Last updated: 11/03/2018 14:45:02
A Clinical Study to Assess the Safety and Pharmacokinetics of SRT2104 in Normal Healthy Male Volunteers
GSK study ID
113259
Clinicaltrials.gov ID
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Completed
Completed
Trial overview
Official title: A Phase I Randomized, Placebo-Controlled, Single-Blind, Multiple-Dose, Dose-Escalation Clinical Study to Assess the Safety and Pharmacokinetics of SRT2104 in Normal Healthy Male Volunteers
Trial description: The purpose of this study is to determine the safety and tolerability of SRT2104 (0.03, 0.1, 0.25, 0.5, 1.0, 2.0, and 3.0 g/day) in healthy male volunteers when administered after a single dose and once daily for 7 consecutive days.The purpose is also to characterize the pharmacokinetic profile of SRT2104 (0.03, 0.1, 0.25, 0.5, 1.0, 2.0, and 3.0 g/day) after a single dose and multiple administrations in healthy male volunteers.
Primary purpose:
Basic Science
Trial design:
Crossover Assignment
Masking:
Single (Participant)
Allocation:
Randomized
Primary outcomes:
Safety and tolerability of SRT2104 (0.03, 0.1, 0.25, 0.5, 1.0, 2.0, and 3.0 g/day) when administered as a single dose and when administered once daily for 7 consecutive days.
Timeframe: Adverse events will be monitored continuously while subjects are on study; safety visits will occur every 7 days for the duration of subject participation.
Characterize the pharmacokinetic profile of SRT2104 (0.03, 0.1, 0.25, 0.5, 1.0, 2.0, and 3.0 g/day) when administered as a single dose and when administered as once daily for 7 consecutive days.
Timeframe: Single dose PK timepoints are: predose and 15min, 30min, 1h, 2h, 4h, 8h, 12h, 24hrs postdose. Multiple dose PK timepoints are: Day1 to Day6 predose, Day7 predose, and 15min, 30min, 1h, 2h, 4h, 8h, 12h, 24hrs postdose.
Secondary outcomes:
Not applicable
Interventions:
Drug: SRT2104
Drug: Placebo
Enrollment:
43
Observational study model:
Not applicable
Primary completion date:
Not applicable
Time perspective:
Not applicable
Clinical publications:
Not applicable
Medical condition
Diabetes Mellitus, Type 2, Healthy volunteer
Product
GSK2245840
Collaborators
GSK
Study date(s)
May 2008 to November 2008
Type
Interventional
Phase
1
Participation criteria
Sex
Male
Age
18 - 55 years
Accepts healthy volunteers
Yes
- Be male within the age range of 18 to 55 years.
- Voluntarily sign an Independent Review Board (IRB/IEC)-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 unfavorable for enrollment.
- Subject has renal or liver impairment.
Inclusion and exclusion criteria
Inclusion criteria:
- Be male within the age range of 18 to 55 years.
- Voluntarily sign an Independent Review Board (IRB/IEC)-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 Hematology, Coagulation, Clinical Chemistry 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 30.0 kg/m2.
- Be clear of any history of HIV 1 and 2 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.
- Subject and their partner must 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.
- Subject agrees to refrain from consumption of grapefruits and/or grapefruit juice from time of study enrollment through end of subject’s final study visit.
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 unfavorable for enrollment.
- 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 Screening.
- Subject has a history of smoking, within 3 months, or is currently a smoker.
- Subject has a history of alcoholism (more than two years), 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.
- 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 or prescription drug therapy for which 5 times the half-life is longer than 21 days (i.e., the Screening period) prior to enrollment into the study.
Trial location(s)
Location
GSK Investigational Site
Merthyr Tydfill, Glamorgan, United Kingdom, CF48 4DR
Status
Study Complete
Study documents
No study documents available.
Results overview
Study Results yet to be posted
Recruitment status
Completed
Actual primary completion date
Not applicable
Actual study completion date
2008-11-11
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
Additional information
Not applicable
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