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Relative Bioavailability of Two Different Capsule Formulations of Sitravatinib in Healthy Adults

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ClinicalTrials.gov Identifier: NCT04472650
Recruitment Status : Completed
First Posted : July 15, 2020
Results First Posted : December 27, 2021
Last Update Posted : December 27, 2021
Sponsor:
Information provided by (Responsible Party):
BeiGene

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Tumor Drug: Sitravatinib Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 26 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 1, Open-label, Single-dose, Randomized Crossover Study to Evaluate the Relative Bioavailability of Two Different Capsule Formulations of Sitravatinib in Healthy Subjects
Actual Study Start Date : July 23, 2020
Actual Primary Completion Date : November 9, 2020
Actual Study Completion Date : November 9, 2020
Arms and Interventions
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Arm Intervention/treatment
Experimental: Dosing Sequence 1: Sitravatinib Free Base then Malate Salt
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
 Drug: Sitravatinib
Administered orally as a free base capsule

Drug: Sitravatinib
Administered orally as a malate salt capsule
Experimental: Dosing Sequence 2: Sitravatinib Malate Salt then Free Base
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
 Drug: Sitravatinib
Administered orally as a free base capsule

Drug: Sitravatinib
Administered orally as a malate salt capsule


Outcome Measures
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Primary Outcome Measures :
  1. Area Under the Concentration-time Curve (AUC) From Time Zero to Infinity (AUC0-∞) of Sitravatinib [ Time Frame: Predose and 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72 and 168 hours postdose in each study period ]
  2. Area Under the Concentration-time Curve From Time Zero to Time of the Last Quantifiable Concentration (AUC0-t) of Sitravatinib [ Time Frame: Predose and 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72 and 168 hours postdose in each study period ]
  3. Maximum Observed Plasma Concentration (Cmax) of Sitravatinib [ Time Frame: Predose and 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72 and 168 hours postdose in each study period ]
  4. Time of the Maximum Observed Plasma Concentration (Tmax) of Sitravatinib [ Time Frame: Predose and 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72 and 168 hours postdose in each study period ]
  5. Apparent Terminal Elimination Half-life (T1/2) of Sitravatinib [ Time Frame: Predose and 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72 and 168 hours postdose in each study period ]
  6. Apparent Total Plasma Clearance (CL/F) of Sitravatinib [ Time Frame: Predose and 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72 and 168 hours postdose in each study period ]
  7. Apparent Volume of Distribution (Vz/F) of Sitravatinib [ Time Frame: Predose and 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72 and 168 hours postdose in each study period ]

Secondary Outcome Measures :
  1. Number of Participants With Adverse Events [ Time Frame: Up to Week 8 ]
    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


Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Key Inclusion Criteria:

  1. Body mass index between 18.0 and 32.0 kg/m2, inclusive.
  2. In good health, determined by no clinically significant findings from medical history, physical examination, 12-lead ECG, vital sign measurements, and clinical laboratory evaluations at Screening and/or Check-in as assessed by the Investigator (or designee).
  3. Able to swallow multiple capsules.

Key Exclusion Criteria:

  1. History of stomach or intestinal surgery or resection
  2. Have previously completed or withdrawn from this study or any other study investigating sitravatinib and have previously received the investigational product.
  3. Participants who, in the opinion of the Investigator (or designee), should not participate in this study.

NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04472650


Locations
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Australia, Western Australia
Linear Clinical Research Pty Lt(LCR)
Nedlands, Western Australia, Australia, 6009
Sponsors and Collaborators
BeiGene
Investigators
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Principal Investigator: Study Director BeiGene
  Study Documents (Full-Text)

Documents provided by BeiGene:
Study Protocol  [PDF] July 12, 2020
Statistical Analysis Plan  [PDF] September 9, 2020

More Information
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Responsible Party: BeiGene
ClinicalTrials.gov Identifier: NCT04472650    
Other Study ID Numbers: BGB-Sitravatinib-101
First Posted: July 15, 2020    Key Record Dates
Results First Posted: December 27, 2021
Last Update Posted: December 27, 2021
Last Verified: November 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes