PharmacokineticsPhase 1NCT05967377

Evaluating the Pharmacokinetic Parameters and Relative Bioavailability of Sorafenib (XS005) in Healthy Male Subjects

A Phase 1 study testing Sorafenib - Period 1, XS005 Sorafenib Capsule A - Period 1 and XS005 Sorafenib Tablet A - Period 1 in people with Pharmacokinetics and Bioavailability, run by Xspray Pharma AB at 1 site in United Kingdom.

Completed

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

Official record

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Trial summary

This is a single centre, open-label, randomised, single dose, 3-way crossover comparative (PK) and bioavailability study in healthy male subjects comparing a 200 mg Sorafenib (Nexavar®) reference tablet (Regimen A) to XS005 Sorafenib Capsule A, 2 x 50 mg (Regimen B) and XS005 Sorafenib Tablet A,100 mg (Regimen C)… 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: Pharmacokinetics, Bioavailability
What is being tested?: Sorafenib - Period 1, XS005 Sorafenib Capsule A - Period 1 and XS005 Sorafenib Tablet A - Period 1
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 15 participants
Where: 1 siteUnited Kingdom
Study dates: 16 Nov 2018to 12 Feb 2019
Phase: Phase 1
Are there results?: None posted in the registry

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

Healthy males.
Age 18 to 55 years of age.
Body mass index (BMI) of 18.0 to 32.0 kg/m2.
Must be willing and able to communicate and participate in the whole study.
Must provide written informed consent.
Good state of health (mentally and physically) as indicated by a comprehensive clinical assessment (detailed medical history and a complete physical examination), ECG and laboratory investigations (haematology, biochemistry and urinalysis).
Must adhere to the contraception requirements.

Who cannot join

Subjects who have received any IMP in a clinical research study within the previous 3 months.
Subjects who are study site employees, or immediate family members of a study site or sponsor employee.
Subjects who have previously been enrolled in this study.
History of any drug or alcohol abuse in the past 2 years.
Regular alcohol consumption >21 units per week (1 unit = ½ pint beer, or a 25 mL shot of 40% spirit, 1.5 to 2 Units = 125 mL glass of wine, depending on type).
Current smokers and those who have smoked within the last 12 months. A breath carbon monoxide reading of greater than 10 ppm at screening and admission.

Show all 20Show fewer

Current users of e-cigarettes and nicotine replacement products and those who have used these products within the last 12 months.
Subjects who do not have suitable veins for multiple venepunctures/cannulation as assessed by the investigator at screening.
Clinically significant abnormal biochemistry, haematology or urinalysis as judged by the investigator.
Subjects has amylase or lipase result exceeding >1.5 x upper limit of normal (ULN) at screening.
Positive drugs of abuse or alcohol breath test result.
Positive hepatitis B surface antigen (HBsAg), hepatitis C virus antibody (HCV Ab) or human immunodeficiency virus (HIV) results.
History of clinically significant cardiovascular, renal, hepatic, chronic respiratory or gastrointestinal disease, neurological or psychiatric disorder, as judged by the investigator.
Subject has a QT interval corrected by Fredericia (QTcF) >450 ms based on ECG at screening or at pre-dose Period 1 or a history of additional risk factors for Torsades de Pointe (eg hypokalaemia, hypomagnesia, a family history of long QT syndrome).
Serious adverse reaction or serious hypersensitivity to any drug or the formulation excipients.
Presence or history of clinically significant allergy requiring treatment, as judged by the investigator. Hayfever is allowed unless it is active.
Donation or loss of greater than 400 mL of blood within the previous 3 months.
Subjects who are taking, or have taken, any prescribed or over-the-counter drug (other than 4 g per day paracetamol) or herbal remedies in the 14 days before IMP administration. Exceptions may apply on a case by case basis, if considered not to interfere with the objectives of the study, as agreed by the PI and sponsor's medical monitor.
Subjects with pregnant partners.
Failure to satisfy the investigator of fitness to participate for any other reason.

Trial locations and contacts

1 site in 1 country.

