Atrophy, MuscularPhase 1NCT00964340
A Clinical Study to Assess the Safety, Tolerability and Pharmacokinetics of Oral SRT2104 Capsules Administered to Healthy Elderly Subjects for 28 Days
A Phase 1 study testing SRT2104 in people with Atrophy, Muscular, run by GlaxoSmithKline at 1 site in United Kingdom.
Trial summary
The primary objective is to determine the pharmacokinetics, safety and tolerability of SRT2104 in healthy elderly subjects following single and 28 days dosing. The secondary objectives of the study are: 1. Read more about this study
- Who is it for?
- Ages 60 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Atrophy, Muscular
- What is being tested?
- SRT2104
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Oct 2009to 27 Apr 2010
- 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 60 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Independently ambulatory, healthy male and female subjects within the age range of 60 to 80 years (inclusive) at the time of screening
- All female subjects must be of non-childbearing potential. For the purposes of this study, women need to be amenorrheic for at least 12 consecutive months, at least 6 weeks postsurgical bilateral oophorectomy (with or without hysterectomy) or post tubal ligation. Menopausal status will be confirmed by demonstrating levels of follicle stimulating hormone (FSH) 40 - 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 with agreement of the independent Medical Monitor
- All male subjects must agree with their partners to use double-barrier birth control or abstinence while participating in the study and for 12 weeks following the last dose of study drug
- Willingness to provide written informed consent to participate in the study
- Body Mass Index (BMI) 18-30 kg/m^2 (inclusive)
- No prior history of HIV 1 or 2
Show all 13Show fewer
- No prior history of disease markers for hepatitis B \& C virus
- Absence of significant disease or clinically significant abnormal laboratory values on the laboratory evaluations, medical history or physical examination during screening; normal end organ function at the discretion of the Principal Investigator
- Have a normal 12-lead ECG or one with changes considered to be clinically insignificant on medical review. QTcF must be <430msec for males and <450msec for females
- Resting supine BP <160/90 mmHg.
- Comprehension of the nature and purpose of the study and compliance with the requirement of the entire protocol
- Able to communicate in person and by telephone in a manner that allows all protocol procedures to be carried out safety and reliably in the opinion of the investigative site staff
- Able to take 8 capsules of study medication
Who cannot join
- Limitation to free passive or active movement of leg or foot by pain, prior injury, or developmental abnormality
- Any major illness in the past three months or any ongoing chronic medical illness which in the opinion of the PI or Medical Monitor could risk subject safety or interpretation of the results
- Ongoing or chronic history of renal or liver impairment, defined as serum creatinine clearance level less than 80ml/min as determined by Cockcroft-Gault formula (adjusted for ideal body weight), and greater than two times the upper limit of normal for liver enzymes, respectively
- Subjects with a CPK> upper limit of normal. CPK values that are marginally above the upper limit of normal may be retested at the discretion of the Principal Investigator in conjunction with the Sponsor's approval
- History, within 3 years, of drug abuse (including but not limited to anxiolytics or pain medication)
- History of alcoholism (more than two years), drinkers of more than three units per day (one unit of alcohol is equivalent to one small glass of wine, half pint of beer or one measure of spirit)
Show all 18Show fewer
- Participation in any clinical trial with an investigative medicinal product within the past three months prior to the first dose in the current study
- Exposure to more than three new chemical entities within 12 months prior to the first dose in the current study
- History of difficulty in donating blood or accessibility of veins in left or right arm
- Donation of blood (one unit or 350 ml) within three months prior to receiving the first dose of test material
- History of sensitivity to any of the study medications, or components thereof or a history of drug or other allergy that, in the opinion of the Investigator or Medical Monitor, contraindicates their participation
- Ongoing, or history of endocrine, inflammatory, cardiovascular (in particular cardiac hypertrophy or cardiac dysrrhythmia, cardiac failure or history of prolonged QT interval), gastro-intestinal (except for appendectomy), neurological, psychiatric or metabolic disease which in the opinion of the Investigator or Medical Monitor could risk subject safety or interpretation of the results
- Active neoplastic disease or history of neoplastic disease (except for basal cell carcinoma of the skin)
- Contraindications to MRI including, but not limited to: intracranial aneurism clips (except Sugita), history of metal lathe work or possibility of intra-orbital metal fragments, pacemakers and non-MR compatible heart valves or other non-MR compatible implants, history of claustrophobia or subject feels unable to lie still on their back for a period of 1 hour in the MRI scanner
- Subjects receiving steroids, estrogens insulin or creatine will be excluded. Other concomitant medications and herbal products administered in a stable dose for at least 3 months may be permitted at the discretion of the Principal Investigator
- Subjects who spend less than 1 hour per week walking outside the home and subjects who participate in light sports and exercise for more than 6 hours per week
- A positive pre-study drug/alcohol screen
- Ongoing, or history of Type 1 or Type 2 diabetes mellitus or mOGTT results at screening that in the opinion of the PI indicates diabetes or pre-diabetes
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Placebo-Controlled, Double-Blind, Clinical Study to Assess the Safety, Tolerability and Pharmacokinetics of Oral SRT2104 Capsules Administered to Healthy Elderly Subjects for 28 Days
The primary objective is to determine the pharmacokinetics, safety and tolerability of SRT2104 in healthy elderly subjects following single and 28 days dosing.
