[14C]KPS-0373 - Absorption, Metabolism and Excretion Study

• Research type

  Research Study

• Full title

  [14C]KPS-0373 - A Phase I, Open-Label Study of Absorption, Metabolism and Excretion Following a Single Oral Dose to Healthy Male Subjects

• IRAS ID

  114828

• Contact name

  Contact Details not provided

• Sponsor organisation

  Kissei Pharmaceuticals Co., Ltd.

• Eudract number

  2012-004407-12

• ISRCTN Number

  N/A

• Research summary

  KPS-0373 is a novel derivative of thyrotropin-releasing hormone (TRH). TRH agents such as Protirelin and Taltirelin are currently being prescribed to treat ataxia in Japan. However, these medications have drawbacks such as short duration of action requiring frequent visits to hospital or hospitalisation and low bioavailability. KPS-0373 has an advantage over other TRH compounds and derivatives (eg, Protirelin and Taltirelin) in that it is an oral preparation with an improved pharmacokinetic (PK) profile, such as greater oral absorption, enhanced in vivo stability, and distribution into the brain. The current radio labelled study of [14C]KPS-0373 will be an open-label, single oral dose study. Six subjects will be studied as a single group. Each subject will reside at the CRU from Day ??1 (the day before dosing) until at least Day 11 (240 hours post-dose). Each subject will receive a single oral dose of [14C]KPS-0373 in the fasted state on the morning of Day 1. On Day 11, subjects may be asked to remain resident within the CRU for a further period, or to attend additional non-residential visits on a daily basis, to allow for ongoing 24 hour excreta collections: ?½ If the criteria for discharge are not met, subjects will be asked to remain resident and continue collections up to 336 hours post dose (Day 15). ?½ If after 336 hours post-dose, the criteria for discharge are not met subjects may be asked to collect 24 hour excreta samples on up to 2 further occasions on a non-residential basis to allow extrapolation of urinary and faecal excretion. If needed, the 2 additional 24-hour non-residential collections will occur on Day 21 (ñ 1 day) and Day 28 (ñ 1 day).

• REC name

  North East - York Research Ethics Committee

• REC reference

  12/NE/0378

• Date of REC Opinion

  14 Nov 2012

• REC opinion

  Favourable Opinion