mg/kg.
DRUGBrentuximab vedotin and rifampicin
Brentuximab vedotin will be administered every 3 weeks at a dose of 1.8 mg/kg beginning on Cycle 1, Day 1; daily rifampicin (600 mg PO) will be administered during Cycles 0 through 3 only, beginning on Cycle 0, Day 1 (7 days before the Cycle 1, Day 1 dose of brentuximab vedotin) and continuing through Cycle 3, Day 21.
Sponsors
Millennium Pharmaceuticals, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Male or female participants between 18 years and 75 years old, with relapsed or refractory HL or relapsed or refractory sALCL who have previously received at least 1 multiagent chemotherapy * Measurable disease * An Eastern Cooperative Oncology Group (ECOG) performance of 0 or 1 * Female participants who are postmenopausal for at least 1 year before the screening visit, surgically sterile, or agree to practice 2 effective methods of contraception, at the same time, from the time of signing the informed consent form through 30 days after the last dose of study drug, or agree to practice true abstinence * Male participants who agree to practice effective barrier contraception during the entire study treatment period through 6 months after the last dose of study drug or agree to practice true abstinence * Clinical laboratory values as specified in the study protocol
Exclusion criteria
* Participants for whom rifampicin is contraindicated * Previously received an allogeneic transplant. * Participants with current diagnosis of primary cutaneous anaplastic large cell lymphoma (ALCL) (participants whose ALCL has transformed to sALCL are eligible). * Known cerebral/meningeal disease including signs or symptoms of progressive multifocal leukoencephalopathy (PML) * Female participants who are lactating and breastfeeding or pregnant * Known human immunodeficiency virus (HIV) positive, * Known hepatitis B surface antigen-positive, or known or suspected active hepatitis C infection
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Amount of Monomethylauristatin E (MMAE) and Its Metabolites Excreted in Urine at Cycle 3, 480-504 Hours Postdose | Cycle 3: 480-504 hours postdose | Metabolites of MMAE includes C4, C5, C7, C8 and C13. Amount of MMAE and its metabolites in urine were determined by multiplying the volume of urine obtained and the concentration of MMAE and its metabolites present in it, respectively. The LLQ for determining the concentration was 0.01 ng/mL. |
| Amount of Monomethylauristatin E (MMAE) and Its Metabolites Excreted in Urine at Cycle 3, 48-72 Hours Postdose | Cycle 3: 48-72 hours postdose | Metabolites of MMAE includes C4, C5, C7, C8 and C13. Amount of MMAE and its metabolites in urine were determined by multiplying the volume of urine obtained and the concentration of MMAE and its metabolites present in it, respectively. The LLQ for determining the concentration was 0.01 ng/mL. |
| Amount of Monomethylauristatin E (MMAE) and Its Metabolites Excreted in Urine at Cycle 3, 72-96 Hours Postdose | Cycle 3: 72-96 hours postdose | Metabolites of MMAE includes C4, C5, C7, C8 and C13. Amount of MMAE and its metabolites in urine were determined by multiplying the volume of urine obtained and the concentration of MMAE and its metabolites present in it, respectively. The LLQ for determining the concentration was 0.01 ng/mL. |
| Amount of Monomethylauristatin E (MMAE) and Its Metabolites Excreted in Urine at Cycle 3, 96-120 Hours Postdose | Cycle 3: 96-120 hours postdose | Metabolites of MMAE includes C4, C5, C7, C8 and C13. Amount of MMAE and its metabolites in urine were determined by multiplying the volume of urine obtained and the concentration of MMAE and its metabolites present in it, respectively. The LLQ for determining the concentration was 0.01 ng/mL. |
| Amount of Monomethylauristatin E (MMAE) and Its Metabolites Excreted in Urine at Cycle 3, 120-144 Hours Postdose | Cycle 3: 120-144 hours postdose | Metabolites of MMAE includes C4, C5, C7, C8 and C13. Amount of MMAE and its metabolites in urine were determined by multiplying the volume of urine obtained and the concentration of MMAE and its metabolites present in it, respectively. The LLQ for determining the concentration was 0.01 ng/mL. |
| Amount of Monomethylauristatin E (MMAE) and Its Metabolites Excreted in Urine at Cycle 3, 144-168 Hours Postdose | Cycle 3: 144-168 hours postdose | Metabolites of MMAE includes C4, C5, C7, C8 and C13. Amount of MMAE and its metabolites in urine were determined by multiplying the volume of urine obtained and the concentration of MMAE and its metabolites present in it, respectively. The LLQ for determining the concentration was 0.01 ng/mL. |
| Amount of Monomethylauristatin E (MMAE) and Its Metabolites Excreted in Urine at Cycle 3, 336-360 Hours Postdose | Cycle 3: 336-360 hours postdose | Metabolites of MMAE includes C4, C5, C7, C8 and C13. Amount of MMAE and its metabolites in urine were determined by multiplying the volume of urine obtained and the concentration of MMAE and its metabolites present in it, respectively. The LLQ for determining the concentration was 0.01 ng/mL. |
| Plasma Concentration of Monomethylauristatin E (MMAE) and Its Metabolites at Cycle 2, 0.5 Hour Postdose | Cycle 2: 0.5 hour postdose | Metabolites of MMAE includes C4, C5, C7, C8 and C13. The LLQ for all the observations was 0.01 ng/mL. |
| Plasma Concentration of Monomethylauristatin E (MMAE) and Its Metabolites at Cycle 1, Predose | Cycle 1: Predose | Metabolites of MMAE includes C4, C5, C7, C8 and C13. The lower limit of Quantification (LLQ) for all the observations was 0.01 nanogram/milliliter (ng/mL). |
| Plasma Concentration of Monomethylauristatin E (MMAE) and Its Metabolites at Cycle 2, Predose | Cycle 2: Predose | Metabolites of MMAE includes C4, C5, C7, C8 and C13. The LLQ for all the observations was 0.01 ng/mL. |
| Plasma Concentration of Monomethylauristatin E (MMAE) and Its Metabolites at Cycle 3, Predose | Cycle 3: Predose | Metabolites of MMAE includes C4, C5, C7, C8 and C13. The LLQ for all the observations was 0.01 ng/mL. |
| Plasma Concentration of Monomethylauristatin E (MMAE) and Its Metabolites at Cycle 1, 0.5 Hour Postdose | Cycle 1: 0.5 hour postdose | Metabolites of MMAE includes C4, C5, C7, C8 and C13. The LLQ for all the observations was 0.01 ng/mL. |
| Plasma Concentration of Monomethylauristatin E (MMAE) and Its Metabolites at Cycle 3, 0.5 Hour Postdose | Cycle 3: 0.5 hour postdose | Metabolites of MMAE includes C4, C5, C7, C8 and C13. The LLQ for all the observations was 0.01 ng/mL. |
| Plasma Concentration of Monomethylauristatin E (MMAE) and Its Metabolites at Cycle 1, 4 Hour Postdose | Cycle 1: 4 hour postdose | Metabolites of MMAE includes C4, C5, C7, C8 and C13. The LLQ for all the observations was 0.01 ng/mL. |
| Plasma Concentration of Monomethylauristatin E (MMAE) and Its Metabolites at Cycle 3, 4 Hour Postdose | Cycle 3: 4 hour postdose | Metabolites of MMAE includes C4, C5, C7, C8 and C13. The LLQ for all the observations was 0.01 ng/mL. |
| Plasma Concentration of Monomethylauristatin E (MMAE) and Its Metabolites at Cycle 1, 24 Hour Postdose | Cycle 1: 24 hour postdose | Metabolites of MMAE includes C4, C5, C7, C8 and C13. The LLQ for all the observations was 0.01 ng/mL. |
| Plasma Concentration of Monomethylauristatin E (MMAE) and Its Metabolites at Cycle 3, 24 Hour Postdose | Cycle 3: 24 hour postdose | Metabolites of MMAE includes C4, C5, C7, C8 and C13. The LLQ for all the observations was 0.01 ng/mL. |
| Plasma Concentration of Monomethylauristatin E (MMAE) and Its Metabolites at Cycle 1, 48 Hour Postdose | Cycle 1: 48 hour postdose | Metabolites of MMAE includes C4, C5, C7, C8 and C13. The LLQ for all the observations was 0.01 ng/mL. |
| Plasma Concentration of Monomethylauristatin E (MMAE) and Its Metabolites at Cycle 3, 48 Hour Postdose | Cycle 3: 48 hour postdose | Metabolites of MMAE includes C4, C5, C7, C8 and C13. The LLQ for all the observations was 0.01 ng/mL. |
| Plasma Concentration of Monomethylauristatin E (MMAE) and Its Metabolites at Cycle 1, 72 Hour Postdose | Cycle 1: 72 hour postdose | Metabolites of MMAE includes C4, C5, C7, C8 and C13. The LLQ for all the observations was 0.01 ng/mL. |
| Plasma Concentration of Monomethylauristatin E (MMAE) and Its Metabolites at Cycle 3, 72 Hour Postdose | Cycle 3: 72 hour postdose | Metabolites of MMAE includes C4, C5, C7, C8 and C13. The LLQ for all the observations was 0.01 ng/mL. |
| Plasma Concentration of Monomethylauristatin E (MMAE) and Its Metabolites at Cycle 1, 96 Hour Postdose | Cycle 1: 96 hour postdose | Metabolites of MMAE includes C4, C5, C7, C8 and C13. The LLQ for all the observations was 0.01 ng/mL. |
| Plasma Concentration of Monomethylauristatin E (MMAE) and Its Metabolites at Cycle 3, 96 Hour Postdose | Cycle 3: 96 hour postdose | Metabolites of MMAE includes C4, C5, C7, C8 and C13. The LLQ for all the observations was 0.01 ng/mL. |
| Plasma Concentration of Monomethylauristatin E (MMAE) and Its Metabolites at Cycle 1, 144 Hour Postdose | Cycle 1: 144 hour postdose | Metabolites of MMAE includes C4, C5, C7, C8 and C13. The LLQ for all the observations was 0.01 ng/mL. |
| Plasma Concentration of Monomethylauristatin E (MMAE) and Its Metabolites at Cycle 3, 144 Hour Postdose | Cycle 3: 144 hour postdose | Metabolites of MMAE includes C4, C5, C7, C8 and C13. The LLQ for all the observations was 0.01 ng/mL. |
| Plasma Concentration of Monomethylauristatin E (MMAE) and Its Metabolites at Cycle 1, 336 Hour Postdose | Cycle 1: 336 hour postdose | Metabolites of MMAE includes C4, C5, C7, C8 and C13. The LLQ for all the observations was 0.01 ng/mL. |
| Plasma Concentration of Monomethylauristatin E (MMAE) and Its Metabolites at Cycle 3, 336 Hour Postdose | Cycle 3: 336 hour postdose | Metabolites of MMAE includes C4, C5, C7, C8 and C13. The LLQ for all the observations was 0.01 ng/mL. |
| Plasma Concentration of Monomethylauristatin E (MMAE) and Its Metabolites at Cycle 3, 480 Hour Postdose | Cycle 3: 480 hour postdose | Metabolites of MMAE includes C4, C5, C7, C8 and C13. The LLQ for all the observations was 0.01 ng/mL. |
| Amount of Monomethylauristatin E (MMAE) and Its Metabolites Excreted in Urine at Cycle 1, Predose | Cycle 1: Predose | Metabolites of MMAE includes C4, C5, C7, C8 and C13. Amount of MMAE and its metabolites in urine were determined by multiplying the volume of urine obtained and the concentration of MMAE and its metabolites present in it, respectively. The LLQ for determining the concentration was 0.01 ng/mL. |
| Amount of Monomethylauristatin E (MMAE) and Its Metabolites Excreted in Urine at Cycle 1, 0-24 Hours Postdose | Cycle 1: 0-24 hours postdose | Metabolites of MMAE includes C4, C5, C7, C8 and C13. Amount of MMAE and its metabolites in urine were determined by multiplying the volume of urine obtained and the concentration of MMAE and its metabolites present in it, respectively. The LLQ for determining the concentration was 0.01 ng/mL. |
| Amount of Monomethylauristatin E (MMAE) and Its Metabolites Excreted in Urine at Cycle 1, 24-48 Hours Postdose | Cycle 1: 24-48 hours postdose | Metabolites of MMAE includes C4, C5, C7, C8 and C13. Amount of MMAE and its metabolites in urine were determined by multiplying the volume of urine obtained and the concentration of MMAE and its metabolites present in it, respectively. The LLQ for determining the concentration was 0.01 ng/mL. |
| Amount of Monomethylauristatin E (MMAE) and Its Metabolites Excreted in Urine at Cycle 1, 48-72 Hours Postdose | Cycle 1: 48-72 hours postdose | Metabolites of MMAE includes C4, C5, C7, C8 and C13. Amount of MMAE and its metabolites in urine were determined by multiplying the volume of urine obtained and the concentration of MMAE and its metabolites present in it, respectively. The LLQ for determining the concentration was 0.01 ng/mL. |
| Amount of Monomethylauristatin E (MMAE) and Its Metabolites Excreted in Urine at Cycle 1, 72-96 Hours Postdose | Cycle 1: 72-96 hours postdose | Metabolites of MMAE includes C4, C5, C7, C8 and C13. Amount of MMAE and its metabolites in urine were determined by multiplying the volume of urine obtained and the concentration of MMAE and its metabolites present in it, respectively. The LLQ for determining the concentration was 0.01 ng/mL. |
| Amount of Monomethylauristatin E (MMAE) and Its Metabolites Excreted in Urine at Cycle 1, 96-120 Hours Postdose | Cycle 1: 96-120 hours postdose | Metabolites of MMAE includes C4, C5, C7, C8 and C13. Amount of MMAE and its metabolites in urine were determined by multiplying the volume of urine obtained and the concentration of MMAE and its metabolites present in it, respectively. The LLQ for determining the concentration was 0.01 ng/mL. |
| Amount of Monomethylauristatin E (MMAE) and Its Metabolites Excreted in Urine at Cycle 1, 120-144 Hours Postdose | Cycle 1: 120-144 hours postdose | Metabolites of MMAE includes C4, C5, C7, C8 and C13. Amount of MMAE and its metabolites in urine were determined by multiplying the volume of urine obtained and the concentration of MMAE and its metabolites present in it, respectively. The LLQ for determining the concentration was 0.01 ng/mL. |
| Amount of Monomethylauristatin E (MMAE) and Its Metabolites Excreted in Urine at Cycle 1, 144-168 Hours Postdose | Cycle 1: 144-168 hours postdose | Metabolites of MMAE includes C4, C5, C7, C8 and C13. Amount of MMAE and its metabolites in urine were determined by multiplying the volume of urine obtained and the concentration of MMAE and its metabolites present in it, respectively. The LLQ for determining the concentration was 0.01 ng/mL. |
| Amount of Monomethylauristatin E (MMAE) and Its Metabolites Excreted in Urine at Cycle 1, 336-360 Hours Postdose | Cycle 1: 336-360 hours postdose | Metabolites of MMAE includes C4, C5, C7, C8 and C13. Amount of MMAE and its metabolites in urine were determined by multiplying the volume of urine obtained and the concentration of MMAE and its metabolites present in it, respectively. The LLQ for determining the concentration was 0.01 ng/mL. |
| Amount of Monomethylauristatin E (MMAE) and Its Metabolites Excreted in Urine at Cycle 1, 480-504 Hours Postdose | Cycle 1: 480-504 hours postdose | Metabolites of MMAE includes C4, C5, C7, C8 and C13. Amount of MMAE and its metabolites in urine were determined by multiplying the volume of urine obtained and the concentration of MMAE and its metabolites present in it, respectively. The LLQ for determining the concentration was 0.01 ng/mL. |
| Amount of Monomethylauristatin E (MMAE) and Its Metabolites Excreted in Urine at Cycle 3, Predose | Cycle 3: Predose | Metabolites of MMAE includes C4, C5, C7, C8 and C13. Amount of MMAE and its metabolites in urine were determined by multiplying the volume of urine obtained and the concentration of MMAE and its metabolites present in it, respectively. The LLQ for determining the concentration was 0.01 ng/mL. |
| Amount of Monomethylauristatin E (MMAE) and Its Metabolites Excreted in Urine at Cycle 3, 0-24 Hours Postdose | Cycle 3: 0-24 hours postdose | Metabolites of MMAE includes C4, C5, C7, C8 and C13. Amount of MMAE and its metabolites in urine were determined by multiplying the volume of urine obtained and the concentration of MMAE and its metabolites present in it, respectively. The LLQ for determining the concentration was 0.01 ng/mL. |
| Amount of Monomethylauristatin E (MMAE) and Its Metabolites Excreted in Urine at Cycle 3, 24-48 Hours Postdose | Cycle 3: 24-48 hours postdose | Metabolites of MMAE includes C4, C5, C7, C8 and C13. Amount of MMAE and its metabolites in urine were determined by multiplying the volume of urine obtained and the concentration of MMAE and its metabolites present in it, respectively. The LLQ for determining the concentration was 0.01 ng/mL. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Serum Concentration of Total Antibody (TAb) | Cycle 1 and 3: Predose, 0.5, 4, 72, 336 hours post-dose; Cycle 2: Predose, 0.5 hours post-dose; Cycle 3: 480 hours post-dose | The LLQ for all the observations was 12.5 ng/mL. |
| Number of Participants Reporting One or More Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) | Baseline up to 30 days after last dose of study drug (30 days after Cycle 16) | An Adverse Event (AE) is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (example, a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug, whether or not it is considered related to the drug. A treatment-emergent adverse event (TEAE) is defined as an adverse event with an onset that occurs after receiving study drug. A serious adverse event (SAE) is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; or congenital anomaly; or a medically important event. AEs included both SAE and non-SAE. |
| Number of Participants With Anti-therapeutic Antibodies (ATA) to Brentuximab Vedotin | Day 1 of Cycle 1 and 3 | Participants with positive ATA at both Cycle 1 and 3, negative ATA at both Cycle 1 and 3, and transient positive (positive at one time point, but negative at the other) ATA for brentuximab vedotin were reported. |
| Number of Participants With Markedly Abnormal Laboratory Values | Baseline up to 30 days after last dose of study drug (30 Days after Cycle 16) | The number of participants with any markedly abnormal standard safety laboratory values collected throughout study. |
| Number of Participants With Clinically Significant Change From Baseline in Vital Signs | Baseline up to 30 days after last dose of study drug (30 Days after Cycle 16) | Vital signs included body temperature, body weight, blood pressure and heart rate. |
| Serum Concentrations of Antibody-drug Conjugate (ADC) | Cycle 1 and 3: Predose, 0.5, 4, 72, 336 hours post-dose; Cycle 2: Predose, 0.5 hours post-dose; Cycle 3: 480 hours post-dose | The LLQ for all the observations was 12.5 ng/mL. |
Countries
Belgium, Lithuania, Spain
Participant flow
Recruitment details
Participants took part in the study at 5 investigative sites in Belgium, Lithuania and Spain from 27 November 2013 to 16 June 2015.
Pre-assignment details
Participants with a historical diagnosis of relapsed or refractory classical hodgkin lymphoma (HL) or relapsed or refractory systemic anaplastic large cell lymphoma (sALCL) were enrolled in 1 of 2 treatment groups: Brentuximab vedotin; Brentuximab vedotin + Rifampicin.
Participants by arm
| Arm | Count |
|---|---|
| Brentuximab Vedotin Brentuximab vedotin 1.8 mg/kg, injection, intravenously, every 3 weeks on Day 1 of each 21-day treatment cycle up to a maximum of 16 brentuximab vedotin doses. | 10 |
| Brentuximab Vedotin + Rifampicin Brentuximab vedotin 1.8 mg/kg, injection, intravenously, every 3 weeks on Day 1 of each 21-day treatment cycle up to a maximum of 16 brentuximab vedotin doses and rifampicin, 600 mg, capsules, orally, once daily from Day 1 of treatment Cycle 0 through Day 21 of treatment cycle 3. | 10 |
| Total | 20 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 3 | 0 |
| Overall Study | Disease Progression | 5 | 2 |
| Overall Study | Protocol Violation | 0 | 1 |
| Overall Study | Stem Cell Transplant | 2 | 6 |
| Overall Study | Withdrawal by Subject | 0 | 1 |
Baseline characteristics
| Characteristic | Brentuximab Vedotin + Rifampicin | Total | Brentuximab Vedotin |
|---|---|---|---|
| Age, Continuous | 40.1 years STANDARD_DEVIATION 9.13 | 41.2 years STANDARD_DEVIATION 10.52 | 42.3 years STANDARD_DEVIATION 12.15 |
| Ann Arbor Stage I | 0 participants | 1 participants | 1 participants |
| Ann Arbor Stage II | 6 participants | 8 participants | 2 participants |
| Ann Arbor Stage III | 0 participants | 1 participants | 1 participants |
| Ann Arbor Stage IV | 4 participants | 10 participants | 6 participants |
| Disease Type Hodgkin lymphoma | 10 participants | 20 participants | 10 participants |
| Disease Type sALCL | 0 participants | 0 participants | 0 participants |
| Eastern Cooperative Oncology Group (ECOG) Performance Status 0 | 6 participants | 9 participants | 3 participants |
| Eastern Cooperative Oncology Group (ECOG) Performance Status 1 | 4 participants | 10 participants | 6 participants |
| Eastern Cooperative Oncology Group (ECOG) Performance Status 2 | 0 participants | 1 participants | 1 participants |
| Height | 169.7 centimeter (cm) STANDARD_DEVIATION 6.45 | 169.8 centimeter (cm) STANDARD_DEVIATION 5.15 | 169.9 centimeter (cm) STANDARD_DEVIATION 3.8 |
| Months from Initial Diagnosis to First Dose | 61.9 months STANDARD_DEVIATION 46.96 | 48.3 months STANDARD_DEVIATION 41.25 | 34.7 months STANDARD_DEVIATION 31.23 |
| Race/Ethnicity, Customized Not Hispanic or Latino | 10 participants | 20 participants | 10 participants |
| Race/Ethnicity, Customized White | 10 participants | 20 participants | 10 participants |
| Region of Enrollment Belgium | 1 participants | 3 participants | 2 participants |
| Region of Enrollment Lithuania | 4 participants | 8 participants | 4 participants |
| Region of Enrollment Spain | 5 participants | 9 participants | 4 participants |
| Sex: Female, Male Female | 6 Participants | 9 Participants | 3 Participants |
| Sex: Female, Male Male | 4 Participants | 11 Participants | 7 Participants |
| Weight | 76.84 kilogram (kg) STANDARD_DEVIATION 24.213 | 73.98 kilogram (kg) STANDARD_DEVIATION 20.595 | 71.11 kilogram (kg) STANDARD_DEVIATION 17.056 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 9 / 10 | 9 / 10 |
| serious Total, serious adverse events | 4 / 10 | 0 / 10 |
Outcome results
Primary
Amount of Monomethylauristatin E (MMAE) and Its Metabolites Excreted in Urine at Cycle 1, 0-24 Hours Postdose
Metabolites of MMAE includes C4, C5, C7, C8 and C13. Amount of MMAE and its metabolites in urine were determined by multiplying the volume of urine obtained and the concentration of MMAE and its metabolites present in it, respectively. The LLQ for determining the concentration was 0.01 ng/mL.
