Opicapone - A Phase I Crossover Study in Healthy Subjects

• Research type

  Research Study

• Full title

  A Phase I, Open-Label, Randomised, Three-period, Three-sequence, Partial-replicate Crossover Study to Investigate the Relative Bioavailability and Bioequivalence of Opicapone obtained from Two Different Sources, under Fasting Conditions after Single-dose Administration in Healthy Subjects

• IRAS ID

  259002

• Contact name

  Lisa Husband

• Contact email

  lisa.husband@covance.com

• Sponsor organisation

  BIAL - Portela & Cª., S.A

• Eudract number

  2018-004748-45

• Clinicaltrials.gov Identifier

  NCT03820037

• Duration of Study in the UK

  0 years, 2 months, 22 days

• Research summary

  Opicapone is currently being developed to help people suffering from Parkinson’s Disease. Opicapone is currently approved for adjunctive treatment in Parkinson’s Disease as a once-daily 50 mg dose. There is no curative treatment for this potentially debilitating neurological disease so far.

  The purpose of this study is to understand the relative bioavailability (The proportion of drug absorbed in to body after administration) and bioequivalence (measure of comparability between two formulations of a drug) of two formulations of Opicapone.

  A total of 45 subjects will be randomized in a 3-period, 3-sequence crossover design. Each subject will receive 2 single oral 50 mg doses of the Reference Opicapone formulation (Ongentys®), and a single 50 mg dose of the Test OPC formulation as capsules under fasting conditions.
  The treatment sequence is outline within the Protocol.

  Potential subjects will be screened to assess their eligibility to enter the study within 28 days prior to the first dose administration. Subjects will be admitted into the Clinical Research Unit (CRU) on Day -1(the day before dosing) and be confined to the CRU until discharge on Day 3. There will be a washout period of at least 14 days between each dose. A follow-up visit will be performed 7 to 14 days after dosing in the last treatment period or early discontinuation.
  Healthy male and female subjects (gender-balanced to the extent possible), between 18 and 55 years of age inclusive and with a body mass index of 18.0 to 30.0 kg/m2 (inclusive) will be screened for the study.

• REC name

  North West - Greater Manchester Central Research Ethics Committee

• REC reference

  19/NW/0036

• Date of REC Opinion

  25 Feb 2019

• REC opinion

  Favourable Opinion