A Phase 1, Double-Blind, Randomized Clinical Study to Assess the Safety, Pharmacokinetics, and Pharmacodynamics of SRT501 in Subjects With Colorectal Cancer and Hepatic Metastases
This is a randomized, double-blind, placebo-controlled, inpatient/outpatient study to assess
the safety, pharmacokinetics, and pharmacodynamics of SRT501 in subjects diagnosed with
colorectal cancer and hepatic metastases. Fifteen subjects aged 18 years of age and older
who fulfill the inclusion/exclusion criteria, will be enrolled in this study. Ten
subjects, if eligible, will be randomized to receive SRT501 and 5 subjects, if eligible,
will be randomized to receive placebo. Subjects will sign the informed consent form prior
to any study-related procedures. If eligible, subjects will consent to receive 5.0 g of
SRT501 or placebo, to be administered once daily as an oral reconstituted powder, for 14
days at the same time each day. On Days 1 and 2, SRT501 or placebo will be administered
approximately 15-30 minutes following the consumption of a standardized breakfast to allow
for PK sample collection. On all other days, SRT501 or placebo will be administered
approximately 15-30 minutes following the consumption of the evening meal. Following the
course of SRT501 or placebo administration, subjects will undergo scheduled surgical removal
of their metastatic liver disease as well as non-diseased tissue and these samples will be
evaluated for SRT501 concentrations and pharmacodynamic markers of neoplastic activity (such
as cell differentiation, apoptosis, proliferation, etc.). Due to scheduling and surgical
availability, subjects can receive SRT501 or placebo for a minimum of 10 days and a maximum
of 21 days. If diseased colon tissue is also scheduled to be removed during resection,
both diseased and normal colon tissue will also be collected for analysis. Participants
will be required to return to the study center on Day 2 for a 24-hour PK sample and the
evening prior to their scheduled surgical resection as well as per the Institution's
standards of care for recovery following the surgical procedure.
Interventional
Allocation: Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Basic Science
To determine the safety and tolerability of SRT501 when administered once daily for 14 days.
Safety will be continually assessed while subjects are on study.
No
GSK Clinical Trials
Study Director
GlaxoSmithKline
United Kingdom: Medicines and Healthcare Products Regulatory Agency
113221
NCT00920803
August 2008
November 2009
Name | Location |
---|