The secondary objectives of the study are:
- To contrast changes in leg muscle function following repeat doses of SRT2104 or placebo: Endurance exercise tolerance 31P MRS measures of mitochondrial oxidative capacity in the gastrocnemius muscle
- To test for a change in the ratio of visceral to subcutaneous body fat following repeat doses of SRT2104 relative to placebo using MRI
- To estimate any changes in insulin sensitivity (using mOGTT) following repeat doses of SRT2104 or placebo
- To test for dose-related effects on the exploratory pharmacodynamic measures above
Read the detailed description
This is a double-blind, randomized, parallel group, placebo-controlled study of healthy 60-80 year old community-dwelling male and female subjects. The study consists of 8 outpatient clinic visits, 2 inpatient clinic visits and 8 telephone contacts (including the pre-screening call to determine a subject's interest in participation).
Subjects will undergo a preliminary telephone pre-screening assessment to determine their interest in participating in the study. Once interest has been confirmed, subjects will sign an informed consent and undergo screening procedures. Subjects meeting the inclusion and exclusion criteria will be enrolled in the study and randomized to receive either 0.5 g/day of SRT2104, 2.0 g/day of SRT2104 or placebo once daily for up to 28 consecutive days. After the completion of the screening assessments and confirmation of eligibility, subjects will return to the site on Day -9 and will undergo a practice endurance testing session. In addition, on Day -9 subjects will be given a pedometer which they will be asked to wear while awake for 7 consecutive days from Day -8 and 7 consecutive days from Day 20 to estimate daily physical mobility levels in the home environment. Subjects will return to the site on Days -1 and 27 for safety assessments, MRI/MRS assessments and exercise endurance tests.
On Days 1 and 28 subjects will be admitted overnight as inpatients. PK samples will be collected through 24 hours post-dose on Days 2 and 29.
During the dosing period safety visits will be performed on approximately Days 7, 14, and 21. Additional telephone safety assessments will be made approximately on Days 3, 5, 10, 17, 20 and 24.
The End of Dosing Follow-up visit will be performed approximately 35 days following the first dose of SRT2104 or placebo. An additional follow up safety telephone call will be made to each subject 30 days following their final dose of SRT2104 and/or placebo. The end of the study is defined as the last subject's last assessment (i.e. Day 58, the date of the last subject communication).
Subjects will be instructed to self administer test material at home on study days 3-27. All study visits are outpatient visits except for Day 1 and Day 28. Subjects will stay overnight at the site the evening of Day 1 and Day 28. On Day 2 and Day 29 subjects will be discharged home following the completion of study assessments and when considered clinically appropriate by the study physician.
- Conditions
- Atrophy, Muscular
- Being tested
- Placebo, SRT2104
- Medical subject headings
- Muscular Atrophy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboDrug
For the placebo product, the SRT2104 drug substance will be replaced by microcrystalline cellulose (Avicel® PH 105) to match the SRT2104 investigational product. The ratio of active to placebo capsules will vary according to the subject's dosing level.
SRT2104Drug
SRT2104 drug substance is a new chemical entity which is supplied as a fine, yellowish/amber powder. The SRT2104 investigational product is prepared by packing 250 mg of the SRT2104 powder into a size 00 opaque capsule, which is then stored in dosing bottles.
