OPEN LABEL PHASE I STUDY TO INVESTIGATE THE EFFECT OF MULTIPLE DOSES OF KETOCONAZOLE ON THE SINGLE-DOSE PHARMACOKINETICS OF TASQUINIMOD IN HEALTHY SUBJECTS

OPEN LABEL PHASE I STUDY TO INVESTIGATE THE EFFECT OF MULTIPLE DOSES OF KETOCONAZOLE ON THE SINGLE-DOSE PHARMACOKINETICS OF TASQUINIMOD IN HEALTHY SUBJECTS - Ketoconazole * Tasquinimod Interaction Study

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON35292

Enrollment

Registered

2011-10-24

Start date

2011-11-08

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

Active substance: tasquinimod Activity: anti-angiogenic Strength: 0.5 mg Dosage form: per oral capsule Active substance: ketoconazole Activity: antimycotic Indication: mycotic infections Strength: 20

a dose of 400 mg will be administered Dosage form: per oral tablets

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
Pharmacokinetics: primary: maximum plasma concentration (Cmax), area under the concentration-time curve (AUC) from time 0 to time t (AUC0-t), AUC from time 0 extrapolated to infinity (AUC0-inf), and elimination half-life (t*) of tasquinimod Safety: AEs, vital signs, 12-lead ECG; clinical laboratory, physical examination	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)