Time frame: Cycle 1: 0-24 hours postdose
Population: PK analysis set included all participants who received brentuximab vedotin at 1.8 mg/kg throughout Cycles 1 to 3 and had sufficient dosing and PK data to reliably estimate PK parameters.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| Brentuximab Vedotin | Amount of Monomethylauristatin E (MMAE) and Its Metabolites Excreted in Urine at Cycle 1, 0-24 Hours Postdose | MMAE | 12.5668 ng | Standard Deviation 5.31374 |
| Brentuximab Vedotin | Amount of Monomethylauristatin E (MMAE) and Its Metabolites Excreted in Urine at Cycle 1, 0-24 Hours Postdose | C4 | 0.0878 ng | Standard Deviation 0.13223 |
| Brentuximab Vedotin | Amount of Monomethylauristatin E (MMAE) and Its Metabolites Excreted in Urine at Cycle 1, 0-24 Hours Postdose | C5 | 0.0883 ng | Standard Deviation 0.10135 |
| Brentuximab Vedotin | Amount of Monomethylauristatin E (MMAE) and Its Metabolites Excreted in Urine at Cycle 1, 0-24 Hours Postdose | C7 | NA ng | — |
| Brentuximab Vedotin | Amount of Monomethylauristatin E (MMAE) and Its Metabolites Excreted in Urine at Cycle 1, 0-24 Hours Postdose | C8 | 0.5967 ng | Standard Deviation 0.56221 |
| Brentuximab Vedotin | Amount of Monomethylauristatin E (MMAE) and Its Metabolites Excreted in Urine at Cycle 1, 0-24 Hours Postdose | C13 | 0.0786 ng | Standard Deviation 0.1146 |
| Brentuximab Vedotin + Rifampicin | Amount of Monomethylauristatin E (MMAE) and Its Metabolites Excreted in Urine at Cycle 1, 0-24 Hours Postdose | C8 | 0.1047 ng | Standard Deviation 0.07785 |
| Brentuximab Vedotin + Rifampicin | Amount of Monomethylauristatin E (MMAE) and Its Metabolites Excreted in Urine at Cycle 1, 0-24 Hours Postdose | MMAE | 12.5020 ng | Standard Deviation 6.85958 |
| Brentuximab Vedotin + Rifampicin | Amount of Monomethylauristatin E (MMAE) and Its Metabolites Excreted in Urine at Cycle 1, 0-24 Hours Postdose | C7 | NA ng | — |
| Brentuximab Vedotin + Rifampicin | Amount of Monomethylauristatin E (MMAE) and Its Metabolites Excreted in Urine at Cycle 1, 0-24 Hours Postdose | C4 | 0.0521 ng | Standard Deviation 0.02335 |
| Brentuximab Vedotin + Rifampicin | Amount of Monomethylauristatin E (MMAE) and Its Metabolites Excreted in Urine at Cycle 1, 0-24 Hours Postdose | C13 | 0.0456 ng | Standard Deviation 0.03714 |
| Brentuximab Vedotin + Rifampicin | Amount of Monomethylauristatin E (MMAE) and Its Metabolites Excreted in Urine at Cycle 1, 0-24 Hours Postdose | C5 | 0.0254 ng | Standard Deviation 0.00847 |
Primary
Amount of Monomethylauristatin E (MMAE) and Its Metabolites Excreted in Urine at Cycle 1, 120-144 Hours Postdose
Metabolites of MMAE includes C4, C5, C7, C8 and C13. Amount of MMAE and its metabolites in urine were determined by multiplying the volume of urine obtained and the concentration of MMAE and its metabolites present in it, respectively. The LLQ for determining the concentration was 0.01 ng/mL.
Time frame: Cycle 1: 120-144 hours postdose
Population: PK analysis set included all participants who received brentuximab vedotin at 1.8 mg/kg throughout Cycles 1 to 3 and had sufficient dosing and PK data to reliably estimate PK parameters.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| Brentuximab Vedotin | Amount of Monomethylauristatin E (MMAE) and Its Metabolites Excreted in Urine at Cycle 1, 120-144 Hours Postdose | MMAE | 6.7161 ng | Standard Deviation 6.13997 |
| Brentuximab Vedotin | Amount of Monomethylauristatin E (MMAE) and Its Metabolites Excreted in Urine at Cycle 1, 120-144 Hours Postdose | C4 | 0.0730 ng | Standard Deviation 0.08387 |
| Brentuximab Vedotin | Amount of Monomethylauristatin E (MMAE) and Its Metabolites Excreted in Urine at Cycle 1, 120-144 Hours Postdose | C5 | 0.0836 ng | Standard Deviation 0.07377 |
| Brentuximab Vedotin | Amount of Monomethylauristatin E (MMAE) and Its Metabolites Excreted in Urine at Cycle 1, 120-144 Hours Postdose | C7 | NA ng | — |
| Brentuximab Vedotin | Amount of Monomethylauristatin E (MMAE) and Its Metabolites Excreted in Urine at Cycle 1, 120-144 Hours Postdose | C8 | 0.4477 ng | Standard Deviation 0.56047 |
| Brentuximab Vedotin | Amount of Monomethylauristatin E (MMAE) and Its Metabolites Excreted in Urine at Cycle 1, 120-144 Hours Postdose | C13 | 0.0551 ng | Standard Deviation 0.05107 |
| Brentuximab Vedotin + Rifampicin | Amount of Monomethylauristatin E (MMAE) and Its Metabolites Excreted in Urine at Cycle 1, 120-144 Hours Postdose | C8 | 0.0910 ng | Standard Deviation 0.06044 |
| Brentuximab Vedotin + Rifampicin | Amount of Monomethylauristatin E (MMAE) and Its Metabolites Excreted in Urine at Cycle 1, 120-144 Hours Postdose | MMAE | 7.9830 ng | Standard Deviation 4.33309 |
| Brentuximab Vedotin + Rifampicin | Amount of Monomethylauristatin E (MMAE) and Its Metabolites Excreted in Urine at Cycle 1, 120-144 Hours Postdose | C7 | NA ng | — |
| Brentuximab Vedotin + Rifampicin | Amount of Monomethylauristatin E (MMAE) and Its Metabolites Excreted in Urine at Cycle 1, 120-144 Hours Postdose | C4 | 0.0335 ng | Standard Deviation 0.02037 |
| Brentuximab Vedotin + Rifampicin | Amount of Monomethylauristatin E (MMAE) and Its Metabolites Excreted in Urine at Cycle 1, 120-144 Hours Postdose | C13 | 0.0345 ng | Standard Deviation 0.01738 |
| Brentuximab Vedotin + Rifampicin | Amount of Monomethylauristatin E (MMAE) and Its Metabolites Excreted in Urine at Cycle 1, 120-144 Hours Postdose | C5 | 0.0301 ng | Standard Deviation 0.01767 |
Primary
Amount of Monomethylauristatin E (MMAE) and Its Metabolites Excreted in Urine at Cycle 1, 144-168 Hours Postdose
Metabolites of MMAE includes C4, C5, C7, C8 and C13. Amount of MMAE and its metabolites in urine were determined by multiplying the volume of urine obtained and the concentration of MMAE and its metabolites present in it, respectively. The LLQ for determining the concentration was 0.01 ng/mL.
Time frame: Cycle 1: 144-168 hours postdose
Population: PK analysis set included all participants who received brentuximab vedotin at 1.8 mg/kg throughout Cycles 1 to 3 and had sufficient dosing and PK data to reliably estimate PK parameters.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| Brentuximab Vedotin | Amount of Monomethylauristatin E (MMAE) and Its Metabolites Excreted in Urine at Cycle 1, 144-168 Hours Postdose | C8 | 0.3916 ng | Standard Deviation 0.34491 |
| Brentuximab Vedotin | Amount of Monomethylauristatin E (MMAE) and Its Metabolites Excreted in Urine at Cycle 1, 144-168 Hours Postdose | C13 | 0.0438 ng | Standard Deviation 0.03146 |
| Brentuximab Vedotin | Amount of Monomethylauristatin E (MMAE) and Its Metabolites Excreted in Urine at Cycle 1, 144-168 Hours Postdose | MMAE | 5.5693 ng | Standard Deviation 3.50945 |
| Brentuximab Vedotin | Amount of Monomethylauristatin E (MMAE) and Its Metabolites Excreted in Urine at Cycle 1, 144-168 Hours Postdose | C4 | 0.0579 ng | Standard Deviation 0.06807 |
| Brentuximab Vedotin | Amount of Monomethylauristatin E (MMAE) and Its Metabolites Excreted in Urine at Cycle 1, 144-168 Hours Postdose | C5 | 0.0747 ng | Standard Deviation 0.05078 |
| Brentuximab Vedotin | Amount of Monomethylauristatin E (MMAE) and Its Metabolites Excreted in Urine at Cycle 1, 144-168 Hours Postdose | C7 | NA ng | — |
| Brentuximab Vedotin + Rifampicin | Amount of Monomethylauristatin E (MMAE) and Its Metabolites Excreted in Urine at Cycle 1, 144-168 Hours Postdose | C5 | 0.0287 ng | Standard Deviation 0.01527 |
| Brentuximab Vedotin + Rifampicin | Amount of Monomethylauristatin E (MMAE) and Its Metabolites Excreted in Urine at Cycle 1, 144-168 Hours Postdose | C8 | 0.0706 ng | Standard Deviation 0.03027 |
| Brentuximab Vedotin + Rifampicin | Amount of Monomethylauristatin E (MMAE) and Its Metabolites Excreted in Urine at Cycle 1, 144-168 Hours Postdose | C4 | 0.0448 ng | Standard Deviation 0.02158 |
| Brentuximab Vedotin + Rifampicin | Amount of Monomethylauristatin E (MMAE) and Its Metabolites Excreted in Urine at Cycle 1, 144-168 Hours Postdose | C13 | 0.0363 ng | Standard Deviation 0.01283 |
| Brentuximab Vedotin + Rifampicin | Amount of Monomethylauristatin E (MMAE) and Its Metabolites Excreted in Urine at Cycle 1, 144-168 Hours Postdose | C7 | NA ng | — |
| Brentuximab Vedotin + Rifampicin | Amount of Monomethylauristatin E (MMAE) and Its Metabolites Excreted in Urine at Cycle 1, 144-168 Hours Postdose | MMAE | 5.8025 ng | Standard Deviation 3.45889 |
Primary
Amount of Monomethylauristatin E (MMAE) and Its Metabolites Excreted in Urine at Cycle 1, 24-48 Hours Postdose
Metabolites of MMAE includes C4, C5, C7, C8 and C13. Amount of MMAE and its metabolites in urine were determined by multiplying the volume of urine obtained and the concentration of MMAE and its metabolites present in it, respectively. The LLQ for determining the concentration was 0.01 ng/mL.
Time frame: Cycle 1: 24-48 hours postdose
Population: PK analysis set included all participants who received brentuximab vedotin at 1.8 mg/kg throughout Cycles 1 to 3 and had sufficient dosing and PK data to reliably estimate PK parameters.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| Brentuximab Vedotin | Amount of Monomethylauristatin E (MMAE) and Its Metabolites Excreted in Urine at Cycle 1, 24-48 Hours Postdose | MMAE | 12.6225 ng | Standard Deviation 6.93735 |
| Brentuximab Vedotin | Amount of Monomethylauristatin E (MMAE) and Its Metabolites Excreted in Urine at Cycle 1, 24-48 Hours Postdose | C4 | 0.0690 ng | Standard Deviation 0.10935 |
| Brentuximab Vedotin | Amount of Monomethylauristatin E (MMAE) and Its Metabolites Excreted in Urine at Cycle 1, 24-48 Hours Postdose | C5 | 0.0863 ng | Standard Deviation 0.09138 |
| Brentuximab Vedotin | Amount of Monomethylauristatin E (MMAE) and Its Metabolites Excreted in Urine at Cycle 1, 24-48 Hours Postdose | C7 | NA ng | — |
| Brentuximab Vedotin | Amount of Monomethylauristatin E (MMAE) and Its Metabolites Excreted in Urine at Cycle 1, 24-48 Hours Postdose | C8 | 0.7275 ng | Standard Deviation 0.59716 |
| Brentuximab Vedotin | Amount of Monomethylauristatin E (MMAE) and Its Metabolites Excreted in Urine at Cycle 1, 24-48 Hours Postdose | C13 | 0.0722 ng | Standard Deviation 0.07482 |
| Brentuximab Vedotin + Rifampicin | Amount of Monomethylauristatin E (MMAE) and Its Metabolites Excreted in Urine at Cycle 1, 24-48 Hours Postdose | C8 | 0.1568 ng | Standard Deviation 0.08381 |
| Brentuximab Vedotin + Rifampicin | Amount of Monomethylauristatin E (MMAE) and Its Metabolites Excreted in Urine at Cycle 1, 24-48 Hours Postdose | MMAE | 11.7995 ng | Standard Deviation 6.20286 |
| Brentuximab Vedotin + Rifampicin | Amount of Monomethylauristatin E (MMAE) and Its Metabolites Excreted in Urine at Cycle 1, 24-48 Hours Postdose | C7 | NA ng | — |
| Brentuximab Vedotin + Rifampicin | Amount of Monomethylauristatin E (MMAE) and Its Metabolites Excreted in Urine at Cycle 1, 24-48 Hours Postdose | C4 | 0.0392 ng | Standard Deviation 0.0301 |
| Brentuximab Vedotin + Rifampicin | Amount of Monomethylauristatin E (MMAE) and Its Metabolites Excreted in Urine at Cycle 1, 24-48 Hours Postdose | C13 | 0.0405 ng | Standard Deviation 0.03473 |
| Brentuximab Vedotin + Rifampicin | Amount of Monomethylauristatin E (MMAE) and Its Metabolites Excreted in Urine at Cycle 1, 24-48 Hours Postdose | C5 | 0.0277 ng | Standard Deviation 0.017 |
Primary
Amount of Monomethylauristatin E (MMAE) and Its Metabolites Excreted in Urine at Cycle 1, 336-360 Hours Postdose
Metabolites of MMAE includes C4, C5, C7, C8 and C13. Amount of MMAE and its metabolites in urine were determined by multiplying the volume of urine obtained and the concentration of MMAE and its metabolites present in it, respectively. The LLQ for determining the concentration was 0.01 ng/mL.
Time frame: Cycle 1: 336-360 hours postdose
Population: PK analysis set included all participants who received brentuximab vedotin at 1.8 mg/kg throughout Cycles 1 to 3 and had sufficient dosing and PK data to reliably estimate PK parameters.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| Brentuximab Vedotin | Amount of Monomethylauristatin E (MMAE) and Its Metabolites Excreted in Urine at Cycle 1, 336-360 Hours Postdose | C5 | 0.0289 ng | Standard Deviation 0.00963 |
| Brentuximab Vedotin | Amount of Monomethylauristatin E (MMAE) and Its Metabolites Excreted in Urine at Cycle 1, 336-360 Hours Postdose | MMAE | 1.0727 ng | Standard Deviation 0.55233 |
| Brentuximab Vedotin | Amount of Monomethylauristatin E (MMAE) and Its Metabolites Excreted in Urine at Cycle 1, 336-360 Hours Postdose | C4 | 0.0459 ng | Standard Deviation 0.0153 |
| Brentuximab Vedotin | Amount of Monomethylauristatin E (MMAE) and Its Metabolites Excreted in Urine at Cycle 1, 336-360 Hours Postdose | C7 | NA ng | — |
| Brentuximab Vedotin | Amount of Monomethylauristatin E (MMAE) and Its Metabolites Excreted in Urine at Cycle 1, 336-360 Hours Postdose | C8 | 0.0751 ng | Standard Deviation 0.04505 |
| Brentuximab Vedotin | Amount of Monomethylauristatin E (MMAE) and Its Metabolites Excreted in Urine at Cycle 1, 336-360 Hours Postdose | C13 | NA ng | — |
| Brentuximab Vedotin + Rifampicin | Amount of Monomethylauristatin E (MMAE) and Its Metabolites Excreted in Urine at Cycle 1, 336-360 Hours Postdose | C8 | 0.0401 ng | Standard Deviation 0.02242 |
| Brentuximab Vedotin + Rifampicin | Amount of Monomethylauristatin E (MMAE) and Its Metabolites Excreted in Urine at Cycle 1, 336-360 Hours Postdose | C7 | NA ng | — |
| Brentuximab Vedotin + Rifampicin | Amount of Monomethylauristatin E (MMAE) and Its Metabolites Excreted in Urine at Cycle 1, 336-360 Hours Postdose | MMAE | 1.3326 ng | Standard Deviation 0.80959 |
| Brentuximab Vedotin + Rifampicin | Amount of Monomethylauristatin E (MMAE) and Its Metabolites Excreted in Urine at Cycle 1, 336-360 Hours Postdose | C13 | NA ng | — |
| Brentuximab Vedotin + Rifampicin | Amount of Monomethylauristatin E (MMAE) and Its Metabolites Excreted in Urine at Cycle 1, 336-360 Hours Postdose | C4 | NA ng | — |
| Brentuximab Vedotin + Rifampicin | Amount of Monomethylauristatin E (MMAE) and Its Metabolites Excreted in Urine at Cycle 1, 336-360 Hours Postdose | C5 | NA ng | — |
Primary
Amount of Monomethylauristatin E (MMAE) and Its Metabolites Excreted in Urine at Cycle 1, 480-504 Hours Postdose
Metabolites of MMAE includes C4, C5, C7, C8 and C13. Amount of MMAE and its metabolites in urine were determined by multiplying the volume of urine obtained and the concentration of MMAE and its metabolites present in it, respectively. The LLQ for determining the concentration was 0.01 ng/mL.
Time frame: Cycle 1: 480-504 hours postdose
Population: PK analysis set included all participants who received brentuximab vedotin at 1.8 mg/kg throughout Cycles 1 to 3 and had sufficient dosing and PK data to reliably estimate PK parameters.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| Brentuximab Vedotin | Amount of Monomethylauristatin E (MMAE) and Its Metabolites Excreted in Urine at Cycle 1, 480-504 Hours Postdose | MMAE | 0.4420 ng | Standard Deviation 0.30745 |
| Brentuximab Vedotin | Amount of Monomethylauristatin E (MMAE) and Its Metabolites Excreted in Urine at Cycle 1, 480-504 Hours Postdose | C4 | NA ng | — |
| Brentuximab Vedotin | Amount of Monomethylauristatin E (MMAE) and Its Metabolites Excreted in Urine at Cycle 1, 480-504 Hours Postdose | C5 | NA ng | — |
| Brentuximab Vedotin | Amount of Monomethylauristatin E (MMAE) and Its Metabolites Excreted in Urine at Cycle 1, 480-504 Hours Postdose | C7 | NA ng | — |
| Brentuximab Vedotin | Amount of Monomethylauristatin E (MMAE) and Its Metabolites Excreted in Urine at Cycle 1, 480-504 Hours Postdose | C8 | 0.0578 ng | Standard Deviation 0.03314 |
| Brentuximab Vedotin | Amount of Monomethylauristatin E (MMAE) and Its Metabolites Excreted in Urine at Cycle 1, 480-504 Hours Postdose | C13 | NA ng | — |
| Brentuximab Vedotin + Rifampicin | Amount of Monomethylauristatin E (MMAE) and Its Metabolites Excreted in Urine at Cycle 1, 480-504 Hours Postdose | C8 | NA ng | — |
| Brentuximab Vedotin + Rifampicin | Amount of Monomethylauristatin E (MMAE) and Its Metabolites Excreted in Urine at Cycle 1, 480-504 Hours Postdose | MMAE | 0.3505 ng | Standard Deviation 0.14592 |
| Brentuximab Vedotin + Rifampicin | Amount of Monomethylauristatin E (MMAE) and Its Metabolites Excreted in Urine at Cycle 1, 480-504 Hours Postdose | C7 | NA ng | — |
| Brentuximab Vedotin + Rifampicin | Amount of Monomethylauristatin E (MMAE) and Its Metabolites Excreted in Urine at Cycle 1, 480-504 Hours Postdose | C4 | NA ng | — |
| Brentuximab Vedotin + Rifampicin | Amount of Monomethylauristatin E (MMAE) and Its Metabolites Excreted in Urine at Cycle 1, 480-504 Hours Postdose | C13 | NA ng | — |
| Brentuximab Vedotin + Rifampicin | Amount of Monomethylauristatin E (MMAE) and Its Metabolites Excreted in Urine at Cycle 1, 480-504 Hours Postdose | C5 | NA ng | — |
Primary
Amount of Monomethylauristatin E (MMAE) and Its Metabolites Excreted in Urine at Cycle 1, 48-72 Hours Postdose
Metabolites of MMAE includes C4, C5, C7, C8 and C13. Amount of MMAE and its metabolites in urine were determined by multiplying the volume of urine obtained and the concentration of MMAE and its metabolites present in it, respectively. The LLQ for determining the concentration was 0.01 ng/mL.
