First in Human Study of ALS-002200; Single Dose, Food Effect in Healthy Volunteers; Multiple Doses in Chronic Hepatitis C Genotype 1
This trial is active, not recruiting.
|Condition||hepatitis c, chronic|
|Sponsor||Alios Biopharma Inc.|
|Collaborator||Vertex Pharmaceuticals Incorporated|
|Start date||December 2011|
|End date||February 2013|
|Trial size||80 participants|
|Trial identifier||NCT01590407, ALS-2200-101|
This randomized, double-blind, placebo-controlled, 3-part study will assess the safety, tolerability, and pharmacokinetics of orally administered ALS-002200 in healthy volunteers (HV) and subjects with chronic hepatitis C (CHC) genotype 1 infection.
Part 1 will assess single ascending dosing pharmacokinetics and safety in HV. Part 2 will assess food effects on pharmacokinetics in HV. Part 3 will assess multiple ascending dosing pharmacokinetics and safety in subjects with CHC genotype 1 infection.
|United States||No locations recruiting|
|Other countries||No locations recruiting|
|Endpoint classification||safety study|
|Intervention model||parallel assignment|
|Masking||double blind (subject, investigator)|
Number of Participants with Adverse Events as a Measure of Safety and Tolerability
time frame: up to Day 31
time frame: pre-dose and 0.25, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, 96, 120 and 240 hours post dose
time frame: pre-dose and 0.25, 0.5, 1, 2, 3,4, 6, 8, 12, 24, 36, 48, 72, 96, 120 and 240 hours post dose
HCV ribonucleic acid (RNA) viral load reduction
time frame: Baseline to Day 31
Amino Acid Changes in HCV polymerase NS5b
time frame: Baseline up to Month 6
Male or female participants from 18 years up to 65 years old.
Inclusion Criteria: - Subject has provided written consent. - In the investigator's opinion, the subject is able to understand and comply with protocol requirements, instructions, and protocol stated restrictions and is likely to complete the study as planned. - Subject is in good health as deemed by the investigator. - Creatinine clearance of greater than 50 mL/min (Cockcroft-Gault) - Male or female, 18-55 years of age for HV and 18-65 years of age for subjects with CHC. - Body mass index (BMI) 18-32 kg/m2 inclusive for HV and 18-36 kg/m2 for subjects with CHC, minimum weight 50 kg in both populations. - A female is eligible to participate in this study if she is of non childbearing potential. - If male, subject is surgically sterile or practicing specific forms of birth control. Additional inclusion criteria for subjects with CHC genotype 1 infection: - Positive HCV antibody and a positive HCV RNA at screening. - Documentation of CHC infection for greater than 6 months at screening - CHC genotype 1 infection at screening - HCV RNA viral load ≥ 105 and ≤108 IU/mL using a sensitive quantitative assay. - Liver biopsy within two years or Fibroscan evaluation within 6 months prior to screening that clearly excludes cirrhosis. Fibroscan liver stiffness score must be < 12 kPa. - Absence of hepatocellular carcinoma as indicated by an ultrasound scan conducted during screening - No prior treatment for CHC - Absence of history of clinical hepatic decompensation. - Laboratory values include: - Prothrombin time < 1.5x ULN - Platelets > 120,000/mm3 - Albumin > 3.5 g/dL, bilirubin < 1.5 mg/dL at screening (subjects with documented Gilbert's disease allowed). - Serum alanine aminotransferase (ALT) concentration < 5 x ULN - Alpha Fetoprotein (AFP) concentrations ≤ ULN. If AFP is ≥ ULN, absence of a hepatic mass must be demonstrated by ultrasound within the screening period. Exclusion Criteria: - Clinically significant cardiovascular, respiratory, renal, gastrointestinal, hematologic, neurologic, thyroid, or any uncontrolled medical illness or psychiatric disorder. - Positive test for HAV IgM, HBsAg, HCV Ab (HV only), or HIV Ab. - Abnormal screening laboratory results that are considered clinically significant by the investigator. - Drug allergy such as, but not limited to, sulfonamides and penicillins, including those experienced in previous trials with experimental drugs. - Participation in an investigational drug trial or having received an investigational vaccine within 30 days or 5 half lives (whichever is longer) prior to study medication. - Clinically significant blood loss or elective blood donation of significant volume. - For healthy subjects, history of regular use of tobacco. - The subject has a positive pre-study drug screen. - Laboratory abnormalities including: - Thyroid Stimulating Hormone (TSH) > ULN - Hematocrit < 34 % - White blood cell counts < 3,500/mm3
|Official title||A Randomized, Double-blind, Placebo-controlled, First-in-human, 3-Part Study of Orally Administered ALS-002200 to Evaluate the Safety, Tolerability, and Pharmacokinetics of Single Ascending Dosing and Food-effect in Healthy Volunteers, and Multiple Ascending Dosing in Subjects With Chronic Hepatitis C Genotype 1 Infection|
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