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

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 - Tasquinimod - Warfarin Interaction Study

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON35250

Enrollment

Registered

2011-09-26

Start date

2011-11-01

Completion date

Unknown

Last updated

2024-05-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

prostate cancer

Interventions

Study medication Active substance: tasquinimod Activity: anti-angiogenic Indication: not applicable Strength: 0.5 mg Dosage form: oral capsule Active substance: warfarin Activity: anticoagulant Indic

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: healthy male and female volunteers age: 18-55 years, inclusive BMI: 18.0-30.0 kg/m2, inclusive

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
Pharmacodynamics: international normalised ratio (INR) values: area under the INR effect curve (AUEC) from time 0 to 144 h (AUEC0-144), baseline corrected AUEC (AUECcorr0-144), maximum INR value (INRmax), and maximum increase in INR	—

Secondary

Measure	Time frame
Pharmacokinetics: maximum plasma concentration (Cmax), area under the concentration-time curve (AUC) from time 0 to time t (AUC0-t), and AUC from time 0 extrapolated to infinity (AUC0-inf) of R warfarin and S-warfarin Safety: AEs, vital signs, 12-lead ECG, clinical laboratory, physical examination	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)