A PHASE 1, RANDOMIZED, DOUBLE-BLIND, SINGLE AND MULTIPLE ASCENDING DOSE STUDY TO INVESTIGATE THE SAFETY, TOLERABILITY, PHARMACOKINETICS AND PHARMACODYNAMICS OF RG2459 IN HEALTHY VOLUNTEERS, INCLUDING A SINGLE DOSE PROOF-OF-CONCEPT PART IN PATIENTS INFECTED WITH HEPATITIS C VIRUS, AND A DRUG INTERACTION PART WITH SIMEPREVIR (TMC435) IN HEALTHY VOLUNTEERS

A PHASE 1, RANDOMIZED, DOUBLE-BLIND, SINGLE AND MULTIPLE ASCENDING DOSE STUDY TO INVESTIGATE THE SAFETY, TOLERABILITY, PHARMACOKINETICS AND PHARMACODYNAMICS OF RG2459 IN HEALTHY VOLUNTEERS, INCLUDING A SINGLE DOSE PROOF-OF-CONCEPT PART IN PATIENTS INFECTED WITH HEPATITIS C VIRUS, AND A DRUG INTERACTION PART WITH SIMEPREVIR (TMC435) IN HEALTHY VOLUNTEERS - RG2459 SAD, MAD, DDI and POC study

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON41383

Enrollment

108

Registered

2013-12-04

Start date

2014-02-13

Completion date

Unknown

Last updated

2024-04-29

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

Conditions

Hepatitic C virus infection

Interventions

RG2459 Simeprevir (Part C only)

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Part A-C: 1.Males, or post-menopausal or hysterectomized females 2.Age:18 * 65 years, inclusive 3.BMI:18.0 * 30.0 kg/m2 ;Part D (SAD POC in HCV Patients) 1.Males, or post-menopausal or hysterectomized females; 2.Age:18 - 65 years, inclusive 3.BMI:18.0 * 38.0 kg/m2 4.Clinical and laboratory findings consistent with a clinical diagnosis of Chronic Hepatitis C

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
Safety and tollerability	—

Secondary

Measure	Time frame
Pharmacokinetics and Pharmacodynamics	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)