United Kingdom1 site

Quotient Sciences
Nottingham, NG11 6JS

Other trials in United Kingdom

About this study

Official title: A Single Part, Open-Label, Randomised, Three-Way Crossover Study Designed to Evaluate the Pharmacokinetic Parameters and Relative Bioavailability of Sorafenib From Sorafenib (XS005) Tablets and Capsules Compared With Nexavar® (Reference Product) in Healthy Male Subjects

Conditions: Pharmacokinetics, Bioavailability
Being tested: Sorafenib - Period 1, XS005 Sorafenib Capsule A - Period 1, XS005 Sorafenib Tablet A - Period 1, XS005 Sorafenib Capsule A - Period 2, XS005 Sorafenib Tablet A - Period 2

What participants receive

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

Sorafenib - Period 1Drug
Also called Regimen A (reference)
Sorafenib (Nexavar®) Tablet, 200 mg
XS005 Sorafenib Capsule A - Period 1Drug
Also called Regimen B
XS005 Sorafenib Capsule A, 100 mg (2 x 50 mg)
XS005 Sorafenib Tablet A - Period 1Drug
Also called Regimen C
XS005 Sorafenib Tablet A, 100 mg
XS005 Sorafenib Capsule A - Period 2Drug
Also called Regimen B
XS005 Sorafenib Capsule A, 100 mg (2 x 50 mg)
XS005 Sorafenib Tablet A - Period 2Drug
Also called Regimen C
XS005 Sorafenib Tablet A, 100 mg
Sorafenib - Period 2Drug
Also called Regimen A (reference)
Sorafenib (Nexavar®) Tablet, 200 mg
XS005 Sorafenib Tablet A - Period 3Drug
Also called Regimen C
XS005 Sorafenib Tablet A, 100 mg
Sorafenib - Period 3Drug
Also called Regimen A (reference)
Sorafenib (Nexavar®) Tablet, 200 mg
XS005 Sorafenib Capsule A - Period 3Drug
Also called Regimen B
XS005 Sorafenib Capsule A, 100 mg (2 x 50 mg)

Study groups in NCT05967377
Study group	Role	What they receive
Sorafenib - Period 1	Active comparator	Subjects were admitted to the clinical unit in the morning of Day 1, and dosed with 200 mg Sorafenib (Nexavar®) in the morning of Day 1 following an overnight fast of a minimum of 10 h. Subjects remained in clinical unit until 24 h post dose (Day 2) when they were discharged from the clinical unit, and then returned to the clinical unit at 48 h and 72 h post-dose (Days 3 and 4) for a PK blood sample.The minimum washout before the next dosing period was 10 days. Receives: Drug: Sorafenib - Period 1
XS005 Sorafenib Capsule A - Period 1	Experimental	Subjects were admitted to the clinical unit in the morning of Day 1, and dosed with 100 mg (2 x 50 mg) XS005 Sorafenib Capsule A in the morning of Day 1 following an overnight fast of a minimum of 10 h. Subjects remained in clinical unit until 24 h post dose (Day 2) when they were discharged from the clinical unit, and then returned to the clinical unit at 48 h and 72 h post-dose (Days 3 and 4) for a PK blood sample.The minimum washout before the next dosing period was 10 days. Receives: Drug: XS005 Sorafenib Capsule A - Period 1
XS005 Sorafenib Tablet A - Period 1	Experimental	Subjects were admitted to the clinical unit in the morning of Day 1, and dosed with 100 mg XS005 Sorafenib Tablet A in the morning of Day 1 following an overnight fast of a minimum of 10 h. Subjects remained in clinical unit until 24 h post dose (Day 2) when they were discharged from the clinical unit, and then returned to the clinical unit at 48 h and 72 h post-dose (Days 3 and 4) for a PK blood sample.The minimum washout before the next dosing period was 10 days. Receives: Drug: XS005 Sorafenib Tablet A - Period 1
XS005 Sorafenib Capsule A - Period 2	Experimental	Subjects were admitted to the clinical unit in the morning of Day 1, and dosed with 100 mg (2 x 50 mg) XS005 Sorafenib Capsule A in the morning of Day 1 following an overnight fast of a minimum of 10 h. Subjects remained in clinical unit until 24 h post dose (Day 2) when they were discharged from the clinical unit, and then returned to the clinical unit at 48 h and 72 h post-dose (Days 3 and 4) for a PK blood sample.The minimum washout before the next dosing period was 10 days. Receives: Drug: XS005 Sorafenib Capsule A - Period 2
XS005 Sorafenib Tablet A - Period 2	Experimental	Subjects were admitted to the clinical unit in the morning of Day 1, and dosed with 100 mg XS005 Sorafenib Tablet A in the morning of Day 1 following an overnight fast of a minimum of 10 h. Subjects remained in clinical unit until 24 h post dose (Day 2) when they were discharged from the clinical unit, and then returned to the clinical unit at 48 h and 72 h post-dose (Days 3 and 4) for a PK blood sample.The minimum washout before the next dosing period was 10 days. Receives: Drug: XS005 Sorafenib Tablet A - Period 2
Sorafenib - Period 2	Active comparator	Subjects were admitted to the clinical unit in the morning of Day 1, and dosed with 200 mg Sorafenib (Nexavar®) in the morning of Day 1 following an overnight fast of a minimum of 10 h. Subjects remained in clinical unit until 24 h post dose (Day 2) when they were discharged from the clinical unit, and then returned to the clinical unit at 48 h and 72 h post-dose (Days 3 and 4) for a PK blood sample.The minimum washout before the next dosing period was 10 days. Receives: Drug: Sorafenib - Period 2
XS005 Sorafenib Tablet A - Period 3	Experimental	Subjects were admitted to the clinical unit in the morning of Day 1, and dosed with 100 mg XS005 Sorafenib Tablet A in the morning of Day 1 following an overnight fast of a minimum of 10 h. Subjects remained in clinical unit until 24 h post dose (Day 2) when they were discharged from the clinical unit, and then returned to the clinical unit at 48 h and 72 h post-dose (Days 3 and 4) for a PK blood sample.The minimum washout before the next dosing period was 10 days. Receives: Drug: XS005 Sorafenib Tablet A - Period 3
Sorafenib - Period 3	Active comparator	Subjects were admitted to the clinical unit in the morning of Day 1, and dosed with 200 mg Sorafenib (Nexavar®) in the morning of Day 1 following an overnight fast of a minimum of 10 h. Subjects remained in clinical unit until 24 h post dose (Day 2) when they were discharged from the clinical unit, and then returned to the clinical unit at 48 h and 72 h post-dose (Days 3 and 4) for a PK blood sample.The minimum washout before the next dosing period was 10 days. Receives: Drug: Sorafenib - Period 3
XS005 Sorafenib Capsule A - Period 3	Experimental	Subjects were admitted to the clinical unit in the morning of Day 1, and dosed with 100 mg (2 x 50 mg) XS005 Sorafenib Capsule A in the morning of Day 1 following an overnight fast of a minimum of 10 h. Subjects remained in clinical unit until 24 h post dose (Day 2) when they were discharged from the clinical unit, and then returned to the clinical unit at 48 h and 72 h post-dose (Days 3 and 4) for a PK blood sample.The minimum washout before the next dosing period was 10 days. Receives: Drug: XS005 Sorafenib Capsule A - Period 3

