A Study to Assess the Relative Bioavailability of New Oral Formulations of SRT2104 in Healthy Male Volunteers
| Status: | Completed |
|---|---|
| Conditions: | Psoriasis |
| Therapuetic Areas: | Dermatology / Plastic Surgery |
| Healthy: | No |
| Age Range: | 18 - 65 |
| Updated: | 4/21/2016 |
| Start Date: | October 2012 |
| End Date: | December 2012 |
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.
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.
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
- 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.
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