SAD/MAD Study in Caucasian and Japanese Subjects

• Research type

  Research Study

• Full title

  5-ALA/SFC: A Phase I, Double-Blind, Placebo-Controlled, Single and Multiple Oral Dose, Safety, Tolerability and Pharmacokinetic Study in Healthy Caucasian and Japanese Subjects.

• IRAS ID

  101812

• Contact name

  Ashley Brooks

• Sponsor organisation

  SBI Pharmaceuticals Co. Ltd.

• Eudract number

  2012-004255-37

• ISRCTN Number

  n/a

• Clinicaltrials.gov Identifier

  n/a

• Research summary

  This is a multi-site, phase I, single and multiple oral dose study to assess the safety, tolerability and blood levels of 5-ALA/SFC in healthy Caucasian and Japanese Subjects and Patients with Chemotherapy Induced Anaemia, conducted in three parts. Part 1: 56 Caucasian subjects will be studied in 7 groups of 8 subjects (Groups A to G), and 24 Japanese subjects will be studied in 3 groups of 8 subjects (Groups H to J). Subjects will participate in 1 treatment period where 6 subjects will receive 5-ALA/SFC and 2 will receive placebo, except for Groups D and G, where subjects will participate in 2 treatment periods separated by at least 6 days. In Group D, all subjects will receive 5-ALA/SFC or placebo fasted in Treatment Period 1 and will receive the same treatment 30 minutes after a high fat breakfast in Treatment Period 2. In Group G, all subjects will receive a single dose of 5-ALA/SFC in both treatment periods; the dose of 5-ALA will remain constant but the dose of SFC will vary. Part 2: 24 Caucasian subjects will be studied in 3 groups of 8 subjects, together with a two groups of 8 Japanese subjects. All subjects will be dosed daily for 7 days with 5-ALA/SFC or placebo. Part 3: 24 patients with anaemia caused by chemotherapy will be studied as a single group. Details on the subject numbers, duration and number of visits, together with a summary of safety, tolerability from earlier studies, will be included in a substantial amendment which will be submitted for MHRA and EC review prior to patient recruitment. All subjects will attend a post study visit 5 to 10 days after their final dose. Doses will range from 50/78.4mg to 1500/2351mg (maximum dose in any subject) of 5-ALA/SFC.

• REC name

  South Central - Berkshire B Research Ethics Committee

• REC reference

  12/SC/0554

• Date of REC Opinion

  14 Nov 2012

• REC opinion

  Further Information Favourable Opinion