* Drug-Drug Interaction Study of TEV-56286 (QSC206250)
Research type
Research Study
Full title
An Open-Label, One-Sequence, Two-Part Drug-Drug Interaction Study in Healthy Volunteers to Assess the CYP1A2 and CYP3A4 Perpetrator Interaction Potential and CYP1A2 Victim Potential of TEV-56286 (anle138b)
IRAS ID
1005958
Contact name
Prof. Dr. Johannes Levin
Contact email
Sponsor organisation
MODAG GmbH
Clinicaltrials.gov Identifier
Research summary
The Sponsor is developing the test medicine TEV-56286 (anle138b) for the potential treatment of neurodegenerative diseases such as Parkinson’s Disease and Multiple System Atrophy (MSA). This two part healthy volunteer study will assess how TEV-56286 interacts with other drugs, such as Caffeine (naturally found in tea and coffee) and Midazolam (a sedative commonly used during surgery and to treat seizures) in Part 1 and Fluvoxamine (a commonly used antidepressant) in Part 2. This study will take place at one non-NHS site, enrolling 26 male and female (of non-childbearing potential) volunteers aged between 18 to 55 years in Part 1 (2 groups of 13 volunteers) and 22 male and female (of non-childbearing potential) volunteers in Part 2 (2 groups of 11 volunteers). In Part 1, the volunteers will receive oral doses of 2 mg Midazolam as an oral solution and 200 mg Caffeine in the form of tablets on Day 1. On Day 3, volunteers will receive a 300 mg oral dose of the test medicine (10 x 30 mg capsules) and further doses of 2 mg Midazolam and 200 mg Caffeine. From Day 5 to Day 17, volunteers will receive a 300 mg dose of the test medicine every morning to reach steady state. On Day 18, volunteers will receive a final 300 mg dose of the test medicine, as well as 2 mg Midazolam and 200 mg Caffeine. Volunteers will be discharged on Day 20 and will return for a follow up visit 5-11 days post final dose. In Part 2, the volunteers will receive a 150 mg oral dose of the test medicine (5 x 30 mg capsules) every day from Day 1 until Day 19. On Day 15 to Day 19, volunteers will also take an oral dose of 100 mg Fluvoxamine in the form of a tablet. Volunteers will be discharged on Day 21 and will return for a follow up visit around 5-11 days post final dose. Volunteer’s blood and urine will be taken throughout the study for analysis of TEV-56286 and for their safety. Volunteers are expected to be involved in this study for 8 weeks for each part from screening to the follow up visit.
REC name
London - Brent Research Ethics Committee
REC reference
22/FT/0098
Date of REC Opinion
18 Aug 2022
REC opinion
Further Information Favourable Opinion