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Sponsored by: |
Achillion Pharmaceuticals |
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Information provided by: | Achillion Pharmaceuticals |
ClinicalTrials.gov Identifier: | NCT00401947 |
The purpose of this study is to Investigate the Safety, Tolerability, Pharmacokinetics and Antiviral Activity of Multiple Doses of ACH-0137171 in Subjects with Chronic Hepatitis C Infection
Condition | Intervention | Phase |
---|---|---|
HCV Infection |
Drug: ACH-0137171 |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Placebo Control, Single Group Assignment |
Official Title: | A Randomized, Double-Blind, Placebo-Controlled, Dose-Escalation Study to Investigate the Safety, Tolerability, Pharmacokinetics and Antiviral Activity of Multiple Doses of ACH-0137171 in Subjects With Chronic Hepatitis C Infection |
Estimated Enrollment: | 30 |
Study Start Date: | November 2006 |
Study Completion Date: | March 2007 |
This is a randomized, double-blind, placebo-controlled, dose escalation study of ACH-0137171 in subjects with chronic HCV infection.
Sequential cohorts of 10 subjects will be randomized (8:2) to receive multiple doses of ACH-0137171 or placebo for 4 days (Days 1 through 4) with a single dose on Day 5 followed by a complete pharmacokinetic profile. Dosing will be 300 – 600 mg administered either every 12 hours or every 6 hours (maximum daily dose of 2400 mg). All doses will be administered with food.
The dose cohorts are as follows:
Study Schema:
Cohort 1: 300 mg ACH-0137171/placebo every 12 hours (600 mg/day)* Cohort 2: 300 mg ACH-0137171/placebo every 6 hours (1200 mg/day)* Cohort 3: 600 mg ACH-0137171/placebo every 6 hours (2400 mg/day)*
A full review of all safety data will occur following each cohort. Depending on the data, the Sponsor, in consultation with the Principal Investigator(s), may consider modifying the planned dose escalation. The Sponsor may choose to interject an intermediate dose cohort between 2 planned dose escalations or repeat a given dose level, or extend the dosing period, or add an additional cohort. If a similar Grade 3 or 4 adverse event occurs in three or more subjects, and is considered to be at least possibly related to study drug, escalation to a higher dose will not occur.
Serial HCV RNA measurements, pharmacokinetic measurements of plasma concentrations of ACH-0137171, and periodic safety monitoring will occur on Days 1 through 5. Additional HCV RNA and PK measurements will be taken on Days 6 through 9. Follow up safety evaluations will be completed out to 14 days after last study drug administration (i.e., on Days 12 and 19).
Ages Eligible for Study: | 18 Years to 60 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, Arizona | |
Mayo Clinic Hospital | |
Phoenix, Arizona, United States, 85054 | |
United States, California | |
University of California, San Francisco | |
San Francisco, California, United States, 94143 | |
University of California, San Diego | |
LaJolla, California, United States, 92093 | |
United States, Massachusetts | |
Beth Israel Deaconess Medical Center | |
Boston, Massachusetts, United States, 02215 | |
United States, New York | |
Mt. Sinai Medical Center | |
New York, New York, United States, 10029 | |
United States, Texas | |
Alamo Medical Research | |
San Antonio, Texas, United States, 78215 | |
The Liver Institute at Methodist-Dallas | |
Dallas, Texas, United States, 75208 | |
Germany | |
Paraxel International GmbH | |
Berlin, Germany, BE 14050 | |
Netherlands | |
Universitair Medisch Centrum Utrecht (AZU) | |
Utrecht, Netherlands, 6584 CX |
Study Director: | John Pottage, MD | Achillion Pharmaceuticals |
Study ID Numbers: | ACH171-002 |
Study First Received: | November 17, 2006 |
Last Updated: | May 10, 2007 |
ClinicalTrials.gov Identifier: | NCT00401947 |
Health Authority: | United States: Food and Drug Administration |
HCV Chronic Hepatitis |
Virus Diseases Hepatitis Liver Diseases Digestive System Diseases |
Hepatitis, Chronic Hepatitis, Viral, Human Hepatitis C Hepatitis C, Chronic |
Communicable Diseases RNA Virus Infections Flaviviridae Infections Infection |