Clinical trial NCT03363984: Pharmacokinetic Interaction Between Midazolam and ID-082 in Healthy Subjects
Official title: 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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Idorsia Pharmaceuticals Ltd.
Sponsor class: INDUSTRY
First posted: 2017-12-06
Enrollment: 20
Sex: MALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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 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.

Primary outcomes:
measure: Cmax of midazolam
timeFrame: From baseline to EOS (i.e. for up to 16 days)
measure: AUC0-24 of midazolam
timeFrame: From baseline to EOS (i.e. for up to 16 days)
Secondary outcomes:
measure: Cmax of 1-hydroxymidazolam
timeFrame: From baseline to EOS (i.e. for up to 16 days)
measure: AUC0-inf of midazolam and 1-hydroxymidazolam and AUC0-24 of 1-hydroxymidazolam
timeFrame: From baseline to EOS (i.e. for up to 16 days)
measure: tmax of midazolam and 1-hydroxymidazolam
timeFrame: From baseline to EOS (i.e. for up to 16 days)
measure: t½ of midazolam and 1-hydroxymidazolam
timeFrame: From baseline to EOS (i.e. for up to 16 days)
measure: Total body apparent plasma clearance (CL/F) of midazolam
timeFrame: From baseline to EOS (i.e. for up to 16 days)
measure: Metabolic ratio (MR) of the AUC0-24 of 1-hydroxymidazolam to the AUC0-24 of midazolam
timeFrame: From baseline to EOS (i.e. for up to 16 days)
Other outcomes:
Locations:
city: Merthyr Tydfil
country: United Kingdom
facility: Simbec Research Limited
state: Mid Galmorgan
Study officials:
affiliation: Idorsia Pharmaceuticals Ltd.
name: Fabienne Le Gac
role: STUDY_DIRECTOR
References: