Hepatitis C, ChronicPhase 1NCT01554085
First in Human Study of ALS-002158; Single Dose, Food Effect in Healthy Volunteers; Multiple Doses in Chronic Hepatitis C Genotype 1
A Phase 1 study testing ALS-002158 in people with Hepatitis C, Chronic, run by Alios Biopharma Inc. at 5 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Hepatitis C, Chronic
- What is being tested?
- ALS-002158
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 78 participants
- Where
- 5 sitesin 2 countries
- Study dates
- 31 Dec 2011to 30 Sep 2012
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
5 sites in 2 countries.
5 sites in 2 countries
Australia3 sites
CMAX
Adelaide, South Australia, 5000
QPharm
Brisbane, Queensland, 4006
Linear Clinical Research Ltd
Perth, Western Australia, 6009
New Zealand2 sites
Auckland Clinical Services
Auckland
Christchurch Clinical Studies Trust Ltd.
Christchurch
About this study
Official 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
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.
- Conditions
- Hepatitis C, Chronic
- Being tested
- ALS-002158, Placebo
- Medical subject headings
- Hepatitis C, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ALS-002158Drug
ALS-002158
PlaceboDrug
placebo
| Study group | Role | What they receive |
|---|---|---|
| ALS-002158 | Experimental | Not described Receives: Drug: ALS-002158 |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tabulation of adverse events, physical exam, vital signs, 12-lead ECGs, and clinical lab results
Measured: Part 1: Day 1-8; Part 2: Day 1-16; Part 3: Day 1-31
Secondary outcomes (3)
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)
Measured: Part 1: Day 1-8; Part 2: Day 1-16; Part 3: Day 1-31
HCV ribonucleic acid (RNA) viral load reduction
Measured: Baseline to Day 31
Sequence analysis of the Hepatitis C virus (HCV) NS5B region
Measured: Baseline up to Month 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Mar 2012 (estimated)
- Study start31 Dec 2011
- Primary completion30 Sep 2012
- Study completion30 Sep 2012
Why it stopped: ALS-2158 showed insufficient antiviral activity to warrant proceeding with further clinical development.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatitis C, ChronicStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 78 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alios Biopharma Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Vertex Pharmaceuticals Incorporated
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01554085
- Sponsor's protocol ID
- ALS-2158-201
- Status last verified
- Oct 2017
- First submitted
- 12 Mar 2012
- Last updated
- 31 Oct 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT01554085
- Acronym / sponsor ID
- ALS-2158-201
- Conditions
- Hepatitis C, Chronic
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: ALS-2158 showed insufficient antiviral activity to warrant proceeding with further clinical development.
- Enrolment
- 78 participants (actual)
- Lead sponsor
- Alios Biopharma Inc.Industry (pharma, biotech, devices)
- Collaborators
- Vertex Pharmaceuticals Incorporated
- Study start
- 31 Dec 2011 (actual)
- Primary completion
- 30 Sep 2012 (actual)
- Study completion
- 30 Sep 2012 (actual)
- First posted
- 14 Mar 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ALS-002158 | Experimental | Drug: ALS-002158 |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (22 listed)
- 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.
Key exclusion criteria (12 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ALS-002158ALS-002158 | Drug | ALS-002158 |
| Placeboplacebo | Drug | Placebo |
Primary outcome
Tabulation of adverse events, physical exam, vital signs, 12-lead ECGs, and clinical lab results
Time frame: Part 1: Day 1-8; Part 2: Day 1-16; Part 3: Day 1-31
3 secondary outcomes
Pharmacokinetic parameters and urinary excretion of ALS-002158 and metabolites
Time frame: Part 1: Day 1-8; Part 2: Day 1-16; Part 3: Day 1-31
HCV ribonucleic acid (RNA) viral load reduction
Time frame: Baseline to Day 31
Sequence analysis of the Hepatitis C virus (HCV) NS5B region
Time frame: Baseline up to Month 6
Results and safety
The study was stopped early (reason given: ALS-2158 showed insufficient antiviral activity to warrant proceeding with further clinical development.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Oct 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
5 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing ALS-002158 in people with Hepatitis C, Chronic, run by Alios Biopharma Inc. at 5 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 22 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 31 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Australia, New Zealand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: ALS-2158 showed insufficient antiviral activity to warrant proceeding with further clinical development.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Tabulation of adverse events, physical exam, vital signs, 12-lead ECGs, and clinical lab results (time frame: Part 1: Day 1-8; Part 2: Day 1-16; Part 3: Day 1-31). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Oct 2017.