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

NCT01277692 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 58

Last updated 2017-06-28

No results posted yet for this study

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).

Conditions

  • Hepatitis C

Interventions

DRUG

GSK2336805 10mg

single dose once daily

DRUG

GSK2336805 30mg

single dose once daily

DRUG

GSK2236805 100mg

single dose once daily

DRUG

GSK2236805 200mg

single dose once daily

DRUG

GSK2236805 10mg

repeat dose once daily for 7 days

DRUG

GSK2236805 dose to be determined up to 100mg

repeat dose once daily for 7 days

DRUG

GSK2236805 5mg

single dose in HCV infected patients

DRUG

GSK2236805 30mg

single dose in HCV infected patients

DRUG

GSK2236805 100mg

single dose in HCV infected patients

Sponsors & Collaborators

Principal Investigators

  • GSK Clinical Trials · GlaxoSmithKline

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
DOUBLE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2010-11-03
Primary Completion
2011-05-09
Completion
2011-05-09

Countries

  • United States

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01277692 on ClinicalTrials.gov