Time frame: Cycle 1: 48-72 hours postdose
Population: PK analysis set included all participants who received brentuximab vedotin at 1.8 mg/kg throughout Cycles 1 to 3 and had sufficient dosing and PK data to reliably estimate PK parameters.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| Brentuximab Vedotin | Amount of Monomethylauristatin E (MMAE) and Its Metabolites Excreted in Urine at Cycle 1, 48-72 Hours Postdose | MMAE | 12.4089 ng | Standard Deviation 4.49922 |
| Brentuximab Vedotin | Amount of Monomethylauristatin E (MMAE) and Its Metabolites Excreted in Urine at Cycle 1, 48-72 Hours Postdose | C4 | 0.0812 ng | Standard Deviation 0.15006 |
| Brentuximab Vedotin | Amount of Monomethylauristatin E (MMAE) and Its Metabolites Excreted in Urine at Cycle 1, 48-72 Hours Postdose | C5 | 0.0867 ng | Standard Deviation 0.10841 |
| Brentuximab Vedotin | Amount of Monomethylauristatin E (MMAE) and Its Metabolites Excreted in Urine at Cycle 1, 48-72 Hours Postdose | C7 | NA ng | — |
| Brentuximab Vedotin | Amount of Monomethylauristatin E (MMAE) and Its Metabolites Excreted in Urine at Cycle 1, 48-72 Hours Postdose | C8 | 0.7973 ng | Standard Deviation 0.38226 |
| Brentuximab Vedotin | Amount of Monomethylauristatin E (MMAE) and Its Metabolites Excreted in Urine at Cycle 1, 48-72 Hours Postdose | C13 | 0.0786 ng | Standard Deviation 0.05672 |
| Brentuximab Vedotin + Rifampicin | Amount of Monomethylauristatin E (MMAE) and Its Metabolites Excreted in Urine at Cycle 1, 48-72 Hours Postdose | C8 | 0.1189 ng | Standard Deviation 0.08494 |
| Brentuximab Vedotin + Rifampicin | Amount of Monomethylauristatin E (MMAE) and Its Metabolites Excreted in Urine at Cycle 1, 48-72 Hours Postdose | MMAE | 11.6600 ng | Standard Deviation 5.45329 |
| Brentuximab Vedotin + Rifampicin | Amount of Monomethylauristatin E (MMAE) and Its Metabolites Excreted in Urine at Cycle 1, 48-72 Hours Postdose | C7 | NA ng | — |
| Brentuximab Vedotin + Rifampicin | Amount of Monomethylauristatin E (MMAE) and Its Metabolites Excreted in Urine at Cycle 1, 48-72 Hours Postdose | C4 | 0.0419 ng | Standard Deviation 0.02694 |
| Brentuximab Vedotin + Rifampicin | Amount of Monomethylauristatin E (MMAE) and Its Metabolites Excreted in Urine at Cycle 1, 48-72 Hours Postdose | C13 | 0.0382 ng | Standard Deviation 0.02718 |
| Brentuximab Vedotin + Rifampicin | Amount of Monomethylauristatin E (MMAE) and Its Metabolites Excreted in Urine at Cycle 1, 48-72 Hours Postdose | C5 | 0.0322 ng | Standard Deviation 0.01859 |
Primary
Amount of Monomethylauristatin E (MMAE) and Its Metabolites Excreted in Urine at Cycle 1, 72-96 Hours Postdose
Metabolites of MMAE includes C4, C5, C7, C8 and C13. Amount of MMAE and its metabolites in urine were determined by multiplying the volume of urine obtained and the concentration of MMAE and its metabolites present in it, respectively. The LLQ for determining the concentration was 0.01 ng/mL.
Time frame: Cycle 1: 72-96 hours postdose
Population: PK analysis set included all participants who received brentuximab vedotin at 1.8 mg/kg throughout Cycles 1 to 3 and had sufficient dosing and PK data to reliably estimate PK parameters.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| Brentuximab Vedotin | Amount of Monomethylauristatin E (MMAE) and Its Metabolites Excreted in Urine at Cycle 1, 72-96 Hours Postdose | MMAE | 10.7766 ng | Standard Deviation 8.14858 |
| Brentuximab Vedotin | Amount of Monomethylauristatin E (MMAE) and Its Metabolites Excreted in Urine at Cycle 1, 72-96 Hours Postdose | C4 | 0.0867 ng | Standard Deviation 0.16449 |
| Brentuximab Vedotin | Amount of Monomethylauristatin E (MMAE) and Its Metabolites Excreted in Urine at Cycle 1, 72-96 Hours Postdose | C5 | 0.0882 ng | Standard Deviation 0.11202 |
| Brentuximab Vedotin | Amount of Monomethylauristatin E (MMAE) and Its Metabolites Excreted in Urine at Cycle 1, 72-96 Hours Postdose | C7 | NA ng | — |
| Brentuximab Vedotin | Amount of Monomethylauristatin E (MMAE) and Its Metabolites Excreted in Urine at Cycle 1, 72-96 Hours Postdose | C8 | 0.7480 ng | Standard Deviation 0.61219 |
| Brentuximab Vedotin | Amount of Monomethylauristatin E (MMAE) and Its Metabolites Excreted in Urine at Cycle 1, 72-96 Hours Postdose | C13 | 0.0754 ng | Standard Deviation 0.0682 |
| Brentuximab Vedotin + Rifampicin | Amount of Monomethylauristatin E (MMAE) and Its Metabolites Excreted in Urine at Cycle 1, 72-96 Hours Postdose | C8 | 0.1247 ng | Standard Deviation 0.08379 |
| Brentuximab Vedotin + Rifampicin | Amount of Monomethylauristatin E (MMAE) and Its Metabolites Excreted in Urine at Cycle 1, 72-96 Hours Postdose | MMAE | 12.8426 ng | Standard Deviation 5.93538 |
| Brentuximab Vedotin + Rifampicin | Amount of Monomethylauristatin E (MMAE) and Its Metabolites Excreted in Urine at Cycle 1, 72-96 Hours Postdose | C7 | NA ng | — |
| Brentuximab Vedotin + Rifampicin | Amount of Monomethylauristatin E (MMAE) and Its Metabolites Excreted in Urine at Cycle 1, 72-96 Hours Postdose | C4 | 0.0427 ng | Standard Deviation 0.02848 |
| Brentuximab Vedotin + Rifampicin | Amount of Monomethylauristatin E (MMAE) and Its Metabolites Excreted in Urine at Cycle 1, 72-96 Hours Postdose | C13 | 0.0415 ng | Standard Deviation 0.02723 |
| Brentuximab Vedotin + Rifampicin | Amount of Monomethylauristatin E (MMAE) and Its Metabolites Excreted in Urine at Cycle 1, 72-96 Hours Postdose | C5 | 0.0394 ng | Standard Deviation 0.02131 |
Primary
Amount of Monomethylauristatin E (MMAE) and Its Metabolites Excreted in Urine at Cycle 1, 96-120 Hours Postdose
Metabolites of MMAE includes C4, C5, C7, C8 and C13. Amount of MMAE and its metabolites in urine were determined by multiplying the volume of urine obtained and the concentration of MMAE and its metabolites present in it, respectively. The LLQ for determining the concentration was 0.01 ng/mL.
Time frame: Cycle 1: 96-120 hours postdose
Population: PK analysis set included all participants who received brentuximab vedotin at 1.8 mg/kg throughout Cycles 1 to 3 and had sufficient dosing and PK data to reliably estimate PK parameters.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| Brentuximab Vedotin | Amount of Monomethylauristatin E (MMAE) and Its Metabolites Excreted in Urine at Cycle 1, 96-120 Hours Postdose | C5 | 0.1053 ng | Standard Deviation 0.10639 |
| Brentuximab Vedotin | Amount of Monomethylauristatin E (MMAE) and Its Metabolites Excreted in Urine at Cycle 1, 96-120 Hours Postdose | C7 | NA ng | — |
| Brentuximab Vedotin | Amount of Monomethylauristatin E (MMAE) and Its Metabolites Excreted in Urine at Cycle 1, 96-120 Hours Postdose | C8 | 0.7360 ng | Standard Deviation 1.02417 |
| Brentuximab Vedotin | Amount of Monomethylauristatin E (MMAE) and Its Metabolites Excreted in Urine at Cycle 1, 96-120 Hours Postdose | C4 | 0.0885 ng | Standard Deviation 0.11811 |
| Brentuximab Vedotin | Amount of Monomethylauristatin E (MMAE) and Its Metabolites Excreted in Urine at Cycle 1, 96-120 Hours Postdose | C13 | 0.0630 ng | Standard Deviation 0.08155 |
| Brentuximab Vedotin | Amount of Monomethylauristatin E (MMAE) and Its Metabolites Excreted in Urine at Cycle 1, 96-120 Hours Postdose | MMAE | 10.8018 ng | Standard Deviation 12.03431 |
| Brentuximab Vedotin + Rifampicin | Amount of Monomethylauristatin E (MMAE) and Its Metabolites Excreted in Urine at Cycle 1, 96-120 Hours Postdose | C13 | 0.0380 ng | Standard Deviation 0.03436 |
| Brentuximab Vedotin + Rifampicin | Amount of Monomethylauristatin E (MMAE) and Its Metabolites Excreted in Urine at Cycle 1, 96-120 Hours Postdose | MMAE | 9.5626 ng | Standard Deviation 7.2602 |
| Brentuximab Vedotin + Rifampicin | Amount of Monomethylauristatin E (MMAE) and Its Metabolites Excreted in Urine at Cycle 1, 96-120 Hours Postdose | C4 | 0.0414 ng | Standard Deviation 0.03529 |
| Brentuximab Vedotin + Rifampicin | Amount of Monomethylauristatin E (MMAE) and Its Metabolites Excreted in Urine at Cycle 1, 96-120 Hours Postdose | C7 | NA ng | — |
| Brentuximab Vedotin + Rifampicin | Amount of Monomethylauristatin E (MMAE) and Its Metabolites Excreted in Urine at Cycle 1, 96-120 Hours Postdose | C8 | 0.1034 ng | Standard Deviation 0.10563 |
| Brentuximab Vedotin + Rifampicin | Amount of Monomethylauristatin E (MMAE) and Its Metabolites Excreted in Urine at Cycle 1, 96-120 Hours Postdose | C5 | 0.0406 ng | Standard Deviation 0.02753 |
Primary
Amount of Monomethylauristatin E (MMAE) and Its Metabolites Excreted in Urine at Cycle 1, Predose
Metabolites of MMAE includes C4, C5, C7, C8 and C13. Amount of MMAE and its metabolites in urine were determined by multiplying the volume of urine obtained and the concentration of MMAE and its metabolites present in it, respectively. The LLQ for determining the concentration was 0.01 ng/mL.
Time frame: Cycle 1: Predose
Population: PK analysis set included all participants who received brentuximab vedotin at 1.8 mg/kg throughout Cycles 1 to 3 and had sufficient dosing and PK data to reliably estimate PK parameters.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| Brentuximab Vedotin | Amount of Monomethylauristatin E (MMAE) and Its Metabolites Excreted in Urine at Cycle 1, Predose | MMAE | NA ng | — |
| Brentuximab Vedotin | Amount of Monomethylauristatin E (MMAE) and Its Metabolites Excreted in Urine at Cycle 1, Predose | C4 | NA ng | — |
| Brentuximab Vedotin | Amount of Monomethylauristatin E (MMAE) and Its Metabolites Excreted in Urine at Cycle 1, Predose | C5 | NA ng | — |
| Brentuximab Vedotin | Amount of Monomethylauristatin E (MMAE) and Its Metabolites Excreted in Urine at Cycle 1, Predose | C7 | NA ng | — |
| Brentuximab Vedotin | Amount of Monomethylauristatin E (MMAE) and Its Metabolites Excreted in Urine at Cycle 1, Predose | C8 | NA ng | — |
| Brentuximab Vedotin | Amount of Monomethylauristatin E (MMAE) and Its Metabolites Excreted in Urine at Cycle 1, Predose | C13 | NA ng | — |
| Brentuximab Vedotin + Rifampicin | Amount of Monomethylauristatin E (MMAE) and Its Metabolites Excreted in Urine at Cycle 1, Predose | C8 | 0.0712 ng | Standard Deviation 0.02373 |
| Brentuximab Vedotin + Rifampicin | Amount of Monomethylauristatin E (MMAE) and Its Metabolites Excreted in Urine at Cycle 1, Predose | MMAE | 7.8900 ng | Standard Deviation 2.63 |
| Brentuximab Vedotin + Rifampicin | Amount of Monomethylauristatin E (MMAE) and Its Metabolites Excreted in Urine at Cycle 1, Predose | C7 | NA ng | — |
| Brentuximab Vedotin + Rifampicin | Amount of Monomethylauristatin E (MMAE) and Its Metabolites Excreted in Urine at Cycle 1, Predose | C4 | NA ng | — |
| Brentuximab Vedotin + Rifampicin | Amount of Monomethylauristatin E (MMAE) and Its Metabolites Excreted in Urine at Cycle 1, Predose | C13 | NA ng | — |
| Brentuximab Vedotin + Rifampicin | Amount of Monomethylauristatin E (MMAE) and Its Metabolites Excreted in Urine at Cycle 1, Predose | C5 | NA ng | — |
Primary
Amount of Monomethylauristatin E (MMAE) and Its Metabolites Excreted in Urine at Cycle 3, 0-24 Hours Postdose
Metabolites of MMAE includes C4, C5, C7, C8 and C13. Amount of MMAE and its metabolites in urine were determined by multiplying the volume of urine obtained and the concentration of MMAE and its metabolites present in it, respectively. The LLQ for determining the concentration was 0.01 ng/mL.
Time frame: Cycle 3: 0-24 hours postdose
Population: PK analysis set included all participants who received brentuximab vedotin at 1.8 mg/kg throughout Cycles 1 to 3 and had sufficient dosing and PK data to reliably estimate PK parameters.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| Brentuximab Vedotin | Amount of Monomethylauristatin E (MMAE) and Its Metabolites Excreted in Urine at Cycle 3, 0-24 Hours Postdose | MMAE | 10.7174 ng | Standard Deviation 15.35912 |
| Brentuximab Vedotin | Amount of Monomethylauristatin E (MMAE) and Its Metabolites Excreted in Urine at Cycle 3, 0-24 Hours Postdose | C4 | 0.0454 ng | Standard Deviation 0.07644 |
| Brentuximab Vedotin | Amount of Monomethylauristatin E (MMAE) and Its Metabolites Excreted in Urine at Cycle 3, 0-24 Hours Postdose | C5 | 0.0509 ng | Standard Deviation 0.04623 |
| Brentuximab Vedotin | Amount of Monomethylauristatin E (MMAE) and Its Metabolites Excreted in Urine at Cycle 3, 0-24 Hours Postdose | C7 | NA ng | — |
| Brentuximab Vedotin | Amount of Monomethylauristatin E (MMAE) and Its Metabolites Excreted in Urine at Cycle 3, 0-24 Hours Postdose | C8 | 0.4657 ng | Standard Deviation 0.41352 |
| Brentuximab Vedotin | Amount of Monomethylauristatin E (MMAE) and Its Metabolites Excreted in Urine at Cycle 3, 0-24 Hours Postdose | C13 | 0.0516 ng | Standard Deviation 0.07045 |
| Brentuximab Vedotin + Rifampicin | Amount of Monomethylauristatin E (MMAE) and Its Metabolites Excreted in Urine at Cycle 3, 0-24 Hours Postdose | C8 | 0.1285 ng | Standard Deviation 0.1793 |
| Brentuximab Vedotin + Rifampicin | Amount of Monomethylauristatin E (MMAE) and Its Metabolites Excreted in Urine at Cycle 3, 0-24 Hours Postdose | MMAE | 12.4438 ng | Standard Deviation 8.86144 |
| Brentuximab Vedotin + Rifampicin | Amount of Monomethylauristatin E (MMAE) and Its Metabolites Excreted in Urine at Cycle 3, 0-24 Hours Postdose | C7 | NA ng | — |
| Brentuximab Vedotin + Rifampicin | Amount of Monomethylauristatin E (MMAE) and Its Metabolites Excreted in Urine at Cycle 3, 0-24 Hours Postdose | C4 | 0.0451 ng | Standard Deviation 0.02977 |
| Brentuximab Vedotin + Rifampicin | Amount of Monomethylauristatin E (MMAE) and Its Metabolites Excreted in Urine at Cycle 3, 0-24 Hours Postdose | C13 | 0.0676 ng | Standard Deviation 0.05022 |
| Brentuximab Vedotin + Rifampicin | Amount of Monomethylauristatin E (MMAE) and Its Metabolites Excreted in Urine at Cycle 3, 0-24 Hours Postdose | C5 | 0.0301 ng | Standard Deviation 0.01847 |
Primary
Amount of Monomethylauristatin E (MMAE) and Its Metabolites Excreted in Urine at Cycle 3, 120-144 Hours Postdose
Metabolites of MMAE includes C4, C5, C7, C8 and C13. Amount of MMAE and its metabolites in urine were determined by multiplying the volume of urine obtained and the concentration of MMAE and its metabolites present in it, respectively. The LLQ for determining the concentration was 0.01 ng/mL.
Time frame: Cycle 3: 120-144 hours postdose
Population: PK analysis set included all participants who received brentuximab vedotin at 1.8 mg/kg throughout Cycles 1 to 3 and had sufficient dosing and PK data to reliably estimate PK parameters.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| Brentuximab Vedotin | Amount of Monomethylauristatin E (MMAE) and Its Metabolites Excreted in Urine at Cycle 3, 120-144 Hours Postdose | MMAE | 7.3500 ng | Standard Deviation 3.78427 |
| Brentuximab Vedotin | Amount of Monomethylauristatin E (MMAE) and Its Metabolites Excreted in Urine at Cycle 3, 120-144 Hours Postdose | C4 | 0.0461 ng | Standard Deviation 0.03666 |
| Brentuximab Vedotin | Amount of Monomethylauristatin E (MMAE) and Its Metabolites Excreted in Urine at Cycle 3, 120-144 Hours Postdose | C5 | 0.0657 ng | Standard Deviation 0.04811 |
| Brentuximab Vedotin | Amount of Monomethylauristatin E (MMAE) and Its Metabolites Excreted in Urine at Cycle 3, 120-144 Hours Postdose | C7 | NA ng | — |
| Brentuximab Vedotin | Amount of Monomethylauristatin E (MMAE) and Its Metabolites Excreted in Urine at Cycle 3, 120-144 Hours Postdose | C8 | 0.4700 ng | Standard Deviation 0.37131 |
| Brentuximab Vedotin | Amount of Monomethylauristatin E (MMAE) and Its Metabolites Excreted in Urine at Cycle 3, 120-144 Hours Postdose | C13 | 0.0386 ng | Standard Deviation 0.03212 |
| Brentuximab Vedotin + Rifampicin | Amount of Monomethylauristatin E (MMAE) and Its Metabolites Excreted in Urine at Cycle 3, 120-144 Hours Postdose | C8 | 0.0869 ng | Standard Deviation 0.07672 |
| Brentuximab Vedotin + Rifampicin | Amount of Monomethylauristatin E (MMAE) and Its Metabolites Excreted in Urine at Cycle 3, 120-144 Hours Postdose | MMAE | 7.5871 ng | Standard Deviation 4.66863 |
| Brentuximab Vedotin + Rifampicin | Amount of Monomethylauristatin E (MMAE) and Its Metabolites Excreted in Urine at Cycle 3, 120-144 Hours Postdose | C7 | NA ng | — |
| Brentuximab Vedotin + Rifampicin | Amount of Monomethylauristatin E (MMAE) and Its Metabolites Excreted in Urine at Cycle 3, 120-144 Hours Postdose | C4 | 0.0520 ng | Standard Deviation 0.0387 |
| Brentuximab Vedotin + Rifampicin | Amount of Monomethylauristatin E (MMAE) and Its Metabolites Excreted in Urine at Cycle 3, 120-144 Hours Postdose | C13 | 0.0429 ng | Standard Deviation 0.0282 |
| Brentuximab Vedotin + Rifampicin | Amount of Monomethylauristatin E (MMAE) and Its Metabolites Excreted in Urine at Cycle 3, 120-144 Hours Postdose | C5 | 0.0342 ng | Standard Deviation 0.02508 |
Primary
Amount of Monomethylauristatin E (MMAE) and Its Metabolites Excreted in Urine at Cycle 3, 144-168 Hours Postdose
Metabolites of MMAE includes C4, C5, C7, C8 and C13. Amount of MMAE and its metabolites in urine were determined by multiplying the volume of urine obtained and the concentration of MMAE and its metabolites present in it, respectively. The LLQ for determining the concentration was 0.01 ng/mL.
