NCT03363984CompletedPhase 1
A Single-center, Open-label Study to Investigate the Effect of a Single Oral Dose and Repeated Oral Doses of ID-082 on the Pharmacokinetics of Midazolam and Its Metabolite 1-hydroxymidazolam in Healthy Male Subjects.
Idorsia Pharmaceuticals Ltd.1 site in 1 country20 target enrollmentStarted: November 27, 2017Last updated:
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- Idorsia Pharmaceuticals Ltd.
- Enrollment
- 20
- Locations
- 1
- Primary Endpoint
- Cmax of midazolam
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Other
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 45 Years (Adult)
- Sex
- Male
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •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 Criteria
- •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.
Arms & Interventions
Midazolam & ID-082
Experimental
Single oral administration of 2 mg midazolam on Day 1, Day 2, and Day 11. Administration of ID-082 from Day 2 through Day 11.
Intervention: Midazolam (Drug)
Midazolam & ID-082
Experimental
Single oral administration of 2 mg midazolam on Day 1, Day 2, and Day 11. Administration of ID-082 from Day 2 through Day 11.
Intervention: ID-082 (Drug)
Outcomes
Primary Outcomes
Cmax of midazolam
Time Frame: From baseline to EOS (i.e. for up to 16 days)
Maximum plasma concentration
AUC0-24 of midazolam
Time Frame: From baseline to EOS (i.e. for up to 16 days)
Area under the plasma concentration-time curvefrom time zero to 24 h
Secondary Outcomes
- Cmax of 1-hydroxymidazolam(From baseline to EOS (i.e. for up to 16 days))
- AUC0-inf of midazolam and 1-hydroxymidazolam and AUC0-24 of 1-hydroxymidazolam(From baseline to EOS (i.e. for up to 16 days))
- tmax of midazolam and 1-hydroxymidazolam(From baseline to EOS (i.e. for up to 16 days))
- t½ of midazolam and 1-hydroxymidazolam(From baseline to EOS (i.e. for up to 16 days))
- Total body apparent plasma clearance (CL/F) of midazolam(From baseline to EOS (i.e. for up to 16 days))
- Metabolic ratio (MR) of the AUC0-24 of 1-hydroxymidazolam to the AUC0-24 of midazolam(From baseline to EOS (i.e. for up to 16 days))
Investigators
Study Sites (1)
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