A Three Part Study Evaluating the Pharmacokinetics of Intravenous (IV) Danoprevir (DNV)/Oral Low Dose Ritonavir (RTV), a Drug-Drug Interaction Study Between IV DNV/Oral Low Dose RTV and Oral Cyclosporine, and the Absolute Bioavailability of IV DNV as Compared to DNV Tablets Together With Oral Low Dose RTV in Healthy Adult Volunteers

A Three Part Study Evaluating the Pharmacokinetics of Intravenous (IV) Danoprevir (DNV)/Oral Low Dose Ritonavir (RTV), a Drug-Drug Interaction Study Between IV DNV/Oral Low Dose RTV and Oral Cyclosporine, and the Absolute Bioavailability of IV DNV as Compared to DNV Tablets Together With Oral Low Dose RTV in Healthy Adult Volunteers - DNV DDI with Ritonavir and Cyclosporine and Absolute Bioavailability

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON37643

Enrollment

Registered

2012-06-04

Start date

2012-06-13

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

Chronic Hepatitis C Jaundice

Interventions

Part 1: Period 1: All volunteers will receive 100 mg Ritonavir (RTV). after 2 hours 2 mg Danoprevir (DNV) or placebo (2:1) will be administered as a 60 minutes IV. Period 2: All volunteers will recei

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: healthy male or female subjects 18-55 yrs, inclusive BMI: 18.0-32.0 kg/m2, inclusive Weight: * 50.0 kg

Exclusion criteria

Exclusion criteria: Suffering from hepatitis B, hepatitis C, cancer or HIV/AIDS. In case of participation in another drug study within 60 days before the start of this study or being a blood donor within 60 days from the start of the study. In case of donating more than 1.5 liters of blood in the 10 months prior the start of this study.

Design outcomes

Primary

Measure	Time frame
Pharmacokinetics : Part 1: Plasma drug concentrations for DNV (following IV administration) and RTV. Part 2: Plasma drug concentrations for DNV (following oral and IV administration) and RTV. Part 3: Plasma drug concentrations for DNV (following IV administration), RTV, and cyclosporine. Urine drug concentrations for DNV and RTV (Parts 2 and 3), and cyclosporine (Part 3 only).	—

Secondary

Measure	Time frame
AEs, vital signs, 12-lead ECGs, clinical laboratory testing	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)