Time frame: Cycle 3: 144-168 hours postdose
Population: PK analysis set included all participants who received brentuximab vedotin at 1.8 mg/kg throughout Cycles 1 to 3 and had sufficient dosing and PK data to reliably estimate PK parameters.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| Brentuximab Vedotin | Amount of Monomethylauristatin E (MMAE) and Its Metabolites Excreted in Urine at Cycle 3, 144-168 Hours Postdose | MMAE | 6.1125 ng | Standard Deviation 3.83207 |
| Brentuximab Vedotin | Amount of Monomethylauristatin E (MMAE) and Its Metabolites Excreted in Urine at Cycle 3, 144-168 Hours Postdose | C4 | 0.0538 ng | Standard Deviation 0.04252 |
| Brentuximab Vedotin | Amount of Monomethylauristatin E (MMAE) and Its Metabolites Excreted in Urine at Cycle 3, 144-168 Hours Postdose | C5 | 0.0662 ng | Standard Deviation 0.0611 |
| Brentuximab Vedotin | Amount of Monomethylauristatin E (MMAE) and Its Metabolites Excreted in Urine at Cycle 3, 144-168 Hours Postdose | C7 | NA ng | — |
| Brentuximab Vedotin | Amount of Monomethylauristatin E (MMAE) and Its Metabolites Excreted in Urine at Cycle 3, 144-168 Hours Postdose | C8 | 0.3485 ng | Standard Deviation 0.45898 |
| Brentuximab Vedotin | Amount of Monomethylauristatin E (MMAE) and Its Metabolites Excreted in Urine at Cycle 3, 144-168 Hours Postdose | C13 | 0.0402 ng | Standard Deviation 0.04117 |
| Brentuximab Vedotin + Rifampicin | Amount of Monomethylauristatin E (MMAE) and Its Metabolites Excreted in Urine at Cycle 3, 144-168 Hours Postdose | C8 | 0.0651 ng | Standard Deviation 0.03984 |
| Brentuximab Vedotin + Rifampicin | Amount of Monomethylauristatin E (MMAE) and Its Metabolites Excreted in Urine at Cycle 3, 144-168 Hours Postdose | MMAE | 4.6823 ng | Standard Deviation 2.80767 |
| Brentuximab Vedotin + Rifampicin | Amount of Monomethylauristatin E (MMAE) and Its Metabolites Excreted in Urine at Cycle 3, 144-168 Hours Postdose | C7 | NA ng | — |
| Brentuximab Vedotin + Rifampicin | Amount of Monomethylauristatin E (MMAE) and Its Metabolites Excreted in Urine at Cycle 3, 144-168 Hours Postdose | C4 | 0.0562 ng | Standard Deviation 0.02674 |
| Brentuximab Vedotin + Rifampicin | Amount of Monomethylauristatin E (MMAE) and Its Metabolites Excreted in Urine at Cycle 3, 144-168 Hours Postdose | C13 | 0.0481 ng | Standard Deviation 0.01603 |
| Brentuximab Vedotin + Rifampicin | Amount of Monomethylauristatin E (MMAE) and Its Metabolites Excreted in Urine at Cycle 3, 144-168 Hours Postdose | C5 | 0.0308 ng | Standard Deviation 0.01718 |
Primary
Amount of Monomethylauristatin E (MMAE) and Its Metabolites Excreted in Urine at Cycle 3, 24-48 Hours Postdose
Metabolites of MMAE includes C4, C5, C7, C8 and C13. Amount of MMAE and its metabolites in urine were determined by multiplying the volume of urine obtained and the concentration of MMAE and its metabolites present in it, respectively. The LLQ for determining the concentration was 0.01 ng/mL.
Time frame: Cycle 3: 24-48 hours postdose
Population: PK analysis set included all participants who received brentuximab vedotin at 1.8 mg/kg throughout Cycles 1 to 3 and had sufficient dosing and PK data to reliably estimate PK parameters.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| Brentuximab Vedotin | Amount of Monomethylauristatin E (MMAE) and Its Metabolites Excreted in Urine at Cycle 3, 24-48 Hours Postdose | MMAE | 11.1360 ng | Standard Deviation 6.73693 |
| Brentuximab Vedotin | Amount of Monomethylauristatin E (MMAE) and Its Metabolites Excreted in Urine at Cycle 3, 24-48 Hours Postdose | C4 | 0.0604 ng | Standard Deviation 0.05049 |
| Brentuximab Vedotin | Amount of Monomethylauristatin E (MMAE) and Its Metabolites Excreted in Urine at Cycle 3, 24-48 Hours Postdose | C5 | 0.0808 ng | Standard Deviation 0.06838 |
| Brentuximab Vedotin | Amount of Monomethylauristatin E (MMAE) and Its Metabolites Excreted in Urine at Cycle 3, 24-48 Hours Postdose | C7 | NA ng | — |
| Brentuximab Vedotin | Amount of Monomethylauristatin E (MMAE) and Its Metabolites Excreted in Urine at Cycle 3, 24-48 Hours Postdose | C8 | 0.5750 ng | Standard Deviation 0.58196 |
| Brentuximab Vedotin | Amount of Monomethylauristatin E (MMAE) and Its Metabolites Excreted in Urine at Cycle 3, 24-48 Hours Postdose | C13 | 0.0637 ng | Standard Deviation 0.05102 |
| Brentuximab Vedotin + Rifampicin | Amount of Monomethylauristatin E (MMAE) and Its Metabolites Excreted in Urine at Cycle 3, 24-48 Hours Postdose | C8 | 0.1600 ng | Standard Deviation 0.11946 |
| Brentuximab Vedotin + Rifampicin | Amount of Monomethylauristatin E (MMAE) and Its Metabolites Excreted in Urine at Cycle 3, 24-48 Hours Postdose | MMAE | 13.2483 ng | Standard Deviation 4.79482 |
| Brentuximab Vedotin + Rifampicin | Amount of Monomethylauristatin E (MMAE) and Its Metabolites Excreted in Urine at Cycle 3, 24-48 Hours Postdose | C7 | NA ng | — |
| Brentuximab Vedotin + Rifampicin | Amount of Monomethylauristatin E (MMAE) and Its Metabolites Excreted in Urine at Cycle 3, 24-48 Hours Postdose | C4 | 0.0413 ng | Standard Deviation 0.03095 |
| Brentuximab Vedotin + Rifampicin | Amount of Monomethylauristatin E (MMAE) and Its Metabolites Excreted in Urine at Cycle 3, 24-48 Hours Postdose | C13 | 0.0507 ng | Standard Deviation 0.03607 |
| Brentuximab Vedotin + Rifampicin | Amount of Monomethylauristatin E (MMAE) and Its Metabolites Excreted in Urine at Cycle 3, 24-48 Hours Postdose | C5 | 0.0311 ng | Standard Deviation 0.02021 |
Primary
Amount of Monomethylauristatin E (MMAE) and Its Metabolites Excreted in Urine at Cycle 3, 336-360 Hours Postdose
Metabolites of MMAE includes C4, C5, C7, C8 and C13. Amount of MMAE and its metabolites in urine were determined by multiplying the volume of urine obtained and the concentration of MMAE and its metabolites present in it, respectively. The LLQ for determining the concentration was 0.01 ng/mL.
Time frame: Cycle 3: 336-360 hours postdose
Population: PK analysis set included all participants who received brentuximab vedotin at 1.8 mg/kg throughout Cycles 1 to 3 and had sufficient dosing and PK data to reliably estimate PK parameters.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| Brentuximab Vedotin | Amount of Monomethylauristatin E (MMAE) and Its Metabolites Excreted in Urine at Cycle 3, 336-360 Hours Postdose | MMAE | 1.2811 ng | Standard Deviation 1.55068 |
| Brentuximab Vedotin | Amount of Monomethylauristatin E (MMAE) and Its Metabolites Excreted in Urine at Cycle 3, 336-360 Hours Postdose | C4 | 0.0377 ng | Standard Deviation 0.01812 |
| Brentuximab Vedotin | Amount of Monomethylauristatin E (MMAE) and Its Metabolites Excreted in Urine at Cycle 3, 336-360 Hours Postdose | C5 | 0.0347 ng | Standard Deviation 0.02457 |
| Brentuximab Vedotin | Amount of Monomethylauristatin E (MMAE) and Its Metabolites Excreted in Urine at Cycle 3, 336-360 Hours Postdose | C7 | NA ng | — |
| Brentuximab Vedotin | Amount of Monomethylauristatin E (MMAE) and Its Metabolites Excreted in Urine at Cycle 3, 336-360 Hours Postdose | C8 | 0.0734 ng | Standard Deviation 0.10958 |
| Brentuximab Vedotin | Amount of Monomethylauristatin E (MMAE) and Its Metabolites Excreted in Urine at Cycle 3, 336-360 Hours Postdose | C13 | 0.0227 ng | Standard Deviation 0.00757 |
| Brentuximab Vedotin + Rifampicin | Amount of Monomethylauristatin E (MMAE) and Its Metabolites Excreted in Urine at Cycle 3, 336-360 Hours Postdose | C8 | 0.0277 ng | Standard Deviation 0.01306 |
| Brentuximab Vedotin + Rifampicin | Amount of Monomethylauristatin E (MMAE) and Its Metabolites Excreted in Urine at Cycle 3, 336-360 Hours Postdose | MMAE | 0.8271 ng | Standard Deviation 0.43597 |
| Brentuximab Vedotin + Rifampicin | Amount of Monomethylauristatin E (MMAE) and Its Metabolites Excreted in Urine at Cycle 3, 336-360 Hours Postdose | C7 | NA ng | — |
| Brentuximab Vedotin + Rifampicin | Amount of Monomethylauristatin E (MMAE) and Its Metabolites Excreted in Urine at Cycle 3, 336-360 Hours Postdose | C4 | NA ng | — |
| Brentuximab Vedotin + Rifampicin | Amount of Monomethylauristatin E (MMAE) and Its Metabolites Excreted in Urine at Cycle 3, 336-360 Hours Postdose | C13 | NA ng | — |
| Brentuximab Vedotin + Rifampicin | Amount of Monomethylauristatin E (MMAE) and Its Metabolites Excreted in Urine at Cycle 3, 336-360 Hours Postdose | C5 | NA ng | — |
Primary
Amount of Monomethylauristatin E (MMAE) and Its Metabolites Excreted in Urine at Cycle 3, 480-504 Hours Postdose
Metabolites of MMAE includes C4, C5, C7, C8 and C13. Amount of MMAE and its metabolites in urine were determined by multiplying the volume of urine obtained and the concentration of MMAE and its metabolites present in it, respectively. The LLQ for determining the concentration was 0.01 ng/mL.
Time frame: Cycle 3: 480-504 hours postdose
Population: PK analysis set included all participants who received brentuximab vedotin at 1.8 mg/kg throughout Cycles 1 to 3 and had sufficient dosing and PK data to reliably estimate PK parameters.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| Brentuximab Vedotin | Amount of Monomethylauristatin E (MMAE) and Its Metabolites Excreted in Urine at Cycle 3, 480-504 Hours Postdose | MMAE | 0.4660 ng | Standard Deviation 0.41713 |
| Brentuximab Vedotin | Amount of Monomethylauristatin E (MMAE) and Its Metabolites Excreted in Urine at Cycle 3, 480-504 Hours Postdose | C4 | 0.0248 ng | Standard Deviation 0.00827 |
| Brentuximab Vedotin | Amount of Monomethylauristatin E (MMAE) and Its Metabolites Excreted in Urine at Cycle 3, 480-504 Hours Postdose | C5 | 0.0377 ng | Standard Deviation 0.01257 |
| Brentuximab Vedotin | Amount of Monomethylauristatin E (MMAE) and Its Metabolites Excreted in Urine at Cycle 3, 480-504 Hours Postdose | C7 | NA ng | — |
| Brentuximab Vedotin | Amount of Monomethylauristatin E (MMAE) and Its Metabolites Excreted in Urine at Cycle 3, 480-504 Hours Postdose | C8 | 0.0620 ng | Standard Deviation 0.04967 |
| Brentuximab Vedotin | Amount of Monomethylauristatin E (MMAE) and Its Metabolites Excreted in Urine at Cycle 3, 480-504 Hours Postdose | C13 | NA ng | — |
| Brentuximab Vedotin + Rifampicin | Amount of Monomethylauristatin E (MMAE) and Its Metabolites Excreted in Urine at Cycle 3, 480-504 Hours Postdose | C8 | 0.0221 ng | Standard Deviation 0.00737 |
| Brentuximab Vedotin + Rifampicin | Amount of Monomethylauristatin E (MMAE) and Its Metabolites Excreted in Urine at Cycle 3, 480-504 Hours Postdose | MMAE | 0.3334 ng | Standard Deviation 0.25074 |
| Brentuximab Vedotin + Rifampicin | Amount of Monomethylauristatin E (MMAE) and Its Metabolites Excreted in Urine at Cycle 3, 480-504 Hours Postdose | C7 | NA ng | — |
| Brentuximab Vedotin + Rifampicin | Amount of Monomethylauristatin E (MMAE) and Its Metabolites Excreted in Urine at Cycle 3, 480-504 Hours Postdose | C4 | NA ng | — |
| Brentuximab Vedotin + Rifampicin | Amount of Monomethylauristatin E (MMAE) and Its Metabolites Excreted in Urine at Cycle 3, 480-504 Hours Postdose | C13 | NA ng | — |
| Brentuximab Vedotin + Rifampicin | Amount of Monomethylauristatin E (MMAE) and Its Metabolites Excreted in Urine at Cycle 3, 480-504 Hours Postdose | C5 | NA ng | — |
Primary
Amount of Monomethylauristatin E (MMAE) and Its Metabolites Excreted in Urine at Cycle 3, 48-72 Hours Postdose
Metabolites of MMAE includes C4, C5, C7, C8 and C13. Amount of MMAE and its metabolites in urine were determined by multiplying the volume of urine obtained and the concentration of MMAE and its metabolites present in it, respectively. The LLQ for determining the concentration was 0.01 ng/mL.
Time frame: Cycle 3: 48-72 hours postdose
Population: PK analysis set included all participants who received brentuximab vedotin at 1.8 mg/kg throughout Cycles 1 to 3 and had sufficient dosing and PK data to reliably estimate PK parameters.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| Brentuximab Vedotin | Amount of Monomethylauristatin E (MMAE) and Its Metabolites Excreted in Urine at Cycle 3, 48-72 Hours Postdose | MMAE | 12.7267 ng | Standard Deviation 8.96991 |
| Brentuximab Vedotin | Amount of Monomethylauristatin E (MMAE) and Its Metabolites Excreted in Urine at Cycle 3, 48-72 Hours Postdose | C4 | 0.0620 ng | Standard Deviation 0.06222 |
| Brentuximab Vedotin | Amount of Monomethylauristatin E (MMAE) and Its Metabolites Excreted in Urine at Cycle 3, 48-72 Hours Postdose | C5 | 0.0746 ng | Standard Deviation 0.09237 |
| Brentuximab Vedotin | Amount of Monomethylauristatin E (MMAE) and Its Metabolites Excreted in Urine at Cycle 3, 48-72 Hours Postdose | C7 | NA ng | — |
| Brentuximab Vedotin | Amount of Monomethylauristatin E (MMAE) and Its Metabolites Excreted in Urine at Cycle 3, 48-72 Hours Postdose | C8 | 0.6950 ng | Standard Deviation 0.83588 |
| Brentuximab Vedotin | Amount of Monomethylauristatin E (MMAE) and Its Metabolites Excreted in Urine at Cycle 3, 48-72 Hours Postdose | C13 | 0.0632 ng | Standard Deviation 0.0648 |
| Brentuximab Vedotin + Rifampicin | Amount of Monomethylauristatin E (MMAE) and Its Metabolites Excreted in Urine at Cycle 3, 48-72 Hours Postdose | C8 | 0.1598 ng | Standard Deviation 0.14846 |
| Brentuximab Vedotin + Rifampicin | Amount of Monomethylauristatin E (MMAE) and Its Metabolites Excreted in Urine at Cycle 3, 48-72 Hours Postdose | MMAE | 13.8072 ng | Standard Deviation 8.63973 |
| Brentuximab Vedotin + Rifampicin | Amount of Monomethylauristatin E (MMAE) and Its Metabolites Excreted in Urine at Cycle 3, 48-72 Hours Postdose | C7 | NA ng | — |
| Brentuximab Vedotin + Rifampicin | Amount of Monomethylauristatin E (MMAE) and Its Metabolites Excreted in Urine at Cycle 3, 48-72 Hours Postdose | C4 | 0.0524 ng | Standard Deviation 0.04691 |
| Brentuximab Vedotin + Rifampicin | Amount of Monomethylauristatin E (MMAE) and Its Metabolites Excreted in Urine at Cycle 3, 48-72 Hours Postdose | C13 | 0.0746 ng | Standard Deviation 0.05134 |
| Brentuximab Vedotin + Rifampicin | Amount of Monomethylauristatin E (MMAE) and Its Metabolites Excreted in Urine at Cycle 3, 48-72 Hours Postdose | C5 | 0.0406 ng | Standard Deviation 0.03034 |
Primary
Amount of Monomethylauristatin E (MMAE) and Its Metabolites Excreted in Urine at Cycle 3, 72-96 Hours Postdose
Metabolites of MMAE includes C4, C5, C7, C8 and C13. Amount of MMAE and its metabolites in urine were determined by multiplying the volume of urine obtained and the concentration of MMAE and its metabolites present in it, respectively. The LLQ for determining the concentration was 0.01 ng/mL.
Time frame: Cycle 3: 72-96 hours postdose
Population: PK analysis set included all participants who received brentuximab vedotin at 1.8 mg/kg throughout Cycles 1 to 3 and had sufficient dosing and PK data to reliably estimate PK parameters.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| Brentuximab Vedotin | Amount of Monomethylauristatin E (MMAE) and Its Metabolites Excreted in Urine at Cycle 3, 72-96 Hours Postdose | MMAE | 11.2527 ng | Standard Deviation 8.65574 |
| Brentuximab Vedotin | Amount of Monomethylauristatin E (MMAE) and Its Metabolites Excreted in Urine at Cycle 3, 72-96 Hours Postdose | C4 | 0.0702 ng | Standard Deviation 0.07079 |
| Brentuximab Vedotin | Amount of Monomethylauristatin E (MMAE) and Its Metabolites Excreted in Urine at Cycle 3, 72-96 Hours Postdose | C5 | 0.0937 ng | Standard Deviation 0.10757 |
| Brentuximab Vedotin | Amount of Monomethylauristatin E (MMAE) and Its Metabolites Excreted in Urine at Cycle 3, 72-96 Hours Postdose | C7 | NA ng | — |
| Brentuximab Vedotin | Amount of Monomethylauristatin E (MMAE) and Its Metabolites Excreted in Urine at Cycle 3, 72-96 Hours Postdose | C8 | 0.5276 ng | Standard Deviation 0.95507 |
| Brentuximab Vedotin | Amount of Monomethylauristatin E (MMAE) and Its Metabolites Excreted in Urine at Cycle 3, 72-96 Hours Postdose | C13 | 0.0573 ng | Standard Deviation 0.07734 |
| Brentuximab Vedotin + Rifampicin | Amount of Monomethylauristatin E (MMAE) and Its Metabolites Excreted in Urine at Cycle 3, 72-96 Hours Postdose | C8 | 0.1510 ng | Standard Deviation 0.11532 |
| Brentuximab Vedotin + Rifampicin | Amount of Monomethylauristatin E (MMAE) and Its Metabolites Excreted in Urine at Cycle 3, 72-96 Hours Postdose | MMAE | 12.2263 ng | Standard Deviation 6.09003 |
| Brentuximab Vedotin + Rifampicin | Amount of Monomethylauristatin E (MMAE) and Its Metabolites Excreted in Urine at Cycle 3, 72-96 Hours Postdose | C7 | NA ng | — |
| Brentuximab Vedotin + Rifampicin | Amount of Monomethylauristatin E (MMAE) and Its Metabolites Excreted in Urine at Cycle 3, 72-96 Hours Postdose | C4 | 0.0611 ng | Standard Deviation 0.05055 |
| Brentuximab Vedotin + Rifampicin | Amount of Monomethylauristatin E (MMAE) and Its Metabolites Excreted in Urine at Cycle 3, 72-96 Hours Postdose | C13 | 0.0564 ng | Standard Deviation 0.03759 |
| Brentuximab Vedotin + Rifampicin | Amount of Monomethylauristatin E (MMAE) and Its Metabolites Excreted in Urine at Cycle 3, 72-96 Hours Postdose | C5 | 0.0437 ng | Standard Deviation 0.03084 |
Primary
Amount of Monomethylauristatin E (MMAE) and Its Metabolites Excreted in Urine at Cycle 3, 96-120 Hours Postdose
Metabolites of MMAE includes C4, C5, C7, C8 and C13. Amount of MMAE and its metabolites in urine were determined by multiplying the volume of urine obtained and the concentration of MMAE and its metabolites present in it, respectively. The LLQ for determining the concentration was 0.01 ng/mL.
