Safety, Tolerability, PK and PD of anle138b in Patients (QSC203925)
Research type
Research Study
Full title
A Single Part Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Multiple Ascending Oral Doses of anle138b, and to Characterise the Effect of Food on the Pharmacokinetics of anle138b in Patients with Mild to Moderate Parkinson’s Disease
IRAS ID
288036
Contact name
Prof. Dr. Johannes Levin
Contact email
Sponsor organisation
MODAG GmbH
Eudract number
2020-004869-38
Clinicaltrials.gov Identifier
Duration of Study in the UK
0 years, 5 months, 26 days
Research summary
The Sponsor is developing the test medicine, anle138b, for the potential treatment of neurodegenerative diseases such as Parkinson’s Disease (PD) and Multiple System Atrophy. These are conditions where parts of the brain become progressively damaged over many years due to the accumulation (aggregation) of proteins, forming plaques.
The study will try to assess the safety and tolerability of the test medicine, when given in multiple ascending doses and in the fed and fasted state, in PD patients. The study will also try to assess how the test medicine is taken up by the body (pharmacokinetics) and the effect of food on this.
The study will consist of up to five cohorts (A – E) involving up to 40 male and female patients [of non-childbearing potential] with mild to moderate PD. Up to eight participants will be enrolled in each cohort. Sentinel dosing will be used in each cohort, meaning two volunteers will be dosed 96 hours before the rest of the group, so that their safety data can be reviewed before the rest are dosed. One will receive active test medicine and the other will receive the placebo.
Participants in cohorts A and B will receive multiple ascending doses of the test medicine or placebo once daily for seven days in the fasted state, and one single dose in the fed state. Participants will return three to five days after discharge for safety assessments to ensure their continued wellbeing.
Participants in cohort C and optional cohorts D and E will receive multiple ascending doses of the test medicine or placebo either once or twice daily for seven days in the fasted state. Participants will return five to seven days after discharge for safety assessments to ensure their continued wellbeing.
REC name
HSC REC A
REC reference
20/NI/0158
Date of REC Opinion
16 Dec 2020
REC opinion
Further Information Favourable Opinion