What is being measured

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

Time of Maximum Observed Plasma Concentration (Tmax) of XS005 and Nexavar®
The pharmacokinetic parameters (Tmax) were determined for the test and reference products (XS005 Sorafenib Capsule A, 2 x 50 mg and XS005 Tablet A, 100 mg and reference Sorafenib tablets (Nexavar®), respectively) for each subject using non-compartmental methods.
Measured: For each study period, blood samples collected at 15 time points (including pre-dose) during the study period on Day 1 and Day 4.
Maximum Observed Plasma Concentration (Cmax) of XS005 and Nexavar®
The pharmacokinetic parameters (Cmax) were determined for the test and reference products (XS005 Sorafenib Capsule A, 2 x 50 mg and XS005 Tablet A, 100 mg and reference Sorafenib tablets (Nexavar®), respectively) for each subject using non-compartmental methods.
Measured: For each study period, blood samples collected at 15 time points (including pre-dose) during the study period on Day 1 and Day 4.
Area Under the Plasma Concentration-Time Curve from 0 time to the last measurable of concentration AUC(0-last) of XS005 and Nexavar®
The pharmacokinetic parameters AUC(0-last) were determined for the test and reference products (XS005 Sorafenib Capsule A, 2 x 50 mg and XS005 Tablet A, 100 mg and reference Sorafenib tablets (Nexavar®), respectively) for each subject using non-compartmental methods.
Measured: For each study period, blood samples collected at 15 time points (including pre-dose) during the study period on Day 1 and Day 4.
Area Under the Plasma Concentration-Time Curve from 0 time Extrapolated to Infinity (AUC0-inf) of XS005 and Nexavar®
The pharmacokinetic parameters (AUC 0-inf) were determined for the test and reference products (XS005 Sorafenib Capsule A, 2 x 50 mg and XS005 Tablet A, 100 mg and reference Sorafenib tablets (Nexavar®), respectively) for each subject using non-compartmental methods.
Measured: For each study period, blood samples collected at 15 time points (including pre-dose) during the study period on Day 1 and Day 4.
Plasma half-life of drug (T1/2) of XS005 and Nexavar®
The pharmacokinetic parameters (T1/2) were determined for the test and reference products (XS005 Sorafenib Capsule A, 2 x 50 mg and XS005 Tablet A, 100 mg and reference Sorafenib tablets (Nexavar®), respectively) for each subject using non-compartmental methods.
Measured: For each study period, blood samples collected at 15 time points (including pre-dose) during the study period on Day 1 and Day 4.
Relative bioavailability (Frel) of XS005 and Nexavar®
The relative bioavailability (Frel) of Sorafenib following administration of XS005 Sorafenib Capsule A, 50 mg and Tablet A, 100 mg compared to reference Sorafenib tablets (Nexavar®).
Measured: For each study period, blood samples collected at 15 time points (including pre-dose) during the study period on Day 1 and Day 4.

