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Phase 1 Dose Escalating Study to Assess Safety, Tolerability, Food Effect and PK of CHR-5154 in Healthy Male Volunteers

NCT01934101 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 64

Last updated 2017-05-15

No results posted yet for this study

Summary

Primary Objective:

• To determine the safety and tolerability of single and multiple ascending oral doses of CHR-5154 in healthy volunteers.

Secondary Objectives:

* To determine the pharmacokinetic profile of CHR-5154 and its metabolite CHR-5426.
* To compare the pharmacokinetic profile of CHR-5154 and CHR-5426 after a single dose of CHR-5154 in the fed and fasted state.

Conditions

  • Arthritis, Rheumatoid

Interventions

DRUG

CHR-5154

CHR-5154

DRUG

Placebo

Placebo

Sponsors & Collaborators

Principal Investigators

  • GSK Clinical Trials · GlaxoSmithKline

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2013-08-12
Primary Completion
2014-05-28
Completion
2014-05-28

Countries

  • United Kingdom

Study Locations

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Entities

Drugs
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 NCT01934101 on ClinicalTrials.gov