PsoriasisPhase 1NCT01702493
A Study to Assess the Relative Bioavailability of New Oral Formulations of SRT2104 in Healthy Male Volunteers
A Phase 1 study testing Cap SRT2104, Tab SRT2104 slow release and Tab SRT2104 intermediate release in people with Psoriasis, run by Sirtris, a GSK Company at 1 site in United States.
Trial summary
This is an open-label, randomized, controlled, single center study to assess the safety, variability in exposure, and relative bioavailability of new oral formulations of SRT2104. 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
- Psoriasis
- What is being tested?
- Cap SRT2104, Tab SRT2104 slow release and Tab SRT2104 intermediate release
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Oct 2012to 5 Dec 2012
- 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 as determined by a responsible and experienced physician.
- Males between 18 and 65 years of age inclusive, at the time of signing the informed consent.
- Body weight >=50 kilogram (kg) (110 lbs) and body mass index (BMI) >=18.
- Capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the consent form.
Who cannot join
- Past or present disease that is judged by the investigator to have the potential to interfere with the study procedures or compromise the subject's safety.
- Current or chronic history of liver disease, or known hepatic or biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones), or aspartate aminotranferase (AST), alanine aminotranferase (ALT), alkaline phosphatase and bilirubin >1.5 x upper limit of normal (ULN).
- Abnormalities on the Screening or Day -1: electrocardiogram (ECG) that, in the opinion of the investigator, will compromise subject safety in the study or QT corrected using Fridericia's formula (QTcF) > 450 milliseconds (msec).
- A history of Hepatitis B, Hepatitis C or human immunodeficiency virus (HIV), or positive serology at Screening.
- History of regular alcohol consumption within 6 months of the Screening (Screening visit) and a positive pre-study drug/alcohol screen.
- Participation in a clinical trial and treatment with an investigational product within 3 months prior to Screening visit.
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- Use of prescription or non-prescription drugs, including vitamins, herbal and dietary supplements.
- History of sensitivity to any of the study medications, or components thereof or a history of drug or other allergy that contraindicates their participation.
- History of sensitivity to heparin or heparin-induced thrombocytopenia.
- Where participation in the study would result in the inability to donate blood or blood products in excess of 500 milliliter (mL) within a 56 day period.
- Urinary cotinine levels indicative of smoking or history of regular use of tobacco- or nicotine-containing products within 6 months prior to screening.
- Consumption of red wine, seville oranges, grapefruit or grapefruit juice [and/or pummelos, exotic citrus fruits, grapefruit hybrids or fruit juices] from 7 days prior to the first dose of study medication.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 1, Open-Label, Randomized, Controlled, Four-Period Crossover Study to Assess the Relative Bioavailability of New Oral Formulations of SRT2104 in Healthy Male Volunteers
This is an open-label, randomized, controlled, single center study to assess the safety, variability in exposure, and relative bioavailability of new oral formulations of SRT2104. This is a two part study and each part consists of screening (within 21 days of the first scheduled dose of SRT2104), treatment period and follow-up visit (approximately 6 days after the last dose). Part 1: Subjects will receive all four fomulations of SRT2104 and their order of their doses will be randomized. Each subject will receive one formulation as a 500 milligram (mg) dose (in the form of two 250 mg capsules or tablets) in each session given in the fasted state. Each dose will be separated by at least 6 days. Pharmacokinetic (PK) sampling will be done pre and post each scheduled dosing session. After all 4 dosing sessions, the safety and PK data will be reviewed to determine which, if any, formulation(s) will be carried forward into Part 2. The total duration will be approximately 7 weeks. Part 2: Is further divided into Part 2A, 2B and 2C of the study and are optional. After the completion of Part 1, the sponsor will decide whether to proceed with any or all of Part 2, and whether the selected formulation(s) is to be administered in the fed or fasted state for Parts 2B and 2C. For all the sub parts of Part 2 the pre and post-dose PK samples will be obtained. Part 2A: A single-dose of the selected formulation(s) from Part 1 will be administered after a standard meal to assess the effect of food on the bioavailability of SRT2104 at the 500 mg dose. The total duration will be approximately 4 weeks. Part 2B: A single alternative dose (other than 500 mg, but not to exceed 2000 mg) of the selected formulation(s) from Part 1 will be administered to assess the safety and PK profile of this dose level. The total duration will be approximately 4 weeks. Part 2C: The selected formulation(s) from Part 1 will be administered at the 500 mg dose once daily for 7 consecutive days, to assess the safety and tolerability and characterize the PK profile of repeat dosing. The total duration will be approximately 5 weeks.
