Last updated: 11/07/2018 05:42:16
Clinical Study to Assess the Pharmacokinetics, Safety and Tolerability of SRT2104 Administered to Normal Healthy Male Volunteers
Clinicaltrials.gov ID
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Completed
Completed
Trial overview
Official title: A Randomized, Double-Blind, Placebo-Controlled, Phase I Clinical Study to Assess the Pharmacokinetics, Safety and Tolerability of SRT2104 Administered as Single and Multiple Doses in the Fed State to Normal Healthy Male Volunteers
Trial description: The purpose of this study is to assess the pharmacokinetic profile, safety, and tolerability of SRT2104 following administration of single and multiple oral doses (once a day for seven days) at a single dose level (2.0 g/day) to healthy male volunteers in the fed state.
Primary purpose:
Basic Science
Trial design:
Parallel Assignment
Masking:
Triple (Participant, Care Provider, Investigator)
Allocation:
Randomized
Primary outcomes:
To assess the plasma pharmacokinetic profile of SRT2104 following administration of single and multiple oral doses (once a day for seven days) at a single dose level (2.0 g/day) to healthy male volunteers in the fed state.
Timeframe: Plasma samples will be collected pre-dose (0 h) and at the following time points following dosing on Days 1 and 21: 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 15, 24, 48, 72 and 168 h post-dose.
Secondary outcomes:
To assess the safety and tolerability of SRT2104 following administration of single and multiple oral doses (once a day for seven days) at a single dose level (2.0 g/day) to healthy male volunteers in the fed state.
Timeframe: Safety will be monitored by AEs, VS, physical exam, labs and ECGs during the study.
Interventions:
Drug: SRT2104
Drug: Placebo
Enrollment:
10
Observational study model:
Not applicable
Primary completion date:
Not applicable
Time perspective:
Not applicable
Clinical publications:
Hoffman E, Wald J, Lavu S, Roberts J, Beaumont C, Haddad J, Elliott P, Westphal C, Jacobson E. Pharmacokinetics and tolerability of SRT2104, a first-in-class small molecule activator of SIRT1, after single and repeated oral administration in man. Br J Clin Pharmacol. 2012;(May 23):
Hoffman E, Wald J, Lavu S, Roberts J, Beaumont C, Haddad J, Elliott P, Westphal C, Jacobson E.Pharmacokinetics and tolerability of SRT2104, a first-in-class small molecule activator of SIRT1, after single and repeated oral administration in man. Br J Clin Pharmacol. 2012;75(1):186-96
Medical condition
Diabetes Mellitus, Type 2
Product
GSK2245840
Collaborators
Not applicable
Study date(s)
March 2009 to May 2009
Type
Interventional
Phase
1
Participation criteria
Sex
Male
Age
18 - 60 years
Accepts healthy volunteers
Yes
- Be a healthy male within the age range of 18 to 60 years.
- Voluntarily sign a Research Ethics Committee (REC)-approved informed consent form to participate in the study after all relevant aspects of the study have been explained and discussed with the subject.
- Subject has had a major illness in the past three months or any significant ongoing chronic medical illness that the Investigator would deem unfavourable for enrolment.
- Subject has renal or liver impairment.
Inclusion and exclusion criteria
Inclusion criteria:
- Be a healthy male within the age range of 18 to 60 years.
- Voluntarily sign a Research Ethics Committee (REC)-approved informed consent form to participate in the study after all relevant aspects of the study have been explained and discussed with the subject.
- Have biochemistry, coagulation, haematology and urinalysis test results that are within normal, allowable limits (if out-of-range, must be considered clinically significant to be exclusionary) and performed within 21 days of receiving first dose of test material.
- Have a BMI (Body Mass Index) between 18.0 and 32.0 kg/m2.
- Be clear of any history of HIV and hepatitis B and C.
- Have no significant disease or clinically significant abnormal laboratory value as deemed by the investigator on the laboratory evaluations, medical history, or physical exam.
- Have a normal 12-lead ECG or an ECG with abnormality considered to be clinically insignificant.
- Have the ability to communicate with the investigative site staff in a manner sufficient to carry out all protocol procedures as described.
- Agree to use an acceptable double barrier method for birth control from the Screening visit through 3 months after the last dose of test material.
- Agree to refrain from consumption of grapefruits and/or grapefruit juice from 7 days prior to Day -1 of treatment visit 1 through to the end of subject’s final study visit on Day 29.
Exclusion criteria:
- Subject has had a major illness in the past three months or any significant ongoing chronic medical illness that the Investigator would deem unfavourable for enrolment.
- Subject has renal or liver impairment.
- Subject has a history of gastro-intestinal surgery or has a current gastrointestinal disease which may influence drug absorption.
- Subject has a history, within 3 years, of drug abuse (including Benzodiazepines, opioids, amphetamine, cocaine, and THC) or a positive drug result at the Screening Visit.
- Subject smokes more than 5 cigarettes a day.
- Subject has a history of alcoholism, and/or is currently drinking more than three drinks per day [one drink is equal to one unit of alcohol (one glass of wine, half a pint of beer, one measure of a spirit)].
- Subject has participated in a clinical trial within the past three months (defined as three months from the date of last dose of an investigational medicinal product), with the exception of the SRT-2104-004 study (EudraCT number: 2008-007364-41).
- Subject has a history of difficulty in donating blood or accessibility of veins in left or right arm.
- Subject has donated blood (one unit or 350 mL) within three months prior to receiving test material.
- Subject is taking herbal products, over-the-counter medication or prescription drug therapy for which 5 times the half-life is longer than 21 days (i.e., the Screening Period) prior to enrolment into the study.
Trial location(s)
Location
GSK Investigational Site
Merthyr Tydfill, Glamorgan, United Kingdom, CF48 4DR
Status
Study Complete
Study documents
Clinical study report
Available language(s): English
Scientific result summary
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Refer to study documents
Recruitment status
Completed
Actual primary completion date
Not applicable
Actual study completion date
2009-12-05
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.
Additional information about the trial
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Additional information
Results for study 113140 can be found on the GSK Clinical Study Register.
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