Status:
COMPLETED
Mass Balance and Pharmacokinetics Study of Derazantinib in Healthy Male Subjects
Lead Sponsor:
Basilea Pharmaceutica
Conditions:
Healthy Volunteers
Eligibility:
MALE
18-65 years
Phase:
PHASE1
Brief Summary
This is a Phase 1, two-part, open-label, single centre, single arm study in healthy male subjects to investigate the oral PK, intravenous (IV) PK, mass balance, bioavailability and metabolites profili...
Eligibility Criteria
Inclusion
- Healthy males
- Age 18 to ≤ 55 years (Part 1)
- Age 30 to ≤ 65 years (Part 2)
- Body mass index of 18.0 to 29.0 kg/m² and a minimum body weight of 50 kg
- Must have regular bowel movements
- Must agree to adhere to the contraception requirements
Exclusion
- Male subjects with pregnant partners
- Subjects who have received any investigational medicine 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
- History of any drug or alcohol abuse in the 12 months prior to dosing
- Regular alcohol consumption in males \> 21 units per week
- Smokers and users of e-cigarettes and nicotine replacement products and those who have used these products within the last 3 months
- Radiation exposure (diagnostic x-rays and other medical exposures, exceeding 5 mSv in the last 12 months or 10 mSv in the last 5 years. No occupationally exposed worker, as defined in the Ionising Radiation Regulations 2017, shall participate in the study
- Participation in any study involving administration of any \[14C\]-labelled compound within 12 months prior to screening (Part 1 only)
- Excessive caffeine consumption within 14 days prior to screening, defined as 800 mg per day (approximately 6 large cups of coffee)
- Subjects who do not have suitable veins
- Clinically significant abnormal biochemistry, haematology or urinalysis as judged by the Investigator
- Confirmed positive drugs of abuse test result
- Positive hepatitis B surface antigen (HBsAg), hepatitis C virus antibody (HCV Ab) or human immunodeficiency virus (HIV) results, or history of immunodeficiency diseases, including a positive HIV (ELISA and western blot) test result
- Evidence of renal impairment at screening, as indicated by an estimated creatinine clearance of \< 70 mL/min using the Cockcroft-Gault equation
- History of clinically significant cardiovascular, renal, hepatic, chronic respiratory or gastrointestinal disease, neurological or psychiatric disorder or current clinical evidence of any corneal or retinal disorder
- Presence or history of clinically significant allergy requiring treatment, as judged by the investigator. Hay fever is allowed unless it is active
- Known hypersensitivity or allergy to natural rubber latex
- History of any food allergies
- History of clinically significant ECG abnormalities
- Familial history of sick-sinus syndrome
- Recent (within the last 3 years) and/or recurrent history of autonomic dysfunction
- Recent (within the last 3 years) and/or recurrent history of acute or chronic bronchospastic disease (including asthma disease, treated or not treated)
- History of malignancy of any organ system (other than localised basal cell carcinoma of the skin), treated or untreated, within the past 5 years
- Use of any prescription drugs (including vaccines), herbal supplements (such as St. John's Wort, homeopathic preparations), within 4 weeks prior to initial dosing, and/or over-the-counter medication, dietary supplements (vitamins and minerals included) within 2 weeks prior to initial dosing
- Donation or loss of 400 mL or more of blood and/or plasma within 3 months prior to initial dosing
- Any history or presence of frequent episodes of diarrhoea (defined as an increase of 4 to 6 stools per day over usual individual defecation pattern).
- Significant illness within 2 weeks prior to initial dosing
- Any surgical or medical condition which might significantly alter the absorption, distribution, metabolism, or excretion of drugs, or which may jeopardise the subject in case of participation in the study.
- NOTE: Other protocol defined Inclusion/ Exclusion criteria may apply.
Key Trial Info
Start Date :
August 8 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 18 2019
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT04098692
Start Date
August 8 2019
End Date
November 18 2019
Last Update
January 19 2021
Active Locations (1)
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1
Quotient Sciences, Ruddington
Nottingham, United Kingdom