TumorPhase 1NCT04472650

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

A Phase 1 study testing Sitravatinib in people with Tumor, run by BeiGene at 1 site in Australia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial 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. Read more about this study

Who is it for?: Ages 18 to 55 years, men onlyHealthy volunteers can take part
Conditions the study is for: Tumor
What is being tested?: Sitravatinib
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 26 participants
Where: 1 siteAustralia
Study dates: 23 Jul 2020to 9 Nov 2020
Phase: Phase 1
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 55 years
Men only
Healthy volunteers accepted
Adult

Who may be able to join

Body mass index between 18.0 and 32.0 kg/m2, inclusive.
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).
Able to swallow multiple capsules.

Who cannot join

History of stomach or intestinal surgery or resection
Have previously completed or withdrawn from this study or any other study investigating sitravatinib and have previously received the investigational product.
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.

Trial locations and contacts

1 site in 1 country.

Australia1 site

Linear Clinical Research
Nedlands, Western Australia, 6009

Other trials in Australia

About this study

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

Conditions: Tumor
Being tested: Sitravatinib
Medical subject headings: Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

SitravatinibDrug
Administered orally as a free base capsule
SitravatinibDrug
Administered orally as a malate salt capsule

Study groups in NCT04472650
Study group	Role	What they receive
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 Receives: Drug: Sitravatinib
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 Receives: Drug: Sitravatinib

What is being measured

The primary outcome is the main question the study is designed to answer.

Area Under the Concentration-time Curve (AUC) From Time Zero to Infinity (AUC0-∞) of Sitravatinib
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: Predose and 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72 and 168 hours postdose in each study period

Secondary outcomes (1)

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
Measured: Up to Week 8

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

23 Jul 20209 Nov 2020

First posted15 Jul 2020
Study start23 Jul 2020
Primary completion9 Nov 2020
Study completion9 Nov 2020

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for TumorStudies of the same condition, open and under way.
More trials run by BeiGeneThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Enrolment: 26 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04472650
Sponsor's protocol ID: BGB-Sitravatinib-101
Status last verified: Oct 2024
First submitted: 14 Jul 2020
Last updated: 26 Oct 2024
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: Yes

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Tumor trials

Study at a glance

From the registry record, last updated by the sponsor on 26 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT04472650
Acronym / sponsor ID: BGB-Sitravatinib-101
Conditions: Tumor
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 26 participants (actual)
Lead sponsor: BeiGeneIndustry (pharma, biotech, devices)
Study start: 23 Jul 2020 (actual)
Primary completion: 9 Nov 2020 (actual)
Study completion: 9 Nov 2020 (actual)
First posted: 15 Jul 2020 (actual)
Results: Posted 27 Dec 2021

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Dosing Sequence 1: Sitravatinib Free Base then Malate Salt	Experimental	Drug: SitravatinibSitravatinib 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	Drug: SitravatinibSitravatinib 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

Who may qualify

Ages: 18 to 55 years
Sex: Male only
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (3 listed)

Body mass index between 18.0 and 32.0 kg/m2, inclusive.
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).
Able to swallow multiple capsules.

Key exclusion criteria (4 listed)

History of stomach or intestinal surgery or resection
Have previously completed or withdrawn from this study or any other study investigating sitravatinib and have previously received the investigational product.
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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
SitravatinibAdministered orally as a free base capsule	Drug	Dosing Sequence 1: Sitravatinib Free Base then Malate Salt, Dosing Sequence 2: Sitravatinib Malate Salt then Free Base
SitravatinibAdministered orally as a malate salt capsule	Drug	Dosing Sequence 1: Sitravatinib Free Base then Malate Salt, Dosing Sequence 2: Sitravatinib Malate Salt then Free Base

Primary outcome

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
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
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
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
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
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
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

1 secondary outcome

Number of Participants With Adverse Events
Time frame: Up to Week 8

Results and safety

Results posted to the registry on 27 Dec 2021, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Dosing Sequence 1: Sitravatinib Free Base Capsule Then Malate Salt Capsule	13	13
Dosing Sequence 2: Sitravatinib Malate Salt Capsule Then Free Base Capsule	13	13

Primary outcome: 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. Geometric mean (Geometric Coefficient of Variation). Unit: h*ng/mL

Measure	Sitravatinib Malate Salt Capsule n = 25	Sitravatinib Free Base Capsule n = 26
Value	2524.7 (28.8)	2892.6 (34.5)

Sitravatinib Malate Salt Capsule vs Sitravatinib Free Base Capsule: Ratio of Geometric Least Squares Means: 87.63 (90% CI 78.273 to 98.111)

Population analysed: 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

Primary outcome: 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. Geometric mean (Geometric Coefficient of Variation). Unit: h*ng/mL

Measure	Sitravatinib Malate Salt Capsule n = 25	Sitravatinib Free Base Capsule n = 26
Value	2458.4 (28.2)	2821.8 (34.3)

Sitravatinib Malate Salt Capsule vs Sitravatinib Free Base Capsule: Ratio of Geometric Least Squares Means: 87.50 (90% CI 78.12 to 98.01)

Population analysed: 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

Primary outcome: 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. Geometric mean (Geometric Coefficient of Variation). Unit: ng/mL

Measure	Sitravatinib Malate Salt Capsule n = 25	Sitravatinib Free Base Capsule n = 26
Value	54.96 (32.9)	62.40 (37.7)

Sitravatinib Malate Salt Capsule vs Sitravatinib Free Base Capsule: Ratio of Geometric Least Squares Means: 88.80 (90% CI 77.41 to 101.87)

Population analysed: 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

Primary outcome: 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. Median (Full Range). Unit: Hours

Measure	Sitravatinib Malate Salt Capsule n = 25	Sitravatinib Free Base Capsule n = 26
Value	8.000 (6.00 to 12.02)	8.000 (6.00 to 12.00)

Population analysed: 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

1 secondary outcome is reported in the full results.

Adverse events

Time frame: Up to Week 8. Other adverse events reported at 3% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Sitravatinib Malate Salt Capsule	0 of 25 (0%)	10 of 25 (40%)	0 of 25
Sitravatinib Free Base Capsule	0 of 26 (0%)	8 of 26 (30.8%)	0 of 26

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: Yes

Related trials for Tumor

Not yet recruitingPhase 1
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RecruitingPhase 2
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Active, not recruitingPhase 1/2
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Recruiting
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Study Director principal investigator

BeiGene

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Sitravatinib in people with Tumor, run by BeiGene at 1 site in Australia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 26 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 27 Dec 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04472650.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Oct 2024.