SPARTA Doublet: A Phase 2, Randomized, Double-Blind (Subject- and Investigator-Blind, Sponsor-Open), Placebo-Controlled Trial to Investigate the Safety, Tolerability, and Efficacy of ACH-0143422 in Combination with ACH-0143102 for 12, 8, or 6 Weeks in Treatment-Naive Subjects with Chronic Hepatitis C
Achillion Pharmaceuticals, Inc
60 participants
Jun 22, 2015
Interventional
Conditions
Summary
The purpose of the study is to examine the safety, efficacy, and tolerability of ACH-0143422 when used in combination with ACH-0143102. The effect of treatment duration, 12 weeks, 8 weeks, and 6 weeks, will also be examined. Within each treatment duration cohort (i.e. 12, 8, or 6 weeks), subjects will be randomized to receive either an active or placebo regimen. Cohort 1 will have 24 patients, Cohort 2 and Cohort 3 will have 18 patients. The 12-week groups will be closely monitored during drug treatment for safety or PK issues which might indicate an unacceptable risk to treated subjects, and continuation of dosing will depend on the outcome of early safety and PK assessments. An analysis of safety and PK data will be performed after all subjects in the 12-week cohort have completed 4 weeks of combination treatment, and dosing will continue in the 12-week cohorts assuming that no safety or PK issues are identified that would preclude continued dosing. Intensive PK sampling will be performed during the first 2 weeks of treatment in these groups to evaluate the PK of ACH-0143422 and ACH-0143102 when dosed in combination. In order to preserve the blind of this study, safety and PK sampling assessments will also be required for subjects receiving placebo. In the absence of drug exposures that exceed threshold levels in the 12-week cohort, no intensive PK will be performed on subjects in the 8- and 6-week cohorts. After a 4-week review of safety and PK from the 12-week cohort, enrolment into the 8-week cohort will be initiated if safety and PK findings in the 12-week cohort are considered acceptable for continued dosing. Enrolment into the 6-week cohort will be initiated after subjects in the 12-week cohort have completed 6 weeks of treatment if safety and PK findings in the 12-week cohort are considered acceptable for continued dosing.
Eligibility
Inclusion Criteria8
- Males and females aged 18 years and less than 70 years.
- Chronic Hepatitis C infection
- Genotype 1 infection
- HCV RNA more than or equal to 10,000 IU/mL at screening
- No clinically relevant health abnormalities
- Agree to use effective contraception (defined in the protocol)
- Participants must be HCV treatment naïve
- Participants must have absence of cirrhosis
Exclusion Criteria6
- BMI of more than 36.0 kg/m2.
- Pregnant or nursing females
- Participation in any clinical trial within 30 days prior to study drug administration.
- Previous treatment (defined in the protocol)
- Previous use of certain medication (defined in protocol)
- Have clinically significant laboratory abnormalities or illnesses (defined in protocol), including liver damage or heart conditions
Interventions
Active treatment is 700 mg of ACH-0143422 (oral capsule) with 50 mg of ACH-0143102 (oral tablet) once daily (QD) or placebo taken for the following durations. Cohort 1 Group 1 – ACH-0143422 for 3 days, then 12 weeks of active treatment Group 2 – ACH-0143422 placebo for 3 days, then 12 weeks active treatment Group 3 – ACH-0143422 placebo for 3 days, then 12 weeks placebo for each drug Cohort 2 Group 4 – 8 weeks of active treatment Group 5 – 8 weeks placebo for each drug Cohort 3 Group 6 – 6 weeks of active treatment Group 7 – 6 weeks placebo for each drug All groups will be dosed under fed conditions. Adherence to required dosing will be monitored by counting number of returned tablets/capsules.
Locations(1)
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ACTRN12615000390583