A 2 part study to investigate Lumateperone & ITI-1284 in healthy volun
Research type
Research Study
Full title
A Phase 1, Single Ascending Dose and Multiple Ascending Dose Study Conducted in Two Parts to Evaluate the Pharmacokinetics of Lumateperone (ITI-007) and ITI-1284 (D2-ITI-007) Orally Disintegrating Tablets in Healthy Volunteers
IRAS ID
274249
Contact name
Annelize Koch
Contact email
Sponsor organisation
Intra-Cellular Therapies, Inc.
Eudract number
2019-004334-42
Duration of Study in the UK
0 years, 4 months, 27 days
Research summary
Research Summary\nThe purpose of this study is to investigate the safety of two study drugs (lumateperone & ITI-1284) and how the levels of the study drugs change in the blood over a period of time when they are given in the form of an oral disintegrating tablet which is a type of tablet that dissolves under the tongue.\n\nThis study is split into 2 parts: Part 1 and Part 2. In Part 1 of the study, the safety and drug levels in the blood will be investigated after administration of one single dose of lumateperone and ITI-1284 on one occasion each (Day 1 and Day 8) and at different dose strengths ranging from 10 mg to 40 mg.\n\nIn Part 2 of the study, the safety and drug levels in the blood will be investigated after administration of a single dose of lumateperone or ITI-1284 once daily for a period of 7 days and at different dose strengths ranging from 6 mg to 40 mg.\n\nBetween each study group in each study part, there will be a review of safety data and PK data (if available) to determine as to whether it is suitable to dose escalate to the next planned dose level.\n\nThis study will be conducted in up to 56 healthy volunteers (24 in Part 1 and 32 in Part 2); both males and females of child bearing potential.\n\nResults Summary\nThe purpose of this study was to investigate the safety of the two study drugs (lumateperone & ITI-1284) and to measure the concentration of the study drugs in the blood and how these changed over a period of time when the drugs were given in the form of an oral disintegrating tablet which is a type of tablet that dissolves under the tongue.\n\nThe two drugs were tested at different dose strengths and for different lengths of time.\n\nThe two study drugs under investigation (lumateperone and ITI-1284) are being developed for the purposes of treating schizophrenia and bipolar depression; which are 2 types of mental illness associated with debilitating symptoms.\n\nThis study was split into 3 parts: Part 1, Part 2 and Part 3. \nIn Part 1 of the study, the safety and drug levels in the blood were evaluated after administration of one single dose of lumateperone and ITI-1284 on one occasion and at different dose strengths ranging from 10 mg to 40 mg.\n\nIn Part 2 of the study, the safety and drug levels in the blood were evaluated after administration of a single dose of lumateperone or ITI-1284 once daily for a period of 7 days and at different dose strengths ranging from 6 mg to 40 mg.\n\nIn Part 3 of the study, the safety and drug levels in the blood were evaluated after administration of a single dose of lumateperone or ITI-1284 once daily for a period of 7 days at a dose strength of either 10 mg or 20 mg in a population of healthy elderly volunteers aged 65 and above.\n\nAs well as investigating how the levels of the study drugs change in the blood over time, the levels of what are known as drug metabolites in the blood were measured and compared between the two study drugs. \n\nWith respect to the safety objectives of the study, it was determined that both study drugs were considered to be safe and well tolerated for all dose strengths and all study populations, inclusive of study parts 1, 2 & 3. All adverse events (side effects) which were reported were considered to be mild to moderate in severity and resolved before the study completed.\n\nWith respect to the measurement of the levels of the study drugs in the blood and the measurement of the metabolites in the blood, the following outcomes were reported:\n\n- Both study drugs demonstrated a similar concentration profile in the blood and showed similar decreases over a period of time.\n- The levels observed were similar to that which was observed with the oral capsule form of the drug which had been evaluated in previous clinical trials.\n- Following multiple dosing over a period of 7 days, the levels of the study drug remained consistent between Day 1 and Day 7, and showed that the drugs did not accumulate in the body.\n- The levels in the blood were shown to be similar between the young healthy volunteer population and the elderly population\n\nIn summary, the data gathered during the study was considered sufficient to meet the objectives of the study and warrant further clinical trials and investigations of the study drugs.\n
REC name
Wales REC 1
REC reference
19/WA/0335
Date of REC Opinion
15 Jan 2020
REC opinion
Further Information Favourable Opinion