- Conditions
- Psoriasis
- Being tested
- Cap SRT2104, Tab SRT2104 slow release, Tab SRT2104 intermediate release, Tab SRT2104 fast release, Selected formulations of SRT2104 from Part 1
- Keywords
- SRT2104, Modified Release, Bioavailability, Crossover
- Medical subject headings
- Psoriasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cap SRT2104Drug
Micronized free base in a 250 mg SRT2104 (active equivalents) capsule
Tab SRT2104 slow releaseDrug
New 250 mg SRT2104 mesylate salt slow release tablet
Tab SRT2104 intermediate releaseDrug
New 250 mg SRT2104 mesylate salt intermediate release tablet
Tab SRT2104 fast releaseDrug
New 250 mg SRT2104 mesylate salt fast release tablet
Selected formulations of SRT2104 from Part 1Drug
SRT2104 500 mg of selected formulation(s) from Part 1 in single-dose or daily for 7 days
Selected formulations of SRT2104 from Part 1 single alternative doseDrug
SRT2104 single alternative dose (other than 500 mg, but not to exceed 2000 mg) of selected formulation(s) from Part 1
| Study group | Role | What they receive |
|---|---|---|
| Part 1: Cap SRT2104 | Active comparator | 500 mg SRT2104 (in the form of two, 250 mg capsules) will be administered as a single oral dose in the fasting state Receives: Drug: Cap SRT2104 |
| Part 1: Tab SRT2104 (slow release) | Experimental | 500 mg SRT2104 (in the form of two, 250 mg slow release tablets) will be administered as a single oral dose in the fasting state. Receives: Drug: Tab SRT2104 slow release |
| Part 1: Tab SRT2104 (intermediate release) | Experimental | 500 mg SRT2104 (in the form of two, 250 mg intermediate release tablets) will be administered as a single oral dose in the fasting state. Receives: Drug: Tab SRT2104 intermediate release |
| Part 1: Tab SRT2104 (fast release) | Experimental | 500 mg SRT2104 (in the form of two, 250 mg fast release tablets) will be administered as a single oral dose in the fasting state. Receives: Drug: Tab SRT2104 fast release |
| Part 2A: SRT2104 500 mg single-dose | Experimental | 500 mg SRT2104 (formulation selected from Part 1) will be administered as a single oral dose in the fed state. Receives: Drug: Selected formulations of SRT2104 from Part 1 |
| Part 2B: SRT2104 single alternative dose | Experimental | An alternative dose (other than 500 mg, but not to exceed 2000 mg) of SRT2104 (formulation selected from Part 1) will be administered as a single oral dose. Receives: Drug: Selected formulations of SRT2104 from Part 1 single alternative dose |
| Part 2C: SRT2104 500 mg daily for 7 days | Experimental | 500 mg SRT2104 (formulation selected from Part 1) will be administered daily for 7 days. Receives: Drug: Selected formulations of SRT2104 from Part 1 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measure of variability in exposure-CVw
The variability in exposure of SRT2104 will be assessed by calculating the within subject coefficient of variation (CVw).
Measured: Part 1: Days 1, 8, 15 and 22; Parts 2A and 2B: Day 1; Part 2C: Days 1 to 7. Pre dose and post-dose at 15 minutes, 30 minutes, 1, 1.5, 2, 3, 4, 6, 8, 12 and 24 hours after each scheduled dosing session.