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | The Placebo treatment group will be administered eight placebo capsules per day. Placebo will be administered orally once daily for twenty-eight consecutive days. Dosing will take place at approximately the same time every day, approximately 15 minutes following the consumption of a standardized meal, and subjects must wait at least 1-2hrs after dosing before consuming additional calories. Water is permitted ad libitum. Receives: Drug: Placebo |
| 0.5g SRT2104 | Active comparator | The 0.5g SRT2104 treatment group will be administered 2 SRT2104 capsules with 6 matching placebo capsules, for a total of 8 capsules per day. 0.5g SRT2104 will be administered orally once daily for twenty-eight consecutive days. Dosing will take place at approximately the same time every day, approximately 15 minutes following the consumption of a standardized meal, and subjects must wait at least 1-2hrs after dosing before consuming additional calories. Water is permitted ad libitum. Receives: Drug: Placebo; Drug: SRT2104 |
| 2.0g SRT2104 | Active comparator | The 2.0g SRT2104 treatment group will be administered 8 SRT2104 capsules per day. 2.0g SRT2104 will be administered orally once daily for twenty-eight consecutive days. Dosing will take place at approximately the same time every day, approximately 15 minutes following the consumption of a standardized meal, and subjects must wait at least 1-2hrs after dosing before consuming additional calories. Water is permitted ad libitum. Receives: Drug: SRT2104 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Determine the pharmacokinetics of SRT2104 in healthy elderly subjects following single and 28 days dosing.
Measured: PK samples will be collected on Days 1 and 28 at pre-dose and at 15 min, 30 min, and 1, 2, 3, 4, 8, 12 hrs post-dose. PK samples will also be collected 24 hrs post-dose on Days 2 and 29.
Safety and tolerability of SRT2104 in healthy elderly subjects following single and 28 days dosing.
Measured: Safety will be monitored by AEs, VS, physical exam, labs and ECGs during the study.
Secondary outcomes (4)
Contrast changes in leg muscle function following repeat doses of SRT2104.
Measured: On Day -1 and Day 27, 31P MRS will measure mitochondrial oxidative capacity in the gastrocnemius muscle of the dominant leg; exercise in the MR scanner and a staged bicycle exercise test will record the exercise endurance tolerance.
Test for a change in the ratio of visceral to subcutaneous body fat by MRI following repeat doses of SRT2104 or placebo.
Measured: On Day -1 and Day 27 MRI and MRS assessments will be performed to measure compartmental fat distribution.
Measure changes in insulin sensitivity (using mOGTT) and dose-related effects on pharmacodynamics following repeat doses of SRT2104 or placebo.
Measured: OGTT is measured to assess PD effects of SRT2104 at screening and on Day 29 prior to the administration of 75g of oral glucose, and at 10min, 20min, 30min, 1hr, 1.5hr, 2hr, and 3 hr following glucose administration.
Test for an increase in overall endurance and activity following repeat doses of SRT2104.
Measured: Pedometer will be worn by subjects while awake for 7 consecutive days from Day -8 until Day -1 and on Day 20 until Day 27.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2009 (estimated)
- Study start1 Oct 2009
- Primary completion27 Apr 2010
- Study completion27 Apr 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Atrophy, MuscularStudies of the same condition, open and under way.
- More trials run by GlaxoSmithKlineThe sponsor's other registered studies.
- 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
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- GlaxoSmithKline
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- GSK Clinical Trials, Study director, GlaxoSmithKline
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00964340
- Sponsor's protocol ID
- 113312
- Status last verified
- Jun 2017
- First submitted
- 20 Aug 2009
- Last updated
- 16 Jun 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes: Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
Publications
Libri V, Brown AP, Gambarota G, Haddad J, Shields GS, Dawes H, Pinato DJ, Hoffman E, Elliot PJ, Vlasuk GP, Jacobson E, Wilkins MR, Matthews PM. A pilot randomized, placebo controlled, double blind phase I trial of the novel SIRT1 activator SRT2104 in elderly volunteers. PLoS One. 2012;7(12):e51395. doi: 10.1371/journal.pone.0051395. Epub 2012 Dec 20.
PubMed 23284689
Study at a glance
From the registry record, last updated by the sponsor on 16 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Placebo-Controlled, Double-Blind, Clinical Study to Assess the Safety, Tolerability and Pharmacokinetics of Oral SRT2104 Capsules Administered to Healthy Elderly Subjects for 28 Days
- ClinicalTrials.gov ID
- NCT00964340
- Acronym / sponsor ID
- 113312
- Conditions
- Atrophy, Muscular
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- 1 Oct 2009 (actual)
- Primary completion
- 27 Apr 2010 (actual)
- Study completion
- 27 Apr 2010 (actual)
- First posted
- 24 Aug 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 is to determine the pharmacokinetics, safety and tolerability of SRT2104 in healthy elderly subjects following single and 28 days dosing.
