Safety, Tolerability and PK of Single Ascending Doses of SSP-1104 v1

• Research type

  Research Study

• Full title

  A Randomised, Double-blind, Placebo-controlled, Phase 1 Trial to Assess the Safety, Tolerability and Pharmacokinetics of Single, Ascending, Oral Doses of SSP-1104 (as Hydrochloride Salt) in Healthy Adult Male Subjects

• IRAS ID

  70263

• Contact name

  Joseph Chiesa

• Eudract number

  2010-023607-98

• ISRCTN Number

  n/a

• Clinicaltrials.gov Identifier

  n/a

• Research summary

  Shire plc. is developing SSP-1104 for use in moderate to severe pain in adults. Shire designed SSP-1104 to convert to the active form of the drug, oxycodone in the human body. Oxycodone is a semi-synthetic opioid analgesic that has been used clinically since 1917 and today it is one of the most commonly used opioid analgesics for the relief of moderate to severe pain. This study is designed to assess the safety and tolerability of oral doses of SSP-1104A in healthy adult male subjects and to define the Maximum Tolerated Dose (MTD) to SSP-1104A in this population. This study will be conducted at a single centre with a plan to enrol up to 48 healthy adult male subjects in 6 separate cohorts. Each of the 6cohorts will include 8 subjects. Subjects will be randomised within cohorts so that 6 subjects will receive SSP-1104A and 2 subjects will receive placebo. In cohorts 1-5, -sentinel- dosing will occur where 2 subjects (one on sSP-1104A and one on placebo) will be dosed on 1 day and, providing no safety concerns arise, the remaining 6 fasting subjects will be dosed the following day. After the first cohort has been dosed with 10mg and the dose is assessed as safe and tolerable following a 24-hourisafety review, the next treatment cohort will be dosed with 25mg.The dose escalation will proceed in this manner with the following doses:50, 100, and 200mg until an MTD is achieved. Dose levels may be increased, reduced or repeated depending on the outcome of the safety data review meeting between dose escalations. If an MTD is not reached by 200mg, the protocol may be amended to explore higher doses. Before the MTD is reached, all investigational product administration will occur under fasting conditions. After the MTD is achieved or the highest planned dose (200mg) is evaluated, an additional cohort of subjects will be dosed at a previous, tolerated, lower dose level after consuming a standard high-fat, high-calorie meal to assess whether there is any effect of food on sSP-1104A.At least 4 dose escalations for a minimum of 5 treatment cohorts under fasting conditions are planned, before proceeding to the investigation of food effect. For each subject enrolled in the study, the study will consist of a screening period and a single dosing period which requires the subject to stay in the Clinical research Unit (CRU) for a maximum of 4 days/3 nights and attend a follow-up visit.

• REC name

  South Central - Berkshire B Research Ethics Committee

• REC reference

  10/IEC05/34

• Date of REC Opinion

  10 Jan 2011

• REC opinion

  Further Information Favourable Opinion