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NCT01702493 · ClinicalTrials.gov registry record · Phase 1
A Study to Assess the Relative Bioavailability of New Oral Formulations of SRT2104 in Healthy Male Volunteers
A Phase 1 study of Psoriasis, sponsored by Sirtris, a GSK Company.
- Completed
- Registry status
- Phase 1
- Development phase
- 16
- Enrollment target
- 1
- Study location
NCT01702493 is a Phase 1 study of Psoriasis that has completed, run by Sirtris, a GSK Company. The registered enrollment target is 16 participants, below the 489-participant average among 125 other Psoriasis trials with a reported enrollment target (97% lower). The trial reports 1 study location across 1 state.
The verdict
NCT01702493, a Phase 1 study of Psoriasis, has completed, sponsored by Sirtris, a GSK Company.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 16 participants
- Enrollment target
- 1
- Study location
Study 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. 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 saf
Conditions Studied
Interventions
- DRUG Cap SRT2104
- DRUG Tab SRT2104 slow release
- DRUG Tab SRT2104 intermediate release
- DRUG Tab SRT2104 fast release
- DRUG Selected formulations of SRT2104 from Part 1
Study Locations (1)
Maryland
- GSK Investigational Site - Baltimore
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 16 participants |
| Start Date | 2012-10-30 |
| Est. Completion | 2012-12-05 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01702493
The ClinicalTrials.gov registry entry for NCT01702493 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 16 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 489-participant average among 125 other Psoriasis trials with a reported enrollment target (97% lower). The listed sponsor is Sirtris, a GSK Company, which has 3 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Psoriasis appearing as the primary indexed condition, and to 5 interventions - of which Cap SRT2104 is the first listed.
NCT01702493 reports 1 study location spanning 1 distinct geographic area - top geographies include Maryland.
Frequently Asked Questions
What is clinical trial NCT01702493 about?
NCT01702493 is a clinical study titled "A 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), tr...
What is the current status of trial NCT01702493?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 16 participants. The study started on 2012-10-30. Estimated completion is 2012-12-05.
What conditions does trial NCT01702493 study?
This clinical trial studies the following conditions: Psoriasis.
What interventions are being tested in trial NCT01702493?
The interventions under investigation include: Cap SRT2104 (DRUG), Tab SRT2104 slow release (DRUG), Tab SRT2104 intermediate release (DRUG), Tab SRT2104 fast release (DRUG), Selected formulations of SRT2104 from Part 1 (DRUG).
Who is sponsoring clinical trial NCT01702493?
This trial is sponsored by Sirtris, a GSK Company, which has 3 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01702493 being conducted?
This trial has 1 study location across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Read our methodology - how this data is sourced, computed, and verified.
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