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The primary objective of the study was to investigate the relative bioavailability and pharmacokinetics (PK) of sitravatinib free base and malate salt capsule formulations following oral administration in healthy adults.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dosing Sequence 1: Sitravatinib Free Base then Malate Salt | Experimental | Sitravatinib free base capsule 120 mg on Day 1 in Period 1 then sitravatinib malate salt capsule 100 mg on Day 1 in Period 2, with a minimum washout period between dose administrations of 14 days |
|
| Dosing Sequence 2: Sitravatinib Malate Salt then Free Base | Experimental | Sitravatinib malate salt capsule 100 mg on Day 1 in Period 1 then sitravatinib free base capsule 120 mg on Day 1 in Period 2, with a minimum washout period between dose administrations of 14 days |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sitravatinib | Drug | Administered orally as a free base capsule |
|
| Measure | Description | Time Frame |
|---|---|---|
| Area Under the Concentration-time Curve (AUC) From Time Zero to Infinity (AUC0-∞) of Sitravatinib | Predose and 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72 and 168 hours postdose in each study period | |
| Area Under the Concentration-time Curve From Time Zero to Time of the Last Quantifiable Concentration (AUC0-t) of Sitravatinib | Predose and 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72 and 168 hours postdose in each study period | |
| Maximum Observed Plasma Concentration (Cmax) of Sitravatinib | Predose and 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72 and 168 hours postdose in each study period | |
| Time of the Maximum Observed Plasma Concentration (Tmax) of Sitravatinib | Predose and 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72 and 168 hours postdose in each study period | |
| Apparent Terminal Elimination Half-life (T1/2) of Sitravatinib | Predose and 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72 and 168 hours postdose in each study period | |
| Apparent Total Plasma Clearance (CL/F) of Sitravatinib | Predose and 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72 and 168 hours postdose in each study period | |
| Apparent Volume of Distribution (Vz/F) of Sitravatinib | Predose and 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72 and 168 hours postdose in each study period |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Adverse Events | Adverse events (AEs) and serious adverse events are defined as an AE that starts during or after the first dose, or starts prior to the first dose and increases in severity after the first dose, including vital signs, physical examination, electrocardiogram, and laboratory parameters | Up to Week 8 |
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Key Inclusion Criteria:
Key Exclusion Criteria:
NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
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| Name | Affiliation | Role |
|---|---|---|
| Study Director | BeiGene | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Linear Clinical Research | Nedlands | Western Australia | 6009 | Australia |
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Participants were randomized in a 1:1 ratio in two dosing sequences in a 2-period crossover design at a single site in Australia. Periods 1 and 2 were separated by a minimum of 14 days between dose administrations. Total duration of study participation was up to approximately 8 weeks.
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| ID | Title | Description |
|---|---|---|
| FG000 | Dosing Sequence 1: Sitravatinib Free Base Capsule Then Malate Salt Capsule | Sitravatinib free base capsule 120 mg on Day 1 of Period 1 then sitravatinib malate salt capsule 100 mg on Day 1 of Period 2, with a minimum washout period between dose administrations of 14 days |
| FG001 | Dosing Sequence 2: Sitravatinib Malate Salt Capsule Then Free Base Capsule | Sitravatinib malate salt capsule 100 mg on Day 1 of Period 1 then sitravatinib free base capsule 120 mg on Day 1 of Period 2, with a minimum washout period between dose administrations of 14 days |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Period 1 (Up to 15 Days) |
| |||||||||||||
| Washout Period (Minimum 14 Days) |
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| Period 2 (Up to 15 Days) |
|
Safety Analysis Set included participants who received at least 1 dose of sitravatinib
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| ID | Title | Description |
|---|---|---|
| BG000 | Dosing Sequence 1: Sitravatinib Free Base Capsule Then Malate Salt Capsule | Sitravatinib free base capsule 120 mg on Day 1 of Period 1 then sitravatinib malate salt capsule 100 mg on Day 1 of Period 2, with a minimum washout period between dose administrations of 14 days |
| BG001 | Dosing Sequence 2: Sitravatinib Malate Salt Capsule Then Free Base Capsule |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Area Under the Concentration-time Curve (AUC) From Time Zero to Infinity (AUC0-∞) of Sitravatinib | Pharmacokinetic (PK) parameters analysis set included all participants who received at least 1 dose of sitravatinib and had at least 1 PK parameter of sitravatinib | Posted | Geometric Mean | Geometric Coefficient of Variation | h*ng/mL | Predose and 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72 and 168 hours postdose in each study period |
|
Up to Week 8
Safety Analysis Set included participants who received at least 1 dose of sitravatinib
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Sitravatinib Malate Salt Capsule | Sitravatinib malate salt capsule 100 mg on Day 1 in Periods 1 and 2, with a minimum washout period between dose administrations of 14 days |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 23.0 | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Study Director | BeiGene | +1-877-828-5568 | clinicaltrials@beigene.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jul 12, 2020 | Nov 4, 2021 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Sep 9, 2020 | Nov 4, 2021 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| C000611865 | sitravatinib |
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| Sitravatinib | Drug | Administered orally as a malate salt capsule |
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| NOT COMPLETED |
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| NOT COMPLETED |
