Diabetes Mellitus, Type 2Phase 1NCT00937872
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
A Phase 1 study testing 250 mg SRT2104 Suspension and Carbon-14 radio-labeled SRT2104 in people with Diabetes Mellitus, Type 2, run by Sirtris, a GSK Company at 1 site in United Kingdom.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 65 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Diabetes Mellitus, Type 2
- What is being tested?
- 250 mg SRT2104 Suspension and Carbon-14 radio-labeled SRT2104
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 22 Nov 2008to 22 Dec 2008
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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);
Show all 18Show fewer
- 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 locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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.
- Conditions
- Diabetes Mellitus, Type 2
- Being tested
- 250 mg SRT2104 Suspension, Carbon-14 radio-labeled SRT2104
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
250 mg SRT2104 SuspensionDrug
Single 10 mL oral dose of 250 mg SRT2104 delivered as a suspension formulation.
Carbon-14 radio-labeled SRT2104Drug
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.
| Study group | Role | What they receive |
|---|---|---|
| SRT2104 | Experimental | Single arm with crossover from single dose of oral suspension formulation to single dose intravenous formulation. Receives: Drug: 250 mg SRT2104 Suspension; Drug: Carbon-14 radio-labeled SRT2104 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Absolute bioavailability of SRT2104 250 mg suspension.
Measured: 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.
Measured: 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 (1)
Potential systemic metabolite burden of SRT2104 following administration.
Measured: At time points: Pre-dose; 0-12 hrs post dose; 12-24 hrs post dose).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2009 (estimated)
- Study start22 Nov 2008
- Primary completion22 Dec 2008
- Study completion22 Dec 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Mellitus, Type 2Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Basic science
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sirtris, a GSK Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- GlaxoSmithKline
- Responsible party
- Sponsor
- Investigators
- GSK Clinical Trials, Study director, GlaxoSmithKline
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00937872
- Sponsor's protocol ID
- 113260
- Status last verified
- Jun 2017
- First submitted
- 9 Jul 2009
- Last updated
- 5 Jun 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00937872
- Acronym / sponsor ID
- 113260
- Conditions
- Diabetes Mellitus, Type 2
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 9 participants (actual)
- Lead sponsor
- Sirtris, a GSK CompanyIndustry (pharma, biotech, devices)
- Collaborators
- GlaxoSmithKline
- Study start
- 22 Nov 2008 (actual)
- Primary completion
- 22 Dec 2008 (actual)
- Study completion
- 22 Dec 2008 (actual)
- First posted
- 13 Jul 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| SRT2104 | Experimental | Drug: 250 mg SRT2104 Suspension, Drug: Carbon-14 radio-labeled SRT2104Single arm with crossover from single dose of oral suspension formulation to single dose intravenous formulation. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (18 listed)
- 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);
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 250 mg SRT2104 SuspensionSingle 10 mL oral dose of 250 mg SRT2104 delivered as a suspension formulation. | Drug | SRT2104 |
| Carbon-14 radio-labeled SRT2104Single 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. | Drug | SRT2104 |
Primary outcome
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.
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).
1 secondary outcome
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).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jun 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
GSK Clinical Trials study director
GlaxoSmithKline
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing 250 mg SRT2104 Suspension and Carbon-14 radio-labeled SRT2104 in people with Diabetes Mellitus, Type 2, run by Sirtris, a GSK Company at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Jun 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jun 2017.