Last updated: 11/07/2018 05:49:51
A Clinical Study to Evaluate the Pharmacokinetics and the Absolute Bioavailability of SRT2104 Given as a 250mg Oral Suspension and Intravenous Microdose of 100 µg Carbon-14 radio-labeled SRT2104 in Healthy Male Subjects
GSK study ID
113260
Clinicaltrials.gov ID
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Completed
Completed
Trial overview
Official title: A Phase I Study to Evaluate the Intravenous Pharmacokinetics and the Absolute Bioavailability of SRT2104 given as a 250mg Oral Suspension in Healthy Subjects
Trial description: The primary objective of this study is to determine the absolute bioavailability of SRT2104 as a 250 mg suspension, and to define the intravenous pharmacokinetics of SRT2104.The secondary objective of this study is to assess the potential systemic metabolite burden of SRT2104, and to provide plasma and urine samples for subsequent metabolite profiling and identification.
Primary purpose:
Basic Science
Trial design:
Crossover Assignment
Masking:
None (Open Label)
Allocation:
Not applicable
Primary outcomes:
Absolute bioavailability of SRT2104 250 mg suspension.
Timeframe: Time points to measure the bioavailability of SRT2104 oral 250 mg suspension: 0, 1, 2, 3, 4, 5, 6, 8, 10, 12, 18, 24, 48, 72 hrs following administration.
Define the intravenous pharmacokinetics of SRT2104.
Timeframe: Time points to define the IV PK of SRT2104: Just before infusion (0); During infusion (5, 10 min); Post infusion (5, 10, 20, 30, 45 min and 1, 2, 3, 4, 6, 8, 10, 12, 15, 21, 45, 69 hours).
Secondary outcomes:
Potential systemic metabolite burden of SRT2104 following administration.
Timeframe: At time points: Pre-dose; 0-12 hrs post dose; 12-24 hrs post dose).
Interventions:
Drug: 250 mg SRT2104 Suspension
Drug: Carbon-14 radio-labeled SRT2104
Enrollment:
9
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;75(1):186-96
Medical condition
Diabetes Mellitus, Type 2
Product
GSK2245840
Collaborators
GSK
Study date(s)
November 2008 to December 2008
Type
Interventional
Phase
1
Participation criteria
Sex
Male
Age
18 - 65 years
Accepts healthy volunteers
Yes
- Healthy males;
- Aged 18–65 years;
- Participation in a clinical research study involving investigational drugs or dosage forms within the previous 4 months;
- Subjects who have previously been enrolled in this study;
Inclusion and exclusion criteria
Inclusion criteria:
- Healthy males;
- Aged 18–65 years;
- Body Mass Index (BMI) of 18–35 kg/m2;
- Willing and able to participate in the whole study and must provide written informed consent.
Exclusion criteria:
- Participation in a clinical research study involving investigational drugs or dosage forms within the previous 4 months;
- Subjects who have previously been enrolled in this study;
- Subjects who have ever sought advice from or been referred to a GP or counselor for abuse or misuse of alcohol, non medical drugs, medicinal drugs or other substance abuse e.g. solvents;
- Subjects who admit to any current or previous use of Class A drugs such as opiates, cocaine, ecstasy, lysergic acid diethylamide (LSD) and intravenous amphetamines (Subjects who admit to occasional past use of cannabis will not be excluded as long as they have a negative drugs of abuse test and have been abstinent for at least 12 months;)
- Positive drugs of abuse test result (Section 7.8);
- Regular alcohol consumption in males >21 units per week (1 Unit = ½ pint beer, a 25 mL shot of 40% spirit or a 125 mL glass of wine);
- Current smokers and those who have smoked within the last 12 months.
- A breath carbon monoxide reading of greater than 10 ppm at screening;
- Radiation exposure from clinical trials, including that from the present study and from diagnostic x rays but excluding background radiation, exceeding 5 mSv in the last twelve months or 10 mSv in the last five years. No occupationally exposed worker, as defined in the Ionising Radiation Regulations 1999, shall participate in the study;
- Clinically significant abnormal biochemistry, haematology or urinalysis as judged by the PI (Section 7.8 )
- History of adverse reaction or allergy to study drug or its excipients, e.g. lactose.
- History of significant allergy. If subject suffers from hayfever they must not have or be expecting to have symptoms during the study period;
- Donation of blood within the previous three months;
- Subjects will be excluded from the study if they are considered by the PI to be at risk of transmitting, thorough blood or other body fluids, the agents responsible for acquired immunodeficiency syndrome (AIDS) or other sexually transmitted disease or hepatitis;
- Positive HBV, HCV or HIV results;
- Subjects receiving prohibited medication as described in Section 6.10;
- Clinically significant medical history, examination finding or laboratory abnormality which in the opinion of the Investigator makes the subject unsuitable to include in the study;
- Failure to satisfy the PI of fitness to participate for any other reason.
Trial location(s)
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
2008-22-12
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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