Time frame: Cycle 3: 96-120 hours postdose
Population: PK analysis set included all participants who received brentuximab vedotin at 1.8 mg/kg throughout Cycles 1 to 3 and had sufficient dosing and PK data to reliably estimate PK parameters.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| Brentuximab Vedotin | Amount of Monomethylauristatin E (MMAE) and Its Metabolites Excreted in Urine at Cycle 3, 96-120 Hours Postdose | MMAE | 8.3817 ng | Standard Deviation 7.78279 |
| Brentuximab Vedotin | Amount of Monomethylauristatin E (MMAE) and Its Metabolites Excreted in Urine at Cycle 3, 96-120 Hours Postdose | C4 | 0.0710 ng | Standard Deviation 0.05912 |
| Brentuximab Vedotin | Amount of Monomethylauristatin E (MMAE) and Its Metabolites Excreted in Urine at Cycle 3, 96-120 Hours Postdose | C5 | 0.0916 ng | Standard Deviation 0.08893 |
| Brentuximab Vedotin | Amount of Monomethylauristatin E (MMAE) and Its Metabolites Excreted in Urine at Cycle 3, 96-120 Hours Postdose | C7 | NA ng | — |
| Brentuximab Vedotin | Amount of Monomethylauristatin E (MMAE) and Its Metabolites Excreted in Urine at Cycle 3, 96-120 Hours Postdose | C8 | 0.5198 ng | Standard Deviation 0.79634 |
| Brentuximab Vedotin | Amount of Monomethylauristatin E (MMAE) and Its Metabolites Excreted in Urine at Cycle 3, 96-120 Hours Postdose | C13 | 0.0607 ng | Standard Deviation 0.06838 |
| Brentuximab Vedotin + Rifampicin | Amount of Monomethylauristatin E (MMAE) and Its Metabolites Excreted in Urine at Cycle 3, 96-120 Hours Postdose | C8 | 0.1088 ng | Standard Deviation 0.09569 |
| Brentuximab Vedotin + Rifampicin | Amount of Monomethylauristatin E (MMAE) and Its Metabolites Excreted in Urine at Cycle 3, 96-120 Hours Postdose | MMAE | 8.1426 ng | Standard Deviation 7.2953 |
| Brentuximab Vedotin + Rifampicin | Amount of Monomethylauristatin E (MMAE) and Its Metabolites Excreted in Urine at Cycle 3, 96-120 Hours Postdose | C7 | NA ng | — |
| Brentuximab Vedotin + Rifampicin | Amount of Monomethylauristatin E (MMAE) and Its Metabolites Excreted in Urine at Cycle 3, 96-120 Hours Postdose | C4 | 0.0512 ng | Standard Deviation 0.04137 |
| Brentuximab Vedotin + Rifampicin | Amount of Monomethylauristatin E (MMAE) and Its Metabolites Excreted in Urine at Cycle 3, 96-120 Hours Postdose | C13 | 0.0524 ng | Standard Deviation 0.03619 |
| Brentuximab Vedotin + Rifampicin | Amount of Monomethylauristatin E (MMAE) and Its Metabolites Excreted in Urine at Cycle 3, 96-120 Hours Postdose | C5 | 0.0435 ng | Standard Deviation 0.02885 |
Primary
Amount of Monomethylauristatin E (MMAE) and Its Metabolites Excreted in Urine at Cycle 3, Predose
Metabolites of MMAE includes C4, C5, C7, C8 and C13. Amount of MMAE and its metabolites in urine were determined by multiplying the volume of urine obtained and the concentration of MMAE and its metabolites present in it, respectively. The LLQ for determining the concentration was 0.01 ng/mL.
Time frame: Cycle 3: Predose
Population: PK analysis set included all participants who received brentuximab vedotin at 1.8 mg/kg throughout Cycles 1 to 3 and had sufficient dosing and PK data to reliably estimate PK parameters.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| Brentuximab Vedotin | Amount of Monomethylauristatin E (MMAE) and Its Metabolites Excreted in Urine at Cycle 3, Predose | C7 | NA ng | — |
| Brentuximab Vedotin | Amount of Monomethylauristatin E (MMAE) and Its Metabolites Excreted in Urine at Cycle 3, Predose | MMAE | 0.3171 ng | Standard Deviation 0.33548 |
| Brentuximab Vedotin | Amount of Monomethylauristatin E (MMAE) and Its Metabolites Excreted in Urine at Cycle 3, Predose | C8 | 0.0392 ng | Standard Deviation 0.02985 |
| Brentuximab Vedotin | Amount of Monomethylauristatin E (MMAE) and Its Metabolites Excreted in Urine at Cycle 3, Predose | C5 | NA ng | — |
| Brentuximab Vedotin | Amount of Monomethylauristatin E (MMAE) and Its Metabolites Excreted in Urine at Cycle 3, Predose | C13 | NA ng | — |
| Brentuximab Vedotin | Amount of Monomethylauristatin E (MMAE) and Its Metabolites Excreted in Urine at Cycle 3, Predose | C4 | NA ng | — |
| Brentuximab Vedotin + Rifampicin | Amount of Monomethylauristatin E (MMAE) and Its Metabolites Excreted in Urine at Cycle 3, Predose | C13 | NA ng | — |
| Brentuximab Vedotin + Rifampicin | Amount of Monomethylauristatin E (MMAE) and Its Metabolites Excreted in Urine at Cycle 3, Predose | C4 | NA ng | — |
| Brentuximab Vedotin + Rifampicin | Amount of Monomethylauristatin E (MMAE) and Its Metabolites Excreted in Urine at Cycle 3, Predose | MMAE | 0.4227 ng | Standard Deviation 0.17918 |
| Brentuximab Vedotin + Rifampicin | Amount of Monomethylauristatin E (MMAE) and Its Metabolites Excreted in Urine at Cycle 3, Predose | C7 | NA ng | — |
| Brentuximab Vedotin + Rifampicin | Amount of Monomethylauristatin E (MMAE) and Its Metabolites Excreted in Urine at Cycle 3, Predose | C8 | NA ng | — |
| Brentuximab Vedotin + Rifampicin | Amount of Monomethylauristatin E (MMAE) and Its Metabolites Excreted in Urine at Cycle 3, Predose | C5 | NA ng | — |
Primary
Plasma Concentration of Monomethylauristatin E (MMAE) and Its Metabolites at Cycle 1, 0.5 Hour Postdose
Metabolites of MMAE includes C4, C5, C7, C8 and C13. The LLQ for all the observations was 0.01 ng/mL.
Time frame: Cycle 1: 0.5 hour postdose
Population: PK analysis set included all participants who received brentuximab vedotin at 1.8 mg/kg throughout Cycles 1 to 3 and had sufficient dosing and PK data to reliably estimate PK parameters.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| Brentuximab Vedotin | Plasma Concentration of Monomethylauristatin E (MMAE) and Its Metabolites at Cycle 1, 0.5 Hour Postdose | MMAE | 0.3902 ng/mL | Standard Deviation 1.33635 |
| Brentuximab Vedotin | Plasma Concentration of Monomethylauristatin E (MMAE) and Its Metabolites at Cycle 1, 0.5 Hour Postdose | C4 | 0.0184 ng/mL | Standard Deviation 0.00613 |
| Brentuximab Vedotin | Plasma Concentration of Monomethylauristatin E (MMAE) and Its Metabolites at Cycle 1, 0.5 Hour Postdose | C5 | NA ng/mL | — |
| Brentuximab Vedotin | Plasma Concentration of Monomethylauristatin E (MMAE) and Its Metabolites at Cycle 1, 0.5 Hour Postdose | C7 | NA ng/mL | — |
| Brentuximab Vedotin | Plasma Concentration of Monomethylauristatin E (MMAE) and Its Metabolites at Cycle 1, 0.5 Hour Postdose | C8 | 0.0267 ng/mL | Standard Deviation 0.02119 |
| Brentuximab Vedotin | Plasma Concentration of Monomethylauristatin E (MMAE) and Its Metabolites at Cycle 1, 0.5 Hour Postdose | C13 | 0.0108 ng/mL | Standard Deviation 0.0036 |
| Brentuximab Vedotin + Rifampicin | Plasma Concentration of Monomethylauristatin E (MMAE) and Its Metabolites at Cycle 1, 0.5 Hour Postdose | C8 | NA ng/mL | — |
| Brentuximab Vedotin + Rifampicin | Plasma Concentration of Monomethylauristatin E (MMAE) and Its Metabolites at Cycle 1, 0.5 Hour Postdose | MMAE | 0.2149 ng/mL | Standard Deviation 0.439 |
| Brentuximab Vedotin + Rifampicin | Plasma Concentration of Monomethylauristatin E (MMAE) and Its Metabolites at Cycle 1, 0.5 Hour Postdose | C7 | NA ng/mL | — |
| Brentuximab Vedotin + Rifampicin | Plasma Concentration of Monomethylauristatin E (MMAE) and Its Metabolites at Cycle 1, 0.5 Hour Postdose | C4 | NA ng/mL | — |
| Brentuximab Vedotin + Rifampicin | Plasma Concentration of Monomethylauristatin E (MMAE) and Its Metabolites at Cycle 1, 0.5 Hour Postdose | C13 | NA ng/mL | — |
| Brentuximab Vedotin + Rifampicin | Plasma Concentration of Monomethylauristatin E (MMAE) and Its Metabolites at Cycle 1, 0.5 Hour Postdose | C5 | NA ng/mL | — |
Primary
Plasma Concentration of Monomethylauristatin E (MMAE) and Its Metabolites at Cycle 1, 144 Hour Postdose
Metabolites of MMAE includes C4, C5, C7, C8 and C13. The LLQ for all the observations was 0.01 ng/mL.
Time frame: Cycle 1: 144 hour postdose
Population: PK analysis set included all participants who received brentuximab vedotin at 1.8 mg/kg throughout Cycles 1 to 3 and had sufficient dosing and PK data to reliably estimate PK parameters.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| Brentuximab Vedotin | Plasma Concentration of Monomethylauristatin E (MMAE) and Its Metabolites at Cycle 1, 144 Hour Postdose | MMAE | 2.3326 ng/mL | Standard Deviation 1.45619 |
| Brentuximab Vedotin | Plasma Concentration of Monomethylauristatin E (MMAE) and Its Metabolites at Cycle 1, 144 Hour Postdose | C4 | 0.0297 ng/mL | Standard Deviation 0.02569 |
| Brentuximab Vedotin | Plasma Concentration of Monomethylauristatin E (MMAE) and Its Metabolites at Cycle 1, 144 Hour Postdose | C5 | 0.0174 ng/mL | Standard Deviation 0.01006 |
| Brentuximab Vedotin | Plasma Concentration of Monomethylauristatin E (MMAE) and Its Metabolites at Cycle 1, 144 Hour Postdose | C7 | 0.0196 ng/mL | Standard Deviation 0.00693 |
| Brentuximab Vedotin | Plasma Concentration of Monomethylauristatin E (MMAE) and Its Metabolites at Cycle 1, 144 Hour Postdose | C8 | 0.0497 ng/mL | Standard Deviation 0.02722 |
| Brentuximab Vedotin | Plasma Concentration of Monomethylauristatin E (MMAE) and Its Metabolites at Cycle 1, 144 Hour Postdose | C13 | NA ng/mL | — |
| Brentuximab Vedotin + Rifampicin | Plasma Concentration of Monomethylauristatin E (MMAE) and Its Metabolites at Cycle 1, 144 Hour Postdose | C8 | 0.0120 ng/mL | Standard Deviation 0.00542 |
| Brentuximab Vedotin + Rifampicin | Plasma Concentration of Monomethylauristatin E (MMAE) and Its Metabolites at Cycle 1, 144 Hour Postdose | MMAE | 1.7990 ng/mL | Standard Deviation 0.89695 |
| Brentuximab Vedotin + Rifampicin | Plasma Concentration of Monomethylauristatin E (MMAE) and Its Metabolites at Cycle 1, 144 Hour Postdose | C7 | NA ng/mL | — |
| Brentuximab Vedotin + Rifampicin | Plasma Concentration of Monomethylauristatin E (MMAE) and Its Metabolites at Cycle 1, 144 Hour Postdose | C4 | NA ng/mL | — |
| Brentuximab Vedotin + Rifampicin | Plasma Concentration of Monomethylauristatin E (MMAE) and Its Metabolites at Cycle 1, 144 Hour Postdose | C13 | NA ng/mL | — |
| Brentuximab Vedotin + Rifampicin | Plasma Concentration of Monomethylauristatin E (MMAE) and Its Metabolites at Cycle 1, 144 Hour Postdose | C5 | NA ng/mL | — |
Primary
Plasma Concentration of Monomethylauristatin E (MMAE) and Its Metabolites at Cycle 1, 24 Hour Postdose
Metabolites of MMAE includes C4, C5, C7, C8 and C13. The LLQ for all the observations was 0.01 ng/mL.
Time frame: Cycle 1: 24 hour postdose
Population: PK analysis set included all participants who received brentuximab vedotin at 1.8 mg/kg throughout Cycles 1 to 3 and had sufficient dosing and PK data to reliably estimate PK parameters.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| Brentuximab Vedotin | Plasma Concentration of Monomethylauristatin E (MMAE) and Its Metabolites at Cycle 1, 24 Hour Postdose | MMAE | 3.7950 ng/mL | Standard Deviation 4.12446 |
| Brentuximab Vedotin | Plasma Concentration of Monomethylauristatin E (MMAE) and Its Metabolites at Cycle 1, 24 Hour Postdose | C4 | 0.0443 ng/mL | Standard Deviation 0.05328 |
| Brentuximab Vedotin | Plasma Concentration of Monomethylauristatin E (MMAE) and Its Metabolites at Cycle 1, 24 Hour Postdose | C5 | 0.0218 ng/mL | Standard Deviation 0.02814 |
| Brentuximab Vedotin | Plasma Concentration of Monomethylauristatin E (MMAE) and Its Metabolites at Cycle 1, 24 Hour Postdose | C7 | 0.0206 ng/mL | Standard Deviation 0.01477 |
| Brentuximab Vedotin | Plasma Concentration of Monomethylauristatin E (MMAE) and Its Metabolites at Cycle 1, 24 Hour Postdose | C8 | 0.0805 ng/mL | Standard Deviation 0.06986 |
| Brentuximab Vedotin | Plasma Concentration of Monomethylauristatin E (MMAE) and Its Metabolites at Cycle 1, 24 Hour Postdose | C13 | 0.0142 ng/mL | Standard Deviation 0.0066 |
| Brentuximab Vedotin + Rifampicin | Plasma Concentration of Monomethylauristatin E (MMAE) and Its Metabolites at Cycle 1, 24 Hour Postdose | C8 | 0.0196 ng/mL | Standard Deviation 0.01702 |
| Brentuximab Vedotin + Rifampicin | Plasma Concentration of Monomethylauristatin E (MMAE) and Its Metabolites at Cycle 1, 24 Hour Postdose | MMAE | 3.1227 ng/mL | Standard Deviation 2.38909 |
| Brentuximab Vedotin + Rifampicin | Plasma Concentration of Monomethylauristatin E (MMAE) and Its Metabolites at Cycle 1, 24 Hour Postdose | C7 | NA ng/mL | — |
| Brentuximab Vedotin + Rifampicin | Plasma Concentration of Monomethylauristatin E (MMAE) and Its Metabolites at Cycle 1, 24 Hour Postdose | C4 | 0.0191 ng/mL | Standard Deviation 0.00637 |
| Brentuximab Vedotin + Rifampicin | Plasma Concentration of Monomethylauristatin E (MMAE) and Its Metabolites at Cycle 1, 24 Hour Postdose | C13 | 0.0113 ng/mL | Standard Deviation 0.00377 |
| Brentuximab Vedotin + Rifampicin | Plasma Concentration of Monomethylauristatin E (MMAE) and Its Metabolites at Cycle 1, 24 Hour Postdose | C5 | NA ng/mL | — |
Primary
Plasma Concentration of Monomethylauristatin E (MMAE) and Its Metabolites at Cycle 1, 336 Hour Postdose
Metabolites of MMAE includes C4, C5, C7, C8 and C13. The LLQ for all the observations was 0.01 ng/mL.
Time frame: Cycle 1: 336 hour postdose
Population: PK analysis set included all participants who received brentuximab vedotin at 1.8 mg/kg throughout Cycles 1 to 3 and had sufficient dosing and PK data to reliably estimate PK parameters.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| Brentuximab Vedotin | Plasma Concentration of Monomethylauristatin E (MMAE) and Its Metabolites at Cycle 1, 336 Hour Postdose | C4 | NA ng/mL | — |
| Brentuximab Vedotin | Plasma Concentration of Monomethylauristatin E (MMAE) and Its Metabolites at Cycle 1, 336 Hour Postdose | C7 | NA ng/mL | — |
| Brentuximab Vedotin | Plasma Concentration of Monomethylauristatin E (MMAE) and Its Metabolites at Cycle 1, 336 Hour Postdose | MMAE | 0.3130 ng/mL | Standard Deviation 0.15743 |
| Brentuximab Vedotin | Plasma Concentration of Monomethylauristatin E (MMAE) and Its Metabolites at Cycle 1, 336 Hour Postdose | C5 | NA ng/mL | — |
| Brentuximab Vedotin | Plasma Concentration of Monomethylauristatin E (MMAE) and Its Metabolites at Cycle 1, 336 Hour Postdose | C13 | NA ng/mL | — |
| Brentuximab Vedotin | Plasma Concentration of Monomethylauristatin E (MMAE) and Its Metabolites at Cycle 1, 336 Hour Postdose | C8 | 0.0127 ng/mL | Standard Deviation 0.00672 |
| Brentuximab Vedotin + Rifampicin | Plasma Concentration of Monomethylauristatin E (MMAE) and Its Metabolites at Cycle 1, 336 Hour Postdose | C13 | NA ng/mL | — |
| Brentuximab Vedotin + Rifampicin | Plasma Concentration of Monomethylauristatin E (MMAE) and Its Metabolites at Cycle 1, 336 Hour Postdose | MMAE | 0.2723 ng/mL | Standard Deviation 0.16544 |
| Brentuximab Vedotin + Rifampicin | Plasma Concentration of Monomethylauristatin E (MMAE) and Its Metabolites at Cycle 1, 336 Hour Postdose | C4 | NA ng/mL | — |
| Brentuximab Vedotin + Rifampicin | Plasma Concentration of Monomethylauristatin E (MMAE) and Its Metabolites at Cycle 1, 336 Hour Postdose | C5 | NA ng/mL | — |
| Brentuximab Vedotin + Rifampicin | Plasma Concentration of Monomethylauristatin E (MMAE) and Its Metabolites at Cycle 1, 336 Hour Postdose | C7 | NA ng/mL | — |
| Brentuximab Vedotin + Rifampicin | Plasma Concentration of Monomethylauristatin E (MMAE) and Its Metabolites at Cycle 1, 336 Hour Postdose | C8 | NA ng/mL | — |
Primary
Plasma Concentration of Monomethylauristatin E (MMAE) and Its Metabolites at Cycle 1, 48 Hour Postdose
Metabolites of MMAE includes C4, C5, C7, C8 and C13. The LLQ for all the observations was 0.01 ng/mL.
Time frame: Cycle 1: 48 hour postdose
Population: PK analysis set included all participants who received brentuximab vedotin at 1.8 mg/kg throughout Cycles 1 to 3 and had sufficient dosing and PK data to reliably estimate PK parameters.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| Brentuximab Vedotin | Plasma Concentration of Monomethylauristatin E (MMAE) and Its Metabolites at Cycle 1, 48 Hour Postdose | MMAE | 4.2140 ng/mL | Standard Deviation 3.6947 |
| Brentuximab Vedotin | Plasma Concentration of Monomethylauristatin E (MMAE) and Its Metabolites at Cycle 1, 48 Hour Postdose | C4 | 0.0424 ng/mL | Standard Deviation 0.05259 |
| Brentuximab Vedotin | Plasma Concentration of Monomethylauristatin E (MMAE) and Its Metabolites at Cycle 1, 48 Hour Postdose | C5 | 0.0168 ng/mL | Standard Deviation 0.02553 |
| Brentuximab Vedotin | Plasma Concentration of Monomethylauristatin E (MMAE) and Its Metabolites at Cycle 1, 48 Hour Postdose | C7 | 0.0187 ng/mL | Standard Deviation 0.01608 |
| Brentuximab Vedotin | Plasma Concentration of Monomethylauristatin E (MMAE) and Its Metabolites at Cycle 1, 48 Hour Postdose | C8 | 0.0959 ng/mL | Standard Deviation 0.0678 |
| Brentuximab Vedotin | Plasma Concentration of Monomethylauristatin E (MMAE) and Its Metabolites at Cycle 1, 48 Hour Postdose | C13 | 0.0134 ng/mL | Standard Deviation 0.00763 |
| Brentuximab Vedotin + Rifampicin | Plasma Concentration of Monomethylauristatin E (MMAE) and Its Metabolites at Cycle 1, 48 Hour Postdose | C8 | 0.0210 ng/mL | Standard Deviation 0.01455 |
| Brentuximab Vedotin + Rifampicin | Plasma Concentration of Monomethylauristatin E (MMAE) and Its Metabolites at Cycle 1, 48 Hour Postdose | MMAE | 3.3727 ng/mL | Standard Deviation 2.61792 |
| Brentuximab Vedotin + Rifampicin | Plasma Concentration of Monomethylauristatin E (MMAE) and Its Metabolites at Cycle 1, 48 Hour Postdose | C7 | NA ng/mL | — |
| Brentuximab Vedotin + Rifampicin | Plasma Concentration of Monomethylauristatin E (MMAE) and Its Metabolites at Cycle 1, 48 Hour Postdose | C4 | 0.0128 ng/mL | Standard Deviation 0.00565 |
| Brentuximab Vedotin + Rifampicin | Plasma Concentration of Monomethylauristatin E (MMAE) and Its Metabolites at Cycle 1, 48 Hour Postdose | C13 | NA ng/mL | — |
| Brentuximab Vedotin + Rifampicin | Plasma Concentration of Monomethylauristatin E (MMAE) and Its Metabolites at Cycle 1, 48 Hour Postdose | C5 | NA ng/mL | — |
Primary
Plasma Concentration of Monomethylauristatin E (MMAE) and Its Metabolites at Cycle 1, 4 Hour Postdose
Metabolites of MMAE includes C4, C5, C7, C8 and C13. The LLQ for all the observations was 0.01 ng/mL.
