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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

Primary Purpose

Diabetes Mellitus, Type 2

Status
Completed
Phase
Phase 1
Locations
United Kingdom
Study Type
Interventional
Intervention
250 mg SRT2104 Suspension
Carbon-14 radio-labeled SRT2104
Sponsored by
Sirtris, a GSK Company
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Diabetes Mellitus, Type 2

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)MaleAccepts Healthy Volunteers

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.

Sites / Locations

  • GSK Investigational Site

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

SRT2104

Arm Description

Single arm with crossover from single dose of oral suspension formulation to single dose intravenous formulation.

Outcomes

Primary Outcome Measures

Absolute bioavailability of SRT2104 250 mg suspension.
Define the intravenous pharmacokinetics of SRT2104.

Secondary Outcome Measures

Potential systemic metabolite burden of SRT2104 following administration.

Full Information

First Posted
July 9, 2009
Last Updated
June 2, 2017
Sponsor
Sirtris, a GSK Company
Collaborators
GlaxoSmithKline
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1. Study Identification

Unique Protocol Identification Number
NCT00937872
Brief Title
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
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
Study Type
Interventional

2. Study Status

Record Verification Date
June 2017
Overall Recruitment Status
Completed
Study Start Date
November 22, 2008 (Actual)
Primary Completion Date
December 22, 2008 (Actual)
Study Completion Date
December 22, 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sirtris, a GSK Company
Collaborators
GlaxoSmithKline

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
Detailed Description
This will be a single centre, combined IV and oral single dose, open-label study in healthy male volunteers. Each subject will receive the following formulations on a single study day: Regimen A: A single 10 mL oral dose of 250 mg SRT2104 delivered as a suspension formulation; Regimen B: A single intravenous dose of 10 mL containing 100 µg (not more than 250 nCi, 9.25 kBq) Carbon-14 radio-labeled SRT2104 , administered by IV infusion over 15 minutes, starting 2 hours and 45 minutes after the oral dose.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Type 2

7. Study Design

Primary Purpose
Basic Science
Study Phase
Phase 1
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Enrollment
9 (Actual)

8. Arms, Groups, and Interventions

Arm Title
SRT2104
Arm Type
Experimental
Arm Description
Single arm with crossover from single dose of oral suspension formulation to single dose intravenous formulation.
Intervention Type
Drug
Intervention Name(s)
250 mg SRT2104 Suspension
Intervention Description
Single 10 mL oral dose of 250 mg SRT2104 delivered as a suspension formulation.
Intervention Type
Drug
Intervention Name(s)
Carbon-14 radio-labeled SRT2104
Intervention Description
Single 10 mL IV dose containing 100 microgram (not more than 250 nCi, 9.25 kBq) Carbon-14 radio-labeled SRT2104, administered by IV infusion over 15 minutes, starting 2 hours and 45 minutes after the oral dose is administered.
Primary Outcome Measure Information:
Title
Absolute bioavailability of SRT2104 250 mg suspension.
Time Frame
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.
Title
Define the intravenous pharmacokinetics of SRT2104.
Time Frame
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 Outcome Measure Information:
Title
Potential systemic metabolite burden of SRT2104 following administration.
Time Frame
At time points: Pre-dose; 0-12 hrs post dose; 12-24 hrs post dose).

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
GSK Clinical Trials
Organizational Affiliation
GlaxoSmithKline
Official's Role
Study Director
Facility Information:
Facility Name
GSK Investigational Site
City
Nottingham
ZIP/Postal Code
NG11 6JS
Country
United Kingdom

12. IPD Sharing Statement

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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

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