Secondary outcomes (15)

Treatment-emergent adverse events (TEAEs) (ie those beginning after dosing with study drug)
The safety parameters TEAEs were were determined for XS005 Sorafenib Capsule A, 50 mg and Tablet A, 100 mg compared to reference Sorafenib tablets (Nexavar®) for each study subjects using descriptive statistics.
Measured: Adverse event (AE) information collected through study completion, an average of 10 weeks.
Systolic Blood Pressure (mmHg)
The safety parameters Systolic Blood Pressure (mmHg) were determined for XS005 Sorafenib Capsule A, 50 mg and Tablet A, 100 mg compared to reference Sorafenib tablets (Nexavar®) for each study subjects using descriptive statistics.
Measured: For each study period, Systolic Blood Pressure were collected at 4 time points (including pre-dose) during the study period on Day 1 and Day 2.
Diastolic Blood Pressure (mmHg)
The safety parameters Diastolic Blood Pressure (mmHg) were determined for XS005 Sorafenib Capsule A, 50 mg and Tablet A, 100 mg compared to reference Sorafenib tablets (Nexavar®) for each study subjects using descriptive statistics.
Measured: For each study period, Diastolic Blood Pressure were collected at 4 time points (including pre-dose) during the study period on Day 1 and Day 2.
Heart Rate (HR) (bpm)
The safety parameters HR summarizes were determined for XS005 Sorafenib Capsule A, 50 mg and Tablet A, 100 mg compared to reference Sorafenib tablets (Nexavar®) for each study subjects using descriptive statistics.
Measured: For each study period, HR were collected at 4 time points (including pre-dose) during the study period on Day 1 and Day 2.
ECG (12-lead electrocardiogram) - Ventricular Rate (HR) (bpm)
The safety parameters ECG - Ventricular Rate were determined for XS005 Sorafenib Capsule A, 50 mg and Tablet A, 100 mg compared to reference Sorafenib tablets (Nexavar®) for each study subjects using descriptive statistics.
Measured: For each study period, ECG were collected at 4 time points (including pre-dose) during the study period on Day 1 and Day 2.
ECG (12-lead electrocardiogram) - PR Interval (msec)
The safety parameters ECG - PR Interval were determined for XS005 Sorafenib Capsule A, 50 mg and Tablet A, 100 mg compared to reference Sorafenib tablets (Nexavar®) for each study subjects using descriptive statistics.
Measured: For each study period, ECG were collected at 4 time points (including pre-dose) during the study period on Day 1 and Day 2.
ECG (12-lead electrocardiogram) - QRS Duration (msec)
The safety parameters ECG - QRS Duration were determined for XS005 Sorafenib Capsule A, 50 mg and Tablet A, 100 mg compared to reference Sorafenib tablets (Nexavar®) for each study subjects using descriptive statistics.
Measured: For each study period, ECG were collected at 4 time points (including pre-dose) during the study period on Day 1 and Day 2.
ECG (12-lead electrocardiogram) - QT Interval (msec)
The safety parameters ECG - QT Interval were determined for XS005 Sorafenib Capsule A, 50 mg and Tablet A, 100 mg compared to reference Sorafenib tablets (Nexavar®) for each study subjects using descriptive statistics.
Measured: For each study period, ECG were collected at 4 time points (including pre-dose) during the study period on Day 1 and Day 2.
ECG (12-lead electrocardiogram) - QRS Axis (°)
The safety parameters ECG - QRS Axis were determined for XS005 Sorafenib Capsule A, 50 mg and Tablet A, 100 mg compared to reference Sorafenib tablets (Nexavar®) for each study subjects using descriptive statistics.
Measured: For each study period, ECG were collected at 4 time points (including pre-dose) during the study period on Day 1 and Day 2.
ECG (12-lead electrocardiogram) - QTcF Interval (msec)
The safety parameters ECG - QTcF Interval were determined for XS005 Sorafenib Capsule A, 50 mg and Tablet A, 100 mg compared to reference Sorafenib tablets (Nexavar®) for each study subjects using descriptive statistics.
Measured: For each study period, ECG were collected at 4 time points (including pre-dose) during the study period on Day 1 and Day 2.
Number of participants with abnormal laboratory values of Clinical Chemistry
The safety parameters Clinical Chemistry were determined for XS005 Sorafenib Capsule A, 50 mg and Tablet A, 100 mg compared to reference Sorafenib tablets (Nexavar®) for each study subjects using descriptive statistics and presented as number of participants with abnormal laboratory values
Measured: For each study period, blood samples were collected at 2 time points (including pre-dose) during the study period on Day 1 and Day 2.
Number of participants with abnormal hematology values
The safety parameters Haematology were determined for XS005 Sorafenib Capsule A, 50 mg and Tablet A, 100 mg compared to reference Sorafenib tablets (Nexavar®) for each study subjects using descriptive statistics and presented as number of participants with abnormal laboratory values
Measured: For each study period, blood samples were collected at 2 time points (including pre-dose) during the study period on Day1 and Day 2.
Number of participants with abnormal urinalysis values
The safety parameters Urinalysis were determined for XS005 Sorafenib Capsule A, 50 mg and Tablet A, 100 mg compared to reference Sorafenib tablets (Nexavar®) for each study subjects using descriptive statistics and presented as number of participants with abnormal laboratory values.
Measured: For each study period, urine samples were collected at 2 time points (including pre-dose) during the study period on Day1 and Day 2.
Number of participants with abnormal physical examination outcome
The safety parameters physical examination outcome were determined for XS005 Sorafenib Capsule A, 50 mg and Tablet A, 100 mg compared to reference Sorafenib tablets (Nexavar®) for each study subjects using descriptive statistics and presented as number of subjects with abnormal physical examination outcome.
Measured: For each study period, target (symptom driven) physical examination; each subject was assessed by a physician and a physical examination was performed if the subject reported any AEs, on Day 2.
Number of participants with abnormal skin examination outcome
The safety parameters Skin assessment outcome were determined for XS005 Sorafenib Capsule A, 50 mg and Tablet A, 100 mg compared to reference Sorafenib tablets (Nexavar®) for each study subjects using descriptive statistics and presented as number of subjects with abnormal skin examination outcome.
Measured: For each study period, skin assessments were done at 2 time points (including pre-dose) during the study period on Day 1 and Day 2.