Time frame: Cycle 1: 4 hour postdose
Population: PK analysis set included all participants who received brentuximab vedotin at 1.8 mg/kg throughout Cycles 1 to 3 and had sufficient dosing and PK data to reliably estimate PK parameters.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| Brentuximab Vedotin | Plasma Concentration of Monomethylauristatin E (MMAE) and Its Metabolites at Cycle 1, 4 Hour Postdose | C4 | 0.0547 ng/mL | Standard Deviation 0.02737 |
| Brentuximab Vedotin | Plasma Concentration of Monomethylauristatin E (MMAE) and Its Metabolites at Cycle 1, 4 Hour Postdose | MMAE | 2.2778 ng/mL | Standard Deviation 4.42089 |
| Brentuximab Vedotin | Plasma Concentration of Monomethylauristatin E (MMAE) and Its Metabolites at Cycle 1, 4 Hour Postdose | C8 | 0.0557 ng/mL | Standard Deviation 0.05631 |
| Brentuximab Vedotin | Plasma Concentration of Monomethylauristatin E (MMAE) and Its Metabolites at Cycle 1, 4 Hour Postdose | C5 | 0.0254 ng/mL | Standard Deviation 0.01326 |
| Brentuximab Vedotin | Plasma Concentration of Monomethylauristatin E (MMAE) and Its Metabolites at Cycle 1, 4 Hour Postdose | C13 | 0.0151 ng/mL | Standard Deviation 0.00752 |
| Brentuximab Vedotin | Plasma Concentration of Monomethylauristatin E (MMAE) and Its Metabolites at Cycle 1, 4 Hour Postdose | C7 | 0.0195 ng/mL | Standard Deviation 0.01293 |
| Brentuximab Vedotin + Rifampicin | Plasma Concentration of Monomethylauristatin E (MMAE) and Its Metabolites at Cycle 1, 4 Hour Postdose | C13 | NA ng/mL | — |
| Brentuximab Vedotin + Rifampicin | Plasma Concentration of Monomethylauristatin E (MMAE) and Its Metabolites at Cycle 1, 4 Hour Postdose | MMAE | 1.7836 ng/mL | Standard Deviation 0.93129 |
| Brentuximab Vedotin + Rifampicin | Plasma Concentration of Monomethylauristatin E (MMAE) and Its Metabolites at Cycle 1, 4 Hour Postdose | C4 | NA ng/mL | — |
| Brentuximab Vedotin + Rifampicin | Plasma Concentration of Monomethylauristatin E (MMAE) and Its Metabolites at Cycle 1, 4 Hour Postdose | C5 | NA ng/mL | — |
| Brentuximab Vedotin + Rifampicin | Plasma Concentration of Monomethylauristatin E (MMAE) and Its Metabolites at Cycle 1, 4 Hour Postdose | C7 | NA ng/mL | — |
| Brentuximab Vedotin + Rifampicin | Plasma Concentration of Monomethylauristatin E (MMAE) and Its Metabolites at Cycle 1, 4 Hour Postdose | C8 | 0.0160 ng/mL | Standard Deviation 0.00921 |
Primary
Plasma Concentration of Monomethylauristatin E (MMAE) and Its Metabolites at Cycle 1, 72 Hour Postdose
Metabolites of MMAE includes C4, C5, C7, C8 and C13. The LLQ for all the observations was 0.01 ng/mL.
Time frame: Cycle 1: 72 hour postdose
Population: PK analysis set included all participants who received brentuximab vedotin at 1.8 mg/kg throughout Cycles 1 to 3 and had sufficient dosing and PK data to reliably estimate PK parameters.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| Brentuximab Vedotin | Plasma Concentration of Monomethylauristatin E (MMAE) and Its Metabolites at Cycle 1, 72 Hour Postdose | C7 | 0.0241 ng/mL | Standard Deviation 0.0164 |
| Brentuximab Vedotin | Plasma Concentration of Monomethylauristatin E (MMAE) and Its Metabolites at Cycle 1, 72 Hour Postdose | C4 | 0.0501 ng/mL | Standard Deviation 0.06242 |
| Brentuximab Vedotin | Plasma Concentration of Monomethylauristatin E (MMAE) and Its Metabolites at Cycle 1, 72 Hour Postdose | C8 | 0.0899 ng/mL | Standard Deviation 0.06688 |
| Brentuximab Vedotin | Plasma Concentration of Monomethylauristatin E (MMAE) and Its Metabolites at Cycle 1, 72 Hour Postdose | C5 | 0.0190 ng/mL | Standard Deviation 0.02664 |
| Brentuximab Vedotin | Plasma Concentration of Monomethylauristatin E (MMAE) and Its Metabolites at Cycle 1, 72 Hour Postdose | C13 | 0.0133 ng/mL | Standard Deviation 0.00644 |
| Brentuximab Vedotin | Plasma Concentration of Monomethylauristatin E (MMAE) and Its Metabolites at Cycle 1, 72 Hour Postdose | MMAE | 3.8931 ng/mL | Standard Deviation 3.61834 |
| Brentuximab Vedotin + Rifampicin | Plasma Concentration of Monomethylauristatin E (MMAE) and Its Metabolites at Cycle 1, 72 Hour Postdose | C13 | NA ng/mL | — |
| Brentuximab Vedotin + Rifampicin | Plasma Concentration of Monomethylauristatin E (MMAE) and Its Metabolites at Cycle 1, 72 Hour Postdose | MMAE | 3.0948 ng/mL | Standard Deviation 2.03516 |
| Brentuximab Vedotin + Rifampicin | Plasma Concentration of Monomethylauristatin E (MMAE) and Its Metabolites at Cycle 1, 72 Hour Postdose | C5 | NA ng/mL | — |
| Brentuximab Vedotin + Rifampicin | Plasma Concentration of Monomethylauristatin E (MMAE) and Its Metabolites at Cycle 1, 72 Hour Postdose | C7 | NA ng/mL | — |
| Brentuximab Vedotin + Rifampicin | Plasma Concentration of Monomethylauristatin E (MMAE) and Its Metabolites at Cycle 1, 72 Hour Postdose | C8 | 0.0187 ng/mL | Standard Deviation 0.01111 |
| Brentuximab Vedotin + Rifampicin | Plasma Concentration of Monomethylauristatin E (MMAE) and Its Metabolites at Cycle 1, 72 Hour Postdose | C4 | 0.0127 ng/mL | Standard Deviation 0.00423 |
Primary
Plasma Concentration of Monomethylauristatin E (MMAE) and Its Metabolites at Cycle 1, 96 Hour Postdose
Metabolites of MMAE includes C4, C5, C7, C8 and C13. The LLQ for all the observations was 0.01 ng/mL.
Time frame: Cycle 1: 96 hour postdose
Population: PK analysis set included all participants who received brentuximab vedotin at 1.8 mg/kg throughout Cycles 1 to 3 and had sufficient dosing and PK data to reliably estimate PK parameters.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| Brentuximab Vedotin | Plasma Concentration of Monomethylauristatin E (MMAE) and Its Metabolites at Cycle 1, 96 Hour Postdose | MMAE | 2.9148 ng/mL | Standard Deviation 1.705 |
| Brentuximab Vedotin | Plasma Concentration of Monomethylauristatin E (MMAE) and Its Metabolites at Cycle 1, 96 Hour Postdose | C4 | 0.0136 ng/mL | Standard Deviation 0.00481 |
| Brentuximab Vedotin | Plasma Concentration of Monomethylauristatin E (MMAE) and Its Metabolites at Cycle 1, 96 Hour Postdose | C5 | 0.0120 ng/mL | Standard Deviation 0.00643 |
| Brentuximab Vedotin | Plasma Concentration of Monomethylauristatin E (MMAE) and Its Metabolites at Cycle 1, 96 Hour Postdose | C7 | NA ng/mL | — |
| Brentuximab Vedotin | Plasma Concentration of Monomethylauristatin E (MMAE) and Its Metabolites at Cycle 1, 96 Hour Postdose | C8 | 0.0660 ng/mL | Standard Deviation 0.04349 |
| Brentuximab Vedotin | Plasma Concentration of Monomethylauristatin E (MMAE) and Its Metabolites at Cycle 1, 96 Hour Postdose | C13 | NA ng/mL | — |
| Brentuximab Vedotin + Rifampicin | Plasma Concentration of Monomethylauristatin E (MMAE) and Its Metabolites at Cycle 1, 96 Hour Postdose | C8 | 0.0228 ng/mL | Standard Deviation 0.06198 |
| Brentuximab Vedotin + Rifampicin | Plasma Concentration of Monomethylauristatin E (MMAE) and Its Metabolites at Cycle 1, 96 Hour Postdose | MMAE | 3.2956 ng/mL | Standard Deviation 2.97022 |
| Brentuximab Vedotin + Rifampicin | Plasma Concentration of Monomethylauristatin E (MMAE) and Its Metabolites at Cycle 1, 96 Hour Postdose | C7 | 0.0374 ng/mL | Standard Deviation 0.01247 |
| Brentuximab Vedotin + Rifampicin | Plasma Concentration of Monomethylauristatin E (MMAE) and Its Metabolites at Cycle 1, 96 Hour Postdose | C4 | 0.1420 ng/mL | Standard Deviation 0.04733 |
| Brentuximab Vedotin + Rifampicin | Plasma Concentration of Monomethylauristatin E (MMAE) and Its Metabolites at Cycle 1, 96 Hour Postdose | C13 | 0.0108 ng/mL | Standard Deviation 0.0036 |
| Brentuximab Vedotin + Rifampicin | Plasma Concentration of Monomethylauristatin E (MMAE) and Its Metabolites at Cycle 1, 96 Hour Postdose | C5 | 0.0593 ng/mL | Standard Deviation 0.01977 |
Primary
Plasma Concentration of Monomethylauristatin E (MMAE) and Its Metabolites at Cycle 1, Predose
Metabolites of MMAE includes C4, C5, C7, C8 and C13. The lower limit of Quantification (LLQ) for all the observations was 0.01 nanogram/milliliter (ng/mL).
Time frame: Cycle 1: Predose
Population: Pharmacokinetic (PK) analysis set included all participants who received brentuximab vedotin at 1.8 mg/kg throughout Cycles 1 to 3 and had sufficient dosing and PK data to reliably estimate PK parameters.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Brentuximab Vedotin | Plasma Concentration of Monomethylauristatin E (MMAE) and Its Metabolites at Cycle 1, Predose | MMAE | NA ng/mL |
| Brentuximab Vedotin | Plasma Concentration of Monomethylauristatin E (MMAE) and Its Metabolites at Cycle 1, Predose | C4 | NA ng/mL |
| Brentuximab Vedotin | Plasma Concentration of Monomethylauristatin E (MMAE) and Its Metabolites at Cycle 1, Predose | C5 | NA ng/mL |
| Brentuximab Vedotin | Plasma Concentration of Monomethylauristatin E (MMAE) and Its Metabolites at Cycle 1, Predose | C7 | NA ng/mL |
| Brentuximab Vedotin | Plasma Concentration of Monomethylauristatin E (MMAE) and Its Metabolites at Cycle 1, Predose | C8 | NA ng/mL |
| Brentuximab Vedotin | Plasma Concentration of Monomethylauristatin E (MMAE) and Its Metabolites at Cycle 1, Predose | C13 | NA ng/mL |
| Brentuximab Vedotin + Rifampicin | Plasma Concentration of Monomethylauristatin E (MMAE) and Its Metabolites at Cycle 1, Predose | C8 | NA ng/mL |
| Brentuximab Vedotin + Rifampicin | Plasma Concentration of Monomethylauristatin E (MMAE) and Its Metabolites at Cycle 1, Predose | MMAE | NA ng/mL |
| Brentuximab Vedotin + Rifampicin | Plasma Concentration of Monomethylauristatin E (MMAE) and Its Metabolites at Cycle 1, Predose | C7 | NA ng/mL |
| Brentuximab Vedotin + Rifampicin | Plasma Concentration of Monomethylauristatin E (MMAE) and Its Metabolites at Cycle 1, Predose | C4 | NA ng/mL |
| Brentuximab Vedotin + Rifampicin | Plasma Concentration of Monomethylauristatin E (MMAE) and Its Metabolites at Cycle 1, Predose | C13 | NA ng/mL |
| Brentuximab Vedotin + Rifampicin | Plasma Concentration of Monomethylauristatin E (MMAE) and Its Metabolites at Cycle 1, Predose | C5 | NA ng/mL |
Primary
Plasma Concentration of Monomethylauristatin E (MMAE) and Its Metabolites at Cycle 2, 0.5 Hour Postdose
Metabolites of MMAE includes C4, C5, C7, C8 and C13. The LLQ for all the observations was 0.01 ng/mL.
Time frame: Cycle 2: 0.5 hour postdose
Population: PK analysis set included all participants who received brentuximab vedotin at 1.8 mg/kg throughout Cycles 1 to 3 and had sufficient dosing and PK data to reliably estimate PK parameters.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| Brentuximab Vedotin | Plasma Concentration of Monomethylauristatin E (MMAE) and Its Metabolites at Cycle 2, 0.5 Hour Postdose | MMAE | 0.3119 ng/mL | Standard Deviation 1.69249 |
| Brentuximab Vedotin | Plasma Concentration of Monomethylauristatin E (MMAE) and Its Metabolites at Cycle 2, 0.5 Hour Postdose | C4 | NA ng/mL | — |
| Brentuximab Vedotin | Plasma Concentration of Monomethylauristatin E (MMAE) and Its Metabolites at Cycle 2, 0.5 Hour Postdose | C5 | NA ng/mL | — |
| Brentuximab Vedotin | Plasma Concentration of Monomethylauristatin E (MMAE) and Its Metabolites at Cycle 2, 0.5 Hour Postdose | C7 | NA ng/mL | — |
| Brentuximab Vedotin | Plasma Concentration of Monomethylauristatin E (MMAE) and Its Metabolites at Cycle 2, 0.5 Hour Postdose | C8 | NA ng/mL | — |
| Brentuximab Vedotin | Plasma Concentration of Monomethylauristatin E (MMAE) and Its Metabolites at Cycle 2, 0.5 Hour Postdose | C13 | NA ng/mL | — |
| Brentuximab Vedotin + Rifampicin | Plasma Concentration of Monomethylauristatin E (MMAE) and Its Metabolites at Cycle 2, 0.5 Hour Postdose | C8 | 0.0228 ng/mL | Standard Deviation 0.0076 |
| Brentuximab Vedotin + Rifampicin | Plasma Concentration of Monomethylauristatin E (MMAE) and Its Metabolites at Cycle 2, 0.5 Hour Postdose | MMAE | 0.2929 ng/mL | Standard Deviation 1.39185 |
| Brentuximab Vedotin + Rifampicin | Plasma Concentration of Monomethylauristatin E (MMAE) and Its Metabolites at Cycle 2, 0.5 Hour Postdose | C7 | NA ng/mL | — |
| Brentuximab Vedotin + Rifampicin | Plasma Concentration of Monomethylauristatin E (MMAE) and Its Metabolites at Cycle 2, 0.5 Hour Postdose | C4 | NA ng/mL | — |
| Brentuximab Vedotin + Rifampicin | Plasma Concentration of Monomethylauristatin E (MMAE) and Its Metabolites at Cycle 2, 0.5 Hour Postdose | C13 | NA ng/mL | — |
| Brentuximab Vedotin + Rifampicin | Plasma Concentration of Monomethylauristatin E (MMAE) and Its Metabolites at Cycle 2, 0.5 Hour Postdose | C5 | NA ng/mL | — |
Primary
Plasma Concentration of Monomethylauristatin E (MMAE) and Its Metabolites at Cycle 2, Predose
Metabolites of MMAE includes C4, C5, C7, C8 and C13. The LLQ for all the observations was 0.01 ng/mL.
Time frame: Cycle 2: Predose
Population: PK analysis set included all participants who received brentuximab vedotin at 1.8 mg/kg throughout Cycles 1 to 3 and had sufficient dosing and PK data to reliably estimate PK parameters.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| Brentuximab Vedotin | Plasma Concentration of Monomethylauristatin E (MMAE) and Its Metabolites at Cycle 2, Predose | MMAE | 0.0919 ng/mL | Standard Deviation 0.05695 |
| Brentuximab Vedotin | Plasma Concentration of Monomethylauristatin E (MMAE) and Its Metabolites at Cycle 2, Predose | C4 | NA ng/mL | — |
| Brentuximab Vedotin | Plasma Concentration of Monomethylauristatin E (MMAE) and Its Metabolites at Cycle 2, Predose | C5 | NA ng/mL | — |
| Brentuximab Vedotin | Plasma Concentration of Monomethylauristatin E (MMAE) and Its Metabolites at Cycle 2, Predose | C7 | NA ng/mL | — |
| Brentuximab Vedotin | Plasma Concentration of Monomethylauristatin E (MMAE) and Its Metabolites at Cycle 2, Predose | C8 | NA ng/mL | — |
| Brentuximab Vedotin | Plasma Concentration of Monomethylauristatin E (MMAE) and Its Metabolites at Cycle 2, Predose | C13 | NA ng/mL | — |
| Brentuximab Vedotin + Rifampicin | Plasma Concentration of Monomethylauristatin E (MMAE) and Its Metabolites at Cycle 2, Predose | C8 | NA ng/mL | — |
| Brentuximab Vedotin + Rifampicin | Plasma Concentration of Monomethylauristatin E (MMAE) and Its Metabolites at Cycle 2, Predose | MMAE | 0.0795 ng/mL | Standard Deviation 0.1422 |
| Brentuximab Vedotin + Rifampicin | Plasma Concentration of Monomethylauristatin E (MMAE) and Its Metabolites at Cycle 2, Predose | C7 | NA ng/mL | — |
| Brentuximab Vedotin + Rifampicin | Plasma Concentration of Monomethylauristatin E (MMAE) and Its Metabolites at Cycle 2, Predose | C4 | NA ng/mL | — |
| Brentuximab Vedotin + Rifampicin | Plasma Concentration of Monomethylauristatin E (MMAE) and Its Metabolites at Cycle 2, Predose | C13 | NA ng/mL | — |
| Brentuximab Vedotin + Rifampicin | Plasma Concentration of Monomethylauristatin E (MMAE) and Its Metabolites at Cycle 2, Predose | C5 | NA ng/mL | — |
Primary
Plasma Concentration of Monomethylauristatin E (MMAE) and Its Metabolites at Cycle 3, 0.5 Hour Postdose
Metabolites of MMAE includes C4, C5, C7, C8 and C13. The LLQ for all the observations was 0.01 ng/mL.
Time frame: Cycle 3: 0.5 hour postdose
Population: PK analysis set included all participants who received brentuximab vedotin at 1.8 mg/kg throughout Cycles 1 to 3 and had sufficient dosing and PK data to reliably estimate PK parameters.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| Brentuximab Vedotin | Plasma Concentration of Monomethylauristatin E (MMAE) and Its Metabolites at Cycle 3, 0.5 Hour Postdose | MMAE | 0.3307 ng/mL | Standard Deviation 2.33539 |
| Brentuximab Vedotin | Plasma Concentration of Monomethylauristatin E (MMAE) and Its Metabolites at Cycle 3, 0.5 Hour Postdose | C4 | 0.0256 ng/mL | Standard Deviation 0.00905 |
| Brentuximab Vedotin | Plasma Concentration of Monomethylauristatin E (MMAE) and Its Metabolites at Cycle 3, 0.5 Hour Postdose | C5 | NA ng/mL | — |
| Brentuximab Vedotin | Plasma Concentration of Monomethylauristatin E (MMAE) and Its Metabolites at Cycle 3, 0.5 Hour Postdose | C7 | NA ng/mL | — |
| Brentuximab Vedotin | Plasma Concentration of Monomethylauristatin E (MMAE) and Its Metabolites at Cycle 3, 0.5 Hour Postdose | C8 | 0.0323 ng/mL | Standard Deviation 0.03266 |
| Brentuximab Vedotin | Plasma Concentration of Monomethylauristatin E (MMAE) and Its Metabolites at Cycle 3, 0.5 Hour Postdose | C13 | 0.0210 ng/mL | Standard Deviation 0.00742 |
| Brentuximab Vedotin + Rifampicin | Plasma Concentration of Monomethylauristatin E (MMAE) and Its Metabolites at Cycle 3, 0.5 Hour Postdose | C8 | NA ng/mL | — |
| Brentuximab Vedotin + Rifampicin | Plasma Concentration of Monomethylauristatin E (MMAE) and Its Metabolites at Cycle 3, 0.5 Hour Postdose | MMAE | 0.2577 ng/mL | Standard Deviation 0.26736 |
| Brentuximab Vedotin + Rifampicin | Plasma Concentration of Monomethylauristatin E (MMAE) and Its Metabolites at Cycle 3, 0.5 Hour Postdose | C7 | NA ng/mL | — |
| Brentuximab Vedotin + Rifampicin | Plasma Concentration of Monomethylauristatin E (MMAE) and Its Metabolites at Cycle 3, 0.5 Hour Postdose | C4 | NA ng/mL | — |
| Brentuximab Vedotin + Rifampicin | Plasma Concentration of Monomethylauristatin E (MMAE) and Its Metabolites at Cycle 3, 0.5 Hour Postdose | C13 | NA ng/mL | — |
| Brentuximab Vedotin + Rifampicin | Plasma Concentration of Monomethylauristatin E (MMAE) and Its Metabolites at Cycle 3, 0.5 Hour Postdose | C5 | NA ng/mL | — |
Primary
Plasma Concentration of Monomethylauristatin E (MMAE) and Its Metabolites at Cycle 3, 144 Hour Postdose
Metabolites of MMAE includes C4, C5, C7, C8 and C13. The LLQ for all the observations was 0.01 ng/mL.