Measure of relative bioavailability-AUC
Relative bioavailability of SRT2104 will be assessed by evaluating area under the curve (AUC).
Measured: Part 1: Days 1, 8, 15 and 22; Parts 2A and 2B: Day 1; Part 2C: Days 1 to 7. Pre dose and post-dose at 15 minutes, 30 minutes, 1, 1.5, 2, 3, 4, 6, 8, 12 and 24 hours after each scheduled dosing session.
Measure of relative bioavailability-Cmax
Relative bioavailability of SRT2104 will be assessed by measuring maximum observed plasma concentration (Cmax).
Measured: Part 1: Days 1, 8, 15 and 22; Parts 2A and 2B: Day 1; Part 2C: Days 1 to 7. Pre dose and post-dose at 15 minutes, 30 minutes, 1, 1.5, 2, 3, 4, 6, 8, 12 and 24 hours after each scheduled dosing session.
Measure of relative bioavailability-Tmax
Relative bioavailability of SRT2104 will be assessed by measuring the time to reach maximum observed plasma concentration (Tmax).
Measured: Part 1: Days 1, 8, 15 and 22; Parts 2A and 2B: Day 1; Part 2C: Days 1 to 7. Pre dose and post-dose at 15 minutes, 30 minutes, 1, 1.5, 2, 3, 4, 6, 8, 12 and 24 hours after each scheduled dosing session.
Safety of SRT2104 as assessed by number of subjects with adverse events (AE)s
Safety parameter will include recording number of AEs, throughout the study.
Measured: Part 1: 7 weeks; Part 2A: 4 weeks; Part 2B: 4 weeks; Part 2C: 5 weeks.
Safety of SRT2104 as assessed by intensity of AEs
Safety parameter will include recording of intensity of AEs, throughout the study.
Measured: Part 1: 7 weeks; Part 2A: 4 weeks; Part 2B: 4 weeks; Part 2C: 5 weeks.
Safety of SRT2104 as assessed by type of AEs
Safety parameter will include recording of type of AEs, throughout the study.
Measured: Part 1: 7 weeks; Part 2A: 4 weeks; Part 2B: 4 weeks; Part 2C: 5 weeks.
Safety of SRT2104 as assessed by change from Baseline in heart rate
Safety will be assessed by recording heart rate at Baseline and at end of the study.
Measured: Part 1: 7 weeks; Part 2A: 4 weeks; Part 2B: 4 weeks; Part 2C: 5 weeks.
Safety of SRT2104 as assessed by change from Baseline in blood pressure
Safety will be assessed by recording blood pressure at Baseline and at end of the study.
Measured: Part 1: 7 weeks; Part 2A: 4 weeks; Part 2B: 4 weeks; Part 2C: 5 weeks.
Safety of SRT2104 as assessed by change from Baseline in temperature
Safety will be assessed by recording temperature at Baseline and at end of the study.
Measured: Part 1: 7 weeks; Part 2A: 4 weeks; Part 2B: 4 weeks; Part 2C: 5 weeks.
Safety of SRT2104 as assessed by change from Baseline in ECG readings
Safety will be assessed by recording the electrocardiogram (ECG) readings at Baseline and at end of the study.
Measured: Part 1: 7 weeks; Part 2A: 4 weeks; Part 2B: 4 weeks; Part 2C: 5 weeks.
Safety of SRT2104 as assessed by change from Baseline in clinical laboratory parameters
Clinical laboratory parameters will include hematology, clinical chemistry and electrolytes, serology, coagulation and urinalysis. Safety will be assessed by evaluating the clinical laboratory parameter readings at Baseline and at end of the study.