Timeline

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

16 Nov 201812 Feb 2019

First posted1 Aug 2023
Study start16 Nov 2018
Primary completion12 Feb 2019
Study completion12 Feb 2019

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for PharmacokineticsStudies of the same condition, open and under way.
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: Other
Allocation: Randomised
Intervention model: Crossover
Model description: Single centre, open-label, randomised, single dose, 3-way crossover comparative (PK) and bioavailability study.
Masking: None (open label)
Enrolment: 15 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05967377
Sponsor's protocol ID: XS005-01
Status last verified: Jul 2023
First submitted: 26 Jun 2023
Last updated: 1 Aug 2023
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

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?

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Study at a glance

From the registry record, last updated by the sponsor on 1 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Single Part, Open-Label, Randomised, Three-Way Crossover Study Designed to Evaluate the Pharmacokinetic Parameters and Relative Bioavailability of Sorafenib From Sorafenib (XS005) Tablets and Capsules Compared With Nexavar® (Reference Product) in Healthy Male Subjects
ClinicalTrials.gov ID: NCT05967377
Acronym / sponsor ID: XS005-01
Conditions: Pharmacokinetics, Bioavailability
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 15 participants (actual)
Lead sponsor: Xspray Pharma ABIndustry (pharma, biotech, devices)
Study start: 16 Nov 2018 (actual)
Primary completion: 12 Feb 2019 (actual)
Study completion: 12 Feb 2019 (actual)
First posted: 1 Aug 2023 (actual)
Results: Not posted in the source record

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: Other
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Number of arms: 9
Model description: Single centre, open-label, randomised, single dose, 3-way crossover comparative (PK) and bioavailability study.

