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A Clinical Study to Assess the Safety, Pharmacokinetics, and Pharmacodynamics of SRT501 in Subjects With Colorectal Cancer and Hepatic Metastases

NCT00920803 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 9

Last updated 2017-06-14

No results posted yet for this study

Summary

The primary purpose of this study is to determine the safety and tolerability of SRT501 (5.0 g) in subjects with colorectal cancer and hepatic metastases when administered once daily for 14 days.

The purpose is to also characterize the pharmacokinetic profile of SRT501 (5.0 g) by assessing levels of SRT501 and metabolites in blood, urine, bile and normal and malignant metastatic tissues in subjects with colorectal cancer and hepatic metastases when administered once daily for 14 days.

The secondary purpose is to examine the pharmacodynamics of SRT501 activity in both normal and malignant tissue samples, including blood and/or bodily fluids.

Conditions

  • Neoplasms, Colorectal

Interventions

DRUG

Placebo

Placebo will be supplied in clinical kits as a powder which will be reconstituted with vehicle and water into a liquid suspension. Placebo must be used immediately following mixing. Placebo will be administered orally, once daily for 14 days.

DRUG

SRT501

SRT501 will be supplied in clinical kits as a powder which will be reconstituted with vehicle and water into a liquid suspension. The final drug product must be used immediately following mixing. SRT501 will be administered orally, once daily for 14 days.

Sponsors & Collaborators

  • GlaxoSmithKline

    collaborator INDUSTRY

  • Sirtris, a GSK Company

    lead INDUSTRY

Principal Investigators

  • GSK Clinical Trials · GlaxoSmithKline

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-08-19
Primary Completion
2009-11-11
Completion
2009-11-11

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 NCT00920803 on ClinicalTrials.gov