- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01290965
Safety, PK and Efficacy of 15 Days of SCY-635 Treatment in Hepatitis C Patients
November 5, 2014 updated by: Scynexis, Inc.
A Randomized, Double Blind, Placebo-Controlled Study to Evaluate the Safety, Pharmacokinetics, and Effect of Treatment With SCY 635 on Plasma HCV RNA Following 15 Days of Oral Administration in Adult Patients With Chronic Hepatitis C Infection
This study will examine the effectiveness of 15 days of therapy with SCY-635 in reducing hepatitis C virus (HCV) RNA levels.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
57
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
California
-
San Francisco, California, United States, 94115
- Quest Clinical Research
-
-
Virginia
-
Richmond, Virginia, United States, 23249
- McGuire Veterans Affairs Medical Center
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
A potential subject will be eligible for participation in this study if he or she meets all of the following inclusion criteria:
- The subject is either male or female, between the ages of 18 and 65 years (inclusive).
- The subject has read and signed a Subject Informed Consent form to participate in the study. If the subject is not fluent in English, the Subject Informed Consent form must be translated into his or her native language.
- Female subjects of childbearing potential (i.e., women not surgically sterile or at least two years postmenopausal) must agree to utilize one of the following forms of contraception from Screening through completion of the study: abstinence, barrier (condom, diaphragm with spermicide), intrauterine device (IUD), or vasectomized partner (six months minimum). Hormonal contraception (oral, transdermal, implant, or injection) is not permitted during the study period (i.e., from Screening through the Follow-up visit). Note: For women aged <50 years, postmenopausal is defined as at least two years cessation of menses. For women aged ≥50 years, postmenopausal is defined as at least one year cessation of menses. Estrogen replacement is allowed during the study.
- The subject exhibits quantifiable plasma levels of HCV-specific RNA in excess of 100,000 IU/mL as determined by the quantitative Roche COBAS taqMan assay.
- The subject has a negative urine screen for amphetamines, barbiturates, cocaine, opiates, and phencyclidine at Screening.
- If female, the subject has a negative serum pregnancy test at Screening (within 30 days prior to dosing) and a negative urine pregnancy test on Study Day -1.
Exclusion Criteria:
A potential subject will be excluded from participation in the study if he or she meets any of the following exclusion criteria:
- The subject has a history of clinically significant gastrointestinal, renal, hepatic, neurologic, hematologic, endocrine, oncologic, pulmonary, immunologic, psychiatric, or cardiovascular disease, or any other condition which, in the opinion of the Principal Investigator, may jeopardize the safety of the subject or may impact the validity of the study results.
- The subject is infected with any HCV genotype other than genotype 1.
- The subject has documented positive antibody tests for Human Immunodeficiency Virus Types 1 or 2 (p24 antibody specific for HIV-1 or HIV-2) or Hepatitis B virus (HBV) surface antigen (HbSAg) or at Screening exhibits serologic evidence of infection with either HIV-1, HIV-2 or HBV.
- The subject has donated blood within 30 days prior to dosing or donated plasma within 14 days prior to dosing.
- The subject has used any investigational agent within three months prior to dosing.
- The subject has received any FDA-approved anti-HCV therapy (including ribavirin or any product that contains interferon) within three months prior to dosing.
- The subject exhibits evidence of decompensated liver disease, as marked by bilirubin greater than 4 mg/dL, albumin less than 3.0 g/dL, prothrombin time greater than 2 seconds prolonged, or history of bleeding esophageal varices, ascites or hepatic encephalopathy.
- The subject is an organ transplant recipient.
- The subject exhibits ALT values greater than or equal to 2.5 times the upper limit of normal.
- The subject exhibits evidence of hepatocellular carcinoma either by exhibiting a serum alpha-fetoprotein concentration which exceeds 50 mg/L or by exhibiting a mass suggestive of liver cancer by ultrasound or other imaging technology.
- The subject exhibits evidence of ongoing alcohol or substance abuse.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: Placebo comparator
|
Oral tablet given once or three times daily for 15 consecutive days
|
Active Comparator: SCY-635 30 mg once daily
|
oral capsule
|
Active Comparator: SCY-635 100 mg once daily
|
oral capsule
|
Active Comparator: SCY-635 300 mg once daily
|
oral capsule
|
Active Comparator: SCY-635 100 mg three times daily
|
oral capsule
|
Active Comparator: SCY-635 200 mg three times daily
|
oral capsule
|
Active Comparator: SCY-635 300 mg three times daily
|
oral capsule
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Plasma HCV RNA level
Time Frame: 22 days
|
22 days
|
Incidence and severity of treatment-emergent adverse events and changes in laboratory values as measures of safety and tolerability.
Time Frame: 22 days
|
22 days
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Pharmacokinetic assessment of SCY-635
Time Frame: 22 days
|
22 days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Douglas Heuman, MD, McGuire Veterans Affairs Medical Center, Richmond, Virginia
- Principal Investigator: Jacob Lalezari, MD, Quest Clinical Research, San Francisco, California
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
April 1, 2007
Primary Completion (Actual)
December 1, 2008
Study Completion (Actual)
January 1, 2009
Study Registration Dates
First Submitted
February 4, 2011
First Submitted That Met QC Criteria
February 4, 2011
First Posted (Estimate)
February 7, 2011
Study Record Updates
Last Update Posted (Estimate)
November 6, 2014
Last Update Submitted That Met QC Criteria
November 5, 2014
Last Verified
February 1, 2011
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Digestive System Diseases
- RNA Virus Infections
- Virus Diseases
- Infections
- Blood-Borne Infections
- Communicable Diseases
- Liver Diseases
- Flaviviridae Infections
- Hepatitis, Viral, Human
- Enterovirus Infections
- Picornaviridae Infections
- Hepatitis
- Hepatitis A
- Hepatitis C
- Hepatitis, Chronic
- Hepatitis C, Chronic
Other Study ID Numbers
- SCY-635-104
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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