Measured: Part 1: 7 weeks; Part 2A: 4 weeks; Part 2B: 4 weeks; Part 2C: 5 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2012 (estimated)
- Study start30 Oct 2012
- Primary completion5 Dec 2012
- Study completion5 Dec 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PsoriasisStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sirtris, a GSK Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- GSK Clinical Trials, Study director, GlaxoSmithKline
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01702493
- Sponsor's protocol ID
- 117041
- Status last verified
- Jun 2017
- First submitted
- 4 Oct 2012
- Last updated
- 12 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.
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Open-Label, Randomized, Controlled, Four-Period Crossover Study to Assess the Relative Bioavailability of New Oral Formulations of SRT2104 in Healthy Male Volunteers
- ClinicalTrials.gov ID
- NCT01702493
- Acronym / sponsor ID
- 117041
- Conditions
- Psoriasis
- Keywords
- SRT2104, Modified Release, Bioavailability, Crossover
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Sirtris, a GSK CompanyIndustry (pharma, biotech, devices)
- Study start
- 30 Oct 2012 (actual)
- Primary completion
- 5 Dec 2012 (actual)
- Study completion
- 5 Dec 2012 (actual)
- First posted
- 8 Oct 2012 (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.
This is an open-label, randomized, controlled, single center study to assess the safety, variability in exposure, and relative bioavailability of new oral formulations of SRT2104. This is a two part study and each part consists of screening (within 21 days of the first scheduled dose of SRT2104), treatment period and follow-up visit (approximately 6 days after the last dose). Part 1: Subjects will receive all four fomulations of SRT2104 and their order of their doses will be randomized. Each subject will receive one formulation as a 500 milligram (mg) dose (in the form of two 250 mg capsules or tablets) in each session given in the fasted state. Each dose will be separated by at least 6 days. Pharmacokinetic (PK) sampling will be done pre and post each scheduled dosing session. After all 4 dosing sessions, the safety and PK data will be reviewed to determine which, if any, formulation(s) will be carried forward into Part 2. The total duration will be approximately 7 weeks. Part 2: Is further divided into Part 2A, 2B and 2C of the study and are optional. After the completion of Part 1, the sponsor will decide whether to proceed with any or all of Part 2, and whether the selected formulation(s) is to be administered in the fed or fasted state for Parts 2B and 2C. For all the sub parts of Part 2 the pre and post-dose PK samples will be obtained. Part 2A: A single-dose of the selected formulation(s) from Part 1 will be administered after a standard meal to assess the effect of food on the bioavailability of SRT2104 at the 500 mg dose. The total duration will be approximately 4 weeks. Part 2B: A single alternative dose (other than 500 mg, but not to exceed 2000 mg) of the selected formulation(s) from Part 1 will be administered to assess the safety and PK profile of this dose level. The total duration will be approximately 4 weeks. Part 2C: The selected formulation(s) from Part 1 will be administered at the 500 mg dose once daily for 7 consecutive days, to assess the safety and tolerability and characterize the PK profile of repeat dosing. The total duration will be approximately 5 weeks.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 7
| Arm | Type | Receives |
|---|---|---|
| Part 1: Cap SRT2104 | Active comparator | Drug: Cap SRT2104500 mg SRT2104 (in the form of two, 250 mg capsules) will be administered as a single oral dose in the fasting state |
| Part 1: Tab SRT2104 (slow release) | Experimental | Drug: Tab SRT2104 slow release500 mg SRT2104 (in the form of two, 250 mg slow release tablets) will be administered as a single oral dose in the fasting state. |
| Part 1: Tab SRT2104 (intermediate release) | Experimental | Drug: Tab SRT2104 intermediate release500 mg SRT2104 (in the form of two, 250 mg intermediate release tablets) will be administered as a single oral dose in the fasting state. |
| Part 1: Tab SRT2104 (fast release) | Experimental | Drug: Tab SRT2104 fast release500 mg SRT2104 (in the form of two, 250 mg fast release tablets) will be administered as a single oral dose in the fasting state. |
| Part 2A: SRT2104 500 mg single-dose | Experimental | Drug: Selected formulations of SRT2104 from Part 1500 mg SRT2104 (formulation selected from Part 1) will be administered as a single oral dose in the fed state. |
| Part 2B: SRT2104 single alternative dose | Experimental | Drug: Selected formulations of SRT2104 from Part 1 single alternative doseAn alternative dose (other than 500 mg, but not to exceed 2000 mg) of SRT2104 (formulation selected from Part 1) will be administered as a single oral dose. |
| Part 2C: SRT2104 500 mg daily for 7 days | Experimental | Drug: Selected formulations of SRT2104 from Part 1500 mg SRT2104 (formulation selected from Part 1) will be administered daily for 7 days. |
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 as determined by a responsible and experienced physician.