Arm	Type	Receives
Sorafenib - Period 1	Active comparator	Drug: Sorafenib - Period 1Subjects were admitted to the clinical unit in the morning of Day 1, and dosed with 200 mg Sorafenib (Nexavar®) in the morning of Day 1 following an overnight fast of a minimum of 10 h. Subjects remained in clinical unit until 24 h post dose (Day 2) when they were discharged from the clinical unit, and then returned to the clinical unit at 48 h and 72 h post-dose (Days 3 and 4) for a PK blood sample.The minimum washout before the next dosing period was 10 days.
XS005 Sorafenib Capsule A - Period 1	Experimental	Drug: XS005 Sorafenib Capsule A - Period 1Subjects were admitted to the clinical unit in the morning of Day 1, and dosed with 100 mg (2 x 50 mg) XS005 Sorafenib Capsule A in the morning of Day 1 following an overnight fast of a minimum of 10 h. Subjects remained in clinical unit until 24 h post dose (Day 2) when they were discharged from the clinical unit, and then returned to the clinical unit at 48 h and 72 h post-dose (Days 3 and 4) for a PK blood sample.The minimum washout before the next dosing period was 10 days.
XS005 Sorafenib Tablet A - Period 1	Experimental	Drug: XS005 Sorafenib Tablet A - Period 1Subjects were admitted to the clinical unit in the morning of Day 1, and dosed with 100 mg XS005 Sorafenib Tablet A in the morning of Day 1 following an overnight fast of a minimum of 10 h. Subjects remained in clinical unit until 24 h post dose (Day 2) when they were discharged from the clinical unit, and then returned to the clinical unit at 48 h and 72 h post-dose (Days 3 and 4) for a PK blood sample.The minimum washout before the next dosing period was 10 days.
XS005 Sorafenib Capsule A - Period 2	Experimental	Drug: XS005 Sorafenib Capsule A - Period 2Subjects were admitted to the clinical unit in the morning of Day 1, and dosed with 100 mg (2 x 50 mg) XS005 Sorafenib Capsule A in the morning of Day 1 following an overnight fast of a minimum of 10 h. Subjects remained in clinical unit until 24 h post dose (Day 2) when they were discharged from the clinical unit, and then returned to the clinical unit at 48 h and 72 h post-dose (Days 3 and 4) for a PK blood sample.The minimum washout before the next dosing period was 10 days.
XS005 Sorafenib Tablet A - Period 2	Experimental	Drug: XS005 Sorafenib Tablet A - Period 2Subjects were admitted to the clinical unit in the morning of Day 1, and dosed with 100 mg XS005 Sorafenib Tablet A in the morning of Day 1 following an overnight fast of a minimum of 10 h. Subjects remained in clinical unit until 24 h post dose (Day 2) when they were discharged from the clinical unit, and then returned to the clinical unit at 48 h and 72 h post-dose (Days 3 and 4) for a PK blood sample.The minimum washout before the next dosing period was 10 days.
Sorafenib - Period 2	Active comparator	Drug: Sorafenib - Period 2Subjects were admitted to the clinical unit in the morning of Day 1, and dosed with 200 mg Sorafenib (Nexavar®) in the morning of Day 1 following an overnight fast of a minimum of 10 h. Subjects remained in clinical unit until 24 h post dose (Day 2) when they were discharged from the clinical unit, and then returned to the clinical unit at 48 h and 72 h post-dose (Days 3 and 4) for a PK blood sample.The minimum washout before the next dosing period was 10 days.
XS005 Sorafenib Tablet A - Period 3	Experimental	Drug: XS005 Sorafenib Tablet A - Period 3Subjects were admitted to the clinical unit in the morning of Day 1, and dosed with 100 mg XS005 Sorafenib Tablet A in the morning of Day 1 following an overnight fast of a minimum of 10 h. Subjects remained in clinical unit until 24 h post dose (Day 2) when they were discharged from the clinical unit, and then returned to the clinical unit at 48 h and 72 h post-dose (Days 3 and 4) for a PK blood sample.The minimum washout before the next dosing period was 10 days.
Sorafenib - Period 3	Active comparator	Drug: Sorafenib - Period 3Subjects were admitted to the clinical unit in the morning of Day 1, and dosed with 200 mg Sorafenib (Nexavar®) in the morning of Day 1 following an overnight fast of a minimum of 10 h. Subjects remained in clinical unit until 24 h post dose (Day 2) when they were discharged from the clinical unit, and then returned to the clinical unit at 48 h and 72 h post-dose (Days 3 and 4) for a PK blood sample.The minimum washout before the next dosing period was 10 days.
XS005 Sorafenib Capsule A - Period 3	Experimental	Drug: XS005 Sorafenib Capsule A - Period 3Subjects were admitted to the clinical unit in the morning of Day 1, and dosed with 100 mg (2 x 50 mg) XS005 Sorafenib Capsule A in the morning of Day 1 following an overnight fast of a minimum of 10 h. Subjects remained in clinical unit until 24 h post dose (Day 2) when they were discharged from the clinical unit, and then returned to the clinical unit at 48 h and 72 h post-dose (Days 3 and 4) for a PK blood sample.The minimum washout before the next dosing period was 10 days.