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Sitravatinib malate salt capsule 100 mg on Day 1 of Period 1 then sitravatinib free base capsule 120 mg on Day 1 of Period 2, with a minimum washout period between dose administrations of 14 days |
| BG002 | Total | Total of all reporting groups |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
|
|
|
| Primary | Area Under the Concentration-time Curve From Time Zero to Time of the Last Quantifiable Concentration (AUC0-t) of Sitravatinib | Pharmacokinetic (PK) parameters analysis set included all participants who received at least 1 dose of sitravatinib and had at least 1 PK parameter of sitravatinib | Posted | Geometric Mean | Geometric Coefficient of Variation | h*ng/mL | Predose and 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72 and 168 hours postdose in each study period |
|
|
|
|
| Primary | Maximum Observed Plasma Concentration (Cmax) of Sitravatinib | Pharmacokinetic (PK) parameters analysis set included all participants who received at least 1 dose of sitravatinib and had at least 1 PK parameter of sitravatinib | Posted | Geometric Mean | Geometric Coefficient of Variation | ng/mL | Predose and 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72 and 168 hours postdose in each study period |
|
|
|
|
| Primary | Time of the Maximum Observed Plasma Concentration (Tmax) of Sitravatinib | Pharmacokinetic (PK) parameters analysis set included all participants who received at least 1 dose of sitravatinib and had at least 1 PK parameter of sitravatinib | Posted | Median | Full Range | Hours | Predose and 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72 and 168 hours postdose in each study period |
|
|
|
| Primary | Apparent Terminal Elimination Half-life (T1/2) of Sitravatinib | Pharmacokinetic (PK) parameters analysis set included all participants who received at least 1 dose of sitravatinib and had at least 1 PK parameter of sitravatinib | Posted | Median | Full Range | Hours | Predose and 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72 and 168 hours postdose in each study period |
|
|
|
| Primary | Apparent Total Plasma Clearance (CL/F) of Sitravatinib | Pharmacokinetic (PK) parameters analysis set included all participants who received at least 1 dose of sitravatinib and had at least 1 PK parameter of sitravatinib | Posted | Geometric Mean | Geometric Coefficient of Variation | Liters/hour | Predose and 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72 and 168 hours postdose in each study period |
|
|
|
| Primary | Apparent Volume of Distribution (Vz/F) of Sitravatinib | Pharmacokinetic (PK) parameters analysis set included all participants who received at least 1 dose of sitravatinib and had at least 1 PK parameter of sitravatinib | Posted | Geometric Mean | Geometric Coefficient of Variation | Liters | Predose and 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72 and 168 hours postdose in each study period |
|
|
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| Secondary | Number of Participants With Adverse Events | Adverse events (AEs) and serious adverse events are defined as an AE that starts during or after the first dose, or starts prior to the first dose and increases in severity after the first dose, including vital signs, physical examination, electrocardiogram, and laboratory parameters | Safety Analysis Set included participants who received at least 1 dose of sitravatinib | Posted | Count of Participants | Participants | Up to Week 8 |
|
|
|
| 0 |
| 25 |
| 0 |
| 25 |
| 10 |
| 25 |
| EG001 | Sitravatinib Free Base Capsule | Sitravatinib free base capsule 120 mg (reference) on Day 1 in Periods 1 and 2, with a minimum washout period between dose administrations of 14 days | 0 | 26 | 0 | 26 | 8 | 26 |
| Neutropenia | Blood and lymphatic system disorders | MedDRA 23.0 | Non-systematic Assessment |
|
| Abdominal discomfort | Gastrointestinal disorders | MedDRA 23.0 | Non-systematic Assessment |
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| Diarrhoea | Gastrointestinal disorders | MedDRA 23.0 | Non-systematic Assessment |
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| Nausea | Gastrointestinal disorders | MedDRA 23.0 | Non-systematic Assessment |
|
| Palatal ulcer | Gastrointestinal disorders | MedDRA 23.0 | Non-systematic Assessment |
|
| Catheter site bruise | General disorders | MedDRA 23.0 | Non-systematic Assessment |
|
| Catheter site pain | General disorders | MedDRA 23.0 | Non-systematic Assessment |
|
| Catheter site related reaction | General disorders | MedDRA 23.0 | Non-systematic Assessment |
|
| Vessel puncture site bruise | General disorders | MedDRA 23.0 | Non-systematic Assessment |
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| Vessel puncture site pain | General disorders | MedDRA 23.0 | Non-systematic Assessment |
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| Alanine aminotransferase increased | Investigations | MedDRA 23.0 | Non-systematic Assessment |
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| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 23.0 | Non-systematic Assessment |
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| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA 23.0 | Non-systematic Assessment |
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| Dizziness | Nervous system disorders | MedDRA 23.0 | Non-systematic Assessment |
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| Headache | Nervous system disorders | MedDRA 23.0 | Non-systematic Assessment |
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| Hypoaesthesia | Nervous system disorders | MedDRA 23.0 | Non-systematic Assessment |
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| Lethargy | Nervous system disorders | MedDRA 23.0 | Non-systematic Assessment |
|
| Dermatitis contact | Skin and subcutaneous tissue disorders | MedDRA 23.0 | Non-systematic Assessment |
|
BeiGene has 18 months from the end of the study at all sites to publish overall study results. After the 1st multi-site publication or the expiration of publication period, Investigators are free to publish/present the results of the study. Investigators must submit all draft publications/presentations to us for review 60 days prior to the planned publication/presentation date. BeiGene may request deletion of its confidential information and may request a further delay to protect its IP rights.
| Serious adverse events |
|
| TEAE leading to permanent discontinuation of study treatment |
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| TEAE leading to death |
|