Single & Multiple Escalating Doses of RQ-00000010 in Healthy Subjects

• Research type

  Research Study

• Full title

  A Phase I, Randomized, Double-Blind, Placebo-Controlled Study to Investigate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single and Multiple Oral Escalating Doses of RQ-00000010 in Healthy Subjects

• IRAS ID

  95375

• Contact name

  Joseph Chiesa

• Sponsor organisation

  RaQualia Pharma Inc

• Eudract number

  2011-005985-40

• ISRCTN Number

  n/a

• Clinicaltrials.gov Identifier

  n/a

• Research summary

  This study will be conducted in three parts and will investigate the safety, tolerability, pharmacokinetics (PK; levels of drug in the blood) and pharmacodynamics (drug action) of single and multiple oral doses of RQ-00000010, a new drug being developed for the treatment of functional gastrointestinal disorders (e.g. Gastro-esophageal flu disease). In addition, the effects of food, gender and age on the PK of RQ-00000010 will be investigated. Part 1 Twelve male subjects in each of two groups will take part in four treatment periods each. At each treatment period subjects will receive single doses of RQ-00000010 or placebo. There will be a minimum of thirteen days between dosing occasions for individual subjects. At each treatment period, each group will be divided into two cohorts, with cohorts being dosed twenty four hours apart. Part 2 Eight subjects will be included in each of three groups (Groups C to E). Group C Male subjects will take part in two treatment periods each. At the first treatment period subjects will be randomly assigned to receive a dose of RQ-00000010 following an overnight fast or after a high-fat breakfast. At the second treatment period subjects will receive a dose under the alternate condition. Groups D and E Female subjects (Group D) and elderly male and female subjects (Group E) will take part in a single treatment period each where they will receive a single dose of RQ-00000010 or placebo. Part 3 Eight male subjects in each of three groups will take part in a single treatment period each during which time they will receive multiple oral doses of RQ-00000010 or placebo. In all treatment periods subjects will reside at the CRU from the day before dosing until 48 hours after the last dose and will return for a post study visit within seven days after their final dose.

• REC name

  South Central - Berkshire B Research Ethics Committee

• REC reference

  12/SC/0097

• Date of REC Opinion

  21 Feb 2012

• REC opinion

  Favourable Opinion