Status:
COMPLETED
Evaluating the Pharmacokinetic Parameters and Relative Bioavailability of Sorafenib (XS005) in Healthy Male Subjects
Lead Sponsor:
Xspray Pharma AB
Conditions:
Pharmacokinetics
Bioavailability
Eligibility:
MALE
18-55 years
Phase:
PHASE1
Brief 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 tabl...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
- 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.
Key Trial Info
Start Date :
November 16 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 12 2019
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT05967377
Start Date
November 16 2018
End Date
February 12 2019
Last Update
August 1 2023
Active Locations (1)
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1
Quotient Sciences
Nottingham, United Kingdom, NG11 6JS