Ignite Creation Date:
2024-05-05 @ 5:06 PM
Last Modification Date:
2024-10-26 @ 9:27 AM
Study NCT ID:
NCT00382798
Status:
COMPLETED
Last Update Posted:
2009-04-27
First Post:
2006-09-28
Brief Title:
Adaptive Phase I HCV Study With Nucleoside Analogue in Combination With Interferon and Ribavirin
Sponsor:
Pharmasset
Organization:
Pharmasset
Study Overview
Official Title:
A Multiple-Center Observer-Blinded Randomized Placebo-Controlled Single Multiple Ascending Dose Study to Investigate the Pharmacokinetics Pharmacodynamics Safety Tolerability Food Effect of RO5024048 in Healthy Volunteers in Patients With Chronic HCV Infection
Status:
COMPLETED
Status Verified Date:
2009-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
R7128
Brief Summary:
This is an adaptive Phase I study to evaluate RO5024048 in the following groups
Healthy Volunteers Part 1 - Single Ascending Dose Study -Enrollment completed
Hepatitis C virus HCV genotype 1 infected patients who have failed interferon therapy Part 2- Multiple Ascending Dose Study-Enrollment Completed
HCV genotype 1-infected patients who are treatment naive to be dosed in combination with PEG-IFN and RBV Part 3 - Combination Dose Study-Currently Enrolling
HCV genotype 2-3 infected patients who have previously been treated with interferon but who did not respond to be dosed in combination with PEG-IFN and RBV Part 3 - Combination Dose Study- Currently enrolling
The study aims to determine if RO5024048 is safe and well-tolerated in healthy people and in people infected with hepatitis C virus The amount of RO5024048 in the blood will be measured during the study and the amount of hepatitis C virus in the blood after each dose will also be measured
During Part 3 of the study RO5024048 will be given with PEG-IFN and RBV two drugs currently used and approved for the treatment of HCV
Healthy Volunteers Part 1 - Single Ascending Dose Study -Enrollment completed
Hepatitis C virus HCV genotype 1 infected patients who have failed interferon therapy Part 2- Multiple Ascending Dose Study-Enrollment Completed
HCV genotype 1-infected patients who are treatment naive to be dosed in combination with PEG-IFN and RBV Part 3 - Combination Dose Study-Currently Enrolling
HCV genotype 2-3 infected patients who have previously been treated with interferon but who did not respond to be dosed in combination with PEG-IFN and RBV Part 3 - Combination Dose Study- Currently enrolling
The study aims to determine if RO5024048 is safe and well-tolerated in healthy people and in people infected with hepatitis C virus The amount of RO5024048 in the blood will be measured during the study and the amount of hepatitis C virus in the blood after each dose will also be measured
During Part 3 of the study RO5024048 will be given with PEG-IFN and RBV two drugs currently used and approved for the treatment of HCV
Detailed Description:
Part 3 During Part 3 of the study HCV gentoype 1-infected patients who are treatment-naive have not been treated for HCV will be enrolled Up to 75 patients 3 groups of 25 will be dosed for 28 days with RO5024048 PEG-IFN and RBV The first dose of RO5024048 to be given in Part 3 will be 500 mg BID the second dose will be 1500 mg BID and the third group will be 1000 mg BID Standard doses of PEG-IFN and RBV will be used during Part 3 Doses of PEG-IFN and RBV will be modified if necessary
An 4th group of 25 HCV genotype 2 or 3-infected patients who have been previously treated with interferon but who did not respond will also be enrolle in part 3 The dose given to this 4th group will be 1500 mg BID in combination with standard doses of PEG-IFN and RBV
Following 28 days of combination dosing with RO5024048 PEG-IFN and RBV patients will be dosed an additional 28 days through Day 56 of the study with just PEG-IFN and RBV After completing 56 days under this study patients who participate in Part 3 will be optionally enrolled into a standard of care protocol with PEG-IFN and RBV to be conducted by Roche Patients who opt to enroll into the standard of care protocol will be given up to 40 weeks of PEG-IFN and RBV
