Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT01554085




Trial ID
NCT01554085
Ethics application status
Date submitted
12/03/2012
Date registered
13/03/2012
Date last updated
27/10/2017

Titles & IDs
Public title
First in Human Study of ALS-002158; Single Dose, Food Effect in Healthy Volunteers; Multiple Doses in Chronic Hepatitis C Genotype 1
Scientific title
A Randomized, Double-blind, Placebo-controlled, First-in-human, 3-Part Study of Orally Administered ALS-002158 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
Secondary ID [1] 0 0
ALS-2158-201
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Hepatitis C, Chronic 0 0
Condition category
Condition code
Infection 0 0 0 0
Other infectious diseases
Oral and Gastrointestinal 0 0 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - ALS-002158
Treatment: Drugs - Placebo

Experimental: ALS-002158 -

Placebo Comparator: Placebo -


Treatment: Drugs: ALS-002158
ALS-002158

Treatment: Drugs: Placebo
placebo

Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Tabulation of adverse events, physical exam, vital signs, 12-lead ECGs, and clinical lab results
Timepoint [1] 0 0
Part 1: Day 1-8; Part 2: Day 1-16; Part 3: Day 1-31
Secondary outcome [1] 0 0
Pharmacokinetic parameters and urinary excretion of ALS-002158 and metabolites - Maximum measured drug concentration (Cmax), time of maximum concentration (tmax), half-life (t1/2), apparent oral clearance (CL/F), area under the concentration time curve from time zero to infinity (AUC0-inf) or area under the concentration time curve from time zero to last quantifiable concentration (AUC0-last), area under the concentration time curve during the dosing interval (AUC0-tau)
Timepoint [1] 0 0
Part 1: Day 1-8; Part 2: Day 1-16; Part 3: Day 1-31
Secondary outcome [2] 0 0
HCV ribonucleic acid (RNA) viral load reduction
Timepoint [2] 0 0
Baseline to Day 31
Secondary outcome [3] 0 0
Sequence analysis of the Hepatitis C virus (HCV) NS5B region
Timepoint [3] 0 0
Baseline up to Month 6

Eligibility
Key inclusion criteria
- Subject has provided written consent.

- 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 of greater than 6 months duration 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 abdominal ultrasound scan
during screening.

- No prior treatment for CHC.

- Absence of history of clinical hepatic decompensation.

- Laboratory values include:

- prothrombin time < 1.5 × 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 ALT concentration < 5 × ULN.

- Alpha Fetoprotein (AFP) concentration = ULN. If AFP is = ULN, absence of a
hepatic mass must be demonstrated by ultrasound within the screening period.
Minimum age
18 Years
Maximum age
65 Years
Gender
Both males and females
Can healthy volunteers participate?
Yes
Key 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.

- Clinically significant 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 receiving study
medication.

- Clinically significant blood loss or elective blood donation of significant volume.

- Laboratory abnormalities including:

- Thyroid Stimulating Hormone (TSH) >ULN.

- Hematocrit < 34 %.

- White blood cell counts < 3,500/mm3.

- For healthy volunteers, history of regular use of tobacco.

- The subject has a positive pre-study drug screen.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 1
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Terminated
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD,SA,WA
Recruitment hospital [1] 0 0
QPharm - Brisbane
Recruitment hospital [2] 0 0
CMAX - Adelaide
Recruitment hospital [3] 0 0
Linear Clinical Research Ltd - Perth
Recruitment postcode(s) [1] 0 0
4006 - Brisbane
Recruitment postcode(s) [2] 0 0
5000 - Adelaide
Recruitment postcode(s) [3] 0 0
6009 - Perth
Recruitment outside Australia
Country [1] 0 0
New Zealand
State/province [1] 0 0
Auckland
Country [2] 0 0
New Zealand
State/province [2] 0 0
Christchurch

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Alios Biopharma Inc.
Address
Country
Other collaborator category [1] 0 0
Commercial sector/Industry
Name [1] 0 0
Vertex Pharmaceuticals Incorporated
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
This randomized, double-blind, placebo-controlled, 3-part study will assess the safety,
tolerability, and pharmacokinetics of orally administered ALS-002158 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.
Trial website
https://clinicaltrials.gov/show/NCT01554085
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries