Healthy Volunteer PK study with 5-HTP/Carbidopa (QSC201140)
Research type
Research Study
Full title
A Two-Part Study to Evaluate the Proof of Concept of Gastro-Retentive Formulation Viability for a 5-Hydroxytryptophan/Carbidopa Combination Product and a Pharmacoscintigraphic Assessment of 5-Hydroxytryptophan/Carbidopa Gastro-Retentive Formulation Prototypes in Healthy Subjects
IRAS ID
276262
Contact name
Dr. Jacob Jacobsen, PhD
Contact email
Sponsor organisation
Evecxia Therapeutics
Eudract number
2019-004678-25
Duration of Study in the UK
0 years, 10 months, 12 days
Research summary
Summary of Research\nThe Sponsor is developing a combination product of the test medicines 5-Hydroxytryptophan and Carbidopa for the potential treatment of depression that doesn’t respond adequately to available first-line treatments, as an additional treatment to standard therapy. \n\nThe purpose of this study is to determine the best doses of the test medicines to achieve a steady level of test medicine in the blood. This information will be used to develop a gastro-retentive, sustained release tablet formulation, which will be given in Part 2. Some doses will be given over 10 hours using sipping administration, to mimic a drug that releases slowly over time. \n\nThe study will consist of up to 2 parts involving up to 28 healthy male and female volunteers of non-childbearing potential. Part 1 consists of up to 5 periods, in 12 volunteers. In each period volunteers will remain on site until 36-hours post dose. Following each period there will be a washout period of a minimum of 7 days before they return for the next. There will be a follow-up call 7 to 10 days post-final dose to ensure their continued wellbeing. \n\nOptional Part 2 is a scintigraphy and pharmacokinetic (level of test medicine in the blood) evaluation of gastro-retentive sustained-release tablet formulations of the test medicines. Part 2 will involve up to 16 healthy volunteers, in at least 2 cohorts. It will consist of up to 5 periods, in each period volunteers will remain on site until 36-hours post dose. There will be a washout period of a minimum of 7 days between periods. There will be a follow-up call 7 to 10 days post-final dose to ensure their continued wellbeing. \n\n\nSummary of Results\nAs this is a phase 1 trial, no lay summary of results has been provided for reasons of commercial confidentiality.
REC name
Wales REC 2
REC reference
20/WA/0031
Date of REC Opinion
24 Feb 2020
REC opinion
Further Information Favourable Opinion