The primary objective for Part 3 is to assess the safety tolerability and pharmacokinetics of RO5024048 in treatment-naive HCV Genotype 1-infected patients and in non-responder HCV Genotype 23-infected patients after once or twice daily dosing in combination wtih PEG-IFN and RBV for 28 days on an outpatient basis The secondary objective of Part 3 COMBO is to evaluate the short-term decrease in viral load in treatment-naive HCV Genotype 1-infected patients and in non-responder HCV Genotype 23-infected patients after once or twice daily dosing of RO5024048 in combination with PEG-IFN and RBV for 28 days
Part 1 closed for enrollment Single ascending dose study
During Part 1 5 escalating single oral doses of RO5024048 or placebo were given to 40 healthy volunteers when fasted have not eaten any food for at least 10 hours The doses given were 500 mg 1500 mg 4500 mg 6000 mg and 9000 mg Another group of 6 volunteers was given 1500 mg with food
The primary objective of Part 1 was to assess the safety tolerability and pharmacokinetics amount of drug in the blood of RO5024048 under fasting conditions The secondary objective of Part 1 was to explore the effect of food on the pharmacokinetics of RO5024048
Part 2 Closed for enrollment Multiple ascending dose study
During Part 2 of the study 40 HCV-genotype 1-infected patients were given multiple-ascending oral doses of RO5024048 or placebo for 14 days The doses given were 750 mg once daily 1500 mg once daily 750 mg twice daily and 1500 mg twice daily
The primary objective of Part 2 was to assess the safety tolerability and pharmacokinetics of RO5024048 in HCV Genotype 1-infected patients after daily or twice daily dosing for 14 days The secondary objective was to evaluate the decrease in viral load in HCV Genotype 1-infected patients after daily or twice daily dosing of RO5024048 for 14 days
An 4th group of 25 HCV genotype 2 or 3-infected patients who have been previously treated with interferon but who did not respond will also be enrolle in part 3 The dose given to this 4th group will be 1500 mg BID in combination with standard doses of PEG-IFN and RBV
Following 28 days of combination dosing with RO5024048 PEG-IFN and RBV patients will be dosed an additional 28 days through Day 56 of the study with just PEG-IFN and RBV After completing 56 days under this study patients who participate in Part 3 will be optionally enrolled into a standard of care protocol with PEG-IFN and RBV to be conducted by Roche Patients who opt to enroll into the standard of care protocol will be given up to 40 weeks of PEG-IFN and RBV
The primary objective for Part 3 is to assess the safety tolerability and pharmacokinetics of RO5024048 in treatment-naive HCV Genotype 1-infected patients and in non-responder HCV Genotype 23-infected patients after once or twice daily dosing in combination wtih PEG-IFN and RBV for 28 days on an outpatient basis The secondary objective of Part 3 COMBO is to evaluate the short-term decrease in viral load in treatment-naive HCV Genotype 1-infected patients and in non-responder HCV Genotype 23-infected patients after once or twice daily dosing of RO5024048 in combination with PEG-IFN and RBV for 28 days
Part 1 closed for enrollment Single ascending dose study
During Part 1 5 escalating single oral doses of RO5024048 or placebo were given to 40 healthy volunteers when fasted have not eaten any food for at least 10 hours The doses given were 500 mg 1500 mg 4500 mg 6000 mg and 9000 mg Another group of 6 volunteers was given 1500 mg with food
The primary objective of Part 1 was to assess the safety tolerability and pharmacokinetics amount of drug in the blood of RO5024048 under fasting conditions The secondary objective of Part 1 was to explore the effect of food on the pharmacokinetics of RO5024048
Part 2 Closed for enrollment Multiple ascending dose study
During Part 2 of the study 40 HCV-genotype 1-infected patients were given multiple-ascending oral doses of RO5024048 or placebo for 14 days The doses given were 750 mg once daily 1500 mg once daily 750 mg twice daily and 1500 mg twice daily
The primary objective of Part 2 was to assess the safety tolerability and pharmacokinetics of RO5024048 in HCV Genotype 1-infected patients after daily or twice daily dosing for 14 days The secondary objective was to evaluate the decrease in viral load in HCV Genotype 1-infected patients after daily or twice daily dosing of RO5024048 for 14 days
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None