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First in Human Study of ALS-002158; Single Dose, Food Effect in Healthy Volunteers; Multiple Doses in Chronic Hepatitis C Genotype 1 | Clinical Trials | Clareo Health

TERMINATEDPHASE1

First in Human Study of ALS-002158; Single Dose, Food Effect in Healthy Volunteers; Multiple Doses in Chronic Hepatitis C Genotype 1

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

NCT01554085•Alios Biopharma Inc.

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - 65 years

Sex

ALL

Healthy Volunteers

Yes

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.
•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.
+11 more criteria

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.
+2 more criteria

Locations (5)

QPharm

Brisbane, Queensland, Australia

CMAX

Adelaide, South Australia, Australia

Linear Clinical Research Ltd

Perth, Western Australia, Australia

Auckland Clinical Services

Auckland, New Zealand

Christchurch Clinical Studies Trust Ltd.

Christchurch, New Zealand

Key Dates

Start Date

December 31, 2011

Primary Completion Date

September 30, 2012

Completion Date

September 30, 2012

Last Updated

October 31, 2017

Enrollment

ACTUAL participants

Conditions

Hepatitis C, Chronic

Interventions

ALS-002158

DRUG

Placebo

DRUG

Digitalized Surveillance Management for Liver Cancer Risk Population in Improving Eearly Diagnosis Efficancy in Chinese Population (dSEARCH)

NCT05870969

Carcinoma, HepatocellularHepatitis C, Chronic+3 more

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COMPLETEDPHASE4

The No One Waits Study: Acceptability and Feasibility of Community-based Point-of-diagnosis HCV Treatment Study

NCT03987503

Hepatitis C, Chronic

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: October 31, 2017Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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First in Human Study of ALS-002158; Single Dose, Food Effect in Healthy Volunteers; Multiple Doses in Chronic Hepatitis C Genotype 1

Inclusion Criteria

Exclusion Criteria

Digitalized Surveillance Management for Liver Cancer Risk Population in Improving Eearly Diagnosis Efficancy in Chinese Population (dSEARCH)

The No One Waits Study: Acceptability and Feasibility of Community-based Point-of-diagnosis HCV Treatment Study

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The Pharmacokinetics of P1101 + Ribavirin in Interferon Treatment-Naïve Subjects With Chronic Hepatitis C Virus (HCV) Genotype 2 Infection