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
- Conditions
- Hepatitic C virus infectionHepatitis C10047438
- Registration Number
- NL-OMON41383
- Lead Sponsor
- Regulus Therapeutics Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 108
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
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Safety and tollerability</p><br>
- Secondary Outcome Measures
Name Time Method <p>Pharmacokinetics and Pharmacodynamics</p><br>