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.
- 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.
- 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|
Call for more information