Phase 1 PK and ADME study in healthy male subjects (QCL118249)
Research type
Research Study
Full title
An Open Label, Three-part, Study Designed to Assess the Pharmacokinetics of ITI-007 Administered Subcutaneously, Assess the Bioavailability of ITI-1284 Administered Subcutaneously, and Determine the Mass Balance Recovery, Absorption, Metabolism and Excretion of [14C]-ITI-1284 in Healthy Male Subjects
IRAS ID
242171
Contact name
Sharan Sidhu
Contact email
Sponsor organisation
Intra-Cellular Therapies, Inc.
Eudract number
2018-000278-31
Duration of Study in the UK
0 years, 1 months, 5 days
Research summary
The Sponsor is developing new study drugs for the potential treatment of a variety of abnormal behaviours caused by altered chemical pathways in the brain. For example schizophrenia (where the person may not always be able to distinguish their own thoughts and ideas from reality) and symptoms associated with bipolar disorder (where moods can swing from one extreme to another).\n\nThe study will try to identify the level of study drug present in the blood, and how the study drug is taken up, broken down and removed from the body. For some parts of this study the study drug will be radiolabelled to be analysed as it moves through the body. \n\nThe study will consist of 3 parts, in Part 1 up to 6 volunteers will receive a dose of 3 mg of the study drug. Subjects will be dosed on Day 1 and remain in clinic until Day 3. The subjects will attend a return visit on Days 4 and 5 and have a follow-up call 7 days post-dose. For Parts 2 and 3, 6 healthy males will be enrolled. For Part 2, subjects will be dosed on Day 1 and receive 3 mg of the study drug, 45 minutes after this the subjects will receive a dose of 3 µg (µg [microgram] is equal to 1 millionth of a gram) of the radiolabelled study drug. Subjects will be discharged on Day 3 and attend a return visit on Days 4 and 5. There will be a minimum break of 7 days between Part 2 and 3. For Part 3, subjects will return to receive a 3 mg dose of the radiolabelled study drug on Day 1 and be discharged once the discharge criteria have been met (up to Day 11). A follow-up call will take place 7 days post-discharge.\n
REC name
South Central - Oxford A Research Ethics Committee
REC reference
18/SC/0183
Date of REC Opinion
10 May 2018
REC opinion
Further Information Favourable Opinion