Who may qualify

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

Key inclusion criteria (7 listed)

Healthy males.
Age 18 to 55 years of age.
Body mass index (BMI) of 18.0 to 32.0 kg/m2.
Must be willing and able to communicate and participate in the whole study.
Must provide written informed consent.

Key exclusion criteria (20 listed)

Subjects who have received any IMP in a clinical research study within the previous 3 months.
Subjects who are study site employees, or immediate family members of a study site or sponsor employee.
Subjects who have previously been enrolled in this study.
History of any drug or alcohol abuse in the past 2 years.
Regular alcohol consumption >21 units per week (1 unit = ½ pint beer, or a 25 mL shot of 40% spirit, 1.5 to 2 Units = 125 mL glass of wine, depending on type).

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
Sorafenib - Period 1Also: Regimen A (reference)Sorafenib (Nexavar®) Tablet, 200 mg	Drug	Sorafenib - Period 1
XS005 Sorafenib Capsule A - Period 1Also: Regimen BXS005 Sorafenib Capsule A, 100 mg (2 x 50 mg)	Drug	XS005 Sorafenib Capsule A - Period 1
XS005 Sorafenib Tablet A - Period 1Also: Regimen CXS005 Sorafenib Tablet A, 100 mg	Drug	XS005 Sorafenib Tablet A - Period 1
XS005 Sorafenib Capsule A - Period 2Also: Regimen BXS005 Sorafenib Capsule A, 100 mg (2 x 50 mg)	Drug	XS005 Sorafenib Capsule A - Period 2
XS005 Sorafenib Tablet A - Period 2Also: Regimen CXS005 Sorafenib Tablet A, 100 mg	Drug	XS005 Sorafenib Tablet A - Period 2
Sorafenib - Period 2Also: Regimen A (reference)Sorafenib (Nexavar®) Tablet, 200 mg	Drug	Sorafenib - Period 2
XS005 Sorafenib Tablet A - Period 3Also: Regimen CXS005 Sorafenib Tablet A, 100 mg	Drug	XS005 Sorafenib Tablet A - Period 3
Sorafenib - Period 3Also: Regimen A (reference)Sorafenib (Nexavar®) Tablet, 200 mg	Drug	Sorafenib - Period 3
XS005 Sorafenib Capsule A - Period 3Also: Regimen BXS005 Sorafenib Capsule A, 100 mg (2 x 50 mg)	Drug	XS005 Sorafenib Capsule A - Period 3

Primary outcome

Time of Maximum Observed Plasma Concentration (Tmax) of XS005 and Nexavar®
Time frame: For each study period, blood samples collected at 15 time points (including pre-dose) during the study period on Day 1 and Day 4.
The pharmacokinetic parameters (Tmax) were determined for the test and reference products (XS005 Sorafenib Capsule A, 2 x 50 mg and XS005 Tablet A, 100 mg and reference Sorafenib tablets (Nexavar®), respectively) for each subject using non-compartmental methods.
Maximum Observed Plasma Concentration (Cmax) of XS005 and Nexavar®
Time frame: For each study period, blood samples collected at 15 time points (including pre-dose) during the study period on Day 1 and Day 4.
The pharmacokinetic parameters (Cmax) were determined for the test and reference products (XS005 Sorafenib Capsule A, 2 x 50 mg and XS005 Tablet A, 100 mg and reference Sorafenib tablets (Nexavar®), respectively) for each subject using non-compartmental methods.
Area Under the Plasma Concentration-Time Curve from 0 time to the last measurable of concentration AUC(0-last) of XS005 and Nexavar®
Time frame: For each study period, blood samples collected at 15 time points (including pre-dose) during the study period on Day 1 and Day 4.
The pharmacokinetic parameters AUC(0-last) were determined for the test and reference products (XS005 Sorafenib Capsule A, 2 x 50 mg and XS005 Tablet A, 100 mg and reference Sorafenib tablets (Nexavar®), respectively) for each subject using non-compartmental methods.
Area Under the Plasma Concentration-Time Curve from 0 time Extrapolated to Infinity (AUC0-inf) of XS005 and Nexavar®
Time frame: For each study period, blood samples collected at 15 time points (including pre-dose) during the study period on Day 1 and Day 4.
The pharmacokinetic parameters (AUC 0-inf) were determined for the test and reference products (XS005 Sorafenib Capsule A, 2 x 50 mg and XS005 Tablet A, 100 mg and reference Sorafenib tablets (Nexavar®), respectively) for each subject using non-compartmental methods.
Plasma half-life of drug (T1/2) of XS005 and Nexavar®
Time frame: For each study period, blood samples collected at 15 time points (including pre-dose) during the study period on Day 1 and Day 4.
The pharmacokinetic parameters (T1/2) were determined for the test and reference products (XS005 Sorafenib Capsule A, 2 x 50 mg and XS005 Tablet A, 100 mg and reference Sorafenib tablets (Nexavar®), respectively) for each subject using non-compartmental methods.
Relative bioavailability (Frel) of XS005 and Nexavar®
Time frame: For each study period, blood samples collected at 15 time points (including pre-dose) during the study period on Day 1 and Day 4.
The relative bioavailability (Frel) of Sorafenib following administration of XS005 Sorafenib Capsule A, 50 mg and Tablet A, 100 mg compared to reference Sorafenib tablets (Nexavar®).