- Males between 18 and 65 years of age inclusive, at the time of signing the informed consent.
- Body weight >=50 kilogram (kg) (110 lbs) and body mass index (BMI) >=18.
- Capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the consent form.
Key exclusion criteria (12 listed)
- Past or present disease that is judged by the investigator to have the potential to interfere with the study procedures or compromise the subject's safety.
- Current or chronic history of liver disease, or known hepatic or biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones), or aspartate aminotranferase (AST), alanine aminotranferase (ALT), alkaline phosphatase and bilirubin >1.5 x upper limit of normal (ULN).
- Abnormalities on the Screening or Day -1: electrocardiogram (ECG) that, in the opinion of the investigator, will compromise subject safety in the study or QT corrected using Fridericia's formula (QTcF) > 450 milliseconds (msec).
- A history of Hepatitis B, Hepatitis C or human immunodeficiency virus (HIV), or positive serology at Screening.
- History of regular alcohol consumption within 6 months of the Screening (Screening visit) and a positive pre-study drug/alcohol screen.
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 |
|---|---|---|
| Cap SRT2104Micronized free base in a 250 mg SRT2104 (active equivalents) capsule | Drug | Part 1: Cap SRT2104 |
| Tab SRT2104 slow releaseNew 250 mg SRT2104 mesylate salt slow release tablet | Drug | Part 1: Tab SRT2104 (slow release) |
| Tab SRT2104 intermediate releaseNew 250 mg SRT2104 mesylate salt intermediate release tablet | Drug | Part 1: Tab SRT2104 (intermediate release) |
| Tab SRT2104 fast releaseNew 250 mg SRT2104 mesylate salt fast release tablet | Drug | Part 1: Tab SRT2104 (fast release) |
| Selected formulations of SRT2104 from Part 1SRT2104 500 mg of selected formulation(s) from Part 1 in single-dose or daily for 7 days | Drug | Part 2A: SRT2104 500 mg single-dose, Part 2C: SRT2104 500 mg daily for 7 days |
| Selected formulations of SRT2104 from Part 1 single alternative doseSRT2104 single alternative dose (other than 500 mg, but not to exceed 2000 mg) of selected formulation(s) from Part 1 | Drug | Part 2B: SRT2104 single alternative dose |
Primary outcome
Measure of variability in exposure-CVw
Time frame: Part 1: Days 1, 8, 15 and 22; Parts 2A and 2B: Day 1; Part 2C: Days 1 to 7. Pre dose and post-dose at 15 minutes, 30 minutes, 1, 1.5, 2, 3, 4, 6, 8, 12 and 24 hours after each scheduled dosing session.
The variability in exposure of SRT2104 will be assessed by calculating the within subject coefficient of variation (CVw).
Measure of relative bioavailability-AUC
Time frame: Part 1: Days 1, 8, 15 and 22; Parts 2A and 2B: Day 1; Part 2C: Days 1 to 7. Pre dose and post-dose at 15 minutes, 30 minutes, 1, 1.5, 2, 3, 4, 6, 8, 12 and 24 hours after each scheduled dosing session.
Relative bioavailability of SRT2104 will be assessed by evaluating area under the curve (AUC).
Measure of relative bioavailability-Cmax
Time frame: Part 1: Days 1, 8, 15 and 22; Parts 2A and 2B: Day 1; Part 2C: Days 1 to 7. Pre dose and post-dose at 15 minutes, 30 minutes, 1, 1.5, 2, 3, 4, 6, 8, 12 and 24 hours after each scheduled dosing session.
Relative bioavailability of SRT2104 will be assessed by measuring maximum observed plasma concentration (Cmax).
Measure of relative bioavailability-Tmax
Time frame: Part 1: Days 1, 8, 15 and 22; Parts 2A and 2B: Day 1; Part 2C: Days 1 to 7. Pre dose and post-dose at 15 minutes, 30 minutes, 1, 1.5, 2, 3, 4, 6, 8, 12 and 24 hours after each scheduled dosing session.
Relative bioavailability of SRT2104 will be assessed by measuring the time to reach maximum observed plasma concentration (Tmax).
Safety of SRT2104 as assessed by number of subjects with adverse events (AE)s
Time frame: Part 1: 7 weeks; Part 2A: 4 weeks; Part 2B: 4 weeks; Part 2C: 5 weeks.
Safety parameter will include recording number of AEs, throughout the study.
Safety of SRT2104 as assessed by intensity of AEs
Time frame: Part 1: 7 weeks; Part 2A: 4 weeks; Part 2B: 4 weeks; Part 2C: 5 weeks.
Safety parameter will include recording of intensity of AEs, throughout the study.
Safety of SRT2104 as assessed by type of AEs
Time frame: Part 1: 7 weeks; Part 2A: 4 weeks; Part 2B: 4 weeks; Part 2C: 5 weeks.
Safety parameter will include recording of type of AEs, throughout the study.
Safety of SRT2104 as assessed by change from Baseline in heart rate
Time frame: Part 1: 7 weeks; Part 2A: 4 weeks; Part 2B: 4 weeks; Part 2C: 5 weeks.
Safety will be assessed by recording heart rate at Baseline and at end of the study.
Safety of SRT2104 as assessed by change from Baseline in blood pressure
Time frame: Part 1: 7 weeks; Part 2A: 4 weeks; Part 2B: 4 weeks; Part 2C: 5 weeks.
Safety will be assessed by recording blood pressure at Baseline and at end of the study.
Safety of SRT2104 as assessed by change from Baseline in temperature
Time frame: Part 1: 7 weeks; Part 2A: 4 weeks; Part 2B: 4 weeks; Part 2C: 5 weeks.
Safety will be assessed by recording temperature at Baseline and at end of the study.
Safety of SRT2104 as assessed by change from Baseline in ECG readings
Time frame: Part 1: 7 weeks; Part 2A: 4 weeks; Part 2B: 4 weeks; Part 2C: 5 weeks.
Safety will be assessed by recording the electrocardiogram (ECG) readings at Baseline and at end of the study.
Safety of SRT2104 as assessed by change from Baseline in clinical laboratory parameters
Time frame: Part 1: 7 weeks; Part 2A: 4 weeks; Part 2B: 4 weeks; Part 2C: 5 weeks.
Clinical laboratory parameters will include hematology, clinical chemistry and electrolytes, serology, coagulation and urinalysis. Safety will be assessed by evaluating the clinical laboratory parameter readings at Baseline and at end of the study.
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 12 Jun 2017.
- Results for study 117041 can be found on the GSK Clinical Study Register.Link provided by the sponsor.
- 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.
- 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 Cap SRT2104, Tab SRT2104 slow release and Tab SRT2104 intermediate release in people with Psoriasis, run by Sirtris, a GSK Company at 1 site in United States.
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 12 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 12 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 States. 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?
Measure of variability in exposure-CVw (time frame: Part 1: Days 1, 8, 15 and 22; Parts 2A and 2B: Day 1; Part 2C: Days 1 to 7. Pre dose and post-dose at 15 minutes, 30 minutes, 1, 1.5, 2, 3, 4, 6, 8, 12 and 24 hours after each scheduled dosing session.). The study lists 12 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 12 Jun 2017.