Safety, Tolerability and PK study of AMT-126 Formulations (QSC204564)
Research type
Research Study
Full title
A Phase 1 Study in up to 2 Parts, to Assess the Safety, Tolerability, and Pharmacokinetics of Single Ascending Oral Doses of AMT-126 in the Fasted State (in Part 1) and to Evaluate the In Vivo Performance of an AMT-126 Oral Tablet Through Pharmacoscintigraphic Assessment in the Fed and Fasted State (in Optional Part 2) in Healthy Male and Female Subjects
IRAS ID
291234
Contact name
Amelia Cline
Contact email
Sponsor organisation
Applied Molecular Transport Inc.
Eudract number
2020-005779-11
Clinicaltrials.gov Identifier
Duration of Study in the UK
0 years, 6 months, 21 days
Research summary
Summary of Research
Applied Molecular Transport (AMT) (the sponsor) is developing a new test medicine for, but not limited to, the treatment of gut/intestine diseases such as coeliac disease and ulcerative colitis.
The study will consist of up to two parts and will try to identify the safety and tolerability of the test medicine and the pharmacokinetics (PK - what the body does to the drug) of the test medicine in healthy male and female volunteers (non-pregnant, non-lactating). Food effect may also be assessed.
Part 1 will consist of up to 6 cohorts of 6 volunteers, with an optional additional cohort of 6 volunteers. As a safety precaution, two sentinel volunteers from each cohort will be randomised to receive the test medicine or placebo (1:1) first. After at least 24 hours, if the safety profile is acceptable to the investigator, the remaining 4 volunteers will receive the test medicine or placebo (3:1). The dose may be increased for each cohort, if after review of the data from the previous cohort it is considered safe.
Following review of Part 1 data, an optional Part 2 of the study may be executed. Part 2 will consist of two study periods and eight volunteers will receive a radiolabeled form of the test medicine in both the fed and fasted state. The dose given will be based on Part 1 data. Volunteers will be dosed with the test medicine alongside a drink containing a radiolabeled liquid and they will have scintigraphic images taken of their body in intervals for up to 24 hours post-dose. Further images up to 48 hours post-dose may be taken if required.
For both parts, volunteers will be discharged 72 hours post-dose and will return 24 hours later for further assessments. A follow-up phone call will take place 5-7 days post-final dose to monitor volunteer wellbeing.
Summary of Results
Any disclosure for this study has followed all applicable regulatory and health authority requirements. As this is a Phase I study, it is not mandatory for the lay summary of study results to be shared or reported publicly, as these findings are confidential due to commercial sensitivity. As such, there is no current plan to share the lay summary of results at this time.
REC name
Wales REC 2
REC reference
21/WA/0006
Date of REC Opinion
28 Jan 2021
REC opinion
Further Information Favourable Opinion