15 secondary outcomes

Treatment-emergent adverse events (TEAEs) (ie those beginning after dosing with study drug)
Time frame: Adverse event (AE) information collected through study completion, an average of 10 weeks.
Systolic Blood Pressure (mmHg)
Time frame: For each study period, Systolic Blood Pressure were collected at 4 time points (including pre-dose) during the study period on Day 1 and Day 2.
Diastolic Blood Pressure (mmHg)
Time frame: For each study period, Diastolic Blood Pressure were collected at 4 time points (including pre-dose) during the study period on Day 1 and Day 2.
Heart Rate (HR) (bpm)
Time frame: For each study period, HR were collected at 4 time points (including pre-dose) during the study period on Day 1 and Day 2.
ECG (12-lead electrocardiogram) - Ventricular Rate (HR) (bpm)
Time frame: For each study period, ECG were collected at 4 time points (including pre-dose) during the study period on Day 1 and Day 2.
ECG (12-lead electrocardiogram) - PR Interval (msec)
Time frame: For each study period, ECG were collected at 4 time points (including pre-dose) during the study period on Day 1 and Day 2.
ECG (12-lead electrocardiogram) - QRS Duration (msec)
Time frame: For each study period, ECG were collected at 4 time points (including pre-dose) during the study period on Day 1 and Day 2.
ECG (12-lead electrocardiogram) - QT Interval (msec)
Time frame: For each study period, ECG were collected at 4 time points (including pre-dose) during the study period on Day 1 and Day 2.
ECG (12-lead electrocardiogram) - QRS Axis (°)
Time frame: For each study period, ECG were collected at 4 time points (including pre-dose) during the study period on Day 1 and Day 2.
ECG (12-lead electrocardiogram) - QTcF Interval (msec)
Time frame: For each study period, ECG were collected at 4 time points (including pre-dose) during the study period on Day 1 and Day 2.
Number of participants with abnormal laboratory values of Clinical Chemistry
Time frame: For each study period, blood samples were collected at 2 time points (including pre-dose) during the study period on Day 1 and Day 2.
Number of participants with abnormal hematology values
Time frame: For each study period, blood samples were collected at 2 time points (including pre-dose) during the study period on Day1 and Day 2.
Number of participants with abnormal urinalysis values
Time frame: For each study period, urine samples were collected at 2 time points (including pre-dose) during the study period on Day1 and Day 2.
Number of participants with abnormal physical examination outcome
Time frame: For each study period, target (symptom driven) physical examination; each subject was assessed by a physician and a physical examination was performed if the subject reported any AEs, on Day 2.
Number of participants with abnormal skin examination outcome
Time frame: For each study period, skin assessments were done at 2 time points (including pre-dose) during the study period on Day 1 and Day 2.

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 1 Aug 2023.
Individual participant dataSharing planned: No

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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.

Sharan Sidhu, MBChB, BAO, MRCS, MFPM principal investigator

Quotient Sciences

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

Questions about this trial

What is this clinical trial studying?

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 7 inclusion and 20 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 1 Aug 2023. 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 United Kingdom. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Time of Maximum Observed Plasma Concentration (Tmax) of XS005 and Nexavar® (time frame: For each study period, blood samples collected at 15 time points (including pre-dose) during the study period on Day 1 and Day 4.). The study lists 6 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 NCT05967377.

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 1 Aug 2023.