Status:
COMPLETED
A Study of IW-6463 in Healthy Volunteers
Lead Sponsor:
Tisento Therapeutics
Conditions:
Other
Eligibility:
All Genders
Phase:
PHASE1
Brief Summary
Stage 1: To assess the safety and tolerability of single-ascending-dose levels of IW-6463 tablets when administered orally to healthy subjects Stage 2: To assess the safety and tolerability of multip...
Eligibility Criteria
Inclusion
- Subject is an ambulatory adult between 18 and 64 years old at the screening visit with the exception of the elderly cohort, who must be 65 years or older at the screening visit.
- Subject is in good health and has no clinically significant findings on physical examination
- Women of reproductive potential must have a negative pregnancy test at the time of check-in and must agree to use protocol-specified contraception throughout the duration of the study and for 3 months after the final dose of study drug
- Men must agree to use protocol-specified contraception and also to not donate sperm throughout the study and for 3 months after the final dose of study drug
- Other inclusion criteria per protocol
Exclusion
- Any active or unstable clinically significant medical condition
- Use of any prescribed or non-prescribed medication
- Other exclusion criteria per protocol
Key Trial Info
Start Date :
February 6 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 22 2019
Estimated Enrollment :
110 Patients enrolled
Trial Details
Trial ID
NCT03856827
Start Date
February 6 2019
End Date
October 22 2019
Last Update
August 16 2024
Active Locations (1)
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1
Centre for Human Drug Research
Leiden, Netherlands, 2333 CL