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Evaluation Of SB-751689 Administered At Supratherapeutic Dose Levels In Healthy Adult Subjects.

NCT00468689 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 15

Last updated 2008-10-13

No results posted yet for this study

Summary

This study will evaluate the safety, tolerability and exposure of SB-751689 when administered alone at supratherapeutic doses and when SB-751689 is co administered with ketoconazole, a PGP/CYP3A4 inhibitor that increases exposure of SB-751689. Data from this study will enable the planning and conduct of a QTc study for SB-751689.

Conditions

Interventions

DRUG

SB-751689 oral tablets (100 and 400 ng)

DRUG

Ketoconazole (NIZORAL) oral tablets (200 mg)

Sponsors & Collaborators

Principal Investigators

  • GSK Clinical Trials, MD · GlaxoSmithKline

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2007-04-30
Primary Completion
2007-08-31
Completion
2007-08-31

Countries

  • United States

Study Locations

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Entities

Diseases
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 NCT00468689 on ClinicalTrials.gov