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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

26 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-07-23

Study Completion Date

2020-11-09

Brief Summary

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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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Detailed Description

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Conditions

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Tumor

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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

Group Type EXPERIMENTAL

Sitravatinib

Intervention Type DRUG

Administered orally as a free base capsule

Sitravatinib

Intervention Type DRUG

Administered orally as a malate salt capsule

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

Group Type EXPERIMENTAL

Sitravatinib

Intervention Type DRUG

Administered orally as a free base capsule

Sitravatinib

Intervention Type DRUG

Administered orally as a malate salt capsule

Interventions

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Sitravatinib

Administered orally as a free base capsule

Intervention Type DRUG

Sitravatinib

Administered orally as a malate salt capsule

Intervention Type DRUG

Eligibility Criteria

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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.

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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes