Loading clinical trials...

A First Time in Human Study to Assess GSK2336805 in Healthy Volunteers and Single Doses in Chronically Infected Hepatitis C Patients. | Clinical Trials | Clareo Health

COMPLETEDPHASE1

A First Time in Human Study to Assess GSK2336805 in Healthy Volunteers and Single Doses in Chronically Infected Hepatitis C Patients.

A Randomized, Double Blind, Dose Escalation, Fusion, First Time in Human Study to Assess the Safety, Tolerability, Pharmacokinetics, and Antiviral Activity of Single and Repeat Doses of GSK2336805 in Healthy Volunteers and Single Doses in Chronically Infected Hepatitis C Subjects

NCT01277692•GlaxoSmithKline

View on ClinicalTrials.gov

Summary

This study is a three Part, Phase 1, randomized, dose-escalation, fusion, placebo-controlled, double-blind study to determine the safety, tolerability and Pharmacokinetic (PK) profile of GSK2336805 in healthy subjects and the safety, tolerability, PK, and antiviral profile of GSK2336805 in subjects chronically infected with HCV: i. Single doses in healthy subjects and the effect of food on GSK2336805 PK (Part 1). ii. Repeat doses in healthy subjects (Part 2) iii. Single doses in chronically infected HCV positive subjects (Part 3).

Eligibility

Age

18 - 65 years

Sex

ALL

Healthy Volunteers

Yes

Inclusion Criteria

•Healthy as determined by a responsible and experienced physician, based on a medical evaluation including medical history, physical examination, laboratory tests and ECG, including no cardiac, pulmonary, hepatic, biliary (except Gilbert's disease, gastrointestinal, or renal (defined as serum creatinine \>1.5 mg/dL or a calculated creatinine clearance (CrCl)\<50 mL/min), disorders, or cancer within the past 5 years (except localized or in situ cancer of the skin). A subject with a clinical abnormality or laboratory parameters outside the reference range for the population being studied may be included only if the Investigator and the GSK Medical Monitor agree that the finding is unlikely to introduce additional risk factors and will not interfere with the study procedures. A single repeat laboratory evaluation is allowed for eligibility determination.
•Male or female between 18 and 65 years of age inclusive, at the time of signing the informed consent.
•A female is eligible to enter and participate in this study if she is of: Non-childbearing potential defined as pre-menopausal females with a documented tubal ligation, bilateral oophorectomy, hysterectomy; or postmenopausal defined as 12 months of spontaneous amenorrhea.
•Male subjects must agree to use one of the contraception methods listed in the protocol.
•Body weight greater than or equal to 50 kg (110 lbs.) for men and greater than or equal to 45 kg (99 lbs.) for women. For Part 1, body mass index (BMI) between 18.5-32 kg/m2 inclusive will be allowed. For Part 3, BMI between 18.5-35.0 kg/m2 inclusive will be allowed.
•For healthy subjects in Part 1 and Part 2, Aspartate aminotransferase (AST), Alanine aminotransferase (ALT), alkaline phosphatase, bilirubin, and creatinine less than the upper limits of normal (ULN) (isolated bilirubin \<2.0xULN is acceptable if bilirubin is fractionated and direct bilirubin \<35%).
•QTcB or QTcF \< 450 msec; or QTc \<480 msec in subjects with Bundle Branch Block.
•The subject's systolic blood pressure is inside the range of 90-140 mmHg, or diastolic blood pressure is inside the range of 45-90 mmHg or heart rate is inside the range of 50-100 beats per minute (bpm) for female subjects or 45-100 bpm for male subjects.
•Capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the consent form.
•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.

Exclusion Criteria

•ALT greater than or equal to 3x ULN is allowed.
•Liver biopsy within two years prior to screening indicating the absence of cirrhosis.
•Unwillingness or inability to follow the procedures outlined in the protocol.
•A positive pre-study test for Human Immunodeficiency Virus (HIV) antibody or Hepatitis B surface antigen.
•For healthy subjects in Parts 1 and 2, a positive Hepatitis C antibody result within 3 months of screening. Chronic HCV infected subjects in Part 3 will have a positive HCV antibody and a positive HCV RNA.
•Pregnant females as determined by positive serum or urine Human chorionic gonadotropin (hCG) test at screening or prior to dosing.
•Subject is mentally or legally incapacitated.
•Has a history of regular alcohol consumption averaging: \>7 drinks/week for women or \>14 drinks/week for men within 6 months of the screening visit.
•Unwilling to abstain from alcohol for 48 hours prior to the start of dosing until collection of the final pharmacokinetic sample during each treatment period.
•For healthy subjects in Parts 1 and 2, history of regular use of tobacco- or nicotine-containing products within 3 months of the screening visit or indication of tobacco use as evidenced by a positive urine cotinine test at screening. For chronic HCV infected subjects in Part 3, history of regular use of tobacco- or nicotine-containing products is allowed; however, use of tobacco is not allowed on days of PK draws nor at the study site.
+8 more criteria

Locations (3)

GSK Investigational Site

Chula Vista, California, United States

GSK Investigational Site

Lenexa, Kansas, United States

GSK Investigational Site

Willingboro, New Jersey, United States

Key Dates

Start Date

November 3, 2010

Primary Completion Date

May 9, 2011

Completion Date

May 9, 2011

Last Updated

June 28, 2017

Enrollment

ACTUAL participants

Conditions

Hepatitis C

Interventions

GSK2336805 10mg

DRUG

GSK2336805 30mg

DRUG

GSK2236805 100mg

DRUG

GSK2236805 200mg

DRUG

GSK2236805 10mg

DRUG

GSK2236805 dose to be determined up to 100mg

DRUG

GSK2236805 5mg

DRUG

GSK2236805 30mg

DRUG

GSK2236805 100mg

DRUG

Implementing Low-Barrier HCV Treatment in a Jail Setting

NCT06953479

HEPATITIS C (HCV)Incarceration+2 more

View study

RECRUITINGNA

Project I Test: Implementing HIV Testing in Opioid Treatment Programs

NCT03135886

HIV/AIDSHepatitis C+2 more

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: June 28, 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.

View ClinicalTrials.gov Terms and Conditions

A First Time in Human Study to Assess GSK2336805 in Healthy Volunteers and Single Doses in Chronically Infected Hepatitis C Patients.

Inclusion Criteria

Exclusion Criteria

Implementing Low-Barrier HCV Treatment in a Jail Setting

Project I Test: Implementing HIV Testing in Opioid Treatment Programs

Persuasive Health Communication Intervention for HIV/HCV

The National Australian HCV Point-of-Care Testing Program

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

Acceptability of Simultaneous Screening for Viral Hepatitis B, C and HIV Among Drug Users in Non-conventional Structures