Status:
COMPLETED
Pharmacokinetic Interaction Between Midazolam and ID-082 in Healthy Subjects
Lead Sponsor:
Idorsia Pharmaceuticals Ltd.
Conditions:
Healthy
Eligibility:
MALE
18-45 years
Phase:
PHASE1
Brief Summary
A clinical study in healthy male subjects to investigate whether the administration of ID-082 can affect the fate in the body (amount and time of presence in the blood) of midazolam.
Eligibility Criteria
Inclusion
- Signed informed consent in the local language prior to any study-mandated procedure;
- Healthy male subjects aged 18 to 45 years (inclusive) at screening;
- Male subject with a female partner of childbearing potential or a pregnant partner must agree to use a condom from screening, during the study, and for at least 3 months after last study treatment intake;
- Body mass index of 18.0 to 30.0 kg/m2 (inclusive) at screening;
- Healthy on the basis of physical examination, cardiovascular assessments and laboratory tests.
Exclusion
- Contraindication or known hypersensitivity to ID-082, midazolam or drugs of the same classes, or any of their excipients;
- Modified Swiss Narcolepsy Scale total score \< 0 at Screening or history of narcolepsy or cataplexy;
- History or clinical evidence of any disease and/or existence of any surgical or medical condition which might interfere with the absorption, distribution, metabolism or excretion of the study treatment;
- Known hypersensitivity or allergy to natural rubber latex;
- Known hereditary problems of fructose intolerance, glucose-galactose malabsorption, or sucrose-isomaltase insufficiency;
- Previous history of fainting, collapse, syncope, orthostatic hypotension, or vasovagal reactions;
- Any circumstances or conditions, which, in the opinion of the investigator, may affect full participation in the study or compliance with the protocol.
Key Trial Info
Start Date :
November 27 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 19 2017
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT03363984
Start Date
November 27 2017
End Date
December 19 2017
Last Update
June 27 2018
Active Locations (1)
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1
Simbec Research Limited
Merthyr Tydfil, Mid Galmorgan, United Kingdom, CF48 4DR