Time frame: Cycle 3: 144 hour postdose
Population: PK analysis set included all participants who received brentuximab vedotin at 1.8 mg/kg throughout Cycles 1 to 3 and had sufficient dosing and PK data to reliably estimate PK parameters.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| Brentuximab Vedotin | Plasma Concentration of Monomethylauristatin E (MMAE) and Its Metabolites at Cycle 3, 144 Hour Postdose | MMAE | 2.0555 ng/mL | Standard Deviation 1.07315 |
| Brentuximab Vedotin | Plasma Concentration of Monomethylauristatin E (MMAE) and Its Metabolites at Cycle 3, 144 Hour Postdose | C4 | 0.0198 ng/mL | Standard Deviation 0.00976 |
| Brentuximab Vedotin | Plasma Concentration of Monomethylauristatin E (MMAE) and Its Metabolites at Cycle 3, 144 Hour Postdose | C5 | 0.0140 ng/mL | Standard Deviation 0.0076 |
| Brentuximab Vedotin | Plasma Concentration of Monomethylauristatin E (MMAE) and Its Metabolites at Cycle 3, 144 Hour Postdose | C7 | 0.0137 ng/mL | Standard Deviation 0.00484 |
| Brentuximab Vedotin | Plasma Concentration of Monomethylauristatin E (MMAE) and Its Metabolites at Cycle 3, 144 Hour Postdose | C8 | 0.0441 ng/mL | Standard Deviation 0.02147 |
| Brentuximab Vedotin | Plasma Concentration of Monomethylauristatin E (MMAE) and Its Metabolites at Cycle 3, 144 Hour Postdose | C13 | NA ng/mL | — |
| Brentuximab Vedotin + Rifampicin | Plasma Concentration of Monomethylauristatin E (MMAE) and Its Metabolites at Cycle 3, 144 Hour Postdose | C8 | 0.0145 ng/mL | Standard Deviation 0.00648 |
| Brentuximab Vedotin + Rifampicin | Plasma Concentration of Monomethylauristatin E (MMAE) and Its Metabolites at Cycle 3, 144 Hour Postdose | MMAE | 1.2920 ng/mL | Standard Deviation 0.7569 |
| Brentuximab Vedotin + Rifampicin | Plasma Concentration of Monomethylauristatin E (MMAE) and Its Metabolites at Cycle 3, 144 Hour Postdose | C7 | NA ng/mL | — |
| Brentuximab Vedotin + Rifampicin | Plasma Concentration of Monomethylauristatin E (MMAE) and Its Metabolites at Cycle 3, 144 Hour Postdose | C4 | NA ng/mL | — |
| Brentuximab Vedotin + Rifampicin | Plasma Concentration of Monomethylauristatin E (MMAE) and Its Metabolites at Cycle 3, 144 Hour Postdose | C13 | NA ng/mL | — |
| Brentuximab Vedotin + Rifampicin | Plasma Concentration of Monomethylauristatin E (MMAE) and Its Metabolites at Cycle 3, 144 Hour Postdose | C5 | NA ng/mL | — |
Primary
Plasma Concentration of Monomethylauristatin E (MMAE) and Its Metabolites at Cycle 3, 24 Hour Postdose
Metabolites of MMAE includes C4, C5, C7, C8 and C13. The LLQ for all the observations was 0.01 ng/mL.
Time frame: Cycle 3: 24 hour postdose
Population: PK analysis set included all participants who received brentuximab vedotin at 1.8 mg/kg throughout Cycles 1 to 3 and had sufficient dosing and PK data to reliably estimate PK parameters.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| Brentuximab Vedotin | Plasma Concentration of Monomethylauristatin E (MMAE) and Its Metabolites at Cycle 3, 24 Hour Postdose | MMAE | 3.2336 ng/mL | Standard Deviation 2.26369 |
| Brentuximab Vedotin | Plasma Concentration of Monomethylauristatin E (MMAE) and Its Metabolites at Cycle 3, 24 Hour Postdose | C4 | 0.0200 ng/mL | Standard Deviation 0.01071 |
| Brentuximab Vedotin | Plasma Concentration of Monomethylauristatin E (MMAE) and Its Metabolites at Cycle 3, 24 Hour Postdose | C5 | 0.0203 ng/mL | Standard Deviation 0.01109 |
| Brentuximab Vedotin | Plasma Concentration of Monomethylauristatin E (MMAE) and Its Metabolites at Cycle 3, 24 Hour Postdose | C7 | 0.0164 ng/mL | Standard Deviation 0.00868 |
| Brentuximab Vedotin | Plasma Concentration of Monomethylauristatin E (MMAE) and Its Metabolites at Cycle 3, 24 Hour Postdose | C8 | 0.0715 ng/mL | Standard Deviation 0.04523 |
| Brentuximab Vedotin | Plasma Concentration of Monomethylauristatin E (MMAE) and Its Metabolites at Cycle 3, 24 Hour Postdose | C13 | 0.0105 ng/mL | Standard Deviation 0.00371 |
| Brentuximab Vedotin + Rifampicin | Plasma Concentration of Monomethylauristatin E (MMAE) and Its Metabolites at Cycle 3, 24 Hour Postdose | C8 | 0.0177 ng/mL | Standard Deviation 0.01284 |
| Brentuximab Vedotin + Rifampicin | Plasma Concentration of Monomethylauristatin E (MMAE) and Its Metabolites at Cycle 3, 24 Hour Postdose | MMAE | 2.2558 ng/mL | Standard Deviation 1.60345 |
| Brentuximab Vedotin + Rifampicin | Plasma Concentration of Monomethylauristatin E (MMAE) and Its Metabolites at Cycle 3, 24 Hour Postdose | C7 | NA ng/mL | — |
| Brentuximab Vedotin + Rifampicin | Plasma Concentration of Monomethylauristatin E (MMAE) and Its Metabolites at Cycle 3, 24 Hour Postdose | C4 | NA ng/mL | — |
| Brentuximab Vedotin + Rifampicin | Plasma Concentration of Monomethylauristatin E (MMAE) and Its Metabolites at Cycle 3, 24 Hour Postdose | C13 | NA ng/mL | — |
| Brentuximab Vedotin + Rifampicin | Plasma Concentration of Monomethylauristatin E (MMAE) and Its Metabolites at Cycle 3, 24 Hour Postdose | C5 | NA ng/mL | — |
Primary
Plasma Concentration of Monomethylauristatin E (MMAE) and Its Metabolites at Cycle 3, 336 Hour Postdose
Metabolites of MMAE includes C4, C5, C7, C8 and C13. The LLQ for all the observations was 0.01 ng/mL.
Time frame: Cycle 3: 336 hour postdose
Population: PK analysis set included all participants who received brentuximab vedotin at 1.8 mg/kg throughout Cycles 1 to 3 and had sufficient dosing and PK data to reliably estimate PK parameters.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| Brentuximab Vedotin | Plasma Concentration of Monomethylauristatin E (MMAE) and Its Metabolites at Cycle 3, 336 Hour Postdose | MMAE | 0.4258 ng/mL | Standard Deviation 0.30565 |
| Brentuximab Vedotin | Plasma Concentration of Monomethylauristatin E (MMAE) and Its Metabolites at Cycle 3, 336 Hour Postdose | C4 | NA ng/mL | — |
| Brentuximab Vedotin | Plasma Concentration of Monomethylauristatin E (MMAE) and Its Metabolites at Cycle 3, 336 Hour Postdose | C5 | NA ng/mL | — |
| Brentuximab Vedotin | Plasma Concentration of Monomethylauristatin E (MMAE) and Its Metabolites at Cycle 3, 336 Hour Postdose | C7 | NA ng/mL | — |
| Brentuximab Vedotin | Plasma Concentration of Monomethylauristatin E (MMAE) and Its Metabolites at Cycle 3, 336 Hour Postdose | C8 | 0.0168 ng/mL | Standard Deviation 0.01011 |
| Brentuximab Vedotin | Plasma Concentration of Monomethylauristatin E (MMAE) and Its Metabolites at Cycle 3, 336 Hour Postdose | C13 | NA ng/mL | — |
| Brentuximab Vedotin + Rifampicin | Plasma Concentration of Monomethylauristatin E (MMAE) and Its Metabolites at Cycle 3, 336 Hour Postdose | C8 | NA ng/mL | — |
| Brentuximab Vedotin + Rifampicin | Plasma Concentration of Monomethylauristatin E (MMAE) and Its Metabolites at Cycle 3, 336 Hour Postdose | MMAE | 0.2578 ng/mL | Standard Deviation 0.10847 |
| Brentuximab Vedotin + Rifampicin | Plasma Concentration of Monomethylauristatin E (MMAE) and Its Metabolites at Cycle 3, 336 Hour Postdose | C7 | NA ng/mL | — |
| Brentuximab Vedotin + Rifampicin | Plasma Concentration of Monomethylauristatin E (MMAE) and Its Metabolites at Cycle 3, 336 Hour Postdose | C4 | NA ng/mL | — |
| Brentuximab Vedotin + Rifampicin | Plasma Concentration of Monomethylauristatin E (MMAE) and Its Metabolites at Cycle 3, 336 Hour Postdose | C13 | NA ng/mL | — |
| Brentuximab Vedotin + Rifampicin | Plasma Concentration of Monomethylauristatin E (MMAE) and Its Metabolites at Cycle 3, 336 Hour Postdose | C5 | NA ng/mL | — |
Primary
Plasma Concentration of Monomethylauristatin E (MMAE) and Its Metabolites at Cycle 3, 480 Hour Postdose
Metabolites of MMAE includes C4, C5, C7, C8 and C13. The LLQ for all the observations was 0.01 ng/mL.
Time frame: Cycle 3: 480 hour postdose
Population: PK analysis set included all participants who received brentuximab vedotin at 1.8 mg/kg throughout Cycles 1 to 3 and had sufficient dosing and PK data to reliably estimate PK parameters.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| Brentuximab Vedotin | Plasma Concentration of Monomethylauristatin E (MMAE) and Its Metabolites at Cycle 3, 480 Hour Postdose | C4 | NA ng/mL | — |
| Brentuximab Vedotin | Plasma Concentration of Monomethylauristatin E (MMAE) and Its Metabolites at Cycle 3, 480 Hour Postdose | C7 | NA ng/mL | — |
| Brentuximab Vedotin | Plasma Concentration of Monomethylauristatin E (MMAE) and Its Metabolites at Cycle 3, 480 Hour Postdose | MMAE | 0.1189 ng/mL | Standard Deviation 0.15808 |
| Brentuximab Vedotin | Plasma Concentration of Monomethylauristatin E (MMAE) and Its Metabolites at Cycle 3, 480 Hour Postdose | C8 | 0.0114 ng/mL | Standard Deviation 0.00431 |
| Brentuximab Vedotin | Plasma Concentration of Monomethylauristatin E (MMAE) and Its Metabolites at Cycle 3, 480 Hour Postdose | C5 | NA ng/mL | — |
| Brentuximab Vedotin | Plasma Concentration of Monomethylauristatin E (MMAE) and Its Metabolites at Cycle 3, 480 Hour Postdose | C13 | NA ng/mL | — |
| Brentuximab Vedotin + Rifampicin | Plasma Concentration of Monomethylauristatin E (MMAE) and Its Metabolites at Cycle 3, 480 Hour Postdose | C13 | NA ng/mL | — |
| Brentuximab Vedotin + Rifampicin | Plasma Concentration of Monomethylauristatin E (MMAE) and Its Metabolites at Cycle 3, 480 Hour Postdose | MMAE | 0.0941 ng/mL | Standard Deviation 0.03974 |
| Brentuximab Vedotin + Rifampicin | Plasma Concentration of Monomethylauristatin E (MMAE) and Its Metabolites at Cycle 3, 480 Hour Postdose | C4 | NA ng/mL | — |
| Brentuximab Vedotin + Rifampicin | Plasma Concentration of Monomethylauristatin E (MMAE) and Its Metabolites at Cycle 3, 480 Hour Postdose | C5 | NA ng/mL | — |
| Brentuximab Vedotin + Rifampicin | Plasma Concentration of Monomethylauristatin E (MMAE) and Its Metabolites at Cycle 3, 480 Hour Postdose | C7 | NA ng/mL | — |
| Brentuximab Vedotin + Rifampicin | Plasma Concentration of Monomethylauristatin E (MMAE) and Its Metabolites at Cycle 3, 480 Hour Postdose | C8 | NA ng/mL | — |
Primary
Plasma Concentration of Monomethylauristatin E (MMAE) and Its Metabolites at Cycle 3, 48 Hour Postdose
Metabolites of MMAE includes C4, C5, C7, C8 and C13. The LLQ for all the observations was 0.01 ng/mL.
Time frame: Cycle 3: 48 hour postdose
Population: PK analysis set included all participants who received brentuximab vedotin at 1.8 mg/kg throughout Cycles 1 to 3 and had sufficient dosing and PK data to reliably estimate PK parameters.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| Brentuximab Vedotin | Plasma Concentration of Monomethylauristatin E (MMAE) and Its Metabolites at Cycle 3, 48 Hour Postdose | C4 | 0.0193 ng/mL | Standard Deviation 0.01407 |
| Brentuximab Vedotin | Plasma Concentration of Monomethylauristatin E (MMAE) and Its Metabolites at Cycle 3, 48 Hour Postdose | MMAE | 3.4733 ng/mL | Standard Deviation 2.17792 |
| Brentuximab Vedotin | Plasma Concentration of Monomethylauristatin E (MMAE) and Its Metabolites at Cycle 3, 48 Hour Postdose | C5 | 0.0198 ng/mL | Standard Deviation 0.01316 |
| Brentuximab Vedotin | Plasma Concentration of Monomethylauristatin E (MMAE) and Its Metabolites at Cycle 3, 48 Hour Postdose | C7 | 0.0170 ng/mL | Standard Deviation 0.01112 |
| Brentuximab Vedotin | Plasma Concentration of Monomethylauristatin E (MMAE) and Its Metabolites at Cycle 3, 48 Hour Postdose | C8 | 0.0746 ng/mL | Standard Deviation 0.06162 |
| Brentuximab Vedotin | Plasma Concentration of Monomethylauristatin E (MMAE) and Its Metabolites at Cycle 3, 48 Hour Postdose | C13 | 0.0124 ng/mL | Standard Deviation 0.00438 |
| Brentuximab Vedotin + Rifampicin | Plasma Concentration of Monomethylauristatin E (MMAE) and Its Metabolites at Cycle 3, 48 Hour Postdose | C8 | 0.0195 ng/mL | Standard Deviation 0.01114 |
| Brentuximab Vedotin + Rifampicin | Plasma Concentration of Monomethylauristatin E (MMAE) and Its Metabolites at Cycle 3, 48 Hour Postdose | C7 | NA ng/mL | — |
| Brentuximab Vedotin + Rifampicin | Plasma Concentration of Monomethylauristatin E (MMAE) and Its Metabolites at Cycle 3, 48 Hour Postdose | MMAE | 2.2156 ng/mL | Standard Deviation 1.7089 |
| Brentuximab Vedotin + Rifampicin | Plasma Concentration of Monomethylauristatin E (MMAE) and Its Metabolites at Cycle 3, 48 Hour Postdose | C4 | NA ng/mL | — |
| Brentuximab Vedotin + Rifampicin | Plasma Concentration of Monomethylauristatin E (MMAE) and Its Metabolites at Cycle 3, 48 Hour Postdose | C13 | NA ng/mL | — |
| Brentuximab Vedotin + Rifampicin | Plasma Concentration of Monomethylauristatin E (MMAE) and Its Metabolites at Cycle 3, 48 Hour Postdose | C5 | NA ng/mL | — |
Primary
Plasma Concentration of Monomethylauristatin E (MMAE) and Its Metabolites at Cycle 3, 4 Hour Postdose
Metabolites of MMAE includes C4, C5, C7, C8 and C13. The LLQ for all the observations was 0.01 ng/mL.
Time frame: Cycle 3: 4 hour postdose
Population: PK analysis set included all participants who received brentuximab vedotin at 1.8 mg/kg throughout Cycles 1 to 3 and had sufficient dosing and PK data to reliably estimate PK parameters.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| Brentuximab Vedotin | Plasma Concentration of Monomethylauristatin E (MMAE) and Its Metabolites at Cycle 3, 4 Hour Postdose | C8 | 0.0446 ng/mL | Standard Deviation 0.05011 |
| Brentuximab Vedotin | Plasma Concentration of Monomethylauristatin E (MMAE) and Its Metabolites at Cycle 3, 4 Hour Postdose | C13 | 0.0191 ng/mL | Standard Deviation 0.00637 |
| Brentuximab Vedotin | Plasma Concentration of Monomethylauristatin E (MMAE) and Its Metabolites at Cycle 3, 4 Hour Postdose | MMAE | 1.7171 ng/mL | Standard Deviation 4.42914 |
| Brentuximab Vedotin | Plasma Concentration of Monomethylauristatin E (MMAE) and Its Metabolites at Cycle 3, 4 Hour Postdose | C4 | 0.0397 ng/mL | Standard Deviation 0.01323 |
| Brentuximab Vedotin | Plasma Concentration of Monomethylauristatin E (MMAE) and Its Metabolites at Cycle 3, 4 Hour Postdose | C5 | 0.0163 ng/mL | Standard Deviation 0.00804 |
| Brentuximab Vedotin | Plasma Concentration of Monomethylauristatin E (MMAE) and Its Metabolites at Cycle 3, 4 Hour Postdose | C7 | 0.0118 ng/mL | Standard Deviation 0.006 |
| Brentuximab Vedotin + Rifampicin | Plasma Concentration of Monomethylauristatin E (MMAE) and Its Metabolites at Cycle 3, 4 Hour Postdose | C5 | NA ng/mL | — |
| Brentuximab Vedotin + Rifampicin | Plasma Concentration of Monomethylauristatin E (MMAE) and Its Metabolites at Cycle 3, 4 Hour Postdose | C8 | 0.0190 ng/mL | Standard Deviation 0.01265 |
| Brentuximab Vedotin + Rifampicin | Plasma Concentration of Monomethylauristatin E (MMAE) and Its Metabolites at Cycle 3, 4 Hour Postdose | C4 | NA ng/mL | — |
| Brentuximab Vedotin + Rifampicin | Plasma Concentration of Monomethylauristatin E (MMAE) and Its Metabolites at Cycle 3, 4 Hour Postdose | C13 | NA ng/mL | — |
| Brentuximab Vedotin + Rifampicin | Plasma Concentration of Monomethylauristatin E (MMAE) and Its Metabolites at Cycle 3, 4 Hour Postdose | C7 | NA ng/mL | — |
| Brentuximab Vedotin + Rifampicin | Plasma Concentration of Monomethylauristatin E (MMAE) and Its Metabolites at Cycle 3, 4 Hour Postdose | MMAE | 1.4529 ng/mL | Standard Deviation 1.3662 |
Primary
Plasma Concentration of Monomethylauristatin E (MMAE) and Its Metabolites at Cycle 3, 72 Hour Postdose
Metabolites of MMAE includes C4, C5, C7, C8 and C13. The LLQ for all the observations was 0.01 ng/mL.
Time frame: Cycle 3: 72 hour postdose
Population: PK analysis set included all participants who received brentuximab vedotin at 1.8 mg/kg throughout Cycles 1 to 3 and had sufficient dosing and PK data to reliably estimate PK parameters.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| Brentuximab Vedotin | Plasma Concentration of Monomethylauristatin E (MMAE) and Its Metabolites at Cycle 3, 72 Hour Postdose | MMAE | 3.3047 ng/mL | Standard Deviation 2.14127 |
| Brentuximab Vedotin | Plasma Concentration of Monomethylauristatin E (MMAE) and Its Metabolites at Cycle 3, 72 Hour Postdose | C4 | 0.0310 ng/mL | Standard Deviation 0.01563 |
| Brentuximab Vedotin | Plasma Concentration of Monomethylauristatin E (MMAE) and Its Metabolites at Cycle 3, 72 Hour Postdose | C5 | 0.0256 ng/mL | Standard Deviation 0.0151 |
| Brentuximab Vedotin | Plasma Concentration of Monomethylauristatin E (MMAE) and Its Metabolites at Cycle 3, 72 Hour Postdose | C7 | 0.0168 ng/mL | Standard Deviation 0.01126 |
| Brentuximab Vedotin | Plasma Concentration of Monomethylauristatin E (MMAE) and Its Metabolites at Cycle 3, 72 Hour Postdose | C8 | 0.0728 ng/mL | Standard Deviation 0.04348 |
| Brentuximab Vedotin | Plasma Concentration of Monomethylauristatin E (MMAE) and Its Metabolites at Cycle 3, 72 Hour Postdose | C13 | NA ng/mL | — |
| Brentuximab Vedotin + Rifampicin | Plasma Concentration of Monomethylauristatin E (MMAE) and Its Metabolites at Cycle 3, 72 Hour Postdose | C8 | 0.0187 ng/mL | Standard Deviation 0.01079 |
| Brentuximab Vedotin + Rifampicin | Plasma Concentration of Monomethylauristatin E (MMAE) and Its Metabolites at Cycle 3, 72 Hour Postdose | MMAE | 1.9732 ng/mL | Standard Deviation 1.32391 |
| Brentuximab Vedotin + Rifampicin | Plasma Concentration of Monomethylauristatin E (MMAE) and Its Metabolites at Cycle 3, 72 Hour Postdose | C7 | NA ng/mL | — |
| Brentuximab Vedotin + Rifampicin | Plasma Concentration of Monomethylauristatin E (MMAE) and Its Metabolites at Cycle 3, 72 Hour Postdose | C4 | NA ng/mL | — |
| Brentuximab Vedotin + Rifampicin | Plasma Concentration of Monomethylauristatin E (MMAE) and Its Metabolites at Cycle 3, 72 Hour Postdose | C13 | NA ng/mL | — |
| Brentuximab Vedotin + Rifampicin | Plasma Concentration of Monomethylauristatin E (MMAE) and Its Metabolites at Cycle 3, 72 Hour Postdose | C5 | NA ng/mL | — |
Primary
Plasma Concentration of Monomethylauristatin E (MMAE) and Its Metabolites at Cycle 3, 96 Hour Postdose
Metabolites of MMAE includes C4, C5, C7, C8 and C13. The LLQ for all the observations was 0.01 ng/mL.
