Evaluating the Safety of ITX 5061 in Treatment-Naive Hepatitis C (HCV)-Infected Adults
Condition: Hepatitis C
MeSH terms: Hepatitis A; Hepatitis C; Hepatitis
Study type: Interventional
Phase: Phase 1

Summary: 
      Hepatitis C (HCV) is a disease that affects the liver. ITX 5061 is a new medication that is
      being tested to treat HCV. This study will evaluate the safety of ITX 5061 and examine
      different doses of the medication to evaluate which dose is the most effective at lowering
      the amount of HCV in the blood.
    

Detailed description: 
      HCV is a serious health concern and can lead to cirrhosis, liver cancer, and liver failure.
      Currently, HCV is treated with pegylated interferon and ribavirin, but these medications are
      not always effective and may have harmful side effects. ITX 5061 is a new medication that has
      been developed to treat HCV. This study will take place in three parts-Parts A, B, and C.
      Each part of the study will enroll participants for a different period of time, and within
      each part of the study, participants will receive varying amounts of ITX 5061. If ITX 5061 is
      found to be unsafe in any part of the study, the subsequent parts of the study will not
      occur. The purpose of this study is to evaluate the safety of different doses of ITX 5061 and
      determine the amount of time that is needed for ITX 5061 to safely lower the amount of HCV in
      the blood.

      This study will enroll people with HCV who are HIV-uninfected. Participants will enroll in
      one of three parts of the study. They will be randomly assigned to receive ITX 5061 or
      placebo once a day for 3 days in Part A, for 14 days in Part B, or for 28 days in Part C.
      Within Parts A, B, and C, participants will receive either 150 mg, 75, mg, or 25 mg of ITX
      5061. At a baseline study visit, participants will have a physical exam and blood and urine
      collection. All participants will receive their assigned medication at this visit.
      Participants in Part A will return for study visits on the 2 days after the baseline visit.
      During these study visits, participants will undergo a physical exam and will have blood
      collected several times over an 8-hour period. Participants in Part B of the study will
      attend study visits 1, 2, 3, 7, 10, and 13 days after the baseline visit. Participants in
      Part C of the study will attend study visits 1, 2, 3, 7, 10, 14, 21, and 27 days after the
      baseline visit. Participants in Parts B and C will undergo similar study procedures as
      participants in Part A. Throughout the study, participants will record their medication usage
      in a diary.

      All participants will attend a study visit the day after they receive their last medication
      dose. In addition, participants in Part A will attend study visits 9 and 16 days after the
      baseline visit, participants in Part B will attend study visits 20 and 27 days after the
      baseline visit, and participants in Part C will attend study visits 34 and 41 days after the
      baseline visit. At each of these follow-up visits, participants will have a physical exam and
      a blood and urine collection.
    

Intervention name(s): ITX 5061; Placebo ITX 5061
Intervention type(s): Drug; Drug
Intervention description(s): For Part A of the study: 150 mg of ITX 5061, once a day for 3 days; 75 mg of ITX 5061, once a day for 3 days; or 25 mg of ITX 5061, once a day for 3 days.
For Part B of the study: 150 mg of ITX 5061, once a day for 14 days; 75 mg of ITX 5061, once a day for 14 days; or 25 mg of ITX 5061, once a day for 14 days.
For Part C of the study: 150 mg of ITX 5061, once a day for 28 days; 75 mg of ITX 5061, once a day for 28 days; or 25 mg of ITX 5061, once a day for 28 days.; For Part A of the study: placebo, once a day for 3 days.
For Part B of the study: placebo, once a day for 14 days.
For Part C of the study: placebo, once a day for 28 days.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment