Open-label phase I study to investigate the effect of multiple doses of tasquinimod on the single-dose pharmacodynamics and pharmacokinetics of warfarin in healthy subjects
Completed
- Conditions
- prostate cancer1002765610036958
- Registration Number
- NL-OMON35250
- Lead Sponsor
- Active Biotech
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 15
Inclusion Criteria
healthy male and female volunteers
age: 18-55 years, inclusive
BMI: 18.0-30.0 kg/m2, inclusive
Exclusion Criteria
- Suffering from hepatitis B, cancer or HIV/AIDS
- In case of participation in another drug study within 60 days before the start of this study
- In case of donation of more than 50 ml of blood within 60 days prior to drug administration
- Donation of more than 1.5 L of blood (for men) / more than 1.0 L of blood (for women) in the 10 months preceding the start of the study
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Pharmacodynamics: international normalised ratio (INR) values: area under the<br /><br>INR effect curve (AUEC) from time 0 to 144 h (AUEC0-144), baseline corrected<br /><br>AUEC (AUECcorr0-144), maximum INR value (INRmax), and maximum increase in INR</p><br>
- Secondary Outcome Measures
Name Time Method <p>Pharmacokinetics: maximum plasma concentration (Cmax), area under the<br /><br>concentration-time curve (AUC) from time 0 to time t (AUC0-t), and AUC from<br /><br>time 0 extrapolated to infinity (AUC0-inf) of R warfarin and S-warfarin<br /><br><br /><br>Safety: AEs, vital signs, 12-lead ECG, clinical laboratory, physical<br /><br>examination</p><br>