Last updated: 11/07/2018 05:50:04
A clinical study to assess the effect of food and gender on the pharmacokinetics of SRT2104 administered as an oral suspension or capsule formulation to normal healthy volunteers
Clinicaltrials.gov ID
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Trial overview
Official title: Gender vs. Fed/Fasted State vs. Capsule/Liquid Suspension Formulation Study
Trial description: The primary objective of this study is to assess the pharmacokinetic profile of a single 500 mg dose of SRT2104 administered as an oral suspension and a capsule formulation to normal healthy male and female volunteers in both the fed and fasted state.The secondary objective is to assess the safety and tolerance of SRT2104 administered as an oral suspension and as a capsule formulation to healthy male and female volunteers in both the fed and fasted state.
Primary purpose:
Basic Science
Trial design:
Crossover Assignment
Masking:
None (Open Label)
Allocation:
Randomized
Primary outcomes:
Characterize and compare the pharmacokinetic profile of a single 500 mg dose of SRT2104 administered as an oral suspension and as a capsule formulation.
Timeframe: PK time points: pre-dose (0 hrs); 0.25, 0.5, 0.75, 1.0, 1.5, 2.0, 2.5, 3.0, 4.0, 5.0. 6.0, 8.0, 10, 12, 15, 24, 36, 48, 72 hours post dose.
Secondary outcomes:
Assess the safety and tolerance of SRT2104.
Timeframe: AEs, concomitant medications (as applicable), vital signs, physical examinations, laboratory parameters, and ECG parameters will be collected for the duration of the study.
Interventions:
Enrollment:
20
Primary completion date:
Not applicable
Observational study model:
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
GSK
Study date(s)
January 2009 to March 2009
Type
Interventional
Phase
1
Participation criteria
Sex
Female & Male
Age
18 - 55 years
Accepts healthy volunteers
Yes
- Be a healthy male or female within the age range of 18 to 55 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 unfavorable for enrollment.
- Subject has renal or liver impairment.
Inclusion and exclusion criteria
Inclusion criteria:
- Be a healthy male or female within the age range of 18 to 55 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 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/m^2.
- 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.
- All subjects 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.
- All female subjects must be of non-childbearing potential. For the purposes of this study, this is defined as the subject being amenorrheic for at least 12 consecutive months or at least 6 weeks post-surgical bilateral oophorectomy with or without hysterectomy. (Menopausal status will be confirmed by demonstrating levels of follicle stimulating hormone (FSH) of 20 – 138 mIU/ml and oestradiol < 20 pg/ml at entry. In the event a subject's menopause status has been clearly established (for example, the subject indicates she has been amenorrheic for 10 years), but FSH and/or oestradiol levels are not consistent with a post-menopausal condition, determination of subject eligibility will be at the discretion of the principal investigator following consultation with the sponsor.
- Subject agrees 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.
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 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).
- 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 (with the exception of hormone replacement therapy for female subjects) 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
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
Study complete
Actual primary completion date
Not applicable
Actual study completion date
2009-27-03
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.
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