Time frame: Cycle 3: 96 hour postdose
Population: PK analysis set included all participants who received brentuximab vedotin at 1.8 mg/kg throughout Cycles 1 to 3 and had sufficient dosing and PK data to reliably estimate PK parameters.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| Brentuximab Vedotin | Plasma Concentration of Monomethylauristatin E (MMAE) and Its Metabolites at Cycle 3, 96 Hour Postdose | MMAE | 2.4449 ng/mL | Standard Deviation 1.44334 |
| Brentuximab Vedotin | Plasma Concentration of Monomethylauristatin E (MMAE) and Its Metabolites at Cycle 3, 96 Hour Postdose | C4 | 0.0140 ng/mL | Standard Deviation 0.00704 |
| Brentuximab Vedotin | Plasma Concentration of Monomethylauristatin E (MMAE) and Its Metabolites at Cycle 3, 96 Hour Postdose | C5 | 0.0205 ng/mL | Standard Deviation 0.01017 |
| Brentuximab Vedotin | Plasma Concentration of Monomethylauristatin E (MMAE) and Its Metabolites at Cycle 3, 96 Hour Postdose | C7 | 0.0121 ng/mL | Standard Deviation 0.00428 |
| Brentuximab Vedotin | Plasma Concentration of Monomethylauristatin E (MMAE) and Its Metabolites at Cycle 3, 96 Hour Postdose | C8 | 0.0622 ng/mL | Standard Deviation 0.04328 |
| Brentuximab Vedotin | Plasma Concentration of Monomethylauristatin E (MMAE) and Its Metabolites at Cycle 3, 96 Hour Postdose | C13 | 0.0105 ng/mL | Standard Deviation 0.00371 |
| Brentuximab Vedotin + Rifampicin | Plasma Concentration of Monomethylauristatin E (MMAE) and Its Metabolites at Cycle 3, 96 Hour Postdose | C8 | 0.0392 ng/mL | Standard Deviation 0.04163 |
| Brentuximab Vedotin + Rifampicin | Plasma Concentration of Monomethylauristatin E (MMAE) and Its Metabolites at Cycle 3, 96 Hour Postdose | MMAE | 2.2344 ng/mL | Standard Deviation 1.81211 |
| Brentuximab Vedotin + Rifampicin | Plasma Concentration of Monomethylauristatin E (MMAE) and Its Metabolites at Cycle 3, 96 Hour Postdose | C7 | 0.0252 ng/mL | Standard Deviation 0.0084 |
| Brentuximab Vedotin + Rifampicin | Plasma Concentration of Monomethylauristatin E (MMAE) and Its Metabolites at Cycle 3, 96 Hour Postdose | C4 | 0.0418 ng/mL | Standard Deviation 0.01393 |
| Brentuximab Vedotin + Rifampicin | Plasma Concentration of Monomethylauristatin E (MMAE) and Its Metabolites at Cycle 3, 96 Hour Postdose | C13 | NA ng/mL | — |
| Brentuximab Vedotin + Rifampicin | Plasma Concentration of Monomethylauristatin E (MMAE) and Its Metabolites at Cycle 3, 96 Hour Postdose | C5 | 0.0294 ng/mL | Standard Deviation 0.0098 |
Primary
Plasma Concentration of Monomethylauristatin E (MMAE) and Its Metabolites at Cycle 3, Predose
Metabolites of MMAE includes C4, C5, C7, C8 and C13. The LLQ for all the observations was 0.01 ng/mL.
Time frame: Cycle 3: Predose
Population: PK analysis set included all participants who received brentuximab vedotin at 1.8 mg/kg throughout Cycles 1 to 3 and had sufficient dosing and PK data to reliably estimate PK parameters.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| Brentuximab Vedotin | Plasma Concentration of Monomethylauristatin E (MMAE) and Its Metabolites at Cycle 3, Predose | MMAE | 0.1046 ng/mL | Standard Deviation 0.1084 |
| Brentuximab Vedotin | Plasma Concentration of Monomethylauristatin E (MMAE) and Its Metabolites at Cycle 3, Predose | C4 | NA ng/mL | — |
| Brentuximab Vedotin | Plasma Concentration of Monomethylauristatin E (MMAE) and Its Metabolites at Cycle 3, Predose | C5 | NA ng/mL | — |
| Brentuximab Vedotin | Plasma Concentration of Monomethylauristatin E (MMAE) and Its Metabolites at Cycle 3, Predose | C7 | NA ng/mL | — |
| Brentuximab Vedotin | Plasma Concentration of Monomethylauristatin E (MMAE) and Its Metabolites at Cycle 3, Predose | C8 | NA ng/mL | — |
| Brentuximab Vedotin | Plasma Concentration of Monomethylauristatin E (MMAE) and Its Metabolites at Cycle 3, Predose | C13 | NA ng/mL | — |
| Brentuximab Vedotin + Rifampicin | Plasma Concentration of Monomethylauristatin E (MMAE) and Its Metabolites at Cycle 3, Predose | C8 | NA ng/mL | — |
| Brentuximab Vedotin + Rifampicin | Plasma Concentration of Monomethylauristatin E (MMAE) and Its Metabolites at Cycle 3, Predose | MMAE | 0.0727 ng/mL | Standard Deviation 0.05936 |
| Brentuximab Vedotin + Rifampicin | Plasma Concentration of Monomethylauristatin E (MMAE) and Its Metabolites at Cycle 3, Predose | C7 | NA ng/mL | — |
| Brentuximab Vedotin + Rifampicin | Plasma Concentration of Monomethylauristatin E (MMAE) and Its Metabolites at Cycle 3, Predose | C4 | NA ng/mL | — |
| Brentuximab Vedotin + Rifampicin | Plasma Concentration of Monomethylauristatin E (MMAE) and Its Metabolites at Cycle 3, Predose | C13 | NA ng/mL | — |
| Brentuximab Vedotin + Rifampicin | Plasma Concentration of Monomethylauristatin E (MMAE) and Its Metabolites at Cycle 3, Predose | C5 | NA ng/mL | — |
Secondary
Number of Participants Reporting One or More Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
An Adverse Event (AE) is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (example, a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug, whether or not it is considered related to the drug. A treatment-emergent adverse event (TEAE) is defined as an adverse event with an onset that occurs after receiving study drug. A serious adverse event (SAE) is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; or congenital anomaly; or a medically important event. AEs included both SAE and non-SAE.
Time frame: Baseline up to 30 days after last dose of study drug (30 days after Cycle 16)
Population: Safety analysis set included all participants who received at least 1 dose of study drug.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Brentuximab Vedotin | Number of Participants Reporting One or More Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) | AEs | 9 participants |
| Brentuximab Vedotin | Number of Participants Reporting One or More Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) | SAEs | 4 participants |
| Brentuximab Vedotin + Rifampicin | Number of Participants Reporting One or More Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) | AEs | 9 participants |
| Brentuximab Vedotin + Rifampicin | Number of Participants Reporting One or More Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) | SAEs | 0 participants |
Secondary
Number of Participants With Anti-therapeutic Antibodies (ATA) to Brentuximab Vedotin
Participants with positive ATA at both Cycle 1 and 3, negative ATA at both Cycle 1 and 3, and transient positive (positive at one time point, but negative at the other) ATA for brentuximab vedotin were reported.
Time frame: Day 1 of Cycle 1 and 3
Population: Safety analysis set included all participants who received at least 1 dose of study drug.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Brentuximab Vedotin | Number of Participants With Anti-therapeutic Antibodies (ATA) to Brentuximab Vedotin | Negative in both Cycle 1 and 3 | 5 participants |
| Brentuximab Vedotin | Number of Participants With Anti-therapeutic Antibodies (ATA) to Brentuximab Vedotin | Positive in both Cycle 1 and 3 | 1 participants |
| Brentuximab Vedotin | Number of Participants With Anti-therapeutic Antibodies (ATA) to Brentuximab Vedotin | Transient Positive | 2 participants |
| Brentuximab Vedotin + Rifampicin | Number of Participants With Anti-therapeutic Antibodies (ATA) to Brentuximab Vedotin | Negative in both Cycle 1 and 3 | 7 participants |
| Brentuximab Vedotin + Rifampicin | Number of Participants With Anti-therapeutic Antibodies (ATA) to Brentuximab Vedotin | Positive in both Cycle 1 and 3 | 0 participants |
| Brentuximab Vedotin + Rifampicin | Number of Participants With Anti-therapeutic Antibodies (ATA) to Brentuximab Vedotin | Transient Positive | 2 participants |
Secondary
Number of Participants With Clinically Significant Change From Baseline in Vital Signs
Vital signs included body temperature, body weight, blood pressure and heart rate.
Time frame: Baseline up to 30 days after last dose of study drug (30 Days after Cycle 16)
Population: Safety analysis set included all participants who received at least 1 dose of study drug.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Brentuximab Vedotin | Number of Participants With Clinically Significant Change From Baseline in Vital Signs | 1 participants |
| Brentuximab Vedotin + Rifampicin | Number of Participants With Clinically Significant Change From Baseline in Vital Signs | 2 participants |
Secondary
Number of Participants With Markedly Abnormal Laboratory Values
The number of participants with any markedly abnormal standard safety laboratory values collected throughout study.
Time frame: Baseline up to 30 days after last dose of study drug (30 Days after Cycle 16)
Population: Safety analysis set included all participants who received at least 1 dose of study drug.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Brentuximab Vedotin | Number of Participants With Markedly Abnormal Laboratory Values | 5 participants |
| Brentuximab Vedotin + Rifampicin | Number of Participants With Markedly Abnormal Laboratory Values | 5 participants |
Secondary
Serum Concentration of Total Antibody (TAb)
The LLQ for all the observations was 12.5 ng/mL.
Time frame: Cycle 1 and 3: Predose, 0.5, 4, 72, 336 hours post-dose; Cycle 2: Predose, 0.5 hours post-dose; Cycle 3: 480 hours post-dose
Population: PK analysis set included all participants who received brentuximab vedotin at 1.8 mg/kg throughout Cycles 1 to 3 and had sufficient dosing and PK data to reliably estimate PK parameters.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| Brentuximab Vedotin | Serum Concentration of Total Antibody (TAb) | Cycle 2, 0.5 hour | 17378.2105 ng/mL | Standard Deviation 17543.51968 |
| Brentuximab Vedotin | Serum Concentration of Total Antibody (TAb) | Cycle 1, 72 hour | 9931.2943 ng/mL | Standard Deviation 4973.74692 |
| Brentuximab Vedotin | Serum Concentration of Total Antibody (TAb) | Cycle 3, Predose | 1361.3147 ng/mL | Standard Deviation 1592.89993 |
| Brentuximab Vedotin | Serum Concentration of Total Antibody (TAb) | Cycle 1, Predose | NA ng/mL | — |
| Brentuximab Vedotin | Serum Concentration of Total Antibody (TAb) | Cycle 3, 0.5 hour | 15974.3723 ng/mL | Standard Deviation 12467.10368 |
| Brentuximab Vedotin | Serum Concentration of Total Antibody (TAb) | Cycle 1, 336 hour | 2898.2924 ng/mL | Standard Deviation 1831.73997 |
| Brentuximab Vedotin | Serum Concentration of Total Antibody (TAb) | Cycle 3, 4 hour | 11609.1430 ng/mL | Standard Deviation 14719.69968 |
| Brentuximab Vedotin | Serum Concentration of Total Antibody (TAb) | Cycle 1, 4 hour | 28577.3869 ng/mL | Standard Deviation 9365.88746 |
| Brentuximab Vedotin | Serum Concentration of Total Antibody (TAb) | Cycle 3, 72 hour | 13594.2016 ng/mL | Standard Deviation 7492.70742 |
| Brentuximab Vedotin | Serum Concentration of Total Antibody (TAb) | Cycle 2, Predose | 2055.3871 ng/mL | Standard Deviation 10312.9128 |
| Brentuximab Vedotin | Serum Concentration of Total Antibody (TAb) | Cycle 3, 336 hour | 3206.6925 ng/mL | Standard Deviation 3000.22116 |
| Brentuximab Vedotin | Serum Concentration of Total Antibody (TAb) | Cycle 3, 480 hour | 1329.0886 ng/mL | Standard Deviation 2024.17213 |
| Brentuximab Vedotin | Serum Concentration of Total Antibody (TAb) | Cycle 1, 0.5 hour | 30874.4957 ng/mL | Standard Deviation 11904.18494 |
| Brentuximab Vedotin + Rifampicin | Serum Concentration of Total Antibody (TAb) | Cycle 3, 480 hour | 1866.5746 ng/mL | Standard Deviation 1326.12113 |
| Brentuximab Vedotin + Rifampicin | Serum Concentration of Total Antibody (TAb) | Cycle 1, Predose | NA ng/mL | — |
| Brentuximab Vedotin + Rifampicin | Serum Concentration of Total Antibody (TAb) | Cycle 1, 0.5 hour | 30884.9074 ng/mL | Standard Deviation 9956.67036 |
| Brentuximab Vedotin + Rifampicin | Serum Concentration of Total Antibody (TAb) | Cycle 1, 4 hour | 28865.4674 ng/mL | Standard Deviation 8192.50406 |
| Brentuximab Vedotin + Rifampicin | Serum Concentration of Total Antibody (TAb) | Cycle 1, 72 hour | 11626.2147 ng/mL | Standard Deviation 4396.55604 |
| Brentuximab Vedotin + Rifampicin | Serum Concentration of Total Antibody (TAb) | Cycle 1, 336 hour | 3066.5859 ng/mL | Standard Deviation 1017.84204 |
| Brentuximab Vedotin + Rifampicin | Serum Concentration of Total Antibody (TAb) | Cycle 2, Predose | 1363.8319 ng/mL | Standard Deviation 904.27346 |
| Brentuximab Vedotin + Rifampicin | Serum Concentration of Total Antibody (TAb) | Cycle 2, 0.5 hour | 31583.7793 ng/mL | Standard Deviation 7742.69918 |
| Brentuximab Vedotin + Rifampicin | Serum Concentration of Total Antibody (TAb) | Cycle 3, Predose | 1517.6506 ng/mL | Standard Deviation 1200.68646 |
| Brentuximab Vedotin + Rifampicin | Serum Concentration of Total Antibody (TAb) | Cycle 3, 0.5 hour | 33892.4731 ng/mL | Standard Deviation 10595.70675 |
| Brentuximab Vedotin + Rifampicin | Serum Concentration of Total Antibody (TAb) | Cycle 3, 4 hour | 27548.1773 ng/mL | Standard Deviation 7219.71925 |
| Brentuximab Vedotin + Rifampicin | Serum Concentration of Total Antibody (TAb) | Cycle 3, 72 hour | 9588.9374 ng/mL | Standard Deviation 5665.38218 |
| Brentuximab Vedotin + Rifampicin | Serum Concentration of Total Antibody (TAb) | Cycle 3, 336 hour | 3628.9175 ng/mL | Standard Deviation 1802.66091 |
Secondary
Serum Concentrations of Antibody-drug Conjugate (ADC)
The LLQ for all the observations was 12.5 ng/mL.
Time frame: Cycle 1 and 3: Predose, 0.5, 4, 72, 336 hours post-dose; Cycle 2: Predose, 0.5 hours post-dose; Cycle 3: 480 hours post-dose
Population: PK analysis set included all participants who received brentuximab vedotin at 1.8 mg/kg throughout Cycles 1 to 3 and had sufficient dosing and PK data to reliably estimate PK parameters.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| Brentuximab Vedotin | Serum Concentrations of Antibody-drug Conjugate (ADC) | Cycle 1, 4 hour | 24398.6482 ng/mL | Standard Deviation 8092.41448 |
| Brentuximab Vedotin | Serum Concentrations of Antibody-drug Conjugate (ADC) | Cycle 3, Predose | 611.0573 ng/mL | Standard Deviation 786.52082 |
| Brentuximab Vedotin | Serum Concentrations of Antibody-drug Conjugate (ADC) | Cycle 1, 336 hour | 1167.0713 ng/mL | Standard Deviation 740.0565 |
| Brentuximab Vedotin | Serum Concentrations of Antibody-drug Conjugate (ADC) | Cycle 3, 0.5 hour | 20991.9618 ng/mL | Standard Deviation 12662.05087 |
| Brentuximab Vedotin | Serum Concentrations of Antibody-drug Conjugate (ADC) | Cycle 1, 0.5 hour | 29609.7759 ng/mL | Standard Deviation 11865.35702 |
| Brentuximab Vedotin | Serum Concentrations of Antibody-drug Conjugate (ADC) | Cycle 3, 4 hour | 15378.8274 ng/mL | Standard Deviation 9550.99903 |
| Brentuximab Vedotin | Serum Concentrations of Antibody-drug Conjugate (ADC) | Cycle 2, Predose | 794.3851 ng/mL | Standard Deviation 10732.46886 |
| Brentuximab Vedotin | Serum Concentrations of Antibody-drug Conjugate (ADC) | Cycle 3, 72 hour | 3258.7237 ng/mL | Standard Deviation 3358.78504 |
| Brentuximab Vedotin | Serum Concentrations of Antibody-drug Conjugate (ADC) | Cycle 1, 72 hour | 4265.7542 ng/mL | Standard Deviation 2880.3966 |
| Brentuximab Vedotin | Serum Concentrations of Antibody-drug Conjugate (ADC) | Cycle 3, 336 hour | 1381.2290 ng/mL | Standard Deviation 1224.66857 |
| Brentuximab Vedotin | Serum Concentrations of Antibody-drug Conjugate (ADC) | Cycle 2, 0.5 hour | 16032.6494 ng/mL | Standard Deviation 15714.59821 |
| Brentuximab Vedotin | Serum Concentrations of Antibody-drug Conjugate (ADC) | Cycle 3, 480 hour | 648.2492 ng/mL | Standard Deviation 1065.26404 |
| Brentuximab Vedotin | Serum Concentrations of Antibody-drug Conjugate (ADC) | Cycle 1, Predose | NA ng/mL | — |
| Brentuximab Vedotin + Rifampicin | Serum Concentrations of Antibody-drug Conjugate (ADC) | Cycle 3, 480 hour | 734.5557 ng/mL | Standard Deviation 634.23889 |
| Brentuximab Vedotin + Rifampicin | Serum Concentrations of Antibody-drug Conjugate (ADC) | Cycle 1, Predose | NA ng/mL | — |
| Brentuximab Vedotin + Rifampicin | Serum Concentrations of Antibody-drug Conjugate (ADC) | Cycle 1, 0.5 hour | 33125.0025 ng/mL | Standard Deviation 10398.79403 |
| Brentuximab Vedotin + Rifampicin | Serum Concentrations of Antibody-drug Conjugate (ADC) | Cycle 1, 4 hour | 24533.2372 ng/mL | Standard Deviation 6767.70744 |
| Brentuximab Vedotin + Rifampicin | Serum Concentrations of Antibody-drug Conjugate (ADC) | Cycle 1, 72 hour | 5958.0569 ng/mL | Standard Deviation 1788.56378 |
| Brentuximab Vedotin + Rifampicin | Serum Concentrations of Antibody-drug Conjugate (ADC) | Cycle 1, 336 hour | 1108.6515 ng/mL | Standard Deviation 376.81123 |
| Brentuximab Vedotin + Rifampicin | Serum Concentrations of Antibody-drug Conjugate (ADC) | Cycle 2, Predose | 435.1550 ng/mL | Standard Deviation 303.25245 |
| Brentuximab Vedotin + Rifampicin | Serum Concentrations of Antibody-drug Conjugate (ADC) | Cycle 2, 0.5 hour | 31627.2566 ng/mL | Standard Deviation 6716.71906 |
| Brentuximab Vedotin + Rifampicin | Serum Concentrations of Antibody-drug Conjugate (ADC) | Cycle 3, Predose | 536.3692 ng/mL | Standard Deviation 524.72923 |
| Brentuximab Vedotin + Rifampicin | Serum Concentrations of Antibody-drug Conjugate (ADC) | Cycle 3, 0.5 hour | 33040.2245 ng/mL | Standard Deviation 6295.45517 |
| Brentuximab Vedotin + Rifampicin | Serum Concentrations of Antibody-drug Conjugate (ADC) | Cycle 3, 4 hour | 24496.7203 ng/mL | Standard Deviation 4212.84997 |
| Brentuximab Vedotin + Rifampicin | Serum Concentrations of Antibody-drug Conjugate (ADC) | Cycle 3, 72 hour | 4262.0364 ng/mL | Standard Deviation 2431.24647 |
| Brentuximab Vedotin + Rifampicin | Serum Concentrations of Antibody-drug Conjugate (ADC) | Cycle 3, 336 hour | 1363.9488 ng/mL | Standard Deviation 789.04877 |