The secondary objectives of the study are:
- To contrast changes in leg muscle function following repeat doses of SRT2104 or placebo: Endurance exercise tolerance 31P MRS measures of mitochondrial oxidative capacity in the gastrocnemius muscle
- To test for a change in the ratio of visceral to subcutaneous body fat following repeat doses of SRT2104 relative to placebo using MRI
- To estimate any changes in insulin sensitivity (using mOGTT) following repeat doses of SRT2104 or placebo
- To test for dose-related effects on the exploratory pharmacodynamic measures above
Detailed description
This is a double-blind, randomized, parallel group, placebo-controlled study of healthy 60-80 year old community-dwelling male and female subjects. The study consists of 8 outpatient clinic visits, 2 inpatient clinic visits and 8 telephone contacts (including the pre-screening call to determine a subject's interest in participation).
Subjects will undergo a preliminary telephone pre-screening assessment to determine their interest in participating in the study. Once interest has been confirmed, subjects will sign an informed consent and undergo screening procedures. Subjects meeting the inclusion and exclusion criteria will be enrolled in the study and randomized to receive either 0.5 g/day of SRT2104, 2.0 g/day of SRT2104 or placebo once daily for up to 28 consecutive days. After the completion of the screening assessments and confirmation of eligibility, subjects will return to the site on Day -9 and will undergo a practice endurance testing session. In addition, on Day -9 subjects will be given a pedometer which they will be asked to wear while awake for 7 consecutive days from Day -8 and 7 consecutive days from Day 20 to estimate daily physical mobility levels in the home environment. Subjects will return to the site on Days -1 and 27 for safety assessments, MRI/MRS assessments and exercise endurance tests.
On Days 1 and 28 subjects will be admitted overnight as inpatients. PK samples will be collected through 24 hours post-dose on Days 2 and 29.
During the dosing period safety visits will be performed on approximately Days 7, 14, and 21. Additional telephone safety assessments will be made approximately on Days 3, 5, 10, 17, 20 and 24.
The End of Dosing Follow-up visit will be performed approximately 35 days following the first dose of SRT2104 or placebo. An additional follow up safety telephone call will be made to each subject 30 days following their final dose of SRT2104 and/or placebo. The end of the study is defined as the last subject's last assessment (i.e. Day 58, the date of the last subject communication).
Subjects will be instructed to self administer test material at home on study days 3-27. All study visits are outpatient visits except for Day 1 and Day 28. Subjects will stay overnight at the site the evening of Day 1 and Day 28. On Day 2 and Day 29 subjects will be discharged home following the completion of study assessments and when considered clinically appropriate by the study physician.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: PlaceboThe Placebo treatment group will be administered eight placebo capsules per day. Placebo will be administered orally once daily for twenty-eight consecutive days. Dosing will take place at approximately the same time every day, approximately 15 minutes following the consumption of a standardized meal, and subjects must wait at least 1-2hrs after dosing before consuming additional calories. Water is permitted ad libitum. |
| 0.5g SRT2104 | Active comparator | Drug: Placebo, Drug: SRT2104The 0.5g SRT2104 treatment group will be administered 2 SRT2104 capsules with 6 matching placebo capsules, for a total of 8 capsules per day. 0.5g SRT2104 will be administered orally once daily for twenty-eight consecutive days. Dosing will take place at approximately the same time every day, approximately 15 minutes following the consumption of a standardized meal, and subjects must wait at least 1-2hrs after dosing before consuming additional calories. Water is permitted ad libitum. |
| 2.0g SRT2104 | Active comparator | Drug: SRT2104The 2.0g SRT2104 treatment group will be administered 8 SRT2104 capsules per day. 2.0g SRT2104 will be administered orally once daily for twenty-eight consecutive days. Dosing will take place at approximately the same time every day, approximately 15 minutes following the consumption of a standardized meal, and subjects must wait at least 1-2hrs after dosing before consuming additional calories. Water is permitted ad libitum. |
Who may qualify
- Ages
- 60 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Independently ambulatory, healthy male and female subjects within the age range of 60 to 80 years (inclusive) at the time of screening
- All female subjects must be of non-childbearing potential. For the purposes of this study, women need to be amenorrheic for at least 12 consecutive months, at least 6 weeks postsurgical bilateral oophorectomy (with or without hysterectomy) or post tubal ligation. Menopausal status will be confirmed by demonstrating levels of follicle stimulating hormone (FSH) 40 - 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 with agreement of the independent Medical Monitor
- All male subjects must agree with their partners to use double-barrier birth control or abstinence while participating in the study and for 12 weeks following the last dose of study drug
- Willingness to provide written informed consent to participate in the study
- Body Mass Index (BMI) 18-30 kg/m^2 (inclusive)
Key exclusion criteria (18 listed)
- Limitation to free passive or active movement of leg or foot by pain, prior injury, or developmental abnormality
- Any major illness in the past three months or any ongoing chronic medical illness which in the opinion of the PI or Medical Monitor could risk subject safety or interpretation of the results
- Ongoing or chronic history of renal or liver impairment, defined as serum creatinine clearance level less than 80ml/min as determined by Cockcroft-Gault formula (adjusted for ideal body weight), and greater than two times the upper limit of normal for liver enzymes, respectively
- Subjects with a CPK> upper limit of normal. CPK values that are marginally above the upper limit of normal may be retested at the discretion of the Principal Investigator in conjunction with the Sponsor's approval
- History, within 3 years, of drug abuse (including but not limited to anxiolytics or pain medication)
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 |
|---|---|---|
| PlaceboFor the placebo product, the SRT2104 drug substance will be replaced by microcrystalline cellulose (Avicel® PH 105) to match the SRT2104 investigational product. The ratio of active to placebo capsules will vary according to the subject's dosing level. | Drug | 0.5g SRT2104, Placebo |
| SRT2104SRT2104 drug substance is a new chemical entity which is supplied as a fine, yellowish/amber powder. The SRT2104 investigational product is prepared by packing 250 mg of the SRT2104 powder into a size 00 opaque capsule, which is then stored in dosing bottles. | Drug | 0.5g SRT2104, 2.0g SRT2104 |
Primary outcome
Determine the pharmacokinetics of SRT2104 in healthy elderly subjects following single and 28 days dosing.
Time frame: PK samples will be collected on Days 1 and 28 at pre-dose and at 15 min, 30 min, and 1, 2, 3, 4, 8, 12 hrs post-dose. PK samples will also be collected 24 hrs post-dose on Days 2 and 29.
Safety and tolerability of SRT2104 in healthy elderly subjects following single and 28 days dosing.
Time frame: Safety will be monitored by AEs, VS, physical exam, labs and ECGs during the study.
4 secondary outcomes
Contrast changes in leg muscle function following repeat doses of SRT2104.
Time frame: On Day -1 and Day 27, 31P MRS will measure mitochondrial oxidative capacity in the gastrocnemius muscle of the dominant leg; exercise in the MR scanner and a staged bicycle exercise test will record the exercise endurance tolerance.
Test for a change in the ratio of visceral to subcutaneous body fat by MRI following repeat doses of SRT2104 or placebo.
Time frame: On Day -1 and Day 27 MRI and MRS assessments will be performed to measure compartmental fat distribution.
Measure changes in insulin sensitivity (using mOGTT) and dose-related effects on pharmacodynamics following repeat doses of SRT2104 or placebo.
Time frame: OGTT is measured to assess PD effects of SRT2104 at screening and on Day 29 prior to the administration of 75g of oral glucose, and at 10min, 20min, 30min, 1hr, 1.5hr, 2hr, and 3 hr following glucose administration.
Test for an increase in overall endurance and activity following repeat doses of SRT2104.
Time frame: Pedometer will be worn by subjects while awake for 7 consecutive days from Day -8 until Day -1 and on Day 20 until Day 27.
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 16 Jun 2017.
- Background: PubMed 23284689Libri V, Brown AP, Gambarota G, Haddad J, Shields GS, Dawes H, Pinato DJ, Hoffman E, Elliot PJ, Vlasuk GP, Jacobson E, Wilkins MR, Matthews PM. A pilot randomized, placebo controlled, double blind phase I trial of the novel SIRT1 activator SRT2104 in elderly volunteers. PLoS One. 2012;7(12):e51395. doi: 10.1371/journal.pone.0051395. Epub 2012 Dec 20.
- Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.Link provided by the sponsor.
- Results for study 113312 can be found on the GSK Clinical Study Register.Link provided by the sponsor.
- Individual participant dataSharing planned: Yes. Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
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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 SRT2104 in people with Atrophy, Muscular, run by GlaxoSmithKline 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 13 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 16 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. Some participants in this study may receive a placebo. 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?
Determine the pharmacokinetics of SRT2104 in healthy elderly subjects following single and 28 days dosing. (time frame: PK samples will be collected on Days 1 and 28 at pre-dose and at 15 min, 30 min, and 1, 2, 3, 4, 8, 12 hrs post-dose. PK samples will also be collected 24 hrs post-dose on Days 2 and 29.). 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?
On the ClinicalTrials.gov record for NCT00964340, which also lists 1 linked publication.
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 16 Jun 2017.