Status:
COMPLETED
A Study in Healthy Subjects to Investigate Whether Administration of Lucerastat Can Affect Normal Heart Function
Lead Sponsor:
Idorsia Pharmaceuticals Ltd.
Conditions:
Healthy
Eligibility:
All Genders
18-55 years
Phase:
PHASE1
Brief Summary
Two-part Phase 1 study to assess the effect of single therapeutic and supra-therapeutic doses of lucerastat on the QT/QTc interval duration in healthy subjects (Part A: Pilot study; Part B: TQT study)
Eligibility Criteria
Inclusion
- Part A only:
- \- Healthy male subjects aged between 18 and 55 years.
- Part B only:
- Healthy male and female subjects aged between 18 and 55 years.
- Women of childbearing potential must have a negative serum pregnancy test at Screening and a negative urine pregnancy test on Day 1 pre-dose of the first period. They must consistently and correctly use a highly effective method of contraception, or be sexually inactive, or have a vasectomized partner.
- Women of nonchildbearing potential (i.e., postmenopausal, XY genotype, Turner syndrome, uterine agenesis).
- Part A and B:
- Signed informed consent prior to any study-mandated procedure.
- Body mass index of 18.0 to 30.0 kg/m2 (inclusive) at Screening. Body weight at least 50.0 kg at Screening and prior to first study treatment administration.
- Healthy on the basis of medical history, physical examination, cardiovascular assessments and clinical laboratory tests.
Exclusion
- Part B only:
- Known hypersensitivity to moxifloxacin or any of its excipients.
- Pregnant or lactating women.
- Women planning to become pregnant.
- Part A and B:
- Previous exposure to lucerastat.
- Any circumstances or conditions, which, in the opinion of the investigator, may affect full participation in the study or compliance with the protocol.
- History or presence of rhythm disorders.
Key Trial Info
Start Date :
February 14 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 22 2019
Estimated Enrollment :
44 Patients enrolled
Trial Details
Trial ID
NCT03832452
Start Date
February 14 2019
End Date
April 22 2019
Last Update
October 31 2019
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
QPS Netherlands B.V